Stress Urinary IncontinenceNCT03877640

Urinary Stress Incontinence and Urgency in Women With EMSELLA

A study testing BTL EMSELLA in people with Stress Urinary Incontinence and Urge Incontinence, run by San Diego Sexual Medicine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this prospective study is to examine the safety and efficacy of high intensity focused electromagnetic (HIFEM) technology for the treatment of women with stress urinary incontinence (SUI), urge incontinence (UI) and mixed stress urinary and urge incontinence (MUI), looking at any potential sexual health… Read more about this study

Who is it for?: Ages 21 to 80 years, women only
Conditions the study is for: Stress Urinary Incontinence, Urge 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: 21 participants
Where: 1 siteUnited States
Study dates: 11 Jan 2019to Jun 2024
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 21 to 80 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;
Subject is female;
Subject is aged 21-80 years;
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 currently sexually active and willing to continue sexual activity throughout the study;

Show all 9Show fewer

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;
Subject has clinically significant findings on physical examination;
Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
Subject is unwilling to maintain current level of exercise throughout the study;
Subject has been diagnosed with overactive bladder or interstitial cystitis;

Show all 19Show fewer

Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
Subject experiences pain with sexual activity
Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)
Subject planning to have surgery during the study;
Subject has untreated malignancy;
Subject is pregnant, planning to get pregnant or within 3 months postpartum;
Subject has a pacemaker;
Subject has and implant or IUD containing metal (e.g. copper 7);
Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week;
Subject has received an investigational drug within 30 days prior to signing consent;
Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Trial locations and contacts

1 site in 1 country.

Clinical Research Manager contact

619-265-8865

information@sdsm.info

Wendy Ramirez, AB contact

6192658865

wramirez@sdsm.info

United States1 site, 1 recruiting

San Diego Sexual Medicine
San Diego, California, 92120
Clinical Research Manager, 619-265-8865, information@sdsm.info
Wendy Ramirez, AB, 6192658865, wramirez@sdsm.info
Recruiting

Other trials in United States

About this study

Official title: A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)

Read the detailed description

This is a blinded study to be conducted at San Diego Sexual Medicine in San Diego, CA. Participants meeting inclusion and exclusion criteria will receive one treatment cycle of active treatment or sham. The device will be equipped with 3 protocols in addition to the standard protocol, two of which are identical to the standard protocol (for active treatment) and one of which does not deliver HIFEM (for sham treatment). The active treatment arm consists of 6 treatments, 2 per week, with at least one day in between. Follow-up visits will occur at 4 weeks and 12 weeks after the last treatment. Unblinding will take place at the 12 week follow up visit, and subjects assigned to the sham arm will be crossed over to active treatment, beginning their first treatment on that day, completing 6 treatments and 2 follow up visits. Once unblinded the subject will be treated with the standard protocol of the device.

After the informed consent is signed, and inclusion and exclusion criteria completed, participants will complete validated questionnaires and undergo a baseline physical therapy assessment of pelvic floor muscle strength.

Conditions: Stress Urinary Incontinence, Urge Incontinence
Being tested: BTL EMSELLA
Keywords: incontinence, stress urgency incontinence, urge incontinence, EMSELLA
Medical subject headings: Urinary Incontinence, Stress, Urinary Incontinence, Urge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BTL EMSELLADevice
High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.

Study groups in NCT03877640
Study group	Role	What they receive
Active EMSELLA treatment	Active comparator	6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology Receives: Device: BTL EMSELLA
Sham EMSELLA treatment	Sham comparator	6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology Receives: Device: BTL EMSELLA

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events
Serious adverse events and adverse events related to device will be collected to assess safety
Measured: Up to 18 weeks for active arm; up to 32 weeks for sham arm
QUID (Questionnaire for Urinary Incontinence Diagnosis)
Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit
Measured: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks

Secondary outcomes (5)

FSFI (Female Sexual Function Index) Orgasm Domain
Change in Orgasm Domain of the Female Sexual Function Index from pre-treatment to follow up visits. Range is 0-6 with higher the results representing better outcome
Measured: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSFI (Female Sexual Function Index)
Change in total score of the Female Sexual Function Index from pre-treatment to follow up visits. Range is 2-36, with higher results representing better the outcome, and 26.55 and above signifying no sexual dysfunction
Measured: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)
Change in total score of the Female Sexual Distress Score-Desire, Arousal, Orgasm from pre-treatment to follow up visits. Range is from 0-60 with lower results representing the better outcome.
Measured: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
ISCI (Interstitial Cystitis Symptoms Index )/ICPI (Interstitial Cystitis Problem Index)
Change in total score of the ICSI/ICPI Questionnaire from pre-treatment to follow up visits. Range is 0-35, with lower results representing the better the outcome.
Measured: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Modified Oxford Scale measuring pelvic floor strength
Change in degree of force based on the modified Oxford scale measuring pelvic floor muscle strength from pre-treatment to follow up visits. Scale is a single recording from 0 (lack of muscle response) to 5 (strong contraction, firm compression) with higher results representing the better the outcome.
Measured: At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 2019Jun 2024

