Trial Outcomes & Findings for Neuromodulation for Accidental Bowel Leakage (NCT NCT03278613)

Last Updated: 2025-06-03

Results Overview

The primary outcome measure is the change from baseline in St. Mark's (Vaizey) Score 12 weeks after treatment initiation to compare the outcomes of post-tibial nerve stimulation (PTNS) versus sham stimulation. The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent. Change from baseline is calculated as Week \[4, 8, or 12\] Score minus the score at baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

166 participants

Primary outcome timeframe

4, 8, and 12 Weeks

Results posted on

2025-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	Percutaneous Tibial Nerve Stimulation (PTNS) PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Validated Sham Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Overall Study STARTED	111	55
Overall Study COMPLETED	108	54
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Percutaneous Tibial Nerve Stimulation (PTNS) PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Validated Sham Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Neuromodulation for Accidental Bowel Leakage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTNS n=111 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=55 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Total n=166 Participants Total of all reporting groups
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 12 • n=5 Participants	63.8 years STANDARD_DEVIATION 11 • n=7 Participants	63.6 years STANDARD_DEVIATION 12 • n=5 Participants
Sex/Gender, Customized Female	111 Participants n=5 Participants	55 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	49 Participants n=7 Participants	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	39 Participants n=7 Participants	134 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Body Mass Index	29.2 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	29.7 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	29.4 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants
Current Smoker Yes	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Current Smoker No	102 Participants n=5 Participants	50 Participants n=7 Participants	152 Participants n=5 Participants
Ever Pregnant Yes	107 Participants n=5 Participants	50 Participants n=7 Participants	157 Participants n=5 Participants
Ever Pregnant No	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Number of Vaginal Deliveries	2 deliveries per participant n=5 Participants	2 deliveries per participant n=7 Participants	2 deliveries per participant n=5 Participants
Number of Cesarean Deliveries	0 deliveries per participant n=5 Participants	0 deliveries per participant n=7 Participants	0 deliveries per participant n=5 Participants
Menstrual Status pre-menopausal	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Menstrual Status post-menopausal	92 Participants n=5 Participants	49 Participants n=7 Participants	141 Participants n=5 Participants
Menstrual Status not sure	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4, 8, and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=108 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline St. Mark's (Vaizey) Score Week 4	-2.8 units on a scale Interval -3.5 to -2.0	-3.3 units on a scale Interval -4.5 to -2.1
Change From Baseline St. Mark's (Vaizey) Score Week 8	-4.3 units on a scale Interval -5.2 to -3.3	-4.1 units on a scale Interval -5.4 to -2.9
Change From Baseline St. Mark's (Vaizey) Score Week 12	-5.3 units on a scale Interval -6.3 to -4.3	-3.9 units on a scale Interval -5.3 to -2.6

SECONDARY outcome

Timeframe: 4, 8, and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Responder status is based on the primary chnage from St. Mark's Score. A responder is defined as any particpant with at least a 4 point reduction in score compared to their baseline score

Outcome measures

Outcome measures
Measure	PTNS n=108 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Responder to Treatment Week 4 · Responder	39 Participants	24 Participants
Responder to Treatment Week 8 · Responder	54 Participants	29 Participants
Responder to Treatment Week 4 · Non-responder	63 Participants	26 Participants
Responder to Treatment Week 8 · Non-responder	51 Participants	23 Participants
Responder to Treatment Week 12 · Responder	64 Participants	26 Participants
Responder to Treatment Week 12 · Non-responder	40 Participants	28 Participants

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week at 8 and 12 weeks and the number of fecal incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline Number of Fecal Incontinence Events Per Week Week 8	-2.4 episodes per week Interval -3.1 to -1.6	-1.6 episodes per week Interval -3.2 to 0.0
Change From Baseline Number of Fecal Incontinence Events Per Week Week 12	-2.3 episodes per week Interval -3.2 to -1.5	-2.1 episodes per week Interval -3.7 to -0.4

