Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Geisinger Clinic.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Geisinger Clinic
Information provided by:
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT00271102
First received: December 29, 2005
Last updated: July 9, 2010
Last verified: July 2010
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse |
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: | February 2012 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
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
Additional Information:
No publications provided
| Responsible Party: | Vatche Minassian, MD, Geisinger Health System |
| ClinicalTrials.gov Identifier: | NCT00271102 History of Changes |
| Other Study ID Numbers: | 2005-0193 |
| Study First Received: | December 29, 2005 |
| Last Updated: | July 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Geisinger Clinic:
|
Cystocele, prolapse, anterior repair, colporrhaphy |
Additional relevant MeSH terms:
|
Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013