Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2010 by Geisinger Clinic.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Geisinger Clinic

ClinicalTrials.gov Identifier:

NCT00271102

First received: December 29, 2005

Last updated: July 9, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2005

Last Updated Date

July 9, 2010

Start Date ^ICMJE

December 2005

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery

Change History

Complete list of historical versions of study NCT00271102 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The difference in intra-operative and post-operative complications. Patient satisfaction before and one year after surgery based on quality of life and sexual function questionnaires specifically designed for patients with pelvic organ prolapse. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

Official Title ^ICMJE

Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

Brief Summary

The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

Detailed Description

It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Prolapse

Intervention ^ICMJE

Procedure: anterior vaginal repair (colporrhaphy)
vaginal repair
Procedure: abdominal paravaginal defect repair
abdominal repair

Study Arm (s)

Active Comparator: 1
Anterior repair (colporrhaphy) for their cystocele

Intervention: Procedure: anterior vaginal repair (colporrhaphy)
Active Comparator: 2
Abdominal paravaginal defect repair for their cystocele

Intervention: Procedure: abdominal paravaginal defect repair

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2012

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

Patients with at least 2 previous prolapse surgeries
Patients who are pregnant or planning to have a pregnancy

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00271102

Other Study ID Numbers ^ICMJE

2005-0193

Has Data Monitoring Committee

Responsible Party

Vatche Minassian, MD, Geisinger Health System

Study Sponsor ^ICMJE

Geisinger Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vatche A Minassian, MD

Geisinger Clinic

Information Provided By

Geisinger Clinic

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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