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

RecruitingNAAges 18 Years - anyFemaleEspacio Gaspar Clinic
NCT07792031 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Treatment-naive: * With no pharmacologic treatment for OAB/UI in the previous 8 weeks. * With no supervised pelvic floor rehabilitation, electrical stimulation, PTNS, neuromodulation, or prior electromagnetic chair therapy (preferably never, for population homogeneity). * Ability to complete bladder diaries and questionnaires and attend scheduled visits (and all 12 treatment sessions). * Signed informed consent. Exclusion Criteria: * 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. * Major neurological disease affecting bladder or urethral function.
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What it tests

  • Electromagnetic chair therapy
  • Electrical stimulation therapy
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Where

2 sites
Espacio Gaspar
Mendoza, Argentina
Uroclinica
Mendoza, Argentina
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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