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

Sponsor
Espacio Gaspar Clinic
Study ID
NCT07792031
Status
Not Yet Recruiting

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Conditions

  • Mixed Urinary Incontinence
  • Stress Urinary Incontinence (SUI)
  • Stress Urinary Incontinence in Women
  • Urinary Incontinence
  • Urinary Incontinence (UI)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electromagnetic chair therapy — DEVICE
    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.
  • Electrical stimulation therapy — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Electromagnetic chair therapy
    Electromagnetic chair therapy, 2 sessions/week for 6 weeks (12 sessions) - EMS
  • Active Comparator: Electrostimulation w/ biofeedback
    Standard care: Electrostimulation w/ biofeedback, 2 sessions/week for 6 weeks (12 sessions) - ES

Primary Outcome Measure

Number of total incontinence episodes per 24 hours [ Time Frame: 6 weeks ]

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