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge fecal incontinence episodes per week at 8 and 12 weeks and the number of urge fecal incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline Number of Urge Fecal Incontinence Events Per Week Week 8	-1.3 episodes per week Interval -1.8 to -0.8	-0.4 episodes per week Interval -1.1 to 0.2
Change From Baseline Number of Urge Fecal Incontinence Events Per Week Week 12	-1.1 episodes per week Interval -1.6 to -0.6	-0.8 episodes per week Interval -1.4 to -0.1

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of bowel movements per week at 8 and 12 weeks and the number of bowel movements at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline Number of Bowel Movements Per Week Week 8	-1.8 episodes per week Interval -3.0 to -0.6	-0.2 episodes per week Interval -1.6 to 1.1
Change From Baseline Number of Bowel Movements Per Week Week 12	-1.8 episodes per week Interval -2.8 to -0.9	-1.5 episodes per week Interval -2.8 to -0.2

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of urge bowel movements per week at 8 and 12 weeks and the number of urge bowel movements at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline Number of Urge Bowel Movements Per Week Week 8	-1.9 episodes per week Interval -2.9 to -0.8	-1.1 episodes per week Interval -2.2 to -0.1
Change From Baseline Number of Urge Bowel Movements Per Week Week 12	-2.3 episodes per week Interval -3.2 to -1.3	-2.2 episodes per week Interval -3.3 to -1.1

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome variable is computed as the difference in number of days without fecal incontinence episodes per week at 8 and 12 weeks and the number of days without fecal incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week Week 8	1 episodes per week Interval 0.6 to 1.4	0.8 episodes per week Interval 0.3 to 1.3
Change From Baseline Number of Days Without Fecal Incontinence Episodes Per Week Week 12	1.3 episodes per week Interval 0.9 to 1.7	0.8 episodes per week Interval 0.2 to 1.4

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 50% reduction in fecal incontinence episodes per week at 8 and 12 weeks compared to the fecal incontinence episodes at baseline

Outcome measures

Outcome measures
Measure	PTNS n=102 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=50 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
50% Improvement in Fecal Incontinence Episodes Per Week Week 8 · >= 50% Improvement	38 Participants	14 Participants
50% Improvement in Fecal Incontinence Episodes Per Week Week 8 · < 50% Improvement	61 Participants	35 Participants
50% Improvement in Fecal Incontinence Episodes Per Week Week 12 · >= 50% Improvement	51 Participants	19 Participants
50% Improvement in Fecal Incontinence Episodes Per Week Week 12 · < 50% Improvement	46 Participants	29 Participants

SECONDARY outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Based on data collected from participant-completed diaries at baseline, 8, and 12 weeks, the outcome is calculated as any participant with a 75% reduction in fecal incontinence episodes per week at 8, and 12 weeks compared to the fecal incontinence episodes at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=102 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=50 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
75% Improvement in Fecal Incontinence Episodes Per Week Week 8 · >= 75% Improvement	19 Participants	10 Participants
75% Improvement in Fecal Incontinence Episodes Per Week Week 8 · < 75% Improvement	80 Participants	39 Participants
75% Improvement in Fecal Incontinence Episodes Per Week Week 12 · >= 75% Improvement	32 Participants	13 Participants
75% Improvement in Fecal Incontinence Episodes Per Week Week 12 · < 75% Improvement	65 Participants	35 Participants

SECONDARY outcome

Timeframe: 4, 8, and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better) or 2 (much better)

