NCT04570605

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

Completed NA Results posted Last updated 17 March 2022

What this trial tests

NA trial testing parasacral transcutaneous electrical nerve stimulation (PTENS) in Overactive Bladder in 30 participants. Completed in 1 July 2020.

Timeline

1 April 2019

Primary endpoint
1 June 2020

1 July 2020

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 April 2019
Primary completion	1 June 2020
Estimated completion	1 July 2020
Sites	1 location across United States

Drugs / interventions tested

• parasacral transcutaneous electrical nerve stimulation (PTENS)
• Standard Urotherapy

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Voiding Disorders — all drugs for Voiding Disorders →
• Incontinence, Urinary — all drugs for Incontinence, Urinary →

Sponsor

University of Utah

Who can join

Adults 6 to 17, any sex, with Overactive Bladder or Voiding Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Dysfunctional Voiding Symptom Score Primary · week 6

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).

Group	Value	95% CI
Standard Urotherapy	8	5.5 – 11
Standard Urotherapy + PTENS	11	8 – 12

Voiding Diary and the Number of Episodes of Incontinence Per Day Primary · week 6, week 12

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.

6 week Voiding Diary

Group	Value	95% CI
Standard Urotherapy	2	0.5 – 3.5
Standard Urotherapy + PTENS	1	0 – 2

12 week Voiding Diary

Group	Value	95% CI
Standard Urotherapy	1	0.5 – 2
Standard Urotherapy + PTENS	0.5	0 – 3.75

Secondary Outcome. Review of Adverse Events. Secondary · Week 6 through Week 12

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

Group	Value	95% CI
Standard Urotherapy	0
Standard Urotherapy + PTENS	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks (time that data was collected between enrollment and subjects completing their participation in the study). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Urotherapy

Serious: 0/11 (0%)

Deaths: 0/11

Standard Urotherapy + PTENS

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (2 terms — click to expand)

Reaction	System	Standard Urotherapy	Standard Urotherapy + PTENS
Pruritis at Pad Site	Skin and subcutaneous tissue disorders	—	—
Discomfort when removing pad	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04570605 adverse events section.

Sponsor's own description

Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.