Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

NCT07175805 | Not Yet Recruiting FDA Drug

• 1 other identifier: HHC-2025-0168
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

lower urinary tract symtpoms; stress urinary incontinence; urge urinary incontinence; overactive bladder; pelvic organ prolapse; weight loss; fecal incontinence; bariatric surgery; glp1 agonist

Outcome Measures

Primary Outcomes (2)

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

  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)

  6 months

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

  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 the Colorectal-Anal Distress Inventory (CRADI-8).

  6 months

Study Arms (2)

Bariatric Surgery

Patients who plan to undergo bariatric surgery

Procedure: Bariatric Surgery

GLP1 or GLP1/GIP1

Patients who plan to take GLP1 or GLP1/GIP1 medications

Drug: GLP1 receptor agonist

Interventions

Bariatric Surgery PROCEDURE

Patients in this arm plan to undergo gastric sleeve or gastric bypass surgery.

Bariatric Surgery

GLP1 receptor agonist DRUG

Patients in this arm plan to start a GLP-1 receptor agonist.

GLP1 or GLP1/GIP1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seeking medical weight loss or surgical weight loss at the weight loss clinics at Hartford Hospital.

You may qualify if:

• female
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford HealthCare: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Bladder, Overactive; Pelvic Organ Prolapse; Weight Loss; Fecal Incontinence

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Prolapse; Pathological Conditions, Anatomical; Body Weight Changes; Body Weight; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Madeline Carmain, MD

CONTACT

860.972.4338; madeline.carmain@hcchealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Urogynecology

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)