Outcome measures

Outcome measures
Measure	PTNS n=108 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Patient Global Impression-Improvement Week 4 · Improved	20 Participants	13 Participants
Patient Global Impression-Improvement Week 4 · No improvement	83 Participants	37 Participants
Patient Global Impression-Improvement Week 8 · Improved	36 Participants	17 Participants
Patient Global Impression-Improvement Week 8 · No improvement	70 Participants	33 Participants
Patient Global Impression-Improvement Week 12 · Improved	47 Participants	21 Participants
Patient Global Impression-Improvement Week 12 · No improvement	56 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Liquid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of liquid stool. Minimum score is 0 = no problem with liquid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of liquid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Liquid Score Week 8	-0.3 units on a scale Interval -0.4 to -0.1	-0.5 units on a scale Interval -0.8 to -0.2
Change From Baseline ABLe Liquid Score Week 12	-0.6 units on a scale Interval -0.8 to -0.4	-0.7 units on a scale Interval -1.0 to -0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Solid Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of solid stool. Minimum score is 0 = no problem with solid stool leakage; maximum score is 4 = frequent, bothersome leakage of large amounts of solid stool. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Solid Score Week 8	-0.5 units on a scale Interval -0.7 to -0.3	-0.4 units on a scale Interval -0.6 to -0.1
Change From Baseline ABLe Solid Score Week 12	-0.7 units on a scale Interval -0.9 to -0.5	-0.7 units on a scale Interval -1.0 to -0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Mucus Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of mucus from the rectum. Minimum score is 0 = no problem with mucus leakage from the rectum; maximum score is 4 = frequent, bothersome leakage of large amounts of mucus from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=105 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Mucus Score Week 8	-0.5 units on a scale Interval -0.7 to -0.3	-0.4 units on a scale Interval -0.7 to -0.1
Change From Baseline ABLe Mucus Score Week 12	-0.7 units on a scale Interval -0.9 to -0.5	-0.4 units on a scale Interval -0.7 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Gas Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the impact and severity of the leakage of gas from the rectum. Minimum score is 0 = no problem with gas leakage from the rectum; maximum score is 4 = frequent and bothersome leakage of gas from the rectum. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Gas Score Week 8	-0.3 units on a scale Interval -0.5 to -0.1	-0.2 units on a scale Interval -0.5 to 0.1
Change From Baseline ABLe Gas Score Week 12	-0.4 units on a scale Interval -0.6 to -0.3	-0.4 units on a scale Interval -0.7 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Predictability/Awareness Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the predictability of bowel leakage events. Minimum score is 0 = no problems with leakage; maximum score is 4 = leakage without awareness or predictability. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Predictability/Awareness Score Week 8	0 units on a scale Interval -0.2 to 0.1	0 units on a scale Interval -0.2 to 0.2
Change From Baseline ABLe Predictability/Awareness Score Week 12	-0.2 units on a scale Interval -0.4 to -0.1	0 units on a scale Interval -0.2 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Control Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the ability to control bowel movements. Minimum score is 0 = no problems with urgency to empty bowels wthout warning; maximum score is 4 = frequent and bothersome urgency to empty bowels wthout warning.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Control Score Week 8	-0.3 units on a scale Interval -0.5 to -0.2	-0.3 units on a scale Interval -0.6 to -0.1
Change From Baseline ABLe Control Score Week 12	-0.6 units on a scale Interval -0.8 to -0.4	-0.6 units on a scale Interval -0.9 to -0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Ancillary Bowel Symptoms Score is a subscale of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of ancially bowel symptoms. Minimum score is 0 = no problems with pain or incomplete emptying; maximum score is 4 = frequent and bothersome pain or incomplete emptying.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Ancillary Bowel Symptoms Score Week 8	-0.4 units on a scale Interval -0.5 to -0.2	-0.3 units on a scale Interval -0.6 to -0.1
Change From Baseline ABLe Ancillary Bowel Symptoms Score Week 12	-0.7 units on a scale Interval -0.9 to -0.5	-0.4 units on a scale Interval -0.6 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The ABLE Overall Score is the summary score of the validated Accidental Bowel Leakage Evaluation (ABLE) questionnaire which assesses the frequency and impact of accidental bowel leakage and related symptoms. Minimum score is 0 = no problems with bowel leakage and related symptoms; maximum score is 4 = frequent and bothersome problems with bowel leakage and related symptoms.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline ABLe Overall Score Week 8	-0.4 units on a scale Interval -0.5 to -0.2	-0.3 units on a scale Interval -0.6 to -0.1
Change From Baseline ABLe Overall Score Week 12	-0.7 units on a scale Interval -0.9 to -0.5	-0.4 units on a scale Interval -0.6 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4, 8, and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree)

