A randomized controlled pilot trial to assess the effectiveness of a specially formulated food supplement and pelvic floor muscle training in women with stress-predominant urinary incontinence

BackgroundPelvic floor muscle training (PFMT) is the first-line treatment approach for stress urinary incontinence. Creatine and leucine have been shown to improve muscle function. Our aim was to assess the effectiveness of a food supplement and PFMT in women with stress-predominant urinary incontinence.MethodsWomen with stress-predominant urinary incontinence were randomized in 1:1 ratio to receive daily oral supplementation for six weeks with either a food supplement (treatment group) or placebo (control group). Both groups were instructed to perform standardized daily PFMT. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Patient's Global Impression of Severity (PGI-S), and Biomechanical Integrity score (BI-score) measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5% to detect a decrease of 16 points in the UDI-6 score, a sample size of 32 was needed, with 16 patients in each arm of our trial.ResultsSixteen women in the control group and sixteen in the treatment group completed the trial. Between-group analysis revealed no significant differences between the control and treatment group except for mean change (delta) in vaginal squeeze pressure [(cmH2O, mean & PLUSMN; SD), 5 & PLUSMN; 12 vs. 15 & PLUSMN; 15, P = 0.04] and mean change (delta) in PGI-S score [(mean & PLUSMN; SD), -0.2 & PLUSMN; 0.9 vs. -0.8 & PLUSMN; 0.8, P = 0.04]. Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to six weeks in the treatment group but not in the control group [UDI-6 score (mean & PLUSMN; SD) 45 & PLUSMN; 21 vs. 29 & PLUSMN; 21, P = 0.02; 43 & PLUSMN; 18 vs. 33 & PLUSMN; 26, P = 0.22] [IIQ-7 score (mean & PLUSMN; SD) 50 & PLUSMN; 30 vs. 30 & PLUSMN; 21, P = 0.01; 48 & PLUSMN; 23 vs.40 & PLUSMN; 28, P = 0.36]. PGI-S scores only improved in the treatment group from baseline to six weeks after treatment [PGI-S score (mean & PLUSMN; SD) 3.1 & PLUSMN; 0.8 vs. 2.3 & PLUSMN; 0.8, P = 0.0001]. BI-score, on average, improved significantly in the treatment and control group as well [SD unit, mean, from - 1.06 to -0.58, P = 0.001; from - 0.66 to -0.42, P = 0.04].ConclusionsWomen with stress-predominant urinary incontinence receiving a specially formulated supplement in addition to daily PFMT for six weeks had significantly improved urinary symptoms (decrease in UDI-6 score and IIQ-7) and BI-score compared to their baseline.