Compare two pelvic floor stimulation devices to see which helps with urinary incontinence in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group, non-inferiority study will enroll 58 adult women with mixed urinary incontinence, randomizing them 1:1 to receive 12 treatment sessions over six weeks. One group will use the StarFormer electromagnetic chair, and the other will receive standard pelvic-floor electrostimulation with biofeedback. Outcomes will be measured at baseline, week 6, and week 30, with the primary endpoint being the change in average daily urinary incontinence episodes over a three-day bladder diary from baseline to week 6. Secondary outcomes include changes in urgency and stress incontinence episodes, voiding frequency, nocturia, pad use, ICIQ-UI SF scores, patient-reported improvement, responder rates, and urodynamic parameters, along with safety and adherence assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Espacio Gaspar
  Mendoza, Argentina Recruiting
• Uroclinica
  Mendoza, Argentina Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.