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

NCT07792031 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Electromagnetic chair 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.

DEVICE

Electrical stimulation therapy

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.

Sponsors & Collaborators

  • Espacio Gaspar Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-12-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792031 on ClinicalTrials.gov