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

Geisinger Health

Status: Completed

Conditions: Prolapse

Treatments: Procedure: anterior vaginal repair (colporrhaphy); Procedure: abdominal paravaginal defect repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00271102

2005-0193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Anterior colporrhaphy

Active Comparator group

Description:

Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)

Treatment:

Procedure: anterior vaginal repair (colporrhaphy)

Procedure: abdominal paravaginal defect repair

Paravaginal defect repair

Active Comparator group

Description:

Abdominal paravaginal defect repair cystocele (dropped bladder)

Treatment:

Procedure: anterior vaginal repair (colporrhaphy)

Procedure: abdominal paravaginal defect repair