Research from the University of Alabama at Birmingham and other medical centers published in the Journal of the American Medical Association has determined that neither of the two most common surgical procedures for apical vaginal prolapse is significantly superior to the other for anatomic, functional or adverse event outcomes.
Apical prolapse is a descent of the uterus, cervix or vaginal vault and affects a significant proportion of women, with approximately 300,000 inpatient surgical procedures for prolapse performed annually in the United States. Women with prolapse have numerous associated complaints, including the feeling of protrusion or pressure in the vagina. The condition can be so severe that, in some cases, women can see or feel the protrusion through the vagina.
Sacrospinous ligament fixation and uterosacral ligament suspension are commonly performed transvaginal surgeries to correct apical prolapse. Little was known about their comparative efficacy and safety prior to this trial, says study co-author Holly E. Richter, Ph.D., M.D., professor of obstetrics and gynecology, J. Marion Sims Endowed Chair in Obstetrics and Gynecology, and director of the UAB Division of Urogynecology and Pelvic Reconstructive Surgery in the School of Medicine.
“There were not good level one trials that had addressed these issues up to this point,” Richter said. “The findings impact our management of patients in that we can feel good regarding the outcomes of performing either a uterosacral or sacrospinous suspension for apical prolapse as performed in this trial.”
The landmark trial for the surgical management of the condition also revealed that perioperative behavioral therapy at the time of uterosacral or sacrospinous suspension for apical prolapse is not indicated at this time, says Kathryn Burgio, Ph.D., professor of gerontology/geriatrics/palliative care and co-investigator with Richter. Burgio led the design and implementation of the perioperative behavioral therapy intervention for this trial.
The trial was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which sponsors the Pelvic Floor Disorders Network. UAB was one of the original sites in the network, and investigators have been conducting trials and studies on various pelvic floor disorders including pelvic organ prolapse, urinary and bowel incontinence in women as part of the network for 14 years. The UAB site was the largest recruiter for this trial.
In addition to seeing or feeling protrusion, women can experience urinary leakage with apical vaginal prolapse. These conditions can significantly hinder daily activities.
“They don't feel good about doing their usual activities — running, exercising, interacting on a social level,” Richter said. “It impacts all areas of their lives. Women are living longer now and really want to maintain a quality of life so they can keep busy. That means they are seeking care for these types of conditions in increasing numbers.”
This study, known as the OPTIMAL Randomized Trial, was a factorial-designed randomized trial that looked at patients two years after surgery. The study was done in women with an average age of 57 who had symptomatic pelvic organ prolapse and urinary incontinence and were undergoing surgery for these conditions.
For patients to be in this study, the apex of the vagina had to come more than halfway down the total length of the vagina. Women would randomize to either the sacrospinous ligament fixation or the uterosacral ligament suspension in the operating room.
|“The perioperative behavioral therapy outcome was a little surprising. The primary outcome time point for the perioperative intervention was at six months and characterized urinary symptoms; at two years, we primarily assessed prolapse anatomy and symptoms. I thought we might see some benefit at the six-month follow-up and was a bit surprised that we did not.”|
However, preoperatively, they randomized to getting a perioperative behavioral intervention. In this intervention, women were given training in terms of strategies regarding urinary leakage, bowel incontinence and prolapse, as well as pelvic muscle exercises with education regarding the use of their muscles.
Richter says the results of the study, at least in the surgical randomization, were not a surprise.
“My partners and I have been doing both of these techniques for years, and in our hands, we really felt very good about both of them,” Richter said. “The perioperative behavioral therapy outcome was a little surprising. The primary outcome time point for the perioperative intervention was at six months and characterized urinary symptoms; at two years, we primarily assessed prolapse anatomy and symptoms. I thought we might see some benefit at the six-month follow-up and was a bit surprised that we did not.”
The surgeons did not know whether the patients received the behavioral therapy or not.
While the study answered questions in terms of the clinical management of apical prolapse, it also gave researchers other questions to explore.
“We know that both of these procedures have comparable efficacy in a transvaginal approach to the management of prolapse, but we also address prolapse with an abdominal approach at times,” Richter said. “A good next trial may be to look at whether there is a difference in outcomes in a vaginal approach versus an abdominal approach for the treatment of pelvic organ prolapse.
“The behavioral therapy intervention did not work in this trial, but there may be something we can alter in this intervention that might benefit women with these conditions.”
Other UAB clinical investigators participating in the trial include R. Edward Varner, M.D., Robert Holley, M.D., Patricia Goode, M.D., and Alayne Markland, D.O.
Patients for this trial were recruited through both the Urogynecology Care and Continence clinics, which have been designated Centers of Excellence by the National Association for Continence.