Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00714155
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Duration (Months): 30.1
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Other: Questionnaires, Physical Examination

Study Design

• Study Type: Observational
• Actual Enrollment: 48 participants
• Observational Model: Cohort
• Official Title: Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Questionnaires [Post-operative]

Secondary Outcome Measures

1. Physical Examination [Post-operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Erin E. Duecy, MD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erin Duecy, MD, University of Rochester
• ClinicalTrials.gov Identifier: NCT00714155
• Other Study ID Numbers: 15184
• First Posted: Jul 14, 2008
• Last Update Posted: Jun 14, 2012
• Last Verified: Nov 1, 2011

• Keywords provided by Erin Duecy, MD, University of Rochester: Colpocleisis
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

No Results Posted as of Jun 14, 2012