Outcome measures

Outcome measures
Measure	PTNS n=111 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=55 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Patient Global Symptom Control Baseline · No Control	18 Participants	10 Participants
Patient Global Symptom Control Baseline · Control	93 Participants	44 Participants
Patient Global Symptom Control Week 4 · No Control	46 Participants	25 Participants
Patient Global Symptom Control Week 4 · Control	59 Participants	25 Participants
Patient Global Symptom Control Week 8 · No Control	70 Participants	33 Participants
Patient Global Symptom Control Week 8 · Control	36 Participants	19 Participants
Patient Global Symptom Control Week 12 · No Control	82 Participants	40 Participants
Patient Global Symptom Control Week 12 · Control	22 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FIQL Lifestyle Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIQL Lifestyle Score Week 8	0.3 units on a scale Interval 0.2 to 0.5	0.4 units on a scale Interval 0.2 to 0.6
Change From Baseline FIQL Lifestyle Score Week 12	0.6 units on a scale Interval 0.5 to 0.8	0.4 units on a scale Interval 0.2 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FIQL Coping Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIQL Coping Score Week 8	0.4 units on a scale Interval 0.3 to 0.5	0.4 units on a scale Interval 0.2 to 0.6
Change From Baseline FIQL Coping Score Week 12	0.6 units on a scale Interval 0.5 to 0.8	0.5 units on a scale Interval 0.3 to 0.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FIQL Depression Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIQL Depression Score Week 8	0.3 units on a scale Interval 0.2 to 0.4	0.2 units on a scale Interval 0.0 to 0.4
Change From Baseline FIQL Depression Score Week 12	0.5 units on a scale Interval 0.4 to 0.6	0.2 units on a scale Interval 0.1 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FIQL Embarrassment Score is a subscale of the validated Fecal Incontinence Quality of Life (FIQL) questionnaire which assesses the impact of accidental bowel leakage on quality of life. Minimum score is 1 = lower functional quality of life; maximum score is 5 = higher functional quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIQL Embarrassment Score Week 8	0.4 units on a scale Interval 0.3 to 0.5	0.4 units on a scale Interval 0.2 to 0.6
Change From Baseline FIQL Embarrassment Score Week 12	0.7 units on a scale Interval 0.6 to 0.9	0.4 units on a scale Interval 0.3 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FISI Patient Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the patient's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 61 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=102 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FISI Patient Score Week 8	-4.9 units on a scale Interval -7.1 to -2.8	-5.9 units on a scale Interval -8.7 to -3.1
Change From Baseline FISI Patient Score Week 12	-7.5 units on a scale Interval -9.7 to -5.3	-6.7 units on a scale Interval -10.1 to -3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The FISI Doctor Score is a summary score of the validated Fecal Incontinence Severity Index questionnaire which provides a summary metric of the severity of fecal incontinence from the doctor's perspective. Minimum score is 0 = no fecal incontinence; maximum score is 57 = very severe fecal incontinence. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=102 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FISI Doctor Score Week 8	-5 units on a scale Interval -7.3 to -2.8	-6.3 units on a scale Interval -9.2 to -3.4
Change From Baseline FISI Doctor Score Week 12	-7.4 units on a scale Interval -9.8 to -5.0	-7 units on a scale Interval -10.5 to -3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Incontinence Impact Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Incontinence Impact Score Week 8	-9.4 units on a scale Interval -14.5 to -4.2	-11.3 units on a scale Interval -17.9 to -4.6
Change From Baseline MMHQ Incontinence Impact Score Week 12	-17.2 units on a scale Interval -23.0 to -11.5	-15.9 units on a scale Interval -23.4 to -8.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Role Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=104 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Role Limitations Score Week 8	-9.8 units on a scale Interval -14.6 to -5.1	-3.1 units on a scale Interval -10.4 to 4.3
