Trial Outcomes & Findings for Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population (NCT NCT04570605)

Last Updated: 2022-03-17

Results Overview

At week 6 a Dysfunctional Voiding Scoring System Score. Descriptive statistics will be used to analyze these data in comparison to pre-study scores. As stated above, Dysfunctional Voiding Symptom Score is a validated clinical questionnaire designed to quantify the severity of pediatric voiding dysfunction on a scale of 0 (non-existent) to 30 (most severe).

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

week 6

Results posted on

2022-03-17

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Urotherapy Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Overall Study STARTED	15	15
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Urotherapy n=15 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS n=15 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	10 years n=5 Participants	9.1 years n=7 Participants	9.55 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Initail Dysfunctional Voiding Scoring System Score	10 units on a scale n=5 Participants	11 units on a scale n=7 Participants	10.5 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: week 6

Population: Patients who met elegibility criteria and enrolled in the study and then completed the DVSS questionnaire at 6 weeks into the study. These numbers differ from the total number of patients enrolled as there were some who did not complete the 6 week questionnaire.

Outcome measures

Outcome measures
Measure	Standard Urotherapy n=8 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS n=7 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Dysfunctional Voiding Symptom Score	8 score on a scale Interval 5.5 to 11.0	11 score on a scale Interval 8.0 to 12.0

PRIMARY outcome

Timeframe: week 6, week 12

Population: number of patients who completed 48 hour voiding diary at 6 weeks.

48-hour Voiding Diary and Nighttime Wetting log will be repeated and evaluated. This was added as a separate primary outcome as it is separate from the Dysfunctional Voiding Symptom Score. The voiding diary will be used to evaluate the number of episodes of incontinence per day and descriptive statistics will be used to compare this to pre-study numbers.

Outcome measures

Outcome measures
Measure	Standard Urotherapy n=7 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS n=11 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Voiding Diary and the Number of Episodes of Incontinence Per Day 6 week Voiding Diary	2 Incontinence Episodes Interval 0.5 to 3.5	1 Incontinence Episodes Interval 0.0 to 2.0
Voiding Diary and the Number of Episodes of Incontinence Per Day 12 week Voiding Diary	1 Incontinence Episodes Interval 0.5 to 2.0	0.5 Incontinence Episodes Interval 0.0 to 3.75

SECONDARY outcome

Timeframe: Week 6 through Week 12

Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events.

Outcome measures

Outcome measures
Measure	Standard Urotherapy n=11 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS n=13 Participants Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Secondary Outcome. Review of Adverse Events.	0 events	2 events

Adverse Events

Standard Urotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Urotherapy + PTENS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Urotherapy n=11 participants at risk Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Standard Urotherapy + PTENS n=13 participants at risk Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Skin and subcutaneous tissue disorders Pruritis at Pad Site	0.00% 0/11 • 12 weeks (time that data was collected between enrollment and subjects completing their participation in the study)	7.7% 1/13 • Number of events 1 • 12 weeks (time that data was collected between enrollment and subjects completing their participation in the study)
Skin and subcutaneous tissue disorders Discomfort when removing pad	0.00% 0/11 • 12 weeks (time that data was collected between enrollment and subjects completing their participation in the study)	7.7% 1/13 • Number of events 1 • 12 weeks (time that data was collected between enrollment and subjects completing their participation in the study)

Additional Information

Glen Lau, MD

University of Utah School of Medicine

Phone: 801-213-2700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place