Trial Outcomes & Findings for Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS) (NCT NCT04115228)

Last Updated: 2022-04-12

Results Overview

For a participant analyzed, let x0 = average number of voids with leakage per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with leakage per 24 hours in first 72 hours of 13-week diary, and x = percent change of urinary incontinence frequency from baseline to 13 weeks. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 4 voids with leakage per 24 hours in the first 72 hours of the baseline diary and 2 voids with leakage per 24 hours in the first 72 hours of the 13-week diary would have a percent change of urinary incontinence frequency from baseline to 13 weeks of 100 \* (2 - 4) / 4 = -50.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 13 weeks

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Study Device Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Device n=10 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	68.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Met inclusion criterion for incontinence, based on pre-therapy diary	7 Participants n=5 Participants
Met inclusion criterion for frequency, based on pre-therapy diary	2 Participants n=5 Participants
Met inclusion criterion for nocturia, based on pre-therapy diary	7 Participants n=5 Participants
Met inclusion criterion for urgency, based on pre-therapy diary	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 13 weeks

Population: Subjects who met the inclusion criterion for incontinence

Outcome measures

Outcome measures
Measure	Study Device n=7 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks	-89 percent change Standard Deviation 14

PRIMARY outcome

Timeframe: Baseline to 13 weeks

Population: Subjects meeting inclusion criterion for frequency at baseline

For a participant analyzed, let x0 = average number of voids during waking hours per 24 hours in first 72 hours of baseline diary, x1 = average number of voids during waking hours per 24 hours in first 72 hours of 13-week diary, and x = percent change of excess voiding frequency during waking hours from baseline to 13 weeks, where "excess" means voids during waking hours exceeding 7 per 24 hours. Then x = 100 \* (x1 - x0) / (x0 - 7). For example, a participant with an average of 16 voids during waking hours per 24 hours in the first 72 hours of the baseline diary and an average of 10 voids during waking hours per 24 hours during the first 72 hours of the 13-week diary would have a percent change of excess voiding frequency during waking hours from baseline to 13 weeks of 100 \* (10 - 16) / (16 - 7) = -67.

Outcome measures

Outcome measures
Measure	Study Device n=2 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks	-90 percent change Standard Deviation 33

PRIMARY outcome

Timeframe: Baseline to 13 weeks

Population: Subjects meeting inclusion criterion for nocturia at baseline

For a participant analyzed, let x0 = average number of voids awakening from sleep per 24 hours in first 72 hours of baseline diary, x1 = average number of voids awakening from sleep per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids awakening from sleep from baseline to 13 weeks. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 2 voids awakening from sleep per 24 hours in the first 72 hours of the baseline diary and an average of 1 void awakening from sleep per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids awakening from sleep from baseline to 13 weeks of 100 \* (1 - 2) / 2 = -50.

Outcome measures

Outcome measures
Measure	Study Device n=7 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks	-30 percent change Standard Deviation 25

PRIMARY outcome

Timeframe: Baseline to 13 weeks

Population: Subjects meeting inclusion criterion for urgency at baseline

For a participant analyzed, let x0 = average number of voids with urgency per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with urgency per 24 hours in first 72 hours of 13-week diary, and x = percent change of frequency of voids with urgency from baseline to 13 weeks, where "voids with urgency" means voids self-reported with some or severe urgency, or leakage. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 8 voids with urgency per 24 hours in the first 72 hours of the baseline diary and an average of 5 voids with urgency per 24 hours during the first 72 hours of the 13-week diary would have a percent change of frequency of voids with urgency from baseline to 13 weeks of 100 \* (5 - 8) / 8 = -37.5

Outcome measures

Outcome measures
Measure	Study Device n=10 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks	-69 percent change Standard Deviation 23

SECONDARY outcome

Timeframe: 13 weeks

Neuromodulation pulse amplitude required to evoke paresthesia or motor response ("threshold") at 13 weeks.

Outcome measures

Outcome measures
Measure	Study Device n=10 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Threshold at 13 Weeks	1.03 Volts Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline to 13 weeks

The overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale ranges from 0 to 100, and higher symptom bother scores indicate greater symptom bother ( worse outcome). For a participant analyzed, let x0 = symptom bother score at baseline, x1 = symptom bother score at 13 weeks, and x = x0 - x1. For example, a participant with a symptom bother score of 60 at baseline and a symptom bother score of 20 at 13 weeks would have a change of score on the overactive bladder questionnaire short-form (OAB-q SF) symptom bother subscale from baseline to 13 weeks of -40.

Outcome measures

Outcome measures
Measure	Study Device n=10 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Change of Score on an Overactive Bladder Questionnaire Short-form (OAB-q SF) Symptom Bother Subscale From Baseline to 13 Weeks	-40 Scores on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 13 weeks

The global response assessment (GRA) scale ranges from 1 to 6, with 1 corresponding to "markedly worse" and 6 corresponding to "markedly better", so that higher scores represent better outcomes..

Outcome measures

Outcome measures
Measure	Study Device n=10 Participants Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Score on a Global Response Assessment (GRA) Scale at 13 Weeks	5.8 Score on a scale Standard Deviation 0.4

Adverse Events

Study Device

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Device n=10 participants at risk Subjects who provide informed consent, meet all inclusion criteria, and no exclusion criterion, will have a study device implanted and followed closely for 26 weeks. Implantation and neuromodulation therapy: The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
Skin and subcutaneous tissue disorders Incision-site issue	40.0% 4/10 • Number of events 10 • 26 weeks
Renal and urinary disorders Urinary tract infection	20.0% 2/10 • Number of events 10 • 26 weeks
Surgical and medical procedures Previously-planned surgery for unrelated issue	20.0% 2/10 • Number of events 10 • 26 weeks
Product Issues Unconfirmed report that implant "stopped working"	10.0% 1/10 • Number of events 10 • 26 weeks

Additional Information

Peter Jacobson

Nine Continents Medical, Inc.

Phone: 6128105810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For this clinical feasibility study, the investigator agrees to maintain confidentiality and refrain from publication without the sponsor's prior written approval.
Publication restrictions are in place

Restriction type: OTHER