Of the different types of vaginal surgery to repair pelvic organ prolapse (the downward descent of the pelvic organs that results in a protrusion of the vagina, uterus, or both) there is not enough information about which surgery provides the best symptom relief while causing the fewest problems (complications) after surgery. The study population will consist of women with Stage 2-4 prolapse and stress urinary incontinence symptoms who have prolapse at the vaginal apex or uterus and are scheduled for prolapse surgery via a vaginal approach. Prolapse often involves a combination of support defects; of all these repairs the apical suspension procedures have the highest reoperations for surgical failure. Two of the most common vaginal surgeries used to repair apical prolapse are the sacrospinous ligament fixation, called SSLF for short, and the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis. One aim of the study is to find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina (apical prolapse).
Many women who are planning surgery for apical vaginal prolapse also have bladder and bowel symptoms, as well as bulge symptoms. Study eligible patients will have stress urinary incontinence which will be treated surgically with a Tension-Free Vaginal Tape (TVT®) in addition to prolapse repair. Combining prolapse surgery with pelvic muscle exercises and behavioral changes may relieve symptoms that were present before surgery or prevent new symptoms from developing after surgery. Whether PMT is effective in reducing the recurrence of prolapse or its symptoms in the long-term is unknown. Timing the practice of pelvic muscle training shortly before and after surgery for prolapse and urinary incontinence may enhance the outcome of the training and possibly help the results of the prolapse surgery to last longer. The assessment of the short- and long-term effects and the cost-effectiveness of perioperative PMT on the full range of pelvic floor disorders symptoms as well as sexual, QOL and anatomic outcomes of women undergoing vaginal surgery for advanced prolapse, will provide substantial insight into the potential merits of this adjunctive treatment. .
Study surgeons and coordinators will screen eligible individuals. Study eligible patients will be approached to consent for the study. The consented patients’ medical, surgical and obstetrical histories will be collected by interview and medical record review to establish baseline data pre-operatively. Research staff will perform a pelvic examination and assess the stage of prolapse. All physical examinations will be performed by appropriately trained research staff at the clinical site. Subjects who are randomized to perioperative PMT will receive a formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery.
Randomization to the PMT Intervention (PMT vs. usual care) is done preoperatively. Participants will be randomized in the operating room to the surgical intervention (SSLF or ULS). Subjects will receive the allocated vaginal vault suspension along with other vaginal prolapse surgery as indicated and surgical treatment for stress incontinence. The primary outcome measure for the surgical intervention will be surgical “success” or “failure” as a dichotomous outcome at 2 years after surgery. The primary outcome measure has 2 components:
(1) an anatomic assessment of prolapse, using the Pelvic Organ Prolapse Quantification (POPQ) system, and
(2) the presence or absence of bulge symptoms specific to prolapse.
The intent is to assess the superiority of each of the two interventions.
Participation in the study may last for 2 years. The study will include seven to eight clinic visits; a maximum of four study nurse telephone calls and four quality of life telephone interviews over the 24 months of the study. Participants randomized to the perioperative PMT treatment will have an additional visit preoperatively and at 8 weeks post-operatively.