Overactive Bladder Clinical Trial
Official title:
Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
NCT number | NCT04570605 |
Other study ID # | 117756 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | July 1, 2020 |
Verified date | March 2022 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | 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 < 6 or > 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah/Primary Children's Pediatric Urology | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
de Paula LIDS, de Oliveira LF, Cruz BP, de Oliveira DM, Miranda LM, de Moraes Ribeiro M, Duque RO, de Figueiredo AA, de Bessa J Jr, Netto JMB. Parasacral transcutaneous electrical neural stimulation (PTENS) once a week for the treatment of overactive bladder in children: A randomized controlled trial. J Pediatr Urol. 2017 Jun;13(3):263.e1-263.e6. doi: 10.1016/j.jpurol.2016.11.019. Epub 2016 Dec 21. Erratum in: J Pediatr Urol. 2021 Jun;17(3):e1. — View Citation
Farhat W, Bägli DJ, Capolicchio G, O'Reilly S, Merguerian PA, Khoury A, McLorie GA. The dysfunctional voiding scoring system: quantitative standardization of dysfunctional voiding symptoms in children. J Urol. 2000 Sep;164(3 Pt 2):1011-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dysfunctional Voiding Symptom Score | 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). |
week 6 | |
Primary | Voiding Diary and the Number of Episodes of Incontinence Per Day | 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. | week 6, week 12 | |
Secondary | Secondary Outcome. Review of Adverse Events. | Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events. | Week 6 through Week 12 |
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