Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
- Conditions
- Genital Prolapse
- Registration Number
- NCT00784602
- Lead Sponsor
- Melissa Fischer, MD
- Brief Summary
To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.
- Detailed Description
Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 301
- Female
- Pelvic Organ Prolapse
- Able to provide informed consent
- Able to complete study assessments, per clinician judgment
- Age < 21 years
- Currently pregnant or < 6 months post-partum
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires Ongoing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States