Change From Baseline MMHQ Role Limitations Score Week 12	-17.5 units on a scale Interval -22.6 to -12.3	-9.9 units on a scale Interval -17.1 to -2.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Physical Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=104 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Physical Limitations Score Week 8	-10.3 units on a scale Interval -15.3 to -5.3	-3.8 units on a scale Interval -9.2 to 1.6
Change From Baseline MMHQ Physical Limitations Score Week 12	-20.4 units on a scale Interval -25.5 to -15.2	-10.6 units on a scale Interval -16.6 to -4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Social Limitations Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Social Limitations Score Week 8	-9.6 units on a scale Interval -15.3 to -3.9	-1.8 units on a scale Interval -7.5 to 3.9
Change From Baseline MMHQ Social Limitations Score Week 12	-14.8 units on a scale Interval -20.1 to -9.5	-8.6 units on a scale Interval -14.6 to -2.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Personal Relationship Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=75 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=35 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Personal Relationship Score Week 8	-5 units on a scale Interval -11.6 to 1.6	-2.2 units on a scale Interval -11.5 to 7.0
Change From Baseline MMHQ Personal Relationship Score Week 12	-6.2 units on a scale Interval -11.3 to -1.0	-11.4 units on a scale Interval -23.2 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Emotional Function Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=104 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Emotional Function Score Week 12	-14.4 units on a scale Interval -19.1 to -9.6	-7.4 units on a scale Interval -14.3 to -0.4
Change From Baseline MMHQ Emotional Function Score Week 8	-7.2 units on a scale Interval -11.7 to -2.7	-4.6 units on a scale Interval -10.6 to 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Sleep/Energy Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=104 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Sleep/Energy Score Week 8	-7.2 units on a scale Interval -11.4 to -3.0	-4.3 units on a scale Interval -10.8 to 2.3
Change From Baseline MMHQ Sleep/Energy Score Week 12	-11 units on a scale Interval -15.2 to -6.8	-6.4 units on a scale Interval -12.4 to -0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The MMHQ Severity Measures Score is a subscale of the validated Modified-Manchester Health questionnaire (MMHq) which provides a health-related quality of life rating. Minimum score is 0 = high quality of life; maximum score is 100 = low quality of life. Change from baseline is calculated as Week \[8 or 12\] Score minus the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=105 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=51 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline MMHQ Severity Measures Score Week 8	-9.1 units on a scale Interval -13.2 to -5.0	-10.7 units on a scale Interval -15.9 to -5.6
Change From Baseline MMHQ Severity Measures Score Week 12	-17 units on a scale Interval -21.3 to -12.6	-11.8 units on a scale Interval -17.0 to -6.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week \[8, 12\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline CRAIQ Score Week 8	-12.9 units on a scale Interval -17.1 to -8.7	-12.8 units on a scale Interval -19.6 to -5.9
Change From Baseline CRAIQ Score Week 12	-19.1 units on a scale Interval -24.2 to -14.0	-14.5 units on a scale Interval -22.2 to -6.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline POPIQ Score Week 8	-3.3 units on a scale Interval -7.2 to 0.7	-5.1 units on a scale Interval -8.8 to -1.5
Change From Baseline POPIQ Score Week 12	-5.2 units on a scale Interval -8.1 to -2.3	-5.6 units on a scale Interval -9.8 to -1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline UIQ Score Week 8	-3.3 units on a scale Interval -6.4 to -0.1	-10.2 units on a scale Interval -15.3 to -5.0
Change From Baseline UIQ Score Week 12	-7.2 units on a scale Interval -10.6 to -3.8	-10.5 units on a scale Interval -16.5 to -4.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 and 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=106 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PFIQ Score Week 8	-19.4 units on a scale Interval -27.7 to -11.1	-28.1 units on a scale Interval -39.9 to -16.2
Change From Baseline PFIQ Score Week 12	-31.5 units on a scale Interval -40.3 to -22.7	-30.7 units on a scale Interval -43.7 to -17.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Patient Assessment of Constipation - Symptom (PAC-SYM) ia a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-mising responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very sever). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.

