Sexual Function Trial of Overactive Bladder: Medication Versus PTNS

Completed

Conditions studied: Female Sexual Dysfunction, Overactive Bladder

In brief

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.

Key facts

Study ID

NCT03500146

Run by

Medstar Health Research Institute

People needed

175

Starts

2017-01-30

Expected to finish

2019-09-30

Last updated by the study team

2020-08-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients greater than 18 years of age
• Symptomatology of urinary urgency or urge incontinence planning to undergo MT or PTNS. Patients must meet a threshold bother defined by a positive response and bother of "somewhat, quite a bit, a great deal, or a very great deal" to questions #2, #3 or #8 on the OAB-q regarding urinary urgency and urgency incontinence.
• Patients may have tried other medication for overactive bladder in the past but should be off therapy for at least one month
• Patients must be currently sexually active with sexual activity within the past month and plans to continue for the duration of the study. Sexual activity, as defined in the FSFI questionnaire, may include caressing, foreplay, masturbation, and vaginal intercourse.

You may not qualify if…

• Contraindications to PTNS (skin, orthopedic or anatomical limitation that could prevent placement of PTNS electrode, presence of pacemaker)
• Contraindications to both anticholinergic and beta agonist therapy
• Current symptomatic UTI within past week
• Pregnant or planning to become pregnant
• Prior treatment with SNM, PTNS, onobotulinum toxin A or two medications (stopped for reasons unrelated to side effects)
• Diagnosed or suspected interstitial cystitis/painful bladder syndrome
• Diagnosis of neurogenic bladder
• Prolapse greater than Stage 2, pessary use or planned surgery for pelvic floor disorder during the study
• Planned simultaneous treatment with both PTNS and MT

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Oklahoma University — Oklahoma City, Oklahoma, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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