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

Primary Purpose

Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anterior vaginal repair (colporrhaphy)
abdominal paravaginal defect repair
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse focused on measuring Cystocele, prolapse, anterior repair, colporrhaphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anterior colporrhaphy

Paravaginal defect repair

Arm Description

Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)

Abdominal paravaginal defect repair cystocele (dropped bladder)

Outcomes

Primary Outcome Measures

Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.

Secondary Outcome Measures

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.

Full Information

First Posted
December 29, 2005
Last Updated
September 26, 2019
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00271102
Brief Title
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Official Title
Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse
Keywords
Cystocele, prolapse, anterior repair, colporrhaphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anterior colporrhaphy
Arm Type
Active Comparator
Arm Description
Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
Arm Title
Paravaginal defect repair
Arm Type
Active Comparator
Arm Description
Abdominal paravaginal defect repair cystocele (dropped bladder)
Intervention Type
Procedure
Intervention Name(s)
anterior vaginal repair (colporrhaphy)
Intervention Description
vaginal repair
Intervention Type
Procedure
Intervention Name(s)
abdominal paravaginal defect repair
Intervention Description
abdominal repair
Primary Outcome Measure Information:
Title
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
Description
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vatche A Minassian, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Health System
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23508540
Citation
Minassian VA, Parekh M, Poplawsky D, Gorman J, Litzy L. Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse. Neurourol Urodyn. 2014 Jan;33(1):72-7. doi: 10.1002/nau.22396. Epub 2013 Mar 18.
Results Reference
derived
Links:
URL
http://www.geisinger.org/research/
Description
Click here for more information about Clinical Trials at Geisinger Medical Center

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

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