Sexual Function Trial of Overactive Bladder: Medication Versus PTNS

NCT03500146 | Completed

• 1 other identifier: 2016-248
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 5

Brief 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

Female Sexual Dysfunction; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• overall FSFI

  Continuous variable

  After 12 weeks

Study Arms (2)

Normal sexual function

Patients with an overall FSFI score equal to or above 26.5 will be in the normal sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

Drug: Anticholinergic; Procedure: PTNS

Low sexual function

Female sexual dysfunction is defined as an overall FSFI score below 26.5, patients meeting this criteria will be in the low sexual function group. Patients in both groups will be treated with an overactive bladder treatment, either anticholinergics, beta-agonists or PTNS.

Drug: Anticholinergic; Procedure: PTNS

Interventions

Anticholinergic DRUG

Patients prescribed medication for OAB

Also known as: Beta-agonists

Low sexual function; Normal sexual function

PTNS PROCEDURE

Patients prescribed PTNS for OAB

Low sexual function; Normal sexual function

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women presenting to a urology or urogynecology clinic for symptoms of overactive bladder such as urgency and UUI. Eligible subjects must report urinary urgency or urge incontinence and be recommended for treatment with medical therapy (with anticholinergic or beta agonist) or PTNS by the treating physician.

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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Indiana University: collaborator
• University of Oklahoma: collaborator
• University of Texas: collaborator

Study Sites (5)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

University of Texas Southwestern

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Cholinergic Antagonists

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Robert Gutman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: January 30, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)