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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Prolapse	Procedure: anterior vaginal repair (colporrhaphy); Procedure: abdominal paravaginal defect repair	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
Study Start Date :	December 2005
Actual Primary Completion Date :	February 2010
Estimated Study Completion Date :	February 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; Anterior repair (colporrhaphy) for their cystocele	Procedure: anterior vaginal repair (colporrhaphy); vaginal repair
Active Comparator: 2; Abdominal paravaginal defect repair for their cystocele	Procedure: abdominal paravaginal defect repair; abdominal repair

Outcome Measures

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Primary Outcome Measures :

1. Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery [ Time Frame: 4 years ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822

Sponsors and Collaborators

Geisinger Clinic

Investigators

Principal Investigator:	Vatche A Minassian, MD	Geisinger Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about Clinical Trials at Geisinger Medical Center 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Vatche Minassian, MD, Geisinger Health System
ClinicalTrials.gov Identifier:	NCT00271102 History of Changes
Other Study ID Numbers:	2005-0193
First Posted:	December 30, 2005
Last Update Posted:	July 12, 2010
Last Verified:	July 2010

Keywords provided by Geisinger Clinic:

Cystocele, prolapse, anterior repair, colporrhaphy

Additional relevant MeSH terms:

Prolapse; Pathological Conditions, Anatomical