Outcome measures

Outcome measures
Measure	PTNS n=103 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=53 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PAC-SYM Abdominal Score	-0.4 units on a scale Interval -0.6 to -0.3	-0.2 units on a scale Interval -0.4 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=103 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PAC-SYM Rectal Score	-0.1 units on a scale Interval -0.3 to 0.0	-0.1 units on a scale Interval -0.3 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=103 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PAC-SYM Stool Score	-0.3 units on a scale Interval -0.5 to -0.1	-0.2 units on a scale Interval -0.5 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Patient Assessment of Constipation - Symptom (PAC-SYM) is a validated form measuring the frequency and severity of chronic constipation. It consists of an overall score (range: 0-4) consisting of 3 subscales across 12 question: the Abdominal score (range 0-4), the Rectal Score (range 0-4), and the Stool Score (range 0-4). Scores are calculated as the mean of non-missing responses. The range of responses is: 0-4 with 0 (Absent) to 4 (Very severe). Change = (Week 12 Score - Baseline Score). Lower scores indicate less severe constipation.

Outcome measures

Outcome measures
Measure	PTNS n=103 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PAC-SYM Total Score	-0.3 units on a scale Interval -0.4 to -0.2	-0.2 units on a scale Interval -0.4 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure was only collected from participants that were not sexually active.

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Partner Related (NSA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=43 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=29 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR NSA-PR Score	0.1 units on a scale Interval -0.3 to 0.4	-0.1 units on a scale Interval -0.4 to 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Specific (NSA-CS) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=40 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=29 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR NSA-CS Score	0.2 units on a scale Interval -0.1 to 0.5	0.2 units on a scale Interval -0.2 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Global Quality Rating (NSA-GQA) ranges from 1 to 4.5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=41 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=28 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR NSA-GQA Score	0.4 units on a scale Interval 0.1 to 0.6	0.3 units on a scale Interval 0.0 to 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Not Sexually Active-Condition Impact (NSA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=40 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=28 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR NSA-CI Score	0.4 units on a scale Interval 0.1 to 0.7	0.3 units on a scale Interval 0.0 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only calculated for participants that were sexually active.

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Arousal Orgasm (SA-AO) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=46 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=21 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-AO Score	0.2 units on a scale Interval 0.1 to 0.4	0.2 units on a scale Interval 0.0 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. This measure is only collected from participants that were sexually active.

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Partner Related (SA-PR) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=44 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=19 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-PR Score	0.1 units on a scale Interval 0.0 to 0.3	0.0 units on a scale Interval -0.2 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Specific (SA-CS) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=45 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=20 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-CS Score	0.3 units on a scale Interval 0.1 to 0.6	0.5 units on a scale Interval 0.2 to 0.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Global Quality Rating (SA-GQR) ranges from 1 to 4.75 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=46 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=21 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-GQR Score	0.3 units on a scale Interval 0.1 to 0.6	0.4 units on a scale Interval -0.1 to 0.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Condition Impact (SA-CI) ranges from 1 to 4 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=46 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=21 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-CI Score	0.4 units on a scale Interval 0.2 to 0.6	0.3 units on a scale Interval 0.0 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Desire (SA-D) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=45 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=21 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-D Score	0.0 units on a scale Interval -0.1 to 0.2	0.2 units on a scale Interval -0.2 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised measures the impact of incontinence symptoms on sexual function and satisfaction. The Sexually Active-Average (SA-AVG) ranges from 1 to 5 with higher scores indicating greater sexual function. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=44 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=19 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline PISQ-IR SA-AVG Score	0.2 units on a scale Interval 0.1 to 0.4	0.3 units on a scale Interval 0.1 to 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The Fecal Incontinence Adaptation Index (FIAI) is a validated form which measures the adaptation behavios resulting from fecal incontinence. It consists of two subscales: Hygiene (range: 0-100) and Avoidance (range: 0-100). Scores are cal calculated as the average of the non-missing responses multiplied by 25. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=101 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIAI Hygiene Index Score	-10.2 units on a scale Interval -14.0 to -6.5	-2.8 units on a scale Interval -8.4 to 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

Outcome measures

Outcome measures
Measure	PTNS n=101 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=54 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline FIAI Avoidance Index Score	-12.8 units on a scale Interval -16.1 to -9.4	-6.4 units on a scale Interval -12.2 to -0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Physical Score ranges from 24 to 56.6 with higher scores indicating greater physical health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline.

