Skip to main content
Journal cover image

Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.

Publication ,  Journal Article
Brubaker, L; Nager, CW; Richter, HE; Weidner, AC; Hsu, Y; Wai, CY; Paraiso, M; Nolen, TL; Wallace, D; Meikle, S ...
Published in: Am J Obstet Gynecol
November 2014

OBJECTIVE: This planned secondary analysis of the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial assessed whether treatment knowledge differed between randomized groups at 12 months and whether treatment success was affected by treatment perception. STUDY DESIGN: Sham suprapubic tension-free vaginal tape (TVT) incisions were made in the Outcomes Following Vaginal Prolapse Repairs and Midurethral Sling trial participants randomized to no-TVT. Primary surgical outcomes and maintenance of blinding was assessed at 12 months. Knowledge of treatment assignment was compared between groups, and the relationship with treatment success rates was assessed. RESULTS: Prior to the 12 month postoperative visit, only 4% of treated participants (13 of 336) formally reported unmasking. At 12 months, 94% of the randomized participants (315 of 336) provided treatment knowledge data. Sixteen TVT participants (10%) reported treatment knowledge; most (n = 15, 94%) were correct; 17 of the sham participants (11%) reported treatment knowledge; half (n = 8, 47%) were correct. Similar proportions of unmasked participants who reported no treatment knowledge correctly guessed/perceived treatment assignment (sham, 46 [33%] vs TVT, 44 [33%]). We did not detect significant differences in treatment success rates based on perception within and across received treatment groups (perceived sham vs TVT overall [P = .76]). Of those receiving TVT, more participants perceiving TVT had treatment success compared with those who perceived sham (84% vs 74%; P = .29). Among sham participants, more participants perceiving sham had success compared with those who perceived receiving TVT (65% vs 56%; P = .42). CONCLUSION: Sham surgical incisions effectively mask TVT randomization. These findings may help to inform future surgical trial designs.

Duke Scholars

Published In

Am J Obstet Gynecol

DOI

EISSN

1097-6868

Publication Date

November 2014

Volume

211

Issue

5

Start / End Page

554.e1 / 554.e7

Location

United States

Related Subject Headings

  • Uterine Prolapse
  • Urinary Incontinence, Stress
  • Treatment Outcome
  • Suburethral Slings
  • Randomized Controlled Trials as Topic
  • Placebos
  • Placebo Effect
  • Perception
  • Obstetrics & Reproductive Medicine
  • Logistic Models
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Brubaker, L., Nager, C. W., Richter, H. E., Weidner, A. C., Hsu, Y., Wai, C. Y., … NICHD Pelvic Floor Disorders Network, . (2014). Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol, 211(5), 554.e1-554.e7. https://doi.org/10.1016/j.ajog.2014.07.009
Brubaker, Linda, Charles W. Nager, Holly E. Richter, Alison C. Weidner, Yvonne Hsu, Clifford Y. Wai, Marie Paraiso, et al. “Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.Am J Obstet Gynecol 211, no. 5 (November 2014): 554.e1-554.e7. https://doi.org/10.1016/j.ajog.2014.07.009.
Brubaker L, Nager CW, Richter HE, Weidner AC, Hsu Y, Wai CY, et al. Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol. 2014 Nov;211(5):554.e1-554.e7.
Brubaker, Linda, et al. “Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery.Am J Obstet Gynecol, vol. 211, no. 5, Nov. 2014, pp. 554.e1-554.e7. Pubmed, doi:10.1016/j.ajog.2014.07.009.
Brubaker L, Nager CW, Richter HE, Weidner AC, Hsu Y, Wai CY, Paraiso M, Nolen TL, Wallace D, Meikle S, NICHD Pelvic Floor Disorders Network. Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol. 2014 Nov;211(5):554.e1-554.e7.
Journal cover image

Published In

Am J Obstet Gynecol

DOI

EISSN

1097-6868

Publication Date

November 2014

Volume

211

Issue

5

Start / End Page

554.e1 / 554.e7

Location

United States

Related Subject Headings

  • Uterine Prolapse
  • Urinary Incontinence, Stress
  • Treatment Outcome
  • Suburethral Slings
  • Randomized Controlled Trials as Topic
  • Placebos
  • Placebo Effect
  • Perception
  • Obstetrics & Reproductive Medicine
  • Logistic Models