- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877640
Urinary Stress Incontinence and Urgency in Women With EMSELLA
A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Research Manager
- Phone Number: 619-265-8865
- Email: information@sdsm.info
Study Contact Backup
- Name: Wendy Ramirez, AB
- Phone Number: 6192658865
- Email: wramirez@sdsm.info
Study Locations
-
-
California
-
San Diego, California, United States, 92120
- Recruiting
- San Diego Sexual Medicine
-
Contact:
- Clinical Research Manager
- Phone Number: 619-265-8865
- Email: information@sdsm.info
-
Contact:
- Wendy Ramirez, AB
- Phone Number: 6192658865
- Email: wramirez@sdsm.info
-
Principal Investigator:
- Irwin Goldstein, MD
-
Sub-Investigator:
- Julea N Minton, NP-C
-
Sub-Investigator:
- Catherine L Gagnon, FNP-BC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active EMSELLA treatment
6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology
|
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.
|
Sham Comparator: Sham EMSELLA treatment
6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 18 weeks for active arm; up to 32 weeks for sham arm
|
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
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Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit
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At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
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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
|
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.
|
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
|
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.
|
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
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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.
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At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PGI-I (Patient global impression of improvement)
Time Frame: At 18 weeks; for sham arm additionally at 32 weeks
|
Patient global impression of improvement, range 2-14, with higher results representing the better outcome
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At 18 weeks; for sham arm additionally at 32 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sue W Goldstein, BA, Clinical Research Manager
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDSM-2018-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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