Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder - Full Text View

Sponsor:	Geisinger Clinic
Information provided by:	Geisinger Clinic
ClinicalTrials.gov Identifier:	NCT00271102

Purpose

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:

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 ]

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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Anterior repair (colporrhaphy) for their cystocele	Procedure: anterior vaginal repair (colporrhaphy) vaginal repair
2: Active Comparator Abdominal paravaginal defect repair for their cystocele	Procedure: abdominal paravaginal defect repair abdominal repair

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271102

Contacts

Contact: Vatche A Minassian, MD	570-271-6343	vaminassian@geisinger.edu
Contact: Mitesh Parekh, MD	570-271-6343	mparekh1@geisinger.edu

Locations

United States, Pennsylvania
Geisinger Health System	Recruiting
Danville, Pennsylvania, United States, 17822
Principal Investigator: Vatche A Minassian, MD

Sponsors and Collaborators

Geisinger Clinic

Investigators

Principal Investigator:

Vatche A Minassian, MD

Geisinger Clinic

More Information

Additional Information:

Click here for more information about Clinical Trials at Geisinger Medical Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Geisinger Health System ( Vatche Minassian, MD )
Study ID Numbers:	2005-0193
Study First Received:	December 29, 2005
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00271102 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Geisinger Clinic:

Cystocele, prolapse, anterior repair, colporrhaphy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Prolapse

ClinicalTrials.gov processed this record on November 20, 2009