The American Urogynecologic Society (AUGS) operates a quality improvement registry (AQUIRE) that is collecting information on surgical and nonsurgical treatment of POP and stress urinary incontinence – including surgical complications – from a diverse group of physicians, not just those at academic medical centers. AUGS is growing its registry this year to include device identifiers and patient-reported outcomes that are sent directly to the registry by the patient.
The panel generally agreed that postmarket follow-up of synthetic mesh for transvaginal anterior repair of POP should extend up to 5 years, Dr. Isaacson said, though “from the patients’ perspective, 10 years of experience [is meaningful].”
Geoffrey Cundiff, MD, who is AUGS president, told the committee that there are lessons to be gleaned from the CARE trial, which looked at outcomes up to 7 years after abdominal sacrocolpopexy (JAMA. 2013 May 15;309[19]:2016-24). “At 7 years, the complications [including rates of mesh erosion] had increased,” he said. “It’s a different procedure, but it’s a good example.”
Prior to its deliberations, the panel heard preliminary results of the ongoing SUPeR trial (Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22[4]:182-9), a randomized, controlled superiority trial of vaginal hysterectomy with suture apical suspension versus uterine conservation with vaginal mesh (Boston Scientific’s Uphold LITE) hysteropexy for uterovaginal prolapse. Researchers have found comparable rates of primary outcome success – no objective prolapse beyond the hymen, no retreatment, and no bulge symptoms – through 36 months and no differences in patient-reported outcomes thus far.
Hysteroplexy mesh exposure rates were approximately 8% at 36 months, and suture exposure and excessive granulation were 11%-20% in the hysterectomy group. None of these exposure cases has required reoperation. Both groups have shown improvements in sexual function and decreases in dyspareunia, said Charles W. Nager, MD, a San Diego ob.gyn. who is primary investigator of the trial.
The trial is sponsored by the Pelvic Floor Disorders Network of the National Institute of Child Health and Human Development, as was the CARE trial of abdominal sacrocolpopexy. It is following patients for 60 months and collecting data every 6 months, including data from validated functional and quality of life assessments. Patients were masked to their treatment assignment to eliminate patient reporting bias. At 36 months, approximately three-quarters of the patients in each group remained masked.
In addition to the ongoing 522 studies for anterior/apical prolapse, there is another 522 study underway of a mesh device designed for transvaginal repair of total prolapse (the Acell Matristem Pelvic Floor Repair Matrix). In addition, Coloplast is studying a mesh device designed for posterior/apical prolapse (Restorelle DirectFix) as part of its 522 study. Neither device is being marketed currently, however.