Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy (NCT07175805) | Clinical Trial Compass
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 range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pelvic floor symptoms measured by survey the Urogenital Distress Inventory (UDI)
Timeframe: 6 months
2
Change in pelvic floor symptoms measured by validated survey the Colorectal-Anal Distress Inventory (CRADI-8).