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| Sponsored by: |
William Beaumont Hospitals |
|---|---|
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00784602 |
Purpose
To prospectively observe the natural history of genital organ prolapse in women and determine outcomes of conservative and surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.
| Condition |
|---|
|
Genital Prolapse |
| Study Type: | Observational |
| Official Title: | Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes |
| Estimated Enrollment: | 5000 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2028 |
| Estimated Primary Completion Date: | October 2028 (Final data collection date for primary outcome measure) |
Patients meeting the inclusion/exclusion criteria will be identified from urology physician practices and contacted by phone to obtain informed consent. Chart review will be conducted here at William Beaumont Hospital and at The Beaumont Comprehensive Urology Center for enrolled patients. Additionally, questionnaires will be mailed at enrollment, and then yearly to assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, cost, and general health and well being. Enrolled patients who opt for surgical treatment (identified by ongoing monitoring of the hospital's surgical boarding list) will complete an additional set of questionnaires at 6 months post surgery to capture short term outcomes. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with genital prolapse.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kim Killinger, RN | 248-551-9295 | kkillinger@beaumont.edu |
| United States, Michigan | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Kim Killinger, RN 248-551-9295 kkillinger@beaumont.edu | |
| Principal Investigator: Melissa Fischer, MD | |
| Principal Investigator: | Melissa Fischer, MD | William Beaumont Hospitals |
More Information
| Responsible Party: | William Beaumont Hospitals ( Melissa Fischer, MD ) |
| Study ID Numbers: | 2008-242 |
| Study First Received: | November 3, 2008 |
| Last Updated: | November 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00784602 |
| Health Authority: | United States: Institutional Review Board |
|
prolapse pelvic organ prolapse |
|
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |
