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Trial record 11 of 40 for:    Sexual | Recruiting, Not yet recruiting, Available Studies | "sexual dysfunction" women

Sexual Function Trial of Overactive Bladder: Medication Versus PTNS (STOMP)

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ClinicalTrials.gov Identifier: NCT03500146
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
Indiana University
University of Oklahoma
University of Texas
Information provided by (Responsible Party):
Medstar Health Research Institute

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.

Condition or disease Intervention/treatment
Female Sexual Dysfunction Overactive Bladder Drug: Anticholinergic Procedure: PTNS

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 312 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sexual Function Trial of Overactive Bladder: Medication Versus PTNS
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Patients prescribed medication for OAB
Other Name: Beta-agonists

Procedure: PTNS
Patients prescribed PTNS for OAB

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
Patients prescribed medication for OAB
Other Name: Beta-agonists

Procedure: PTNS
Patients prescribed PTNS for OAB




Primary Outcome Measures :
  1. overall FSFI [ Time Frame: After 12 weeks ]
    Continuous variable



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500146


Contacts
Contact: Allison Polland, MD 202-877-6526 allison.r.polland@medstar.net
Contact: Robert Gutman, MD 202-877-6526 Robert.e.Gutman@medstar.net

Locations
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Allison Polland, MD    202-877-6526    allison.r.polland@medstar.net   
Contact: Robert Gutman, MD    202-877-6526    robert.e.gutman@medstar.net   
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Divya Arunchalam, MD         
Contact: Michael Heit, MD         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Ankita Gupta, MD    502-588-4400    ankita.gupta@louisville.edu   
Contact: Kate Meriwether, MD    502-588-4400    kate.meriwether@ulp.org   
United States, Oklahoma
Oklahoma University Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Denicia Dwarica, MD         
Contact: Leischen Quiroz, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75235
Contact: Jennifer Hamner, MD         
Contact: David Rahn, MD         
Sponsors and Collaborators
Medstar Health Research Institute
Indiana University
University of Oklahoma
University of Texas
Investigators
Principal Investigator: Robert Gutman, MD Medstar Washington Hospital Center
  Study Documents (Full-Text)

Documents provided by Medstar Health Research Institute:

Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03500146     History of Changes
Other Study ID Numbers: 2016-248
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs