Urological Survey Voiding Function and Dysfunction, Bladder Physiology and Pharmacology, and Female Urology Re: Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial M. D. Barber, L. Brubaker, K. L. Burgio, H. E. Richter, I. Nygaard, A. C. Weidner, S. A. Menefee, E. S. Lukacz, P. Norton, J. Schaffer, J. N. Nguyen, D. Borello-France, P. S. Goode, S. Jakus-Waldman, C. Spino, L. K. Warren, M. G. Gantz and S. F. Meikle; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network Cleveland Clinic, Cleveland, Ohio, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois, University of Alabama at Birmingham and Department of Veterans Affairs, Birmingham, Alabama, University of Utah Medical Center, Salt Lake City, Utah, Duke University Medical Center, Durham and RTI International, Research Triangle Park, North Carolina, Southern California Kaiser Permanente and University of California San Diego Health Systems, San Diego, California, University of Texas Southwestern Medical Center, Dallas, Texas, Duquesne University, Pittsburgh, Pennsylvania, University of Michigan, Ann Arbor, Michigan, and Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland JAMA 2014; 311: 1023e1034.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2014.12.079 available at http://jurology.com/ Editorial Comment: This report details a comparison of 2 surgical procedures in women 18 years or older undergoing vaginal surgery for stages 2 through 4 prolapse (vaginal or uterine descent 1 cm proximal to the hymen or beyond) with complaints of vaginal bulge symptoms, descent of the vaginal apex at least halfway into the vagina, stress urinary incontinence symptoms and objective demonstration of stress incontinence by office or urodynamic testing. The 2 surgical procedures were sacrospinous ligament fixation (SSLF) and uterosacral ligament vaginal vault suspension (ULS). All patients with uterine prolapse underwent vaginal hysterectomy. A concomitant retropubic mid urethral sling was performed for stress urinary incontinence in addition. There was no biological or synthetic graft material used for the prolapse repair. In addition, because behavioral therapy with pelvic floor muscle training (BPMT) has been reported to be an effective treatment for pelvic floor symptoms, patients were randomized to perioperative BPMT plus usual and routine perioperative care, or usual and routine perioperative care alone. Surgical success, the primary outcome for the surgical intervention, was defined as 1) no apical descent greater than a third into the vaginal canal or anterior or posterior vaginal wall behind the hymen (anatomical success), 2) no bothersome vaginal bulge symptoms and 3) no repeat treatment for prolapse for 2 years. For the BPMT trial the primary outcome was urinary symptom scores at 6 months and prolapse symptom scores at 2 years. At 2 years the type of surgery was not significantly associated with surgical success rates (SSLF 60.5% vs ULS 59.2%), nor were serious adverse event rates (16.7% vs 16.5%). Perioperative BPMT was not associated with greater improvement in urinary scores at 6 months or prolapse scores at 24 months. One gets a glimpse at anatomical success rates by looking at the comparison of failure between behavioral groups within each surgical treatment, ie SSLF plus BPMT, 24.7%; SSLF plus usual care, 33.8% (adjusted odds ratio 0.6); ULF plus BPMT, 33.3%, and ULF plus usual care, 25.6% (adjusted odds ratio 1.8). The criteria for success were quite rigorous and thus lower than the 70% to 90% rates generally reported in the literature for these procedures. Serious adverse events occurred in 16.7% of 0022-5347/15/1933-0943/0 THE JOURNAL OF UROLOGY® © 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2014.12.079 Vol. 193, 943-955, March 2015 Printed in U.S.A.
www.jurology.com
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the SSLF group and 16.5% of the ULS group. There were more ureteral obstructions after ULS (3.2% vs 0%). The rate of neurological pain requiring intervention was higher in the SSLF group (12.4% vs 6.9%). This finding persisted at the 4 to 6-week postoperative visit in more SSLF patients than ULS patients (4.3% vs 0.5%). The ureteral obstruction was recognized and managed intraoperatively in all but 1 case in the ULF group. This is a very well done and precisely reported study that is useful for preoperative discussions of likely and possible adverse events. As the authors suggest, these data “provide a metric against which other vaginal procedures, including those that use synthetic or biologic mesh, can be assessed.” Alan J. Wein, MD, PhD (hon)
Re: Outcomes of Vaginal Prolapse Surgery among Female Medicare Beneficiaries: The Role of Apical Support K. S. Eilber, M. Alperin, A. Khan, N. Wu, C. L. Pashos, J. Q. Clemens and J. T. Anger Division of Urology, Department of Surgery, Cedars-Sinai Medical Center and Department of Urology, University of California, Los Angeles, Los Angeles, Department of Reproductive Medicine, University of California, San Diego School of Medicine, San Diego and United BioSource Corp., San Francisco, California, and Department of Urology, University of Michigan, Ann Arbor, Michigan Obstet Gynecol 2013; 122: 981e987.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2014.12.080 available at http://jurology.com/ Editorial Comment: This study, partially funded by the National Institute of Diabetes and Digestive and Kidney Diseases, looked at only long-term reoperation rates after prolapse surgery performed with and without apical support, specifically in patients who underwent surgery during 1999 and who were followed through 2009. A 5% random national sample of such patients was analyzed. The primary outcome was the rate of repeat treatment, specifically reoperation for prolapse. Insertion of a pessary was also included as evidence of a symptomatic prolapse recurrence. Although it is difficult at some points in the article to separate “recurrence” from “reoperation,” the main point is that the highest cumulative reoperation rate was observed in women who initially underwent an isolated anterior colporrhaphy (20.2%). The reoperation rate was significantly greater than that seen in women who underwent anterior colporrhaphy combined with a procedure for apical support (11.6%, p
Abstract for this article http://dx.doi.org/10.1016/j.juro.2014.12.079 available at http://jurology.com/ Editorial Comment: This report details a comparison of 2 surgical procedures in women 18 years or older undergoing vaginal surgery for stages 2 through 4 prolapse (vaginal or uterine descent 1 cm proximal to the hymen or beyond) with complaints of vaginal bulge symptoms, descent of the vaginal apex at least halfway into the vagina, stress urinary incontinence symptoms and objective demonstration of stress incontinence by office or urodynamic testing. The 2 surgical procedures were sacrospinous ligament fixation (SSLF) and uterosacral ligament vaginal vault suspension (ULS). All patients with uterine prolapse underwent vaginal hysterectomy. A concomitant retropubic mid urethral sling was performed for stress urinary incontinence in addition. There was no biological or synthetic graft material used for the prolapse repair. In addition, because behavioral therapy with pelvic floor muscle training (BPMT) has been reported to be an effective treatment for pelvic floor symptoms, patients were randomized to perioperative BPMT plus usual and routine perioperative care, or usual and routine perioperative care alone. Surgical success, the primary outcome for the surgical intervention, was defined as 1) no apical descent greater than a third into the vaginal canal or anterior or posterior vaginal wall behind the hymen (anatomical success), 2) no bothersome vaginal bulge symptoms and 3) no repeat treatment for prolapse for 2 years. For the BPMT trial the primary outcome was urinary symptom scores at 6 months and prolapse symptom scores at 2 years. At 2 years the type of surgery was not significantly associated with surgical success rates (SSLF 60.5% vs ULS 59.2%), nor were serious adverse event rates (16.7% vs 16.5%). Perioperative BPMT was not associated with greater improvement in urinary scores at 6 months or prolapse scores at 24 months. One gets a glimpse at anatomical success rates by looking at the comparison of failure between behavioral groups within each surgical treatment, ie SSLF plus BPMT, 24.7%; SSLF plus usual care, 33.8% (adjusted odds ratio 0.6); ULF plus BPMT, 33.3%, and ULF plus usual care, 25.6% (adjusted odds ratio 1.8). The criteria for success were quite rigorous and thus lower than the 70% to 90% rates generally reported in the literature for these procedures. Serious adverse events occurred in 16.7% of 0022-5347/15/1933-0943/0 THE JOURNAL OF UROLOGY® © 2015 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
AND
RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2014.12.079 Vol. 193, 943-955, March 2015 Printed in U.S.A.
www.jurology.com
j
943
944
VOIDING FUNCTION, BLADDER PHYSIOLOGY AND PHARMACOLOGY, AND FEMALE UROLOGY
the SSLF group and 16.5% of the ULS group. There were more ureteral obstructions after ULS (3.2% vs 0%). The rate of neurological pain requiring intervention was higher in the SSLF group (12.4% vs 6.9%). This finding persisted at the 4 to 6-week postoperative visit in more SSLF patients than ULS patients (4.3% vs 0.5%). The ureteral obstruction was recognized and managed intraoperatively in all but 1 case in the ULF group. This is a very well done and precisely reported study that is useful for preoperative discussions of likely and possible adverse events. As the authors suggest, these data “provide a metric against which other vaginal procedures, including those that use synthetic or biologic mesh, can be assessed.” Alan J. Wein, MD, PhD (hon)
Re: Outcomes of Vaginal Prolapse Surgery among Female Medicare Beneficiaries: The Role of Apical Support K. S. Eilber, M. Alperin, A. Khan, N. Wu, C. L. Pashos, J. Q. Clemens and J. T. Anger Division of Urology, Department of Surgery, Cedars-Sinai Medical Center and Department of Urology, University of California, Los Angeles, Los Angeles, Department of Reproductive Medicine, University of California, San Diego School of Medicine, San Diego and United BioSource Corp., San Francisco, California, and Department of Urology, University of Michigan, Ann Arbor, Michigan Obstet Gynecol 2013; 122: 981e987.
Abstract for this article http://dx.doi.org/10.1016/j.juro.2014.12.080 available at http://jurology.com/ Editorial Comment: This study, partially funded by the National Institute of Diabetes and Digestive and Kidney Diseases, looked at only long-term reoperation rates after prolapse surgery performed with and without apical support, specifically in patients who underwent surgery during 1999 and who were followed through 2009. A 5% random national sample of such patients was analyzed. The primary outcome was the rate of repeat treatment, specifically reoperation for prolapse. Insertion of a pessary was also included as evidence of a symptomatic prolapse recurrence. Although it is difficult at some points in the article to separate “recurrence” from “reoperation,” the main point is that the highest cumulative reoperation rate was observed in women who initially underwent an isolated anterior colporrhaphy (20.2%). The reoperation rate was significantly greater than that seen in women who underwent anterior colporrhaphy combined with a procedure for apical support (11.6%, p
