Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorHartford HealthCare

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

female

18-89 years old

any race/ethnicity

BMI ≥30 kg/m2

Disqualifiers

Pregnant

≥90 years old

<18 years old

BMI <30 kg/m2

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Bariatric Surgery

    Procedure/Surgery

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

  • GLP1 receptor agonist

    Drug

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Bariatric Surgery1 intervention
Group B: GLP1 or GLP1/GIP11 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
6 months
2

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).

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: