This trial is evaluating two types of surgery to insert slings which fix pelvic organ prolapse. These surgeries may cause stress incontinence. The main outcome to be measured in this trial is the number of patients with stress incontinence after sling surgery. This trial is being carried out in North Carolina and Rhode Island, USA.
The details
Stress incontinence is urine leakage when there is pressure on the bladder. It is often observed when a patient coughs, sneezes or exercises. Stress incontinence happens as a result of weak muscles around the bladder that hold urine in. These muscles may be weakened by pelvic surgery. A lot of women have surgery to fix a pelvic organ prolapse (when organs in the pelvis slip down from their normal position into the vagina). Sometimes this surgery causes stress incontinence.
Surgical slings are used for pelvic organ prolapse. Surgeons insert a sling which then supports the pelvic organs and stops the prolapse. The type of surgery carried out to fit the sling can affect whether or not a patient will develop stress incontinence. The main outcome to be measured in this trial is the number of patients who have stress incontinence and urinary symptoms after sling surgery.
Who are they looking for?
280 patients are needed for this study. To be included in this trial, patients must have pelvic organ prolapse of more than stage 2 and be considered for a native tissue vaginal repair.
Patients cannot be included in the study if they had prior surgery for stress urinary incontinence or prior radiation to the pelvic area. Patients cannot be pregnant or planning to get pregnant within the year after surgery. Patients cannot have poorly controlled diabetes mellitus. Patients cannot have planned bowel related surgery.
How will it work
Patients will be randomly assigned to 1 of 2 groups. Group 1 will have retropubic surgery (a type of lower abdominal surgery) to fit the sling. Group 2 will have single-incision surgery (involves only one incision to the vagina wall) to fit the sling. Patients will fill out questionnaires 12 months after surgery. These will assess the occurrence of stress incontinence, urinary symptoms, complications, patient satisfaction, and pain.
