Urinary Stress Incontinence and Urgency in Women With EMSELLA

NCT03877640 | Unknown FDA Device

• 1 other identifier: SDSM-2018-02
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress Urinary Incontinence; Urge Incontinence

Keywords

incontinence; stress urgency incontinence; urge incontinence; EMSELLA

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• FSFI (Female Sexual Function Index) Orgasm Domain

  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)

  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)

  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)

  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

  At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks

Other Outcomes (1)

• PGI-I (Patient global impression of improvement)

  At 18 weeks; for sham arm additionally at 32 weeks

Study Arms (2)

Active EMSELLA treatment

ACTIVE COMPARATOR

6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology

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

Device: BTL EMSELLA

Interventions

BTL EMSELLA DEVICE

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.

Active EMSELLA treatment; Sham EMSELLA treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Gender Eligibility Details: cis-gender woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• San Diego Sexual Medicine: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

RECRUITING

Related 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.

  PMID: 15017223 BACKGROUND

• 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.

  PMID: 17694560 BACKGROUND

• 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.

  PMID: 10367460 BACKGROUND

• 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.

  PMID: 24320971 BACKGROUND

• 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.

  PMID: 26202157 BACKGROUND

• 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.

  PMID: 11795642 BACKGROUND

• 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.

  PMID: 21817123 BACKGROUND

• 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.

  PMID: 10647653 BACKGROUND

• 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.

  PMID: 9366328 BACKGROUND

• 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.

  PMID: 28082179 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sue W Goldstein, BA

  Clinical Research Manager

  STUDY DIRECTOR

Central Study Contacts

Clinical Research Manager

CONTACT

619-265-8865; information@sdsm.info

Wendy Ramirez, AB

CONTACT

6192658865; wramirez@sdsm.info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Three blinded protocols available on the device, so care provider will not know to which treatment subject is randomized. Active treatment is not blinded for use in open label portion of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active and sham arms 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: March 18, 2019
• Study Start: January 11, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)