With the increasing prevalence of pelvic floor disorders among our aging population, women’s health clinicians should be prepared to counsel patients on treatment options and posttreatment expectations. In this Update, we will review recent literature on surgical treatments for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). We also include our review of an award-winning and practice-changing study on office-based pessary care. Lastly, we will finish with a summary of a recent Society of Gynecologic Surgeons collaborative systematic review on sexual function after surgery.
5-year RCT data on hysteropexy vs hysterectomy for POP
Nager CW, Visco AG, Richter HE, et al; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. Am J Obstet Gynecol. 2021;225:153. e1-153.e31. doi: 10.1016/j.ajog.2021.03.012.
The Pelvic Floor Disorders Network conducted a multisite randomized superiority trial comparing sacrospinous hysteropexy with mesh graft to vaginal hysterectomy with uterosacral ligament suspension for POP.
Study details
Postmenopausal women who desired surgery for symptomatic uterovaginal prolapse were randomly assigned to sacrospinous hysteropexy with polypropylene mesh graft using the Uphold-LITE device (Boston Scientific) versus vaginal hysterectomy with uterosacral ligament suspension. Participants were masked to treatment allocation and completed study visits at 6-month intervals through 60 months. Quantitative prolapse POP-Q exams were performed and patients completed multiple validated questionnaires regarding the presence; severity; and impact of prolapse, urinary, bowel, and pelvic pain symptoms.
Results
A total of 183 postmenopausal women were randomized, and 156 (81 hysteropexy and 75 hysterectomy) patients completed 5-year follow up with no demographic differences between the 2 intervention groups. Operative time was statistically less in the hysteropexy group (111.5 min vs 156.7 min). There were fewer treatment failures (a composite including retreatment for prolapse, prolapse beyond the hymen, and/or bothersome bulge symptoms) in the hysteropexy than in the hysterectomy group (37% vs 54%, respectively) at 5 years of follow up. However, most patients with treatment failure were classified as an intermittent failure, with only 16% of hysteropexy patients and 22% of hysterectomy patients classified as persistent failures. There were no meaningful differences between patient-reported outcomes. Hysteropexy had an 8% mesh exposure risk, with none requiring surgical management.
This study represents the highest quality randomized trial design and boasts high patient retention rates and 5-year follow up. Findings support further investigation on the use of polypropylene mesh for POP. In April of 2019, the US Food and Drug Administration halted the selling and distribution of vaginal mesh products for prolapse repair given the lack of safety outcomes, concerns about mesh exposure rates, and possible increased rates of pelvic pain and adverse events. This study invites pelvic reconstructive surgeons to revisit the debate of hysteropexy versus hysterectomy and synthetic mesh versus native tissue repairs. The 8% mesh exposure rate represents a challenge for the future design and development of vaginal implant materials, weighing the balancing of improved long-term efficacy with the safety and complication concerns.
Continue to: Preliminary 12-month data for a single-incision sling for surgical management of SUI...