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NCT03500146 · ClinicalTrials.gov registry record
Sexual Function Trial of Overactive Bladder: Medication Versus PTNS
A clinical trial, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- 175
- Enrollment target
NCT03500146: Completed study, sponsored by Medstar Health Research Institute.
NCT03500146 is a clinical trial that has completed, run by Medstar Health Research Institute. The registered enrollment target is 175 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03500146 has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- 175 participants
- Enrollment target
Study Summary
Sexual dysfunction affects approximately 45% of women with an even greater incidence reported in women with overactive bladder symptoms, despite this there is a lack of FDA approved treatments for sexual dysfunction in this population. While both medical therapy and electrical neuromodulation have been shown to improve urinary function as well as sexual function, there is a dearth of literature about their comparative effectiveness in the latter. The purpose of this study is to examine the comparative effectiveness of neuromodulation via percutaneous tibial nerve stimulation (PTNS) and medical therapy with anticholinergics or beta-agonists in improving female sexual function. This will be a prospective multi-center cohort study comparing improvement in sexual function as measured by the female sexual function index (FSFI). It is hypothesized that PTNS will improve sexual function to a greater degree than medical therapy as there may be mechanisms by which PTNS directly affects sexual function. Enhanced understanding of the effects of neuromodulation and medical therapy on sexual function may allow for improved patient selection and better outcomes which may lead to widespread use of neuromodulation for female sexual dysfunction.
Primary Outcome
Continuous variable
Interventions
- DRUG Anticholinergic
- PROCEDURE PTNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2017-01-30 |
| Est. Completion | 2019-09-30 |
What the finished NCT03500146 record still lists
NCT03500146 is an observational study that tracks outcomes without assigning an intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Anticholinergic is the first listed.
NCT03500146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03500146 about?
NCT03500146 is a clinical study titled "Sexual Function Trial of Overactive Bladder: Medication Versus PTNS". Sexual dysfunction affects approximately 45% of women with an even greater incidence reported in women with overactive bladder symptoms, despite this there is a lack of FDA approved treatments for sexual dysfunction in this population. While both medical therapy and electrical neuromodulation have b...
What is the current status of trial NCT03500146?
This trial is currently completed. The enrollment target is 175 participants. The study started on 2017-01-30. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03500146?
The interventions under investigation include: Anticholinergic (DRUG), PTNS (PROCEDURE).
Who is sponsoring clinical trial NCT03500146?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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