Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.

This prospective, randomized, parallel‐group, non‐inferiority clinical trial willevaluate whether electromagnetic pelvic‐floor stimulation delivered using the StarFormer®chair is non‐inferior to standard pelvic‐floor electrostimulation combined withbiofeedback in women with mixed urinary incontinence (MUI).The study will enroll 58 women, with 29 participants allocated to each treatment group.Randomization will be performed in a 1:1 ratio and stratified according to thepredominant type of incontinence‐urgency‐predominant, stress‐predominant, or balancedMUI‐and baseline symptom severity.Eligible participants will be women aged 18 years or older with symptoms of both stressurinary incontinence (SUI) and urgency urinary incontinence (UUI) lasting for at leastthree months.The diagnosis of MUI will be confirmed by a baseline three‐day bladder diary documentingat least one SUI episode and one UUI episode.Participants must be treatment‐naive or have received no recent pharmacological orsupervised physical treatment for urinary incontinence. Women with active urinary tractinfection, advanced pelvic organ prolapse, pregnancy, recent childbirth, majorneurological disease affecting bladder function, previous anti‐incontinence surgery,clinically relevant voiding dysfunction, or contraindications to electromagneticstimulation will be excluded.Participants in the investigational group will receive electromagnetic chair therapy,while those in the control group will undergo standard electrostimulation withbiofeedback.Both interventions will consist of two sessions per week for six weeks, resulting in atotal of 12 treatment sessions. Treatment intensity will be set at the maximum leveltolerated by each participant, and session duration, intensity, interruptions, adherence,and any adverse events will be documented. Attendance at a minimum of 10 of the 12planned sessions will be considered adequate adherence.Clinical assessments will be conducted at baseline, at the end of treatment in week 6,and at the long‐term follow‐up in week 30.The primary endpoint will be the between‐group difference in the change from baseline toweek 6 in the average number of total daily incontinence episodes, including both SUI andUUI episodes, as recorded in a three‐day bladder diary.Secondary clinical outcomes will include changes in the frequency of SUI and UUIepisodes, daytime voiding frequency, nocturia, daily pad use, andurinary‐incontinence‐related quality of life assessed using the ICIQ‐UI SF.Patient‐perceived improvement will be assessed using the PGI‐I questionnaire, andtreatment response will be defined as at least a 50% reduction in the total number ofdaily incontinence episodes at week 6. Maintenance of treatment effects will be evaluatedat week 30.Urodynamic assessments will be performed at baseline and at week 30 to explore potentialtreatment‐related physiological changes. These assessments will include freeuroflowmetry, pressure‐flow studies, post‐void residual urine volume, the presence ofdetrusor overactivity, maximum cystometric capacity, evidence of urodynamic stressincontinence, maximum urinary flow rate, and detrusor pressure at maximum flow.Safety will be evaluated through systematic recording of adverse events during treatmentand throughout follow‐up.The primary analysis will follow the intention‐to‐treat principle.