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Sexual Function Trial of Overactive Bladder: Medication Versus PTNS

NCT03500146 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2020-08-18

No results posted yet for this 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.

Conditions

Interventions

DRUG

Anticholinergic

Patients prescribed medication for OAB

PROCEDURE

PTNS

Patients prescribed PTNS for OAB

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • University of Oklahoma

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Robert Gutman, MD · Medstar Health Research Institute

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03500146 on ClinicalTrials.gov