Stress Urinary IncontinenceNCT04031014
High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
A study testing BTL EMSELLA Active treatment in people with Stress Urinary Incontinence and Urge Incontinence, run by Boston Urogynecology Associates at 1 site in United States.
Trial summary
High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Urge Incontinence, Urge and Stress
- What is being tested?
- BTL EMSELLA Active treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
- Age greater than 18
- Subject has a body mass index (BMI) < 37 kg/m2
- Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
- Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
- Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
- Subject agrees to comply with the study procedures and visits.
Who cannot join
- Subject has used the BTL EMSELLA device previously;
- Subject has any significant pelvic organ prolapse; stage III or greater
- Subject is unwilling to maintain current level of exercise throughout the study;
- Subject planning to have surgery during the study;
- Subject has untreated malignancy;
- Subject is pregnant, planning to get pregnant or within 3 months postpartum;
Show all 13Show fewer
- Subject has a pacemaker;
- Subject has and implant or IUD containing metal;
- Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
- Subject is using a pessary or other anti-incontinence device
- Subject has implanted defibrillator, implanted neurostimulator
- Subject has metal implants
- Subject has a drug pump
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Urogynecology Associates
Cambridge, Massachusetts, 02138
About this study
High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will have looking at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.
Read the detailed description
Pelvic floor dysfunction is common and can include symptoms of urinary incontinence, fecal incontinence and prolapse. Studies suggest that pelvic floor dysfunction may affect up to 25% of women in the United States including 17.1% of women with moderate to severe urinary. While most causes of stress/stress predominant urinary incontinence and urge/urge predominant urinary incontinence are due to of poor pelvic floor musculature and abnormal neuromuscular control, the cause of these abnormalities is not known. Traumatic injuries to the pelvic area, such as in an accident, and complications from vaginal childbirth can contribute to this condition. Some cases are due to a learned behavior (repeated actions of straining).
For most pelvic floor disorders, first line therapy involves behavioral modifications and pelvic floor physical therapy. Physical therapy has proven benefits for treatment of pelvic floor disorders and may improve symptoms in up to 70% of patients with any urinary incontinence (either OAB or SUI), and 60-70% patients with FI. Unfortunately, not all patients are able or willing to undergo treatment with pelvic floor physical therapy. During therapy, patients are undressed, and the therapist works internally palpating the muscles in the vagina and rectum to facilitate rehabilitation. Treatment with the BTL EMSELLA allows for similar rehabilitation of the pelvic floor while patients remain comfortably clothed.
The use of magnetic stimulation to treat pelvic floor disorders has been studied previously. In one prospective cohort study of 91 women, treatment with weekly sessions of perineal magnetic stimulation was associated with improved quality of life and decreased urinary leakage episodes. Magnetic stimulation has also been shown to improve urodynamic parameters, both increasing the maximum urethral pressure for patients with stress incontinence, and increase bladder capacity for those with urgency incontinence. The BTL EMSELLA is a device cleared by the Food and Drug Administration (FDA) for entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence. High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will look at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.
- Being tested
- BTL EMSELLA Active treatment, BTL EMSELLA Sham Treatment
- Keywords
- Stress urinary incontinence, urge urinary incontinence, overactive bladder
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL EMSELLA Active treatmentDevice
BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 100% for active treatment
BTL EMSELLA Sham TreatmentDevice
BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 5% for sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Experimental | Treatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total Receives: Device: BTL EMSELLA Active treatment |
| Sham treatment | Sham comparator | Treatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total Receives: Device: BTL EMSELLA Sham Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient global impression of improvement (PGI-I)
The PGI comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The Patient Global Impression of Improvement (PGI-I) has been validated for use in female patients with urinary incontinence and prolapse. Using this measure we hope to assess for overall improvement in symptoms after treatment. Change from baseline will range from -6 to +6 with higher scores representing better outcomes.
Measured: Baseline, 2 weeks after treatment, 3 months after treatment
Secondary outcomes (2)
24 hour voiding diary
A three-day voiding diary is a validated measure based on the International Consultation on Incontinence Questionnaires and involves measurement of fluid intake, leakage episodes and pad useage. There is high correlation between a 24 hour voiding diary and a 3 day voiding diary with higher rates of compliance. Participants will therefore complete a 24 hour voiding diary prior to enrollment, at the conclusion of treatment and again at a 3 month follow up visit. In addition, patients will answer questions on the frequency of pad use. Using the voiding diary we will look specifically at leakage episodes, urgency episodes.
