Urinary Stress Incontinence and Urgency in Women With EMSELLA

October 8, 2023 updated by: San Diego Sexual Medicine

A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)

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.

Study Overview

Status

Recruiting

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

Interventional

Enrollment (Estimated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Recruiting
        • San Diego Sexual Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irwin Goldstein, MD
        • Sub-Investigator:
          • Julea N Minton, NP-C
        • Sub-Investigator:
          • