Methods
urinary incontinence, pelvic organ prolapse
INCONTINENCE, CONTRACTIONS, URINARY INCONTINENCE, COPPER DEFICIENCY, CONNECTIVE TISSUE DISEASE
We have conducted a randomized, double-blind, placebo-controlled pilot trial with a six-week follow-up period at an outpatient medical center between 4/1/22 − 9/1/22. The trial was registered at ClinicalTrials.gov (Identifier: NCT05358769), and IRB approved by the Scientific and Research Ethics Committee of Hungary: 2876-13/2022/EÜIG.The randomization was done in a 1:1 ratio and generated by SAS (SAS Institute, Cary, NC, USA) version 9.4. We have enrolled women with stress or stress-predominant urinary incontinence [based on the Medical, Epidemiologic, and Social Aspects of Aging (MESA) questionnaire] [Exclusion criteria were pregnancy or less than 12 months postpartum; more than three vaginal deliveries or any prior operative delivery; self-reported symptoms of pelvic organ prolapse or POP-Q stage > 2; history of supervised PFMT within 12 months; and current medications for UI or surgical treatment for UI; known zinc or copper deficiency or sensitivity; collagen or connective tissue disease.After enrollment, women were randomized to receive the specially formulated dietary supplement (Incoxil®, Fempharma, LLC, Debrecen, Hungary) (treatment group) or placebo (control group). Women in the treatment group were asked to take the oral dietary supplement every day for six weeks. Dietary supplement of the treatment group included creatine monohydrate 3 g/day, leucine 0.5 g/day, zinc sulfate heptahydrate 5 mg/day, calcium citrate 120 mg/day, and magnesium citrate 60 mg/day) as a water-soluble powder. While in the control group, women received daily supplementation with maltodextrin as a water-soluble powder. The color, texture, solubility, taste, and volume of the powder were similar between the two groups.After randomization, subjects received the dietary supplement in a sealed, uniform box. The completely identical boxes were labeled with codes. The codes were not known by the researchers participating in the clinical trial. The code could not identify the patients. Participants did not know what kind of preparations they were given; they were assigned randomly without informing them which group they belonged to.After enrollment based on the MESA questionnaire, women were asked to complete the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Standardized pelvic exam, including POP-Q measurement, Oxford scale assessment of the pelvic floor strength, the strength of voluntary contractions of vaginal muscles was measured by a perineometer device (Peritron, Laborie, Williston, Vermont, USA) in a standardized fashion [At the six weeks visit, study participants were asked to complete the UDI-6 and IIQ-7 questionnaires again. In addition, repeat pelvic exams, including POP-Q measurement, Oxford scale assessment of the pelvic floor strength, the strength of voluntary contractions of vaginal muscles was measured by a perineometer device in a standardized fashion, and VTI evaluated the biomechanical integrity of the pelvic floor.The primary outcome was the UDI-6 score. Secondary outcomes were the Incontinence Impact Questionnaire (IIQ-7) score, Patient’s Global Impression of Severity (PGI‐S) and Patient’s Global Impression of Improvement (PGI‐I), Biomechanical Integrity score as measured by the Vaginal Tactile Imager and vaginal squeeze pressure measured by perineometer.