Not Yet RecruitingNot Applicable

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

United States200 participantsStarted 2025-10

Plain-language summary

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.

Who can participate

Age range18 Years – 90 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * female * 18-89 years old * any race/ethnicity * BMI ≥30 kg/m2 * current medical weight loss or surgical weight loss patient of Obesity Medicine and Metabolic \& Bariatric Surgery * able/willing to give informed consent * have a home scale to measure weight Patients meeting all the following criteria will be eligible to participate in the medical weight loss therapy arm: * prescribed and start a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or a GLP-1/gastric inhibitory peptide (GIP1) * taking other weight loss agents (such as metformin) Patients meeting all the following criteria will be eligible to participate in the bariatric surgery arm: * plan to undergo gastric sleeve or gastric bypass surgery * taking weight loss agents which are not GLP-1 RA or GLP-1/GIP1 medications at the start of the study. Patients will not be excluded if they are started on GLP-1 RA or GLP-1/GIP1 medications after surgery. Exclusion Criteria: * Pregnant * ≥90 years old * \<18 years old * BMI \<30 kg/m2 * A history of bariatric surgery prior to enrollment * No home scale to measure weight * Active cancer

What they're measuring

Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI)

Timeframe: 6 months

Change in pelvic floor symptoms measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).

Timeframe: 6 months

Trial details

NCT IDNCT07175805

SponsorHartford HealthCare

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

Madeline Carmain, MD

860.972.4338 madeline.carmain@hcchealth.org