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Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy 200

Aún no recluta
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07175805 es un estudio observacional para Síntomas del tracto urinario inferior, Incontinencia urinaria por estrés, Urge Urinary Incontinence, Vejiga hiperactiva, Prolapso de órganos pélvicos, Pérdida de peso, Incontinencia fecal, Cirugía bariátrica, glp1 Agonist. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de octubre de 2025 hasta completar 200 participantes. Dirigido por Hartford HealthCare, se espera que finalice el 1 de junio de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 16 de septiembre de 2025.
Resumen
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...Mostrar más
Descripción detallada
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...Mostrar más
Título oficial

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Condiciones médicas
Síntomas del tracto urinario inferiorIncontinencia urinaria por estrésUrge Urinary IncontinenceVejiga hiperactivaProlapso de órganos pélvicosPérdida de pesoIncontinencia fecalCirugía bariátricaglp1 Agonist
Otros ID del estudio
  • HHC-2025-0168
Número del NCT
NCT07175805
Inicio del estudio (real)
2025-10
Última actualización
2025-09-16
Fecha de finalización (estimada)
2027-06
Inscripción (prevista)
200
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
lower urinary tract symtpoms
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Bariatric Surgery
Patients who plan to undergo bariatric surgery
Cirugía bariátrica
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.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
Admisión de voluntarios sanos
Sí
  • 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
Parte responsable del estudio
Madeline Carmain, Investigador principal, Fellow, Urogynecology, Hartford HealthCare
Contactos centrales del estudio
Contacto: Madeline Carmain, MD, 860.972.4338, [email protected]
1 Centros del estudio en 1 países

Connecticut

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