Measured: Baseline, 2 weeks after treatment, 3 months after treatment
FSFI
The FSFI was developed to measure female sexual function. The FSFI is a 19-item patient-reported outcome measure (PROM), consisting of 6 separate domains of female sexual function, namely desire (items 1-2), arousal (3-6), lubrication (7-10), orgasm (11-13), satisfaction (14-16), and pain (17-19). We will assess for change in total score of the FSFI from pre-treatment to follow up visits. Scores range from 2 to 36 with higher results representing better outcomes.
Measured: Baseline, 2 weeks after treatment, 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Feb 2020
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Active and sham arms 1:1 run in parallel
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Urogynecology Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William D. Winkelman, Boston Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031014
- Sponsor's protocol ID
- 021-2019
- Status last verified
- Aug 2025
- First submitted
- 19 Jul 2019
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04031014
- Acronym / sponsor ID
- 021-2019
- Keywords
- Stress urinary incontinence, urge urinary incontinence, overactive bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boston Urogynecology AssociatesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 24 Jul 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.
High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will have looking at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.
Detailed description
Pelvic floor dysfunction is common and can include symptoms of urinary incontinence, fecal incontinence and prolapse. Studies suggest that pelvic floor dysfunction may affect up to 25% of women in the United States including 17.1% of women with moderate to severe urinary. While most causes of stress/stress predominant urinary incontinence and urge/urge predominant urinary incontinence are due to of poor pelvic floor musculature and abnormal neuromuscular control, the cause of these abnormalities is not known. Traumatic injuries to the pelvic area, such as in an accident, and complications from vaginal childbirth can contribute to this condition. Some cases are due to a learned behavior (repeated actions of straining).
For most pelvic floor disorders, first line therapy involves behavioral modifications and pelvic floor physical therapy. Physical therapy has proven benefits for treatment of pelvic floor disorders and may improve symptoms in up to 70% of patients with any urinary incontinence (either OAB or SUI), and 60-70% patients with FI. Unfortunately, not all patients are able or willing to undergo treatment with pelvic floor physical therapy. During therapy, patients are undressed, and the therapist works internally palpating the muscles in the vagina and rectum to facilitate rehabilitation. Treatment with the BTL EMSELLA allows for similar rehabilitation of the pelvic floor while patients remain comfortably clothed.
The use of magnetic stimulation to treat pelvic floor disorders has been studied previously. In one prospective cohort study of 91 women, treatment with weekly sessions of perineal magnetic stimulation was associated with improved quality of life and decreased urinary leakage episodes. Magnetic stimulation has also been shown to improve urodynamic parameters, both increasing the maximum urethral pressure for patients with stress incontinence, and increase bladder capacity for those with urgency incontinence. The BTL EMSELLA is a device cleared by the Food and Drug Administration (FDA) for entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence. High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will look at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Active and sham arms 1:1 run in parallel
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Experimental | Device: BTL EMSELLA Active treatmentTreatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total |
| Sham treatment | Sham comparator | Device: BTL EMSELLA Sham TreatmentTreatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
- Age greater than 18
- Subject has a body mass index (BMI) < 37 kg/m2
- Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
- Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
Key exclusion criteria (13 listed)
- Subject has used the BTL EMSELLA device previously;
- Subject has any significant pelvic organ prolapse; stage III or greater
- Subject is unwilling to maintain current level of exercise throughout the study;
- Subject planning to have surgery during the study;
- Subject has untreated malignancy;
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 EMSELLA Active treatmentBTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 100% for active treatment | Device | Active treatment |
| BTL EMSELLA Sham TreatmentBTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 5% for sham treatment | Device | Sham treatment |
Primary outcome
Patient global impression of improvement (PGI-I)
Time frame: Baseline, 2 weeks after treatment, 3 months after treatment
The PGI comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The Patient Global Impression of Improvement (PGI-I) has been validated for use in female patients with urinary incontinence and prolapse. Using this measure we hope to assess for overall improvement in symptoms after treatment. Change from baseline will range from -6 to +6 with higher scores representing better outcomes.
2 secondary outcomes
24 hour voiding diary
Time frame: Baseline, 2 weeks after treatment, 3 months after treatment
FSFI
Time frame: Baseline, 2 weeks after treatment, 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Active treatment in people with Stress Urinary Incontinence and Urge Incontinence, run by Boston Urogynecology Associates 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 5 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient global impression of improvement (PGI-I) (time frame: Baseline, 2 weeks after treatment, 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.