Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
This trial is active, not recruiting.
|Treatments||anterior vaginal repair (colporrhaphy), abdominal paravaginal defect repair|
|Start date||December 2005|
|End date||February 2010|
|Trial size||70 participants|
|Trial identifier||NCT00271102, 2005-0193|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
Female participants at least 18 years old.
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
|Official title||Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse|
|Principal investigator||Vatche A Minassian, MD|
|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.|
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