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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prolapse | Procedure: anterior vaginal repair (colporrhaphy) Procedure: abdominal paravaginal defect repair | Not Applicable |
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
|
- Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery [ Time Frame: 4 years ]
- 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, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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