Trial Outcomes & Findings for PTNS for Female Patients Suffering From Multiple Sclerosis (NCT NCT05422625)

Last Updated: 2024-10-09

Results Overview

The PGI-I is a self-reported measure of symptom change after treatment completion. This is a validated 1-question tool. Subjects score their urinary condition now compared to how it was before starting treatment. The score ranges from 1-7. 1= very much better, 2 = much better, 3 = a little better, 4=no change, 5= a little worse, 6= much worse, 7 = very much worse. A higher score indicates a worse outcome. Only one participant completed the primary outcome, thus that subject score will be reported.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

One week after completing all 12 treatments

Results posted on

2024-10-09

Participant Flow

Subjects were recruited from December 2022 through December 2023.

Participant milestones

Participant milestones
Measure	Active PTNS Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active Urgent PC transcutaneous electrical nerve stimulation (TENS) electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Overall Study STARTED	2	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Active PTNS Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active Urgent PC transcutaneous electrical nerve stimulation (TENS) electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

PTNS for Female Patients Suffering From Multiple Sclerosis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: One week after completing all 12 treatments

Population: Of the 2 patients enrolled, only 1 patient completed the study and the primary outcome measure. The other subject withdrew prior to the primary outcome measure.

Outcome measures

Outcome measures
Measure	Active PTNS n=1 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
The Overall Patient Reported Change of Bladder Overactivity (OAB) Symptoms in MS Patients as Reported on the Patient Global Impression of Improvement (PGI-I) Questionnaire	4 score	—

SECONDARY outcome

Timeframe: At baseline and one week after completing all 12 treatments, Visit 13

Population: Of the 2 patients enrolled, only 1 patient completed the study and the secondary outcome measure. The other subject withdrew prior to the secondary outcome measure.

Study participants will complete a 3-day voiding diary to record number of voids. Investigators will analyze the change in urinary voids from before to after treatment. A positive number indicates more voids, and a negative number indicates fewer voids.

Outcome measures

Outcome measures
Measure	Active PTNS n=1 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Change in Urinary Voids in Response to the Treatment Using a 3-day Voiding Diary	1 number of voids Standard Deviation 0	—

SECONDARY outcome

Timeframe: At baseline and one week after completing all 12 treatments, Visit 13

Population: Of the 2 patients enrolled, only 1 patient completed the study and the secondary outcome measure. The other subject withdrew prior to the secondary outcome measure.

Study participants will complete a 3-day voiding diary to record number of urinary incontinence episodes over a 3-day period. Investigators will analyze the change in urinary incontinence episodes from before to after treatment. A positive number indicates more episodes, and a negative number indicates fewer episodes.

Outcome measures

Outcome measures
Measure	Active PTNS n=1 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Change in Urinary Incontinence Episodes in Response to the Treatment Using a 3-day Voiding Diary	-3 number of urgency incontinence episodes Standard Deviation 0	—

SECONDARY outcome

Timeframe: At baseline and one week after completing all 12 treatments, Visit 13

Population: Of the 2 patients enrolled, only 1 patient completed the study and the secondary outcome measure. The other subject withdrew prior to the secondary outcome measure.

Study participants will complete a 3-day voiding diary to record the number of urgency episodes over a 3-day period. Investigators will analyze the change in urinary urgency episodes from before to after treatment. A positive number indicates more episodes, and a negative number indicates fewer episodes.

Outcome measures

Outcome measures
Measure	Active PTNS n=1 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Change in Urinary Urgency Episodes in Response to the Treatment Using a 3-day Voiding Diary	1 number of urgency episodes Standard Deviation 0	—

SECONDARY outcome

Timeframe: At baseline and one week after completing all 12 treatments, Visit 13

Population: Of the 2 patients enrolled, only 1 patient completed the study and the secondary outcome measure. The other subject withdrew prior to the secondary outcome measure.

The Overactive Bladder quality of life questionnaire measures the impact of PTNS treatment on patient quality of life. Patients score symptom severity and impact on quality of life on a scale 1-6, with 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=a great deal, and 6=a very great deal. Symptom severity raw score is calculated from questions 1-6; the lowest possible raw score is 6, the highest score is 36. The health-related quality of life (HRQL) raw score is calculated similarly from questions 1-13; the lowest possible score is 13 and highest score is 78. The formula (actual raw score - lowest possible raw score)/highest possible raw score times 100 is applied to each raw score, which are added to give a final score in the range 0 to 166.6, with low scores indicating fewer symptoms and impact, and high scores indicating more symptoms and impact. Change from baseline is reported, with a positive number indicating worsening and a negative number indicating improvement.

Outcome measures

Outcome measures
Measure	Active PTNS n=1 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.
Change in Overactive Bladder Symptoms in Response to the Treatment Using the Overactive Bladder Quality of Life Short Form Questionnaire.	-47.69 score on a scale Standard Deviation 0	—

Adverse Events

Active PTNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham PTNS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Giordano RN BSN/ Clinical Research Manager

William Beaumont University Hospital

Phone: 248-551-3517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active PTNS n=2 Participants Once a week induction consisting of active PTNS treatments for 30 minutes for 12 consecutive weeks. PTNS Treatment: Patients will be placed in a comfortable position, sitting or supine. The treatment leg will be propped up comfortably on a footrest but draped and out of view from the patient. A 34-gauge needle electrode will be inserted at a 60-degree angle 5 cm cephalad to the medial malleolus and slightly posterior to the tibia. A PTNS surface electrode will be placed on the ipsilateral calcaneus as well as 2 inactive sham surface electrodes, 1 under the little toe and 1 on the top of the foot. When the PTNS lead set is connected to the Urgent PC stimulator, a current level of 0.5 to 9 mA at 20 Hz is selected based on each patient's foot and plantar motor and sensory responses. Treatment lasts 30 minutes and given once weekly for 12 consecutive weeks.	Sham PTNS Once a week induction consisting of Sham PTNS treatments for 30 minutes for 12 consecutive weeks. Sham PTNS Treatment: Patients will be positioned similarly as PTNS patients. A Streitberger needle will be used at the tibial nerve insertion site as described above to simulate needle placement. Three electrodes will be placed on the patient's foot, two active TENS electrodes and one inactive TENS electrode. The TENS "grounding pad" will be a gel electrode pad from a TENS unit device that is placed on the bottom of the foot just below the smallest toe. Another gel electrode will be placed on the top of the foot just above the small toe for conduction. These two electrodes will be connected to the TENS unit lead wires for sham stimulation. A third, inactive, gel electrode, will be placed near the medial aspect of the calcaneus to mimic the PTNS treatment. The TENS electrode will be connected by lead wires to the TENS unit set at 20 HZ. The TENS unit will be turned on and stimulation slowly increased to the patient's first sensory level and then turned off.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 12 • n=5 Participants	—	47 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	2 participants n=5 Participants