Outcome measures

Outcome measures
Measure	PTNS n=89 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=50 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline SF-12 Aggregate Physical Score	2.6 units on a scale Interval 1.1 to 4.2	2.1 units on a scale Interval -1.0 to 5.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Weeks

Population: An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed.

The 12-Item Short-Form Health Survey (SF-12) is a validated survey which assesses overall physical and mental health. The Aggregate Mental Score ranges from 19.06 to 60.86 with higher scores indicating greater mental health. The outcome is calculated as the difference in score at 12 weeks and the score at baseline

Outcome measures

Outcome measures
Measure	PTNS n=89 Participants PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=50 Participants Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Change From Baseline SF-12 Aggregate Mental Score	0.9 units on a scale Interval -1.3 to 3.1	-0.7 units on a scale Interval -4.2 to 2.9

Adverse Events

PTNS

Serious events: 4 serious events

Other events: 72 other events

Deaths: 1 deaths

Sham

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PTNS n=111 participants at risk PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=55 participants at risk Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Cardiac disorders Myocardial infarction	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Colitis	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Gastrointestinal disorders Hiatus hernia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Death	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Localised infection	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Injury, poisoning and procedural complications Femur fracture	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks

Other adverse events

Other adverse events
Measure	PTNS n=111 participants at risk PTNS treatment entails insertion of a 36 gauge needle electrode at a 60 degree angle 3-4 cm deep towards the tibial nerve, approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. The PTNS grounding electrode, placed near the calcaneus and the needle electrode will be connected to the ES-130 device pulse generator. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.	Sham n=55 participants at risk Sham treatment will use the Streitberger acupuncture placebo needle in the same location as the needle electrode for PTNS. The sham uses an active gel surface electrode pad placed on the bottom of the foot just below the fifth (smallest) toe. This location is not part of the acupuncture nerve pathway connected to the bladder, pelvis or any major organs. Electrical current is delivered to this pad via a TENS unit resulting in sensory stimulation. ES-130: The ES-130 device will be used for the indication of "Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence" using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device.
Cardiac disorders Atrial fibrillation	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Cardiac disorders Tachycardia	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Eye disorders Chalazion	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Eye disorders Photopsia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Abdominal discomfort	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Gastrointestinal disorders Abdominal pain	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Abdominal pain upper	0.90% 1/111 • Number of events 1 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Gastrointestinal disorders Anal paraesthesia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Chapped lips	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Constipation	3.6% 4/111 • Number of events 6 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Gastrointestinal disorders Diarrhoea	5.4% 6/111 • Number of events 9 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Gastrointestinal disorders Flatulence	0.90% 1/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Gastritis	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Haematochezia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Hiatus hernia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Nausea	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Rectal haemorrhage	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Gastrointestinal disorders Vomiting	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
General disorders Adverse drug reaction	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Application site pain	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Application site paraesthesia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Asthenia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Chest pain	0.90% 1/111 • Number of events 1 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
General disorders Chills	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Influenza like illness	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Injection site pain	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Malaise	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Medical device site haemorrhage	8.1% 9/111 • Number of events 14 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Medical device site pain	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
General disorders Puncture site pain	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Hepatobiliary disorders Hepatic steatosis	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Immune system disorders Drug hypersensitivity	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Immune system disorders Multiple allergies	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Bronchitis	3.6% 4/111 • Number of events 4 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Eye infection	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Fungal infection	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Gastrointestinal viral infection	0.90% 1/111 • Number of events 1 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Herpes zoster	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Hordeolum	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Influenza	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Nasopharyngitis	6.3% 7/111 • Number of events 8 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Infections and infestations Oral candidiasis	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Pharyngitis	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Pneumonia	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Sinusitis	2.7% 3/111 • Number of events 3 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Streptococcal infection	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Infections and infestations Tooth infection	0.90% 1/111 • Number of events 1 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Infections and infestations Upper respiratory tract infection	0.90% 1/111 • Number of events 1 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Infections and infestations Urinary tract infection	12.6% 14/111 • Number of events 14 • 12 Weeks	7.3% 4/55 • Number of events 4 • 12 Weeks
