Document Detail


Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial.
MedLine Citation:
PMID:  24618964     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
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;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  JAMA     Volume:  311     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2014 Mar 
Date Detail:
Created Date:  2014-03-12     Completed Date:  2014-03-31     Revised Date:  2014-10-10    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1023-34     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00597935
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Behavior Therapy*
Exercise Therapy
Female
Gynecologic Surgical Procedures / adverse effects,  methods*
Humans
Middle Aged
Pelvic Floor / physiopathology*
Suburethral Slings
Treatment Outcome
Urinary Incontinence, Stress / surgery*
Urination
Uterine Prolapse / surgery*
Grant Support
ID/Acronym/Agency:
U01 HD041249/HD/NICHD NIH HHS; U01 HD069031/HD/NICHD NIH HHS; U10 HD041250/HD/NICHD NIH HHS; U10 HD041261/HD/NICHD NIH HHS; U10 HD041267/HD/NICHD NIH HHS; U10 HD041267/HD/NICHD NIH HHS; U10 HD054136/HD/NICHD NIH HHS; U10 HD054136/HD/NICHD NIH HHS; U10 HD054214/HD/NICHD NIH HHS; U10 HD054215/HD/NICHD NIH HHS; U10 HD054215/HD/NICHD NIH HHS; U10 HD054241/HD/NICHD NIH HHS
Investigator
Investigator/Affiliation:
Dennis Wallace / ; Kevin A Wilson / ; Daryl Matthews / ; Tamara L Terry / ; Jutta Thornberry / ; Amanda Youmans-Weisbuch / ; Ryan E Whitworth / ; Michael P Hieronymus / ; Morton Brown / ; Nancy Janz / ; John Wei / ; Xiao Xu / ; Beverley Marchant / ; Donna DiFranco / ; Yang Casher / ; Kristina Slusser / ; Zhen Chen / ; Mark D Walters / ; J Eric Jelovsek / ; Marie F R Paraiso / ; Beri M Ridgeway / ; Ly Pung / ; Cheryl Williams / ; Linda McElrath / ; Betsy O'Dougherty / ; Megan Edgehouse / ; Gouri Diwadkar / ; Anna Frick / ; Mary Tulke / ; Elizabeth Mueller / ; Kimberly Kenton / ; Kathleen Jesse / ; Charles W Nager / ; Michael E Albo / ; Cara Grimes / ; Heidi W Brown / ; Anna C Kirby / ; Leah Merrin / ; JoAnn Columbo / ; Nehal Mehta / ; Mercedes Cardona / ; Eudocia Zapata / ; Emily L Whitcomb / ; Keisha Y Dyer / ; Karl M Luber / ; Jasmine Tan-Kim / ; Gouri B Diwadkar / ; Lynn M Hall / ; Linda M Mackinnon / ; Gisselle Zazueta-Damian / ; Yvonne Hsu / ; Jan Baker / ; Linda Freedman / ; Linda Griffin / ; Maria Masters / ; Amy Orr / ; Kristina Heintz / ; R Edward Varner / ; Robert Holley / ; William J Greer / ; L Keith Lloyd / ; Tracy S Wilson / ; Alayne Markland / ; Jonathan L Gleason / ; Alicia Ballard / ; Candace Parker-Autry / ; Lisa Pair / ; Velria Willis / ; Nancy Saxon / ; Lachele Ward / ; Kathy Carter / ; Julie Burge / ; Anthony G Visco / ; Cindy L Amundsen / ; Nazema Y Siddiqui / ; Jennifer M Wu / ; Mary Raynor / ; Mary McGuire / ; Ingrid Harm-Ernandes / ; David Rahn / ; Marlene Corton / ; Clifford Wai / ; Kelly Moore / ; Shanna Atnip / ; Pam Martinez / ; Deborah Lawson / ; Anne Weber / ; Katherine Hartmann /
Comments/Corrections
Comment In:
Am J Nurs. 2014 Sep;114(9):70   [PMID:  25166255 ]

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