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Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

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ClinicalTrials.gov Identifier: NCT00784602
Recruitment Status : Terminated (Shift in department's research interests)
First Posted : November 4, 2008
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Melissa Fischer, MD, William Beaumont Hospitals

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.

Condition or disease
Genital Prolapse

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.

Study Type : Observational
Actual Enrollment : 301 participants
Observational Model: Other
Time Perspective: Other
Official Title: Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Actual Study Start Date : October 29, 2008
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : August 29, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires [ Time Frame: Ongoing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with genital prolapse.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784602


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Melissa Fischer, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Melissa Fischer, MD William Beaumont Hospitals

Responsible Party: Melissa Fischer, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00784602     History of Changes
Other Study ID Numbers: 2008-242
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Melissa Fischer, MD, William Beaumont Hospitals:
prolapse
pelvic organ prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical