0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Original Investigation |

Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse:  The OPTIMAL Randomized Trial

Matthew D. Barber, MD, MHS1; Linda Brubaker, MD2; Kathryn L. Burgio, PhD3,4; Holly E. Richter, PhD, MD5; Ingrid Nygaard, MD6; Alison C. Weidner, MD7; Shawn A. Menefee, MD8; Emily S. Lukacz, MD9; Peggy Norton, MD6; Joseph Schaffer, MD10; John N. Nguyen, MD11; Diane Borello-France, PhD12; Patricia S. Goode, MD3,4; Sharon Jakus-Waldman, MD11; Cathie Spino, ScD13; Lauren Klein Warren, MS14; Marie G. Gantz, PhD14; Susan F. Meikle, MD15 ; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network
[+] Author Affiliations
1Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio
2Departments of Obstetrics and Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Chicago, Illinois
3Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham
4Department of Veterans Affairs, Birmingham, Alabama
5Department of Obstetrics and Gynecology, University of Alabama at Birmingham
6Department of Obstetrics and Gynecology, University of Utah, Medical Center, Salt Lake City
7Department of Obstetrics and Gynecology, Duke University, Medical Center, Durham, North Carolina
8Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, San Diego
9Department of Reproductive Medicine, University of California San Diego Health Systems
10Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas
11Department of Obstetrics and Gynecology, Southern California Kaiser Permanente, Downey
12Department of Physical Therapy, Duquesne University, Pittsburgh, Pennsylvania
13Department of Biostatistics, University of Michigan, Ann Arbor
14Social, Statistical, and Environmental Sciences, RTI International, Research Triangle Park, North Carolina
15Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland
JAMA. 2014;311(10):1023-1034. doi:10.1001/jama.2014.1719.
Text Size: A A A
Published online

Importance  More than 300 000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.

Objective  To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.

Design, Setting, and Participants  Multicenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.

Interventions  The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).

Main Outcomes and Measures  The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.

Results  At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, −1.3%; 95% CI, −12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, −0.2%; 95% CI, −7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, −6.7; 95% CI, −19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, −8.0; 95% CI, −22.1 to 6.1), or anatomic success at 24 months.

Conclusions and Relevance  Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.

Trial Registration  clinicaltrials.gov Identifier: NCT00597935

Figures in this Article

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Figures

Place holder to copy figure label and caption
Figure.
OPTIMAL Trial Enrollment, Randomization, and Assessment

BPMT indicates behavioral therapy with pelvic floor muscle training; POPDI, Pelvic Organ Prolapse Distress Inventory; SSLF, sacrospinous ligament fixation; ULS, uterosacral ligament suspension.aScreening data not available for 17 mo from 1 site and for 2 mo from 2 sites.bMost common reasons: no stress urinary incontinence (n = 672), other medical condition (n = 228), surgery scheduled <1 month from contact (n = 55).

Graphic Jump Location

Tables

References

Letters

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Sign in

Create a free personal account to sign up for alerts, share articles, and more.

Purchase Options

• Buy this article
• Subscribe to the journal

Related Content

Customize your page view by dragging & repositioning the boxes below.

Related Multimedia

Author Interview

Articles Related By Topic
Related Collections
PubMed Articles
Jobs
JAMAevidence.com

The Rational Clinical Examination
Evidence Summary and Review 5

brightcove.createExperiences();