Outcomes and Patient Satisfaction After Colpocleisis for... | NCT00714155

Studies
Outcomes and Patient Satisfaction After Colpocleisis for Pelvic Organ Prolapse

NCT00714155

Sponsor

University of Rochester

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

48Actual

Phase

Not provided

Conditions

Pelvic Organ Prolapse

Interventions

Questionnaires, Physical Examination

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jul 8, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires, Physical Examination	Other	Questionnaires, Physical Examination	1 2

Measure	Description	Time Frame
Questionnaires		Post-operative

Measure	Description	Time Frame
Physical Examination		Post-operative

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Urogynecology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erin E. Duecy, MD	University of Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester		Rochester	New York	14642	United States

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided