This trial is active, not recruiting.

Condition genital prolapse
Sponsor Melissa Fischer, MD
Collaborator William Beaumont Hospitals
Start date October 2008
End date October 2028
Trial size 5000 participants
Trial identifier NCT00784602, 2008-242


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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
time frame: Ongoing

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - Female - Pelvic Organ Prolapse - Able to provide informed consent - Able to complete study assessments, per clinician judgment Exclusion Criteria: - Age < 21 years - Currently pregnant or < 6 months post-partum

Additional Information

Official title Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Principal investigator Melissa Fischer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.