This trial is active, not recruiting.

Condition prolapse
Treatments anterior vaginal repair (colporrhaphy), abdominal paravaginal defect repair
Sponsor Geisinger Clinic
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Anterior repair (colporrhaphy) for their cystocele
anterior vaginal repair (colporrhaphy)
vaginal repair
(Active Comparator)
Abdominal paravaginal defect repair for their cystocele
abdominal paravaginal defect repair
abdominal repair

Primary Outcomes

Change in the stage of prolapse of the anterior vaginal wall before and one year after surgery
time frame: 4 years

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Geisinger Clinic.