Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

This study is currently recruiting participants.

Verified by University of Rochester, September 2008

Sponsored by:	University of Rochester
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00714155

Purpose

The purpose of this study is to evaluate the long-term success rate of the colpocleisis procedure and its effect on quality of life in women who have this surgery. We want to see if women who have this surgery have problems with recurrent pelvic organ prolapse, urinary incontinence, or bowel problems after the surgery. We also want to see how the surgery affects women's sexuality.

Condition	Intervention
Pelvic Organ Prolapse	Other: Questionnaires, Physical Examination

MedlinePlus related topics: Pelvic Support Problems

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Questionnaires [ Time Frame: Post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical Examination [ Time Frame: Post-operative ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	July 2006

Groups/Cohorts	Assigned Interventions
1 Physical examination, questionnaires, retrospective chart review	Other: Questionnaires, Physical Examination Questionnaires, Physical Examination
2 Questionnaires, retrospective chart review	Other: Questionnaires, Physical Examination Questionnaires, Physical Examination
3 Retrospective chart review

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Urogynecology clinic

Criteria

Inclusion Criteria:

women who underwent either total colpectomy with colpocleisis or partial colpectomy with LeFort-type colpocleisis performed by the Urogynecology service between 1/2000 and 12/2007 at Strong Memorial Hospital

Exclusion Criteria:

women who are not undergone colpocleisis or colpectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714155

Contacts

Contact: Mare Perevich, RN, CCRC	585-273-2996
Contact: Erin E Duecy, MD	585-273-3232

Locations

United States, New York
University of Rochester	Recruiting
Rochester, New York, United States, 14642
Contact: Erin Duecy, MD 585-273-3232
Principal Investigator: Erin E Duecy, MD

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:

Erin E. Duecy, MD

University of Rochester

More Information

Responsible Party:	University of Rochester ( Erin E. Duecy, MD )
Study ID Numbers:	15184
Study First Received:	July 8, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00714155
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Colpocleisis

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on January 16, 2009