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

NCT07792031 | Not Yet Recruiting

• 1 other identifier: ESEMS/01
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

electromagnetic stimulation therapy; electrostimulation therapy; pelvic floor; urinary incontinence; mixed urinary incontinence; pelvic-floor muscle rehabilitation; StarFormer®; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Secondary Outcomes (8)

• Number of UUI episodes / 24h

  6 and 30 weeks

• Number of SUI episodes / 24h

  6 and 30 weeks

• Number of voidings / 24h

  6 and 30 weeks

• Number of nocturia voidings / 24h

  6 and 30 weeks

• Number of incontinence pads used per day

  6 and 30 weeks

Study Arms (2)

Electromagnetic chair therapy

EXPERIMENTAL

Electromagnetic chair therapy, 2 sessions/week for 6 weeks (12 sessions) - EMS

Device: Electromagnetic chair therapy

Electrostimulation w/ biofeedback

ACTIVE COMPARATOR

Standard care: Electrostimulation w/ biofeedback, 2 sessions/week for 6 weeks (12 sessions) - ES

Device: Electrical stimulation therapy

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.

Also known as: StarFormer, Extracorporeal magnetic stimulation (EMS), Functional magnetic stimulation (FMS)

Electromagnetic chair therapy

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.

Also known as: NMES (neuromuscular eletrostimulation), IVES (intravaginal electrical stimulation)

Electrostimulation w/ biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Espacio Gaspar Clinic: lead

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Gynecology at Uroclínica

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share