Danielle D Antosh1, Cheryl B Iglesia, Sonali Vora, Andrew I Sokol. 1. Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington Hospital Center, George Washington University, Washington, DC, USA.
Abstract
OBJECTIVE: To determine whether blinded and unblinded Pelvic Organ Prolapse Quantification (POP-Q) examinations differ in a randomized trial. STUDY DESIGN: Blinded POP-Q examinations performed at 3 months and 1 year were compared with unblinded examinations performed by the surgeon in a randomized trial of vaginal mesh for pelvic organ prolapse. RESULTS:Sixty-five patients were included in the study. Correlations between the blinded and unblinded POP-Q points and stages varied from low to moderate (rho = 0.29-0.78). At 3 months, the blinded overall prolapse recurrence rate was 45.3% compared with 39.1% based on unblinded staging (P = .34). At 1 year, the blinded overall recurrence rate was significantly higher than the unblinded recurrence rate: 68.3% vs 53.3% (P = .004). The 1-year blinded anterior wall recurrence rate was also higher than the recurrence based on unblinded staging: 56.7% vs 43.3% (P = .021). CONCLUSION: Use of unblinded POP-Q staging resulted in underestimation of 1-year overall recurrence after prolapse repair.
RCT Entities:
OBJECTIVE: To determine whether blinded and unblinded Pelvic Organ Prolapse Quantification (POP-Q) examinations differ in a randomized trial. STUDY DESIGN: Blinded POP-Q examinations performed at 3 months and 1 year were compared with unblinded examinations performed by the surgeon in a randomized trial of vaginal mesh for pelvic organ prolapse. RESULTS: Sixty-five patients were included in the study. Correlations between the blinded and unblinded POP-Q points and stages varied from low to moderate (rho = 0.29-0.78). At 3 months, the blinded overall prolapse recurrence rate was 45.3% compared with 39.1% based on unblinded staging (P = .34). At 1 year, the blinded overall recurrence rate was significantly higher than the unblinded recurrence rate: 68.3% vs 53.3% (P = .004). The 1-year blinded anterior wall recurrence rate was also higher than the recurrence based on unblinded staging: 56.7% vs 43.3% (P = .021). CONCLUSION: Use of unblinded POP-Q staging resulted in underestimation of 1-year overall recurrence after prolapse repair.
Authors: Louise T S Arenholt; Bodil Ginnerup Pedersen; Karin Glavind; Susanne Greisen; Karl M Bek; Marianne Glavind-Kristensen Journal: Int Urogynecol J Date: 2018-12-01 Impact factor: 2.894
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
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