Randomization
Arm A · n = 157
Sacrocolpopexy + Burch
Concomitant Burch colposuspension added
Arm B · n = 165
Sacrocolpopexy Alone
No anti-incontinence procedure (control)
Primary Outcome: Met SUI Criteria at 3 Months
33.6%
Burch Group
49 / 146
57.4%
Control Group
89 / 155
OR 0.40
95% CI 0.24–0.66
P < 0.001
Secondary Outcomes
Early Stopping: Trial stopped early after first interim analysis due to significant benefit in Burch group. Effect was independent of preoperative urodynamic findings — even women with no detectable leakage on prolapse reduction testing benefited.
Operative Data: OR time 190 vs 170 min (P=0.002). EBL 265 vs 192 mL (P<0.001). Serious AE rates equivalent: 14.6% vs 14.5%.
Clinical Bottom Line
Prophylactic Burch colposuspension at sacrocolpopexy reduces postoperative SUI by nearly half (NNT ≈ 4) without increasing urge symptoms or serious AEs. Trial stopped early for efficacy. Prolapse correction alone unmasks occult SUI in over half of patients.