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De klinische studie NCT07175805 voor Symptomen van de lagere urinewegen, Stressurine-incontinentie, Urge Urinary Incontinence, Overactieve blaas, Bekkenorgaanprolaps, Gewichtsverlies, Fecale incontinentie, Bariatrische chirurgie, glp1 Agonist is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy 200
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De klinische studie NCT07175805 is een observationeel studie bij Symptomen van de lagere urinewegen, Stressurine-incontinentie, Urge Urinary Incontinence, Overactieve blaas, Bekkenorgaanprolaps, Gewichtsverlies, Fecale incontinentie, Bariatrische chirurgie, glp1 Agonist met de status nog niet rekruterend. De inclusie van 200 deelnemers start op 1 oktober 2025. De studie wordt geleid door Hartford HealthCare en de voltooiing is gepland op 1 juni 2027. Laatste update op ClinicalTrials.gov: 16 september 2025.
Beknopte samenvatting
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...Toon meer
Uitgebreide beschrijving
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...Toon meer
Officiële titel
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
Aandoeningen
Symptomen van de lagere urinewegenStressurine-incontinentieUrge Urinary IncontinenceOveractieve blaasBekkenorgaanprolapsGewichtsverliesFecale incontinentieBariatrische chirurgieglp1 AgonistAndere studie-ID's
- HHC-2025-0168
NCT-ID
Startdatum (Werkelijk)
2025-10
Laatste update geplaatst
2025-09-16
Verwachte einddatum
2027-06
Inschrijving (Geschat)
200
Studietype
Observationeel
Status
Nog niet rekruterend
Trefwoorden
lower urinary tract symtpoms
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
stress urinary incontinence
urge urinary incontinence
overactive bladder
pelvic organ prolapse
weight loss
fecal incontinence
bariatric surgery
glp1 agonist
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Bariatric Surgery Patients who plan to undergo bariatric surgery | Bariatrische chirurgie 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. |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
Accepteert gezonde vrijwilligers
Ja
- 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 HealthCareVerantwoordelijke instantie
Madeline Carmain, Hoofdonderzoeker, Fellow, Urogynecology, Hartford HealthCare
Centraal Contactpersoon
Contact: Madeline Carmain, MD, 860.972.4338, [email protected]
1 Studielocaties in 1 landen
Connecticut
Hartford Hospital, Hartford, Connecticut, 06106, United States
Madeline Carmain, MD, Contact, 860-972-4338, [email protected]