BTL Emsella Chair Versus Sham for the Treatment of Overactive Bladder

Conditions

• Overactive Bladder
• Overactive Bladder Syndrome
• Urinary Frequency
• Urinary Urgency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BTL Emsella Chair — DEVICE
  The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of 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 stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
• Sham BTL Emsella Chair — DEVICE
  The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (less than 10%) power.

Study Details

The purpose of this clinical trial is to compare the Emsella Chair therapy to Sham and to determine whether electromagnetic technology is effective in the treatment of overactive bladder (OAB). Currently there are no other studies utilizing the Emsella Chair for the treatment of OAB. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Key Dates

Start date

Nov 22, 2021

Status verified

Dec 2025

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

166 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Emsella Chair Active Treatment
  Active subjects will be asked to sit on the center of the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. 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 be decreased slightly and stay unchanged for the reminder of the treatment. The treatment threshold should be increased with every treatment until the subject reaches 100%.
• Placebo Comparator: Emsella Chair Sham Treatment
  Sham treatment subjects will be positioned on the device in the same manner. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level (less than 10% power).

Primary Outcome Measure

Compare the efficacy of Emsella Chair versus Sham by evaluating the proportion of subjects reporting "moderately improved" or "markedly improved" responses on the Global Response Assessment (GRA) for overall bladder symptoms. [ Time Frame: 4 weeks after completing all treatments; week 8 of the study ]

Central Contacts

• Danielle Tenney
  248-551-3565
  [email protected]
• Jennifer Giordano, BSN
  248-551-3517
  [email protected]

Locations (1)

Find similar trials in Royal Oak, MI

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