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Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00784602
Enrollment
301
Registered
2008-11-04
Start date
2008-10-29
Completion date
2016-08-29
Last updated
2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genital Prolapse

Keywords

prolapse, pelvic organ prolapse

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.

Interventions

None listed

Sponsors

Corewell Health East
CollaboratorOTHER
Melissa Fischer, MD
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnairesOngoing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026