Urinary Stress Incontinence and Urgency in Women With EMSELLA

NCT ID: NCT03877640

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2024-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active EMSELLA treatment

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

Group Type: ACTIVE_COMPARATOR

BTL EMSELLA

Intervention Type: 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.

Sham EMSELLA treatment

6 treatments on the BTL EMSELLA with a sham device protocol that provides some sensation without active HIFEM technology

Group Type: SHAM_COMPARATOR

BTL EMSELLA

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

San Diego Sexual Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sue W Goldstein, BA

Role: STUDY_DIRECTOR

Clinical Research Manager

Locations

San Diego Sexual Medicine

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Research Manager

Role: CONTACT

information@sdsm.info

619-265-8865

Wendy Ramirez, AB

Role: CONTACT

wramirez@sdsm.info

6192658865

Facility Contacts

Clinical Research Manager

Role: primary

information@sdsm.info

619-265-8865

Wendy Ramirez, AB

Role: backup

wramirez@sdsm.info

6192658865

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Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SDSM-2018-02

Identifier Type: -

Identifier Source: org_study_id