Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714155
• Other study ID #: 15184
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: June 13, 2012
• Start date: July 2006
• Est. completion date: January 2009

Study information

• Verified date: November 2011
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Questionnaires, Physical Examination
Questionnaires, Physical Examination

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaires		Post-operative	No
Secondary	Physical Examination		Post-operative	No