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Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

This study has been terminated.
(Shift in department's research interests)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784602
First Posted: November 4, 2008
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Melissa Fischer, MD, William Beaumont Hospitals
November 3, 2008
November 4, 2008
February 15, 2017
October 2008
October 2028   (Final data collection date for primary outcome measure)
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires [ Time Frame: Ongoing ]
Same as current
Complete list of historical versions of study NCT00784602 on ClinicalTrials.gov Archive Site
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Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
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.
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.
Observational
Observational Model: Other
Time Perspective: Other
Not Provided
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Non-Probability Sample
Patients with genital prolapse.
Genital Prolapse
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
301
December 2028
October 2028   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00784602
2008-242
No
Not Provided
Plan to Share IPD: No
Melissa Fischer, MD, William Beaumont Hospitals
Melissa Fischer, MD
William Beaumont Hospitals
Principal Investigator: Melissa Fischer, MD William Beaumont Hospitals
William Beaumont Hospitals
February 2017