Two-year outcomes were similar between women who underwent transvaginal sacrospinous ligament fixation and those who underwent transvaginal uterosacral ligament suspension to correct apical vaginal or uterine prolapse and stress incontinence in the first randomized trial to compare the two approaches.
The 5-year OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial at nine U.S. medical centers participating in the Pelvic Floor Disorders Network involved 374 women randomly assigned to transvaginal surgery for stage 2 through stage 4 prolapse. A total of 186 underwent sacrospinous ligament fixation (SSLF), while 188 patients underwent uterosacral ligament suspension (ULS).
The women also were separately randomized to receive perioperative behavioral therapy with pelvic floor muscle training or usual perioperative care, wrote Dr. Matthew D. Barber of the department of obstetrics and gynecology and the Women’s Health Institute at the Cleveland Clinic. The report appears in the March 11 issue of JAMA.
At 2-year follow-up, neither surgical approach was superior to the other in the composite primary outcome of the percentage of patients with surgical success: 60.5% for SSLF and 59.2% for ULS. The investigators defined successful surgery as the absence of descent of the vaginal apex more than one-third into the vaginal canal; anterior or posterior vaginal wall descent beyond the hymen; bothersome vaginal bulge symptoms; and further treatment for prolapse. The overall rates of failure were 18% for bothersome vaginal bulge, 17.5% for anterior and/or posterior prolapse, and 5.1% for further treatment such as more surgery or use of a pessary.
The two groups were no different in any secondary outcomes such as blood loss, duration of surgery, length of hospitalization, or postoperative treatment. Serious adverse events including bladder perforation and the formation of vaginal granulation tissue occurred in 16.7% of the SSLF group and 16.5% of the ULS group. There were no significant differences between women who received the behavioral intervention and those who did not, the investigators said (JAMA 2014;311:1023-34).
They noted that 4.3% of the women who underwent SSLF developed persistent pain, confirming previous reports that the procedure may cause acute neurologic pain, particularly buttock pain that may result from gluteal nerve entrapment. This highlights "the need to provide preoperative counseling to patients about this potential risk," Dr. Barber and his associates wrote.
This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Some of Dr. Barber’s coauthors reported ties to Astellas, Pfizer, GlaxoSmithKline, Uromedica, IDEO, Xanodyne, Renew Medical, American Medical Systems, Ethicon/Johnson & Johnson, Boston Scientific, and Ferring Pharmaceuticals.