Urinary Stress Incontinence and Urgency in Women With EMSELLA

Stress Urinary Incontinence Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877640
• Other study ID #: SDSM-2018-02
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2019
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: San Diego Sexual Medicine
• Contact: Clinical Research Manager
• Phone: 619-265-8865
• Email: information[@]sdsm.info
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 benefits that may be concomitantly achieved from this treatment.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;

2. Subject is female;

3. Subject is aged 21-80 years;

4. Subject has a body mass index (BMI) < 37 kg/m2;

5. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;

6. Subject is currently sexually active and willing to continue sexual activity throughout the study;

7. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);

8. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;

9. Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

1. Subject has used the BTL EMSELLA device previously;

2. Subject has any significant pelvic organ prolapse;

3. Subject has clinically significant findings on physical examination;

4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;

5. Subject is unwilling to maintain current level of exercise throughout the study;

6. Subject has been diagnosed with overactive bladder or interstitial cystitis;

7. Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);

8. Subject experiences pain with sexual activity

9. 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)

10. Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)

11. Subject planning to have surgery during the study;

12. Subject has untreated malignancy;

13. Subject is pregnant, planning to get pregnant or within 3 months postpartum;

14. Subject has a pacemaker;

15. Subject has and implant or IUD containing metal (e.g. copper 7);

16. Subject has piercing between the waist and knees and is not willing to remove it before each treatment;

17. Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week;

18. Subject has received an investigational drug within 30 days prior to signing consent;

19. 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.

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urge Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence, Urge

Intervention

Device:
• BTL EMSELLA
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.

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Sexual Medicine

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	PGI-I (Patient global impression of improvement)	Patient global impression of improvement, range 2-14, with higher results representing the better outcome	At 18 weeks; for sham arm additionally at 32 weeks
Primary	Incidence of Treatment-Emergent Adverse Events	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
Primary	QUID (Questionnaire for Urinary Incontinence Diagnosis)	Change in Questionnaire for Urinary Incontinence Diagnosis (QUID) from pre-treatment to each follow up visit	At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary	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	At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary	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	At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary	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.	At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary	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.	At screen, 4 weeks, 6 weeks, 10 weeks, 18 weeks; for sham arm additionally at 20 weeks, 24 weeks, 32 weeks
Secondary	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.	At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks