Stress Urinary IncontinenceNCT04133675
BTL Emsella Chair Versus Sham for the Treatment of Stress Urinary Incontinence
A study testing BTL Emsella in people with Stress Urinary Incontinence, run by Corewell Health East at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- BTL Emsella
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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:
- Pregnant, or planning to become pregnant, at screening or anytime throughout the study period
- History of surgery with insertion of vaginal mesh for SUI
- Vaginal prolapse beyond the introitus
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Katherine Kim, RN, 248-551-0642, Katherine.Kim@corewellhealth.org
Jennifer Giordano, RN, 248-551-3517, Jennifer.Giordano@corewellhealth.org
About this study
Official title: A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- BTL Emsella, Sham BTL Emsella
- Keywords
- urinary incontinence, urine leakage
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL EmsellaDevice
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.
Sham BTL EmsellaDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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). Receives: Device: Sham BTL Emsella |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Change in the total number of subject-reported stress incontinence (SUI) episodes over 3 days based on voiding diaries. Patients will be giving a 3-day void diary to complete.
Measured: 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.
Change in subject-reported impression of SUI severity as measured by the Patient Global Impression of Severity scale (PGI-S). The subject will check the box that describes how their condition is now. The available options are normal, mild, moderate, or severe.
Measured: 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).
Change in subject-reported impression of SUI improvement as measured by the Patient Global Impression of Improvement scale (PGI-I). The subject will select one of the following options, (very much better, much better, a little better, no change, a little worse, much worse, very much worse) to describe their urinary tract symptoms now versus prior to study treatment.
Measured: 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.
Change in subject-reported urogenital distress as measured by the Urinary Distress Inventory questionnaire (UDI-6). The UDI-6 is a six point questionnaire, each question answered is scored as follows; 0 = no, 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit. Add all scores and divide by 6, then multiply by 25 to calculate the raw score. Higher scores = higher disability.
Measured: 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.
Change in subject-reported impact of SUI on daily life as measured by the Incontinence Impact Questionnaire (IIQ-7) Short Form. The IIQ-7, assesses how their problem effects activities, relationships, and feelings. It is a 7 point questionnaire. Each answer is scored on the following scale 0 = not at all, 1 = slightly, 2 = moderately, 3 = greatly. The higher the score the more effected they are by their condition.
Measured: 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 urinary incontinence on daily life measured by the Incontinence Quality of Life questionnaire (I-QOL).
Change in subject-reported impact of urinary incontinence on daily life as measured by the Incontinence Quality of Life questionnaire (I-QOL). The I-QOL is a quality of life measure specific to persons with urinary incontinence. The survey consists of 22 incontinent-specific quality of life items all having the following five-point ordinal response; 1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, 5 = not at all. The summed total score is transformed to a 0-100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).
Measured: 8 weeks after completing all treatments
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).
Change in subject-reported fecal incontinence as measured by the Cleveland clinic incontinence score (Wexner). The type of incontinence of stool (solid, liquid, gas, wears pad, lifestyle altered) are reported by the subject. Each question is measured as 0 = never, 1 = rarely, 2 = sometimes, 4 = usually, 5 = always. The higher the score the more severe the condition.
Measured: 8 weeks after completing all treatments
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.
The change in subject-reported sexual function as measured by the Female Sexual Function Index questionnaire (FSFI) for female subjects. The FSFI is a 19 question survey. A lower the score is equivalent a higher degree of sexual function. Scores range from 0 to 95.
Measured: 8 weeks after completing all treatments
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.
Change in subject-reported sexual function as measured by the Brief Sexual Function Inventory questionnaire (BSFI) for male subjects. The BSFI is a validated questionnaire for male sexual function. Scores range from 0 to 44. A lower score indicates a higher degree of dysfunction.
Measured: 8 weeks after completing all treatments
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and change in reported pain and discomfort.
Change in subject-reported pain and discomfort as measured by the Visual Analog Scale (VAS). The VAS is a validated questionnaire that assesses pain on a scale from 0 = no pain to 10 = Worst possible pain.
Measured: 8 weeks after completing all treatments
Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group
The secondary object for durability for this study are to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group
Measured: 8 weeks after primary efficacy endpoint
Safety objective to determine the safety and tolerability of Emsella Chair compared to sham
Safety and tolerability of the Emsella chair compared to Sham will be assessed in relation the incidence of adverse events.
Measured: 4 weeks after primary efficacy endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start18 Dec 2019
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health William Beaumont University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133675
- Sponsor's protocol ID
- 2019-242
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2019
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 10367836HIFEM 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized Study of the BTL EmsellaTM Chair Versus Sham for the Treatment of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04133675
- Acronym / sponsor ID
- 2019-242
- Conditions
- Stress Urinary Incontinence
- Keywords
- urinary incontinence, urine leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Emsella Chair Active Treatment | Active comparator | Device: BTL EmsellaActive 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%. |
| Emsella Sham Treatment | Sham comparator | Device: Sham BTL EmsellaSham 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTL EmsellaThe 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. | Device | Emsella Chair Active Treatment |
| Sham BTL EmsellaSham 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 | Emsella Sham Treatment |
Primary outcome
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence.
Time frame: 4 weeks after completing all treatments
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.
12 secondary outcomes
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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 urinary incontinence on daily life measured by the Incontinence Quality of Life questionnaire (I-QOL).
Time frame: 8 weeks after completing all treatments
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).
Time frame: 8 weeks after completing all treatments
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.
Time frame: 8 weeks after completing all treatments
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.
Time frame: 8 weeks after completing all treatments
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence and change in reported pain and discomfort.
Time frame: 8 weeks after completing all treatments
Durability to determine whether subjects in the Emsella Chair group continue to have a higher responder rate than the Sham group
Time frame: 8 weeks after primary efficacy endpoint
Safety objective to determine the safety and tolerability of Emsella Chair compared to sham
Time frame: 4 weeks after primary efficacy endpoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 10367836Galloway 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.
- BackgroundHIFEM 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Peters, MD principal investigator
Corewell Health William Beaumont University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL Emsella in people with Stress Urinary Incontinence, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Kim, RN (248-551-0642, Katherine.Kim@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the Emsella chair versus sham to treat stress urinary incontinence. (time frame: 4 weeks after completing all treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.