Isuzu Meyer1, Ryan E Whitworth2, Emily S Lukacz3, Ariana L Smith4, Vivian W Sung5, Anthony G Visco6, Mary F Ackenbom7, Clifford Y Wai8, Donna Mazloomdoost9, Marie G Gantz2, Holly E Richter10. 1. Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu. 2. RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA. 3. Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA. 4. Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA. 5. Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA. 6. Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA. 7. Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA. 8. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA. 9. The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. 10. Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.
Abstract
INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS:Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence. METHODS: This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse. RESULTS: Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II. CONCLUSIONS: Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
Authors: Matthew D Barber; Linda Brubaker; Kathryn L Burgio; Holly E Richter; Ingrid Nygaard; Alison C Weidner; Shawn A Menefee; Emily S Lukacz; Peggy Norton; Joseph Schaffer; John N Nguyen; Diane Borello-France; Patricia S Goode; Sharon Jakus-Waldman; Cathie Spino; Lauren Klein Warren; Marie G Gantz; Susan F Meikle Journal: JAMA Date: 2014-03-12 Impact factor: 56.272
Authors: Matthew D Barber; Linda Brubaker; Ingrid Nygaard; Thomas L Wheeler; Joeseph Schaffer; Zhen Chen; Cathie Spino Journal: Obstet Gynecol Date: 2009-09 Impact factor: 7.661