Status:
NOT_YET_RECRUITING
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
Lead Sponsor:
Hartford HealthCare
Conditions:
Lower Urinary Tract Symptoms
Stress Urinary Incontinence
Eligibility:
FEMALE
18-90 years
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 symp...
Detailed Description
Lower Urinary Tract Symptoms (LUTS) are defined as bothersome symptoms related to the storage of urine, voiding, and postvoid symptoms, and includes urgency, frequency, and urinary incontinence (UI). ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07175805
Start Date
October 1 2025
End Date
June 1 2027
Last Update
September 16 2025
Active Locations (1)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106