NCT00714155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 14, 2012

Status Verified

November 1, 2011

Enrollment Period

2.5 years

First QC Date

July 8, 2008

Last Update Submit

June 13, 2012

Conditions

Pelvic Organ Prolapse

Keywords

Colpocleisis

Outcome Measures

Primary Outcomes (1)

  • Questionnaires

    Post-operative

Secondary Outcomes (1)

  • Physical Examination

    Post-operative

Study Arms (3)

1

Physical examination, questionnaires, retrospective chart review

Other: Questionnaires, Physical Examination

2

Questionnaires, retrospective chart review

Other: Questionnaires, Physical Examination

3

Retrospective chart review

Interventions

Questionnaires, Physical ExaminationOTHER

Questionnaires, Physical Examination

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urogynecology clinic

You may qualify if:

  • 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

You may not qualify if:

  • women who are not undergone colpocleisis or colpectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Erin E. Duecy, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 14, 2008

Study Start

July 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 14, 2012

Record last verified: 2011-11

Locations

US(1)