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

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ClinicalTrials.gov Identifier: NCT00271102
Recruitment Status : Unknown
Verified July 2010 by Geisinger Clinic.
Recruitment status was:  Active, not recruiting
First Posted : December 30, 2005
Last Update Posted : July 12, 2010
Sponsor:
Information provided by:
Geisinger Clinic

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 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

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




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271102


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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    Key Record Dates
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