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001-es BibID:BIBFORM116413
Első szerző:Takács Péter (szülész-nőgyógyász)
Cím: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 / Takács Péter, Krasznai Zoárd, Pákozdy Krisztina, Koroknai Erzsébet, Kozma Bence
Megjegyzések:Introduction: Pelvic floor muscle training (PFMT) is the first-line treatment approach for stress urinary incontinence (SUI). Creatine and leucine have been shown to improve muscle function. Since PFMT has been shown to improve the symptoms of SUI, and creatine- leucine supplementation may augment muscle training, we considered that women with stress urinary incontinence might benefit from supplementation with creatine-leucine while practicing FMT. Objective: To assess the effectiveness of a specially formulated creatine-leucine-zinc-calcium-magnesium based food supplement and PFMT in women with stress-predominant urinary incontinence. Methods: Women with stress or stress-predominant urinary incontinence were randomized in 1:1 ratio to receive daily oral supplementation for six weeks with either a specially formulated food supplement (treatment group) or placebo (control group). Both groups were instructed to perform standardized daily PFMT. Patients and evaluators were blinded to the allocation. Primary outcome was Urogenital Distress Inventory Short Form (UDI-6) score. Secondary outcomes were Incontinence Impact Questionnaire (IIQ?7) score, Patient's Global Impression of Severity (PGI?S), Biomechanical Integrity score (BI-score) measured by Vaginal Tactile Imager and vaginal squeeze pressure measured by perineometer. To have a power of 80% and a significance level of 5% to detect a decrease of 16 points in UDI-6 score a sample size of 32 was needed with 16 patients in each arm of our trial. The trial was registered at and IRB approved. Results: Sixteen 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 +/- SD), 5+/-12 vs. 15+/-15, P=0.04] and mean change (delta) n PGI-S score [(mean +/- SD), -0.2+/-0.9 vs. -0.8+/-0.8, P=0.04]. Out of the 52 examined VTI parameters significantly more parameters improved in the treatment group compared to the control group (11/52 vs. 3/52, P=0.04). Within group analysis showed that UDI-6, IIQ-7 scores improved significantly from baseline to six weeks in the treatment group but not in the control group [UDI-6 score (mean+/-SD) 45+/-21 vs. 29+/-21, P=0.02; 43+/-18 vs. 33+/-26, P=0.22] [IIQ-7 score (mean+/-SD) 50+/-30 vs. 30+/-21, P=0.01; 48+/-23 vs. 40+/-28, P=0.36]. Similarly maximum vaginal squeeze pressure was significantly stronger in the treatment group compared to baseline after ix weeks but not in the control group [Maximum vaginal squeeze pressure (cmH2O, mean+/-SD), 30+/-15 vs. 45+/-28, P=0.001 and 36+/-18 vs. 41+/-21, P=0.13]. PGI-S scores only improved in the treatment group from baseline to six weeks after treatment [PGI-S score (mean+/-SD) 3.1+/-0.8 vs. 2.3+/-0.8, P=0.0001]. BI-score on average improved significantly, twice as much, in the treatment group compared to control group (SD unit, mean, from -1.06 to -0.58, P=0.001 and from -0.66 to -0.42, P=0.04). Conclusions: Women 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. Women in the treatment group on average improved twice as much in their BI-score as women in the control group.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idézhető absztrakt
Megjelenés:International Urogynecology Journal. - 34 : Suppl. 1 (2023), p. S26. -
További szerzők:Krasznai Zoárd Tibor (1973-) (szülész-nőgyógyász, gyermeknőgyógyász) Pákozdy Krisztina (1991-) (szülész-nőgyógyász) Koroknai Erzsébet (1987-) (szülész-nőgyógyász) Kozma Bence (1982-) (szülész-nőgyógyász)
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