This randomized, parallel-group, non-inferiority clinical trial will compare electromagnetic chair therapy with standard electrostimulation combined with biofeedback in 58 adult women with mixed urinary incontinence.
Participants will be randomized 1:1 to receive 12 treatment sessions over six weeks.
Clinical outcomes will be assessed at baseline, at the end of treatment (week 6), and at week 30.
The primary endpoint is the change from baseline to week 6 in the average daily number of total urinary incontinence episodes, recorded in a three-day bladder diary. Secondary outcomes include changes in urgency and stress urinary incontinence episodes, voiding frequency, nocturia, pad use, ICIQ-UI SF scores, patient-reported improvement, responder rates, and urodynamic parameters. Safety and treatment adherence will also be evaluated throughout the study.
Women ≥ 18 years of age.
Diagnosis of mixed urinary incontinence according to the operational definition.
Symptom duration ≥ 3 months.
Minimum severity: ≥ 2 total incontinence episodes documented in the baseline 3-day bladder diary up to 5 incontinence episodes
Active or suspected unresolved urinary tract infection (urinalysis ± culture according to local practice; first episode).
Uninvestigated macroscopic hematuria.
Advanced pelvic organ prolapse (POP-Q stage III-IV).
Pregnancy or postpartum < 2 months.
Parallel
Electromagnetic chair therapy
DevicePulsed magnetic technology - electromagnetic chair therapy - has been developed for the stimulation of pelvic floor muscles. This technology was approved for marketing by the Food and Drug Administration (FDA) in June 1998. For treatment, the patient is positioned in a chair. Within the chair's seat is a magnetic field generator (therapy head) that is powered and controlled by an external power unit. The output of the power unit consists of pulses of current, which can be adjusted in amplitude by the clinician. Adjusting this amplitude determines the size and strength of the magnetic field.
Electrical stimulation therapy
DeviceES of the pelvic floor muscles is via intravaginal electrical stimulation (IVES). This form of treatment is widely recognised and is used in clinical practice as a result of its effectiveness, despite the disadvantages of possible patient discomfort and the requirement of electrode sterilisation. IVES often uses a probe with electrodes on its surface to directly stimulate the pelvic floor muscles. It is these surface electrodes that target the pelvic floor muscles and deliver electrical impulses direct to the treatment area.
Number of total incontinence episodes per 24 hours
Change from baseline to week 6 in total incontinence episodes per 24 hours (UUI + SUI) will be measured by the 3-day bladder diary (daily average).
Number of UUI episodes / 24h
Change from baseline to week 6 and 30 in number of urge urinary incontinence episodes per 24 hours (UUI) will be measured by the 3-day bladder diary (daily average).
Number of SUI episodes / 24h
Change from baseline to week 6 and 30 in number of stress urinary incontinence episodes per 24 hours (SUI) will be measured by the 3-day bladder diary (daily average).
Number of voidings / 24h
Change from baseline to week 6 and 30 in total voiding frequency per 24 hours will be measured by the 3-day bladder diary (daily average).
Number of nocturia voidings / 24h
Change from baseline to week 6 and 30 in total nocturia frequencies per 24 hours will be measured by the 3-day bladder diary (daily average).
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