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Electromagnetic Technology

Emsella Chair Therapy for Overactive Bladder (EmsellaOAB Trial)

N/A

Recruiting

Led By Kenneth Peters, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported failed conservative care of behavioral modifications and/or oral medications

Subject agrees not to start any new treatment for OAB (medication or otherwise) during the treatment and follow-up periods

Must not have

Major metal implants such as: metal plates, screws, joint replacements, implanted cardiac pacemakers, drug pumps, neurostimulators, electronic implants, copper intrauterine devices, defibrillators, and metal implants in the pelvic area. Patients with other metal implants will be evaluated by the investigator for inclusion in the study

Botox® use in bladder or pelvic floor muscles in the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment durability will be assessed 4 weeks after the primary endpoint; week 12 of the study

Summary

This trial is testing the Emsella Chair, which uses electromagnetic waves to strengthen pelvic muscles, on patients with overactive bladder. These patients often seek non-surgical treatments due to medication side effects. The chair helps by making the pelvic muscles stronger, similar to doing many Kegel exercises.

Who is the study for?

This trial is for adults over 18 with overactive bladder symptoms lasting at least 3 months, who've tried and failed conservative treatments. They must be on stable medication or have stopped such medications for two weeks, able to use the toilet without help, not start new OAB treatments during the study, and if female of child-bearing age, agree to use birth control.

What is being tested?

The trial tests the Emsella Chair's electromagnetic technology against a sham (fake treatment) to see if it helps treat overactive bladder. Participants will receive either real or sham therapy twice weekly for four weeks.

What are the potential side effects?

Potential side effects are not specified in this summary but may include discomfort from sitting on the chair or reactions related to electromagnetic exposure; however, these should be minimal as similar devices often have few side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried and not improved with standard treatments like behavior changes or pills.

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I agree not to start new treatments for overactive bladder during the study.

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I have had bladder symptoms for 3 months or more.

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I can walk and use the bathroom by myself without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major metal implants or devices in my body.

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I have used Botox in my bladder or pelvic floor muscles within the last year.

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I have a piercing between my waist and knees and won't remove it for treatment.

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I experience breathing difficulties, chest pain, and other related symptoms.

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I have been diagnosed with vesicoureteral reflux.

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I have an active urethral diverticulum.

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I have bladder control issues due to a neurological condition.

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I am not on treatment for a cancer that would affect this study, except for skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after completing all treatments; week 8 of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after completing all treatments; week 8 of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after completing all treatments; week 8 of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported OAB symptoms (urinary incontinence, urinary urgency, urinary frequency) since start of the study as measured by Global Response Assessment (GRA)

Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL).

Compare the efficacy of Emsella chair versus Sham by evaluating the change in subject-reported overactive bladder symptoms as measured by the Overactive Bladder Questionnaire-Short form (OAB-q).

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Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Emsella Chair Active TreatmentActive Control1 Intervention

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%.

Group II: Emsella Chair Sham TreatmentPlacebo Group1 Intervention

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).

0 / 12Eligibility criteria met