Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

This study is ongoing, but not recruiting participants.
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: July 19, 2014
Last verified: July 2014
  Purpose

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
Genital Prolapse

Study Type: Observational
Official Title: Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ]

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)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Melissa Fischer, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00784602     History of Changes
Other Study ID Numbers: 2008-242
Study First Received: November 3, 2008
Last Updated: July 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
prolapse
pelvic organ prolapse

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

ClinicalTrials.gov processed this record on October 20, 2014