A Randomized Controlled Trial to Assess the Effectiveness of a Specially Formulated Food Supplement and Pelvic Floor Muscle Training in Women With Stress-Predominant Urinary Incontinence [ID: 1372768

Abstract

INTRODUCTION: The objective of this study was to assess the effectiveness of a creatine-leucine-based food supplement and standardized pelvic floor muscle training (PFMT) in women with stress-predominant urinary incontinence (SUI). METHODS: Women with SUI were randomized to receive daily oral supplementation for 6 weeks with either a supplement or placebo. Both groups were instructed to perform daily PFMT at an intensity of at least 75% of one repetition maximum of 45 pelvic floor muscle contractions per day. The primary outcome was the Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Biomechanical Integrity (BI) score measured by Vaginal Tactile Imager. To have a power of 80% and a significance level of 5%, a sample size of 32 was needed. The trial was IRB approved. RESULTS: Within-group analysis showed that UDI-6 and IIQ-7 scores improved significantly from baseline to 6 weeks in the treatment group but not in the control group (UDI-6 score [mean±SD], 45±21 versus 29±21, P=.02; 43±18 versus 33±26, P=.22) (IIQ-7 score [mean±SD], 50±30 versus 30±21, P=.01; 48±23 versus 40±28, P=.36). Out of the 52 examined VTI parameters, significantly more parameters improved in the treatment group compared to the control group (11/52 versus 3/52, P=.04). BI-score, on average, improved significantly in the treatment and control group as well (SD unit, mean, from −1.06 to −0.58, P=.001; from −0.66 to −0.42, P=.04). CONCLUSION: Women with SUI receiving a specially formulated supplement in addition to daily PFMT for 6 weeks had improved urinary symptoms (significant decrease in UDI-6 and IIQ-7 scores) and better BI score compared to baseline.