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Not yet recruiting

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

Enrollment

200

estimated

Study population

Bariatric Surgery Candidate, Obesity / overweight

Key I/E criteria

BMI ≥30Female

Primary endpoint

Pelvic floor symptoms

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07175805
Org study IDHHC-2025-0168

Timeline

Milestones

Study first posted2025-09-16actual
Last update posted2025-09-16actual
Study start2025-10estimated (month precision)
Primary completion2026-10estimated (month precision)
Study completion2027-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric Surgery CandidateObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexFemale
Healthy volunteersAccepted
Sampling methodNon probability sample

Study population text

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

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Patient-reported / QoL

2 endpoints
Primary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Primary/protocol endpoint

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

Time frame:6 months

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.