Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women. (ESEMS)
Randomized Clinical Trial: Electromagnetic Chair Therapy in Female Mixed Urinary Incontinence Compared to Standard Care (Electrostimulation With Biofeedback)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electromagnetic chair therapy
Electromagnetic chair therapy, 2 sessions/week for 6 weeks (12 sessions) - EMS
|
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.
Other Names:
|
|
Active Comparator: Electrostimulation w/ biofeedback
Standard care: Electrostimulation w/ biofeedback, 2 sessions/week for 6 weeks (12 sessions) - ES
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of total incontinence episodes per 24 hours
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of UUI episodes / 24h
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Number of SUI episodes / 24h
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Number of voidings / 24h
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Number of nocturia voidings / 24h
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Number of incontinence pads used per day
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Severity and bother of urinary symptoms measured by ICIQ-UI SF score
Time Frame: 6 and 30 weeks
|
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).
|
6 and 30 weeks
|
|
Satisfaction with treatment as measured by Patient Global Impression of Improvement (PGI-I)
Time Frame: 6 and 30 weeks
|
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.
|
6 and 30 weeks
|
|
Number of responders
Time Frame: 6 weeks
|
Responder is a person with ≥ 50% reduction in total incontinence episodes/24 h.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Urinary Incontinence, Stress
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Electric Stimulation Therapy
Other Study ID Numbers
- ESEMS/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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