BELIEVE Trial - Clinical Trial

¿Cuál es el Propósito de este estudio?

If you join the study, you will be placed into one of two treatment groups. One group will get a sling called a retropubic mid-urethral sling (RP-MUS). The other group will get a treatment called urethral bulking with a gel called polyacrylamide gel (PAHG). After the procedure, you will have check-up visits at 1 month, 6 months, 12 months, and 24 months. You can also choose to take part in interviews about your experience.

¿Cuál es la Condición que se está estudiando?

The Believe study is a research project that looks at how to treat stress urinary incontinence when doctors fix vaginal prolapse. Stress urinary incontinence means leaking urine when you cough, sneeze, or exercise. Vaginal prolapse happens when the muscles that hold the bladder and other organs become weak, and the organs drop down.

¿Quién puede participar en el Estudio?

To join the study, you must be 18 years or older, have stress urinary incontinence (which means leaking urine when you cough, sneeze, or exercise), and be planning to have surgery to fix vaginal prolapse.

Grupo etario
Adultos

¿Qué Implica?

Right now, doctors do not have strong evidence to show which treatment is better, the sling (RP-MUS) or the gel (PAHG), when fixing vaginal prolapse and stress urinary incontinence at the same time. This study will give important information about how these treatments affect patients. This will help doctors and patients choose the best option.

Detalles del Estudio

Título Completo
BELIEVE Trial: Bulking versus sling for treating stress urinary Incontinence at the time of vaginal prolapse repair
Investigador Principal
J. Eric Jelovsek, MD
Especialista en obstetricia y ginecología
Número de Protocolo
IRB: PRO00118020
NCT: NCT06754046
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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Contribuya a Duke Health