First posted18 Mar 2019
Study start11 Jan 2019
Primary completionJun 2024 (estimated)
Study completionJun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)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: Active and sham arms 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03877640
Sponsor's protocol ID: SDSM-2018-02
Status last verified: Oct 2023
First submitted: 30 Jan 2019
Last updated: 10 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Almeida FG, Bruschini H, Srougi M. Urodynamic and clinical evaluation of 91 female patients with urinary incontinence treated with perineal magnetic stimulation: 1-year followup. J Urol. 2004 Apr;171(4):1571-4; discussion 1574-5. doi: 10.1097/01.ju.0000117791.72151.f8.
PubMed 15017223
Coletti D, Teodori L, Albertini MC, Rocchi M, Pristera A, Fini M, Molinaro M, Adamo S. Static magnetic fields enhance skeletal muscle differentiation in vitro by improving myoblast alignment. Cytometry A. 2007 Oct;71(10):846-56. doi: 10.1002/cyto.a.20447.
PubMed 17694560
Ishikawa N, Suda S, Sasaki T, Yamanishi T, Hosaka H, Yasuda K, Ito H. Development of a non-invasive treatment system for urinary incontinence using a functional continuous magnetic stimulator (FCMS). Med Biol Eng Comput. 1998 Nov;36(6):704-10. doi: 10.1007/BF02518872.
PubMed 10367460
Ostrovidov S, Hosseini V, Ahadian S, Fujie T, Parthiban SP, Ramalingam M, Bae H, Kaji H, Khademhosseini A. Skeletal muscle tissue engineering: methods to form skeletal myotubes and their applications. Tissue Eng Part B Rev. 2014 Oct;20(5):403-36. doi: 10.1089/ten.TEB.2013.0534. Epub 2014 Feb 24.
PubMed 24320971
Stolting MN, Arnold AS, Haralampieva D, Handschin C, Sulser T, Eberli D. Magnetic stimulation supports muscle and nerve regeneration after trauma in mice. Muscle Nerve. 2016 Apr;53(4):598-607. doi: 10.1002/mus.24780.
PubMed 26202157
Truijen G, Wyndaele JJ, Weyler J. Conservative treatment of stress urinary incontinence in women: who will benefit? Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):386-90. doi: 10.1007/s001920170018.
PubMed 11795642
Wallis MC, Davies EA, Thalib L, Griffiths S. Pelvic static magnetic stimulation to control urinary incontinence in older women: a randomized controlled trial. Clin Med Res. 2012 Feb;10(1):7-14. doi: 10.3121/cmr.2011.1008. Epub 2011 Aug 4.
PubMed 21817123
Yamanishi T, Yasuda K, Suda S, Ishikawa N, Sakakibara R, Hattori T. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol. 2000 Feb;163(2):456-9.
PubMed 10647653
Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Ito H, Murakami S. Pelvic floor electrical stimulation in the treatment of stress incontinence: an investigational study and a placebo controlled double-blind trial. J Urol. 1997 Dec;158(6):2127-31. doi: 10.1016/s0022-5347(01)68176-x.
PubMed 9366328
Yang SS, Jee S, Hwang SL, Sohn MK. Strengthening of Quadriceps by Neuromuscular Magnetic Stimulation in Healthy Subjects. PM R. 2017 Aug;9(8):767-773. doi: 10.1016/j.pmrj.2016.12.002. Epub 2017 Jan 8.
PubMed 28082179

Want to know more?

Clinical Research Manager

619-265-8865

information@sdsm.info

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
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All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
ClinicalTrials.gov ID: NCT03877640
Acronym / sponsor ID: SDSM-2018-02
Conditions: Stress Urinary Incontinence, Urge Incontinence
Keywords: incontinence, stress urgency incontinence, urge incontinence, EMSELLA
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 21 participants (estimated)
Lead sponsor: San Diego Sexual MedicineUniversity, hospital or other
Study start: 11 Jan 2019 (actual)
Primary completion: Jun 2024 (estimated)
Study completion: Jun 2024 (estimated)
First posted: 18 Mar 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.

Detailed description

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 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.

