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Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

NCT ID: NCT00784602

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-29

Study Completion Date

2016-08-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Genital Prolapse

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role collaborator

Melissa Fischer, MD

OTHER

Sponsor Role lead

Responsible Party

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Melissa Fischer, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Melissa Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2008-242

Identifier Type: -

Identifier Source: org_study_id

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