Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hartford HealthCare
Study ID
NCT07175805
Status
Not Yet Recruiting

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Conditions

  • Bariatric Surgery
  • Fecal Incontinence
  • Lower Urinary Tract Symptoms
  • Overactive Bladder
  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence
  • Urge Urinary Incontinence
  • Weight Loss
  • glp1 Agonist

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Bariatric Surgery — PROCEDURE
    Patients in this arm plan to undergo gastric sleeve or gastric bypass surgery.
  • GLP1 receptor agonist — DRUG
    Patients in this arm plan to start a GLP-1 receptor agonist.

Study Details

The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Participants in this study do not need to have any pelvic floor symptoms to enroll in the study. Understanding how different types of weight loss treatment impact pelvic floor symptoms will help clinicians guide which weight loss treatments are recommended for patients with pelvic floor symptoms in the future.

Key Dates

Start date
Oct 31, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Bariatric Surgery
    Patients who plan to undergo bariatric surgery
  • Arm: GLP1 or GLP1/GIP1
    Patients who plan to take GLP1 or GLP1/GIP1 medications

Primary Outcome Measure

Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hartford HospitalHartfordConnecticut06106
Madeline Carmain, MD
[email protected]
860-972-4338

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By research site
Hartford Hospital· Hartford, CT

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