Injury, poisoning and procedural complications Contusion	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Injury, poisoning and procedural complications Fall	5.4% 6/111 • Number of events 7 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Injury, poisoning and procedural complications Joint injury	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Injury, poisoning and procedural complications Ligament sprain	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Injury, poisoning and procedural complications Limb injury	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Injury, poisoning and procedural complications Post procedural haemorrhage	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Injury, poisoning and procedural complications Procedural haemorrhage	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Injury, poisoning and procedural complications Procedural pain	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Investigations Blood potassium decreased	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Investigations Blood pressure increased	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Investigations Colonoscopy	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Investigations Endoscopy gastrointestinal	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Investigations Oesophagogastroduodenoscopy	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Metabolism and nutrition disorders Gluten sensitivity	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Metabolism and nutrition disorders Gout	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Arthralgia	2.7% 3/111 • Number of events 5 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Musculoskeletal and connective tissue disorders Back pain	2.7% 3/111 • Number of events 3 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Joint swelling	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Limb discomfort	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 3/111 • Number of events 3 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Muscle tightness	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Myalgia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Musculoskeletal and connective tissue disorders Pain in extremity	4.5% 5/111 • Number of events 7 • 12 Weeks	0.00% 0/55 • 12 Weeks
Nervous system disorders Amnesia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Nervous system disorders Cervical radiculopathy	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Nervous system disorders Dizziness	1.8% 2/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Nervous system disorders Headache	3.6% 4/111 • Number of events 4 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Nervous system disorders Hypoaesthesia	0.00% 0/111 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Nervous system disorders Migraine	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Nervous system disorders Nerve compression	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Nervous system disorders Paraesthesia	9.9% 11/111 • Number of events 16 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Nervous system disorders Sciatica	1.8% 2/111 • Number of events 2 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Nervous system disorders Somnolence	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Nervous system disorders Tremor	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Renal and urinary disorders Dysuria	0.90% 1/111 • Number of events 1 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Renal and urinary disorders Pollakiuria	0.00% 0/111 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Renal and urinary disorders Urge incontinence	0.00% 0/111 • 12 Weeks	3.6% 2/55 • Number of events 2 • 12 Weeks
Renal and urinary disorders Urinary incontinence	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Renal and urinary disorders Urinary retention	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Reproductive system and breast disorders Fibrocystic breast disease	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Reproductive system and breast disorders Pelvic pain	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Reproductive system and breast disorders Vaginal discharge	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Reproductive system and breast disorders Vulvovaginal pain	0.90% 1/111 • Number of events 2 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Cough	1.8% 2/111 • Number of events 2 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Dry throat	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Throat irritation	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Alopecia	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Blister	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Eczema	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Ingrowing nail	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Rash	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Rash generalised	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Skin discolouration	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Skin and subcutaneous tissue disorders Skin reaction	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Surgical and medical procedures Abdominal hernia repair	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Surgical and medical procedures Abdominoplasty	0.00% 0/111 • 12 Weeks	1.8% 1/55 • Number of events 1 • 12 Weeks
Surgical and medical procedures Medical device removal	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Vascular disorders Hot flush	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks
Vascular disorders Hypertension	0.90% 1/111 • Number of events 1 • 12 Weeks	0.00% 0/55 • 12 Weeks

Additional Information

Marie Gantz

RTI International

Phone: 919-597-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place