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Sit down and stop leaks: new electromagnetic chair may cure incontinence

NCT ID NCT04031014

Disease control Sponsor: Boston Urogynecology Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a special chair that uses high-intensity electromagnetic waves to make pelvic floor muscles contract very strongly, like doing thousands of Kegel exercises in one session. 36 women with stress or urge urinary incontinence received either the full treatment or a sham version. The goal was to see if the device improves symptoms and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BTL EMSELLA device (high intensity focused electromagnetic technology)
What this could lead to
If it works, this could offer a non-invasive, drug-free option to strengthen pelvic floor muscles and reduce urinary incontinence symptoms.
What could go wrong
This is a small, completed trial with only 36 participants. The sham control used a very low intensity, which may not fully blind participants. Results may not apply to all types of incontinence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Feb 2020

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted 2. Age greater than 18 3. Subject has a body mass index (BMI) \< 37 kg/m2 4. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID; 5. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga); 6. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them; 7. Subject agrees to comply with the study procedures and visits. Exclusion Criteria: 1. Subject has used the BTL EMSELLA device previously; 2. Subject has any significant pelvic organ prolapse; stage III or greater 3. Subject is unwilling to maintain current level of exercise throughout the study; 4. Subject planning to have surgery during the study; 5. Subject has untreated malignancy; 6. Subject is pregnant, planning to get pregnant or within 3 months postpartum; 7. Subject has a pacemaker; 8. Subject has and implant or IUD containing metal; 9. Subject has piercing between the waist and knees and is not willing to remove it before each treatment; 10. Subject is using a pessary or other anti-incontinence device 11. Subject has implanted defibrillator, implanted neurostimulator 12. Subject has metal implants 13. Subject has a drug pump

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Conditions

The condition(s) this trial relates to.

female stress incontinence overactive bladder Urinary Incontinence, Stress Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overactive bladder Stress urinary incontinence Urge and stress Urge incontinence

Contacts and locations

Locations

  • Boston Urogynecology Associates

    Cambridge, Massachusetts, 02138, United States

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