Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Melissa Fischer, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00784602
First received: November 3, 2008
Last updated: October 28, 2013
Last verified: October 2013

November 3, 2008
October 28, 2013
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 ] [ Designated as safety issue: No ]
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
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Non-Probability Sample

Patients with genital prolapse.

Genital Prolapse
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
5000
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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00784602
2008-242
No
Melissa Fischer, MD, William Beaumont Hospitals
Melissa Fischer, MD
William Beaumont Hospitals
Principal Investigator: Melissa Fischer, MD William Beaumont Hospitals
William Beaumont Hospitals
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP