Preoperative Valsava Leak Point Pressure May Not Predict Outcome of Mid-Urethral Slings. Analysis from a Randomized Controlled Trial of Retropubic versus Transobturator Mid-Urethral Slings

Objective: To test the hypothesis that preoperative Valsalva leak point pressure (VLPP) predicts long-term outcome of midurethra slings for female stress urinary incontinence (SUI). Materials and Methods: One hundred and forty-five patients with SUI were prospectively randomized to two mid-urethra sling treatments: Tension free vaginal tape (TVT) or transobturator tape (TOT). They were followed-up at 3, 6, 12 months post-operatively and then annually for the primary outcome variable, i.e. dry or wet and secondary outcome variables such as scores on the urogenital distress inventory (UDI-6) and the impact of incontinence on quality of life (IIQ-7) questionnaire as well as patient satisfaction as scored on a visual analogue scale (VAS). Preoperative VLPP was correlated with primary and secondary outcome variables. Results: Mean follow-ups were 32 ± 12 months (range 12-55) for TVT and 31 ± 15 months (range 12-61) for TOT. When patients were analyzed according to VLPP stratification, 95 (65.5%) patients showed a VLPP > 60 cm H2O and 50 (34.5%) patients had a VLPP ≤ 60 cm H2O. The overall objective cure rates were 75.8% for patients with VLPP > 60 cm H2O and 72% for those with VLPP ≤ 60 cm H2O (p < 0.619). No significant differences in objective cure rates emerged when patients were stratified for pre-operative VLPP and matched for TOT or TVT procedures: VLPP > 60 cm H2O (82 % vs. 68.9% p < 0.172); VLPP ≤ 60 cm H2O (68% vs. 76% p < 0.528). Conclusions: When patients were stratified for preoperative VLPP (≤ or > of 60 cm H2O), preoperative VLPP was not linked to outcome after TVT or TOT procedures.