BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence

Part of paid clinical trials in Royal Oak, Michigan.

Sponsor
Corewell Health East
Study ID
NCT04133675
Status
Recruiting
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Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BTL Emsella — DEVICE
    The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimlulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
  • Sham BTL Emsella — DEVICE
    Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\<10% power).

Study Details

Stress urinary incontinence (SUI) is a condition that affects both men and women. SUI is the involuntary leakage of urine caused by an increase in intra-abdominal pressure from activities such as exercise, coughing, laughing, or sneezing. It can significantly affect quality of life as patients avoid activities or behaviors that cause leakage. This clinical trial will compare the efficacy of the Emsella chair to sham and determine if electromagnetic technology is effective in the treatment of SUI.

Key Dates

Start date
Dec 18, 2019
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Active Comparator: Emsella Chair Active Treatment
    Active treatment subjects will be asked to sit on the center of the Emsella chair. The height of the chair will be adjusted until the participant's feet are on the floor. The Emsella chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.
  • Sham Comparator: Emsella Sham Treatment
    Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (\<10% power).

Primary Outcome Measure

The efficacy of the Emsella chair versus sham to treat stress urinary incontinence. [ Time Frame: 4 weeks after completing all treatments ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Julie Swanson, RN
[email protected]
248-551-3551
Jennifer Giordano, RN
[email protected]
248-551-3517
Kenneth Peters, MD (PRINCIPAL_INVESTIGATOR)

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Corewell Health William Beaumont University Hospital· Royal Oak, MI

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