An interventional study of Electromagnetic chair therapy and Electrical stimulation therapy in Urinary Incontinence, Mixed Urinary Incontinence and Urinary Incontinence (UI), sponsored by Espacio Gaspar Clinic. Recruiting at 2 sites in Argentina. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Espacio Gaspar Clinic · Not applicable, Interventional, and Treatment
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.
This prospective, randomized, parallel-group, non-inferiority clinical trial will evaluate whether electromagnetic pelvic-floor stimulation delivered using the StarFormer® chair is non-inferior to standard pelvic-floor electrostimulation combined with biofeedback 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 the predominant type of incontinence-urgency-predominant, stress-predominant, or balanced MUI-and baseline symptom severity.
Eligible participants will be women aged 18 years or older with symptoms of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI) lasting for at least three months.
The diagnosis of MUI will be confirmed by a baseline three-day bladder diary documenting at least one SUI episode and one UUI episode.
Participants must be treatment-naive or have received no recent pharmacological or supervised physical treatment for urinary incontinence. Women with active urinary tract infection, advanced pelvic organ prolapse, pregnancy, recent childbirth, major neurological disease affecting bladder function, previous anti-incontinence surgery, clinically relevant voiding dysfunction, or contraindications to electromagnetic stimulation will be excluded.
Participants in the investigational group will receive electromagnetic chair therapy, while those in the control group will undergo standard electrostimulation with biofeedback.
Both interventions will consist of two sessions per week for six weeks, resulting in a total of 12 treatment sessions. Treatment intensity will be set at the maximum level tolerated by each participant, and session duration, intensity, interruptions, adherence, and any adverse events will be documented. Attendance at a minimum of 10 of the 12 planned 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 to week 6 in the average number of total daily incontinence episodes, including both SUI and UUI episodes, as recorded in a three-day bladder diary.
Secondary clinical outcomes will include changes in the frequency of SUI and UUI episodes, daytime voiding frequency, nocturia, daily pad use, and urinary-incontinence-related quality of life assessed using the ICIQ-UI SF. Patient-perceived improvement will be assessed using the PGI-I questionnaire, and treatment response will be defined as at least a 50% reduction in the total number of daily incontinence episodes at week 6. Maintenance of treatment effects will be evaluated at week 30.
Urodynamic assessments will be performed at baseline and at week 30 to explore potential treatment-related physiological changes. These assessments will include free uroflowmetry, pressure-flow studies, post-void residual urine volume, the presence of detrusor overactivity, maximum cystometric capacity, evidence of urodynamic stress incontinence, maximum urinary flow rate, and detrusor pressure at maximum flow.
Safety will be evaluated through systematic recording of adverse events during treatment and throughout follow-up.
The primary analysis will follow the intention-to-treat principle.
983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.
This study's planned enrollment of 58 is below the median of 66 across 739 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Espacio Gaspar Clinic is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Treatment-naive:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Electromagnetic chair therapy, 2 sessions/week for 6 weeks (12 sessions) - EMS
Device: Electromagnetic chair therapy
Standard care: Electrostimulation w/ biofeedback, 2 sessions/week for 6 weeks (12 sessions) - ES
Device: Electrical stimulation therapy
Pulsed 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.
Also known as: StarFormer, Extracorporeal magnetic stimulation (EMS), Functional magnetic stimulation (FMS), Fotona
ES 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.
Also known as: NMES (neuromuscular eletrostimulation), IVES (intravaginal electrical stimulation)
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).
Time frame: 6 weeks
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).
Time frame: 6 and 30 weeks
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).
Time frame: 6 and 30 weeks
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).
Time frame: 6 and 30 weeks
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).
Time frame: 6 and 30 weeks
Number of incontinence pads used per day
Change from baseline to week 6 and 30 in number of incontinence pads used per 24 hours will be measured by the 3-day bladder diary (daily average).
Time frame: 6 and 30 weeks
Severity and bother of urinary symptoms measured by ICIQ-UI SF score
Change in ICIQ-UI SF score from baseline to week 6 and 30. The ICIQ-UI SF is a questionairre where a severity of incontinence is evaluated on a total scale range 0-21. There are 4 incontinence severity classes: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).
Time frame: 6 and 30 weeks
Satisfaction with treatment as measured by Patient Global Impression of Improvement (PGI-I)
Improvement from baseline at the week 6 and 30, measured by PGI-I. This is a 7-point scoring scale, where scores 1-3 are used for scale of improvement, 4 marks no observed change and 5-7 marks worsening of symptoms.
Time frame: 6 and 30 weeks
Number of responders
Responder is a person with ≥ 50% reduction in total incontinence episodes/24 h.
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Espacio Gaspar Clinic