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Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy 200

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07175805 est une étude observationnel pour Symptômes des voies urinaires inférieures, Incontinence urinaire d'effort, Urge Urinary Incontinence, Vessie hyperactive, Prolapsus des organes pelviens, Perte de poids, Incontinence fécale, Chirurgie bariatrique, glp1 Agonist. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 octobre 2025, avec un objectif de 200 participants. Dirigée par Hartford HealthCare, l'étude devrait être terminée d'ici le 1 juin 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 16 septembre 2025.
Résumé succinct
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...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Pathologies
Symptômes des voies urinaires inférieuresIncontinence urinaire d'effortUrge Urinary IncontinenceVessie hyperactiveProlapsus des organes pelviensPerte de poidsIncontinence fécaleChirurgie bariatriqueglp1 Agonist
Autres identifiants de l'étude
  • HHC-2025-0168
Numéro NCT
NCT07175805
Date de début (réel)
2025-10
Dernière mise à jour publiée
2025-09-16
Date de fin (estimée)
2027-06
Inscription (estimée)
200
Type d'étude
Observationnel
Statut
Pas encore en recrutement
Mots clés
lower urinary tract symtpoms
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Bariatric Surgery
Patients who plan to undergo bariatric surgery
Chirurgie bariatrique
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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
  • 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 HealthCare logoHartford HealthCare
Partie responsable de l'étude
Madeline Carmain, Investigateur principal, Fellow, Urogynecology, Hartford HealthCare
Contact central de l'étude
Contact: Madeline Carmain, MD, 860.972.4338, [email protected]
1 Centres de l'étude dans 1 pays

Connecticut

Hartford Hospital, Hartford, Connecticut, 06106, United States
Madeline Carmain, MD, Contact, 860-972-4338, [email protected]