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

NCT04133675 | Recruiting FDA Device

• 1 other identifier: 2019-242
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence

Keywords

urinary incontinence; urine leakage

Outcome Measures

Primary Outcomes (1)

• The efficacy of the Emsella chair versus sham to treat stress urinary incontinence.

  The primary objective of this study is to compare the efficacy of Emsella Chair to sham by evaluating the the responder rate, where a patient is called a responder if there is ≥ 50% reduction from baseline in the number stress incontinence events.

  4 weeks after completing all treatments

Secondary Outcomes (12)

• The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in total number of subject-reported stress urinary incontinence (SUI) episodes.

  8 weeks after completing all treatments

• The efficacy of the Emsella chair versus sham to treat SUI in relation to the change in subject-reported impression of SUI severity.

  8 weeks after completing all treatments

• The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impression of SUI improvement as measured by the Patient Global Impression of Improvement scale (PGI-I).

  8 weeks after completing all treatments

• The efficacy of the Emsella chair versus sham to treat stress urinary incontinence related to the change in subject-reported urogenital distress.

  8 weeks after completing all treatments

• The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impact of SUI on daily life.

  8 weeks after completing all treatments

Study Arms (2)

Emsella Chair Active Treatment

ACTIVE COMPARATOR

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%.

Device: BTL Emsella

Emsella Sham Treatment

SHAM COMPARATOR

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).

Device: Sham BTL Emsella

Interventions

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).

Emsella Sham Treatment

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.

Emsella Chair Active Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read, understand, and provide written, dated, informed consent prior to screening, and be likely to comply with study protocol, including independently complete study questionnaires and communicate with study personnel about AEs and other clinically important information.
• Females and males, 18 to 80 years of age, inclusive, at screening
• Positive Cough or Bladder Stress Test at screening
• Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.
• \. Subject agrees to maintain a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, beta-3 adrenergic agonist, or α-adrenergic blockers, throughout the treatment and follow-up periods.
• For Females Only:
• Subject agrees to discontinue use of bladder support devices, including but not limited to vaginal pessary, during the screening, treatment, and follow-up periods.
• If of child-bearing age and female, agree to practice approved birth-control methods (oral contraceptives, condom barrier, injection, diaphragm or cervical cap, vaginal contraceptive ring, IUD, implantable contraceptive, surgical sterilization (bilateral tubal ligation), vasectomized partner(s))
• For Males Only:
• \- Subject must be ≥ 4 months post radical prostatectomy

You may not qualify if:

• Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
• Subject is morbidly obese (defined as body mass index 40 or greater)
• Pulmonary insufficiency, defined as difficulty breathing and fatigue, especially during exercise; chest pain, such as squeezing, pressure or tightness; the sensation of rapid or irregular heartbeat (palpitations); swelling of the legs or feet; dizziness or fainting; and/or bluish discoloration of the nails and/or lips (cyanosis)
• Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
• Implanted cardiac pacemaker or metal in the body, including, but not limited to drug pumps, neurostimulators, electronic implants, copper intrauterine devices (IUDs), and/or defibrillators
• Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
• Active urethral diverticula
• Known vesicoureteral reflux
• Currently healing from surgical procedures where muscle contraction may disrupt the healing process
• Treatment with urethral bulking agents within the 6 months prior to the Screening Visit
• Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
• Subject has used the BTL EMSELLA device previously
• Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
• Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit
• Currently participating in an investigational study that may impact study results or previously received an investigational drug or treatment within 30 days of the Screening Visit

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Related Publications (2)

• Galloway NT, El-Galley RE, Sand PK, Appell RA, Russell HW, Carlan SJ. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology. 1999 Jun;53(6):1108-11. doi: 10.1016/s0090-4295(99)00037-0.

  PMID: 10367836 BACKGROUND

• HIFEM technology in treatment of urinary incontinence mechanism of action. https://www.avantemedicalcenter.com/images/documents/Emsella_study.pdf. Published November 2017. Accessed June 20, 2019.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Swanson, RN

CONTACT

248-551-3551; Julie.Swanson2@corewellhealth.org

Jennifer Giordano, RN

CONTACT

248-551-3517; Jennifer.Giordano@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed using a table of random numbers. A unblinded RNC will be responsible for maintaining the enrollment and randomization log. Randomization envelopes will be provided by the study's biostatistician and will be securely stored in a locked cabinet. The study coordinator(s) will solely be responsible for opening the randomization envelopes and delivering the study treatments, according to group assignment. Ultimately, they will be responsible for maintaining the confidentiality and security of the randomization envelopes. After randomization, the study coordinator(s) will complete the Subject Enrollment and Randomization Log. The log may be stored in a locked cabinet with the randomization envelopes. At study completion the log will be stored in the regulatory binder.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: Subjects will be randomized 1:1 to receive active Emsella chair treatments or sham treatments. Study will be performed in a single-blind manner.(Participant and biostatistician)

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: December 18, 2019
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)