Discussion
obesity, urinary incontinence symptoms, pelvic floor muscle, urinary incontinence, SUI, weakness, pelvic floor muscle exercise
OBESITY, CONTRACTIONS, CONTRACTION, URINARY INCONTINENCE, SECONDARY
We are the first to report the effects of a specially formulated supplement on urinary incontinence symptoms while study participants were engaged in daily PFMT. We have found that daily supplementation, in addition to regular pelvic floor muscle exercise at an intensity of at least 65–75% of one repetition maximum of 45 pelvic floor muscle (PFM) contractions per day (15 PFM contractions performed three times per day) for six weeks resulted in greater vaginal muscle strength change and larger change (decrease) in the PGI-S of UI and improved biomechanical integrity of the pelvic floor (BI-score).Most professional guidelines recommend conservative treatment for first-line treatment of SUI. The European Association of Urology (EAU) recommends that providers should offer supervised intensive pelvic floor muscle training (PFMT), lasting at least three months, as first-line therapy to all women with SUI. At the same time, the American College of Obstetricians and Gynecologists (ACOG) states that behavioral modification and pelvic floor muscle exercises improve symptoms of urinary incontinence and may be recommended as an initial, noninvasive treatment in any women [The number of publications examining the relationship between nutrition and PFMT is very small and almost exclusively focused on the role of nutrition in obesity [Vaginal Tactile Imaging revealed that only three VTI parameters improved in the control group. In contrast, eleven parameters were better in the treatment group, and none of the VTI parameters got worse during the trial. These findings are reassuring and consistent with our clinical findings that women in the treatment group had a larger improvement in UI symptoms, similarly to the improvement in the biomechanical integrity of the pelvic floor. Women in the treatment, on average, improved twice as much in their BI-score as women in the control group. It is not entirely understood how PFMT improves UI symptoms but likely through the improvement of the integrity and coordination of the pelvic floor muscles. In the treatment group, there was a significant improvement in elasticity and relaxation, while in the control group, only in contraction, consistent with the likely impact of PFMT through improving muscle function.The strength of this study is its randomized nature and the first trial testing the effects of a food supplement in combination with PFMT on women with stress pre-dominant UI. An important strength of the study was that participants were blinded to the allocation. Another strength of this RCT is that the evaluators performing the perinoemetry, the vaginal tactile imaging, and the pelvic floor assessment were also blinded to the allocation. In addition, the objective measurements of pelvic floor integrity by VTI were complemented by subjective patient assessments based on validated questionaries. Also, a strength of this study was our participants’ high compliance with taking the supplements and adhering to the daily PFMT based on self-reporting (~ 90%). The trial discontinuation rate in the treatment group was identical in the control and treatment groups. The high (~ 90%) attrition rate was another strength of this randomized controlled trial.One of the main weaknesses of our study was the lack of power to detect differences in several of the secondary outcomes; overall, a relatively low number of women have been enrolled. In addition, we have assumed a very large effect size (Cohen’s d = 1.06) which is difficult to achieve in 6 weeks. A weakness of the study was that we did not assess urinary incontinence by urodynamics or pad-test but only with validated questionaries. Also, a weakness of our study was the homogenous nondiverse study population, which can be explained by the fact that the vast majority of the local population belongs to only one race and ethnicity. Finally, our trial does not provide an accurate insight into the supplement’s mechanism of action. It is possible that the observed effects are secondary through generalized improvement in muscle strength rather than a direct effect on pelvic floor muscles and extracellular matrix.