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Urinary Stress Incontinence and Urgency in Women With EMSELLA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03877640
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
San Diego Sexual Medicine

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Urge Incontinence Device: BTL EMSELLA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Active and sham arms 2:1 run parallel. Upon completion, sham patients repeat visits with open label treatment.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
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)
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active EMSELLA treatment
6 treatments on the BTL EMSELLA using a device protocol that is active HIFEM technology
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.

Sham Comparator: Sham EMSELLA treatment
6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. Modified Oxford Scale measuring pelvic floor strength [ Time Frame: At screen, 10 weeks, 18 weeks; for sham arm additionally at 24 weeks, 32 weeks ]
    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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cis-gender woman
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877640


Contacts
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Contact: Clinical Research Manager 619-265-8865 information@sdsm.info
Contact: Wendy Ramirez, AB 6192658865 wramirez@sdsm.info

Locations
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United States, California
San Diego Sexual Medicine Recruiting
San Diego, California, United States, 92120
Contact: Clinical Research Manager    619-265-8865    information@sdsm.info   
Contact: Wendy Ramirez, AB    6192658865    wramirez@sdsm.info   
Principal Investigator: Irwin Goldstein, MD         
Sub-Investigator: Julea N Minton, NP-C         
Sub-Investigator: Catherine L Gagnon, FNP-BC         
Sponsors and Collaborators
San Diego Sexual Medicine
Investigators
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Study Director: Sue W Goldstein, BA Clinical Research Manager
  Study Documents (Full-Text)

Documents provided by San Diego Sexual Medicine:
Informed Consent Form  [PDF] January 3, 2019

Publications:

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Responsible Party: San Diego Sexual Medicine
ClinicalTrials.gov Identifier: NCT03877640    
Other Study ID Numbers: SDSM-2018-02
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by San Diego Sexual Medicine:
incontinence
stress urgency incontinence
urge incontinence
EMSELLA
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations