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Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy 200

Ainda não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07175805 é um estudo observacional para Sintomas do trato urinário inferior, Incontinência urinária de esforço, Urge Urinary Incontinence, Bexiga hiperativa, Prolapso de órgãos pélvicos, Perda de peso, Incontinência fecal, Cirurgia bariátrica, glp1 Agonist. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de outubro de 2025, com o objetivo de incluir 200 participantes. Coordenado por Hartford HealthCare e deve ser concluído em 1 de junho de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 16 de setembro de 2025.
Resumo
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 mais
Descrição detalhada
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 mais
Título oficial

Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy

Condições médicas
Sintomas do trato urinário inferiorIncontinência urinária de esforçoUrge Urinary IncontinenceBexiga hiperativaProlapso de órgãos pélvicosPerda de pesoIncontinência fecalCirurgia bariátricaglp1 Agonist
Outros IDs do estudo
  • HHC-2025-0168
Número NCT
NCT07175805
Data de início (real)
2025-10
Última atualização postada
2025-09-16
Data de conclusão (estimada)
2027-06
Inscrição (estimada)
200
Tipo de estudo
Observacional
Status
Ainda não recrutando
Palavras-chave
lower urinary tract symtpoms
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Bariatric Surgery
Patients who plan to undergo bariatric surgery
Cirurgia 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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Feminino
Aceita voluntários saudáveis
Sim
  • 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
Responsável pelo estudo
Madeline Carmain, Investigador principal, Fellow, Urogynecology, Hartford HealthCare
Contato central do estudo
Contato: Madeline Carmain, MD, 860.972.4338, [email protected]
1 Locais do estudo em 1 países

Connecticut

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