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Clinical Trial NCT07175805 for Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Urge Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Weight Loss, Fecal Incontinence, Bariatric Surgery, glp1 Agonist is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy 200
Clinical Trial NCT07175805 is an observational study for Lower Urinary Tract Symptoms, Stress Urinary Incontinence, Urge Urinary Incontinence, Overactive Bladder, Pelvic Organ Prolapse, Weight Loss, Fecal Incontinence, Bariatric Surgery, glp1 Agonist and is currently not yet recruiting. Enrollment is planned to begin on October 1, 2025 and continue until the study accrues 200 participants. Led by Hartford HealthCare, this study is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on September 16, 2025.
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. Understand...Show More
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). UI is the involuntary loss of urine and is a common and bothersome form of LUTS. The prevalence of urinary incontinence is high and increasing, with 61.8% of all women over 20 years old reporting urinary incontinence. Hi...Show More
Official Title
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
Conditions
Lower Urinary Tract SymptomsStress Urinary IncontinenceUrge Urinary IncontinenceOveractive BladderPelvic Organ ProlapseWeight LossFecal IncontinenceBariatric Surgeryglp1 AgonistOther Study IDs
- HHC-2025-0168
NCT ID Number
Start Date (Actual)
2025-10
Last Update Posted
2025-09-16
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
200
Study Type
Observational
Status
Not yet recruiting
Keywords
lower urinary tract symtpoms
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Bariatric Surgery Patients who plan to undergo bariatric surgery | Bariatric Surgery Patients in this arm plan to undergo gastric sleeve or gastric bypass surgery. |
GLP1 or GLP1/GIP1 Patients who plan to take GLP1 or GLP1/GIP1 medications | GLP1 receptor agonist Patients in this arm plan to start a GLP-1 receptor agonist. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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.
- 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
Hartford HealthCareStudy Responsible Party
Madeline Carmain, Principal Investigator, Fellow, Urogynecology, Hartford HealthCare
Study Central Contact
Contact: Madeline Carmain, MD, 860.972.4338, [email protected]
1 Study Locations in 1 Countries
Connecticut
Hartford Hospital, Hartford, Connecticut, 06106, United States
Madeline Carmain, MD, Contact, 860-972-4338, [email protected]