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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 is a clinical trial that has completed, run by Medstar Health Research Institute. The registered enrollment target is 175 participants.

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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.

Interventions

  • DRUG Anticholinergic
  • PROCEDURE PTNS

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2017-01-30
Est. Completion 2019-09-30

Sponsor

Medstar Health Research Institute

115 total trials

What the Registry Record Tells You About NCT03500146

The ClinicalTrials.gov registry entry for NCT03500146 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Anticholinergic is the first listed.

NCT03500146 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.