FIVE-YEAR OUTCOMES OF UTEROSACRALLIGAMENT SUSPENSION OR SACROSPINOUS LIGAMENT FIXATION FOR APICALPELVIC ORGAN PROLAPSE: A RANDOMIZED TRIAL
J. E. JELOVSEK1, L.BRUBAKER 2, M. GANTZ 3, N. PUGH 3,A. C. WEIDNER 4, H. E. RICHTER 5, S. MENEFEE 6,P. NORTON 7, J. SCHAFFER 8, S. MEIKLE 9,M. D. BARBER 10;
1Obstetrics, Gynecology &Women's Health Institute, Cleveland Clinic, Cleveland, OH, 2ObGynand Urology, Loyola Univ. Chicago Stritch SOM, Maywood, IL, 3RTIIntl., Research Triangle Park, NC, 4Duke Univ., Durham,NC, 5Univ. of Alabama at Birmingham, Birmingham, AL,6Kaiser, San Diego, CA, 7Obstetrics andGynecology, Univ. of Utah, Salt Lake City, UT, 8UTSouthwestern, Dallas, TX, 9NIH, Bethesda, MD, 10ClevelandClinic, Cleveland, OH.
Introduction: Uterosacralligament suspension (ULS) and Sacrospinous Ligament Fixation (SSLF)are commonly performed vaginal surgeries for pelvic organ prolapsebut little is known about the long-term effectiveness of these twoprocedures.
Objective: Operations and Pelvic MuscleTraining in the Management of Apical Support Loss (OPTIMAL) trialparticipants with Stage II-IV pelvic organ prolapse (POP) and stressurinary incontinence were randomized to ULS or SSLF. In this study, 5year outcomes were assessed.
Methods: Ninety-two percent(285/309) of eligible 2-year OPTIMAL trial completers consented toparticipate in the extended-OPTIMAL study; 273 (96%), 251 (88%), 244(86%) had assessments at 3, 4 and 5-years, respectively, between 2008and 2013 at nine US medical centers. The surgical intervention wastransvaginal surgery including midurethral sling with randomizationto ULS (n=147) or SSLF (n=138); the behavioral intervention wasrandomization to perioperative behavioral therapy with pelvic floormuscle training (PBMT) (n=141) or usual care (n=144). The primarysurgical outcome was defined as time to anatomic or symptomaticfailure or retreatment. Consistent with the primary OPTIMAL study,anatomic failure was defined as apical descent greater than one-thirdof vaginal length (POPQ C > -2/3TVL) or anterior or posteriorvaginal wall beyond the hymen (POPQ Ba or Bp > 0) and symptomaticfailure was defined as bothersome vaginal bulge symptoms. The primaryoutcome for the behavioral intervention was anatomic failure asdefined for the surgical intervention and development of POP symptomsmeasured by the POPDI subscale of the PFDI.
Results: Byyear 5, the estimated probabilities of success from parametricsurvival modeling (Figure) for the ULS group and the SSLF group,respectively, were 0.44 and 0.33 for the primary outcome (differenceof 0.10; 95%CI -0.06, 0.27), 0.57 and 0.42 for anatomic POP(difference of 0.16; 95%CI -0.04, 0.35) and 0.64 and 0.62 forsymptomatic POP (difference of 0.02; 95%CI -0.14, 0.18). POPretreatment at 5 years was 12% and 8% (OR 1.6; 95%CI 0.6, 4.1)including pessary (4.2%) and repeat surgery (5.3%). The 117 anatomicfailures involved the apex only (29%), anterior or posteriorcompartment only (36%) or both apex and anterior or posteriorcompartment (35%). Quality of life scores improved from baseline to 5years including: -68.5 and -74.3 for POPDI (adjusted mean difference(AMD) of 5.9; 95%CI -10.2, 21.9), -76.2 and -80.4 for UDI (AMD of4.2; 95%CI -10.6, 19), and -42.4 and -44 for CRADI (AMD of 1.6; 95%CI-17.3, 20.5). Odds of granulation tissue (6 months to 5 years) werehigher in the ULS group (OR 1.9; 95%CI 1, 3.7) without groupdifferences in suture exposure or mesh erosion/exposure. By year 5,the estimated probabilities of anatomic success for the PBMT groupand the usual care group, respectively, were 0.54 and 0.54(difference of 0.004; 95%CI -0.21, 0.22) with no treatment differencein improvement of POPDI scores -60 and -62 (AMD of 2.1; 95%CI -14,18.1).
Conclusions: Five years after vaginal surgery forStage II-IV POP and SUI, women randomized to ULS and SSLF whoconsented to extended follow up have similar overall anatomic andsubjective surgical cure rates, low rates of retreatment for POP, andsignificant improvement in quality of life.
References:Comparison of 2 transvaginal surgical approaches and perioperativebehavioral therapy for apical vaginal prolapse: the OPTIMALrandomized trial. JAMA. 2014;311(10):1023-1034.