Clinical trial NCT04133675: BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Official title: A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: urinary incontinence
urine leakage
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, sham-controlled, observational study of subjects undergoing electromagnetic perineal stimulation for the treatment of SUI. Eligible subjects will be randomized to receive active treatment or sham in a 1:1 ratio. Eight treatments (2 treatments each week) for 4 weeks will be completed with the Emsella chair to the pelvic floor muscles.

Electromagnetic stimulation of the pelvic floor is a FDA approved therapy whereby a coil generates pulsed electromagnetic fields that penetrate deep into the pelvic floor muscles inducing stimulation and providing rehabilitation of weak pelvic muscles.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.This technology is typically not covered by insurance, is minimally invasive, and safe, but has limited data available.

Currently, there is no data available from sham controlled studies evaluating efficacy of this technology. The purpose of this study is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of SUI.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Females and males, 18 to 80 years of age, inclusive, at screening
3. Positive Cough or Bladder Stress Test at screening
4. Subject agrees not to start any new treatment (medication or otherwise) during the treatment and follow-up periods.

6. 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

Exclusion Criteria:

1. Pelvic floor physical therapy, including muscle training and/or electrostimulation, in a clinical setting within 30 days prior to screening
2. Subject is morbidly obese (defined as body mass index 40 or greater)
3. 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)
4. Any condition that causes a lack of normal skin sensation to the pelvis, buttocks, and lower extremities
5. 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
6. Subject has a piercing between the waist and knees and is not willing to remove it before each treatment
7. Active urethral diverticula
8. Known vesicoureteral reflux
9. Currently healing from surgical procedures where muscle contraction may disrupt the healing process
10. Treatment with urethral bulking agents within the 6 months prior to the Screening Visit
11. Subject is currently receiving treatment for a malignant tumor that would interfere with study participation.
12. Subject has used the BTL EMSELLA device previously
13. Subject has urinary incontinence of neurogenic etiology, such as multiple sclerosis, spina bifida, Parkinson's, spinal cord injury, diabetic neuropathy etc.
14. Clinically confirmed urinary tract infection, requiring treatment as determined by the investigator, at the Screening Visit
15. 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
16. Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation

    For Females Only:
17. Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
18. History of surgery with insertion of vaginal mesh for SUI
19. Vaginal prolapse beyond the introitus
20. Vaginal rejuvenation treatment, including laser treatments and radiofrequency therapy, within the 6 months prior to the Screening Visit

    * Note for the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Primary outcomes:
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence.
timeFrame: 4 weeks after completing all treatments
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat SUI in relation to the change in subject-reported impression of SUI severity.
timeFrame: 8 weeks after completing all treatments
measure: 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).
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence related to the change in subject-reported urogenital distress.
timeFrame: 8 weeks after completing all treatments
measure: 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.
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence in relation to the change in subject-reported impact of urinary incontinence on daily life measured by the Incontinence Quality of Life questionnaire (I-QOL).
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in fecal incontinence as measured by the Cleveland clinic incontinence score (Wexner).
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in subject-reported sexual function as measured by Female Sexual Function Index questionnaire for female subjects.
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and the change in subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects.
timeFrame: 8 weeks after completing all treatments
measure: The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and change in reported pain and discomfort.
timeFrame: 8 weeks after completing all treatments
measure: Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group
timeFrame: 8 weeks after primary efficacy endpoint
measure: Safety objective to determine the safety and tolerability of Emsella Chair compared to sham
timeFrame: 4 weeks after primary efficacy endpoint
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
Study officials:
affiliation: Corewell Health William Beaumont University Hospital
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.