N/A
N=30
Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population
Overactive Bladder · Voiding Disorders · Incontinence, Urinary
Bottom Line
View on ClinicalTrials.gov: NCT04570605 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Dysfunctional Voiding Symptom Score — 8; 11 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- parasacral transcutaneous electrical nerve stimulation (PTENS) (Device); Standard Urotherapy (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dysfunctional Voiding Symptom Score |
8; 11 | — |
| PRIMARY Voiding Diary and the Number of Episodes of Incontinence Per Day |
2; 1; 1; 0.5 | — |
| SECONDARY Secondary Outcome. Review of Adverse Events. |
0; 2 | — |
Summary
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
Eligibility Criteria
Inclusion Criteria
- Toilet trained (age 6) to age 17
- Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency incontinence, nocturnal enuresis. (These patients may also have an element of bowel dysfunction; however, we will not include a patient who had ONLY bowel dysfunction and NOT a voiding dysfunction).
Exclusion Criteria
- Known neurologic diagnosis - such as myelomeningocele, caudal regression
- Known seizure disorder
- Age 17
- Lack of follow-up within 6 months of treatment
- Pacemaker, vagal nerve stimulator, or other implanted electrical device
- Intolerance of electrical nerve stimulation
- Pregnancy
- Implanted metal hardware
- Open sores or wounds over the sacral area
- Currently catheterizing for bladder drainage
- Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic)
- Bowel only voiding dysfunction (Constipation ICD-10 K59.00)
- Non-English speaking families
- Families with health literacy precluding completion of questionnaires and voiding diaries
- Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic treatments
- Untreated urinary tract infection
Data sourced from ClinicalTrials.gov (NCT04570605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.