Arm	Type	Receives
Active EMSELLA treatment	Active comparator	Device: BTL EMSELLA6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology
Sham EMSELLA treatment	Sham comparator	Device: BTL EMSELLA6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology

Who may qualify

Ages: 21 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
Subject is female;
Subject is aged 21-80 years;
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;

Key exclusion criteria (19 listed)

Subject has used the BTL EMSELLA device previously;
Subject has any significant pelvic organ prolapse;
Subject has clinically significant findings on physical examination;
Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
Subject is unwilling to maintain current level of exercise throughout the study;

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 EMSELLAHigh intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.	Device	Active EMSELLA treatment, Sham EMSELLA treatment

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 18 weeks for active arm; up to 32 weeks for sham arm
Serious adverse events and adverse events related to device will be collected to assess safety
QUID (Questionnaire for Urinary Incontinence Diagnosis)
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit

5 secondary outcomes

FSFI (Female Sexual Function Index) Orgasm Domain
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSFI (Female Sexual Function Index)
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
ISCI (Interstitial Cystitis Symptoms Index )/ICPI (Interstitial Cystitis Problem Index)
Time frame: At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Modified Oxford Scale measuring pelvic floor strength
Time frame: At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Background: PubMed 15017223Almeida FG, Bruschini H, Srougi M. Urodynamic and clinical evaluation of 91 female patients with urinary incontinence treated with perineal magnetic stimulation: 1-year followup. J Urol. 2004 Apr;171(4):1571-4; discussion 1574-5. doi: 10.1097/01.ju.0000117791.72151.f8.
Background: PubMed 17694560Coletti D, Teodori L, Albertini MC, Rocchi M, Pristera A, Fini M, Molinaro M, Adamo S. Static magnetic fields enhance skeletal muscle differentiation in vitro by improving myoblast alignment. Cytometry A. 2007 Oct;71(10):846-56. doi: 10.1002/cyto.a.20447.
Background: PubMed 10367460Ishikawa N, Suda S, Sasaki T, Yamanishi T, Hosaka H, Yasuda K, Ito H. Development of a non-invasive treatment system for urinary incontinence using a functional continuous magnetic stimulator (FCMS). Med Biol Eng Comput. 1998 Nov;36(6):704-10. doi: 10.1007/BF02518872.
Background: PubMed 24320971Ostrovidov S, Hosseini V, Ahadian S, Fujie T, Parthiban SP, Ramalingam M, Bae H, Kaji H, Khademhosseini A. Skeletal muscle tissue engineering: methods to form skeletal myotubes and their applications. Tissue Eng Part B Rev. 2014 Oct;20(5):403-36. doi: 10.1089/ten.TEB.2013.0534. Epub 2014 Feb 24.
Background: PubMed 26202157Stolting MN, Arnold AS, Haralampieva D, Handschin C, Sulser T, Eberli D. Magnetic stimulation supports muscle and nerve regeneration after trauma in mice. Muscle Nerve. 2016 Apr;53(4):598-607. doi: 10.1002/mus.24780.
Background: PubMed 11795642Truijen G, Wyndaele JJ, Weyler J. Conservative treatment of stress urinary incontinence in women: who will benefit? Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):386-90. doi: 10.1007/s001920170018.
Background: PubMed 21817123Wallis MC, Davies EA, Thalib L, Griffiths S. Pelvic static magnetic stimulation to control urinary incontinence in older women: a randomized controlled trial. Clin Med Res. 2012 Feb;10(1):7-14. doi: 10.3121/cmr.2011.1008. Epub 2011 Aug 4.
Background: PubMed 10647653Yamanishi T, Yasuda K, Suda S, Ishikawa N, Sakakibara R, Hattori T. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol. 2000 Feb;163(2):456-9.
Background: PubMed 9366328Yamanishi T, Yasuda K, Sakakibara R, Hattori T, Ito H, Murakami S. Pelvic floor electrical stimulation in the treatment of stress incontinence: an investigational study and a placebo controlled double-blind trial. J Urol. 1997 Dec;158(6):2127-31. doi: 10.1016/s0022-5347(01)68176-x.
Background: PubMed 28082179Yang SS, Jee S, Hwang SL, Sohn MK. Strengthening of Quadriceps by Neuromuscular Magnetic Stimulation in Healthy Subjects. PM R. 2017 Aug;9(8):767-773. doi: 10.1016/j.pmrj.2016.12.002. Epub 2017 Jan 8.
Individual participant dataSharing planned: No

Related trials for Stress Urinary Incontinence

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Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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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.

Clinical Research Manager contact

619-265-8865

information@sdsm.info

Wendy Ramirez, AB contact

6192658865

wramirez@sdsm.info

Sue W Goldstein, BA study director

Clinical Research Manager

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 and Urge Incontinence, run by San Diego Sexual Medicine 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 9 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 10 Oct 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Clinical Research Manager (619-265-8865, information@sdsm.info), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: Up to 18 weeks for active arm; up to 32 weeks for sham arm). The study lists 2 primary outcomes in all. 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 NCT03877640, which also lists 10 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 10 Oct 2023.