Clinical trial

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Opening soon · Not applicable · 1 countries · Registry ID NCT07175805

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 90 Years

SexFemale

Healthy volunteersAccepted

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

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI)6 months

The investigators plan to measure the change in pelvic floor symptoms between woman taking glucagon-like peptide-1 receptor agonists (GLP1) medications vs women receiving bariatric surgery. These changes will be measured by validated survey, including the Urogenital Distress Inventory (UDI)

Change in pelvic floor symptoms measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).6 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hartford Hospital🇺🇸 Hartford, Connecticut, United States

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Madeline Carmain, MDContact

Email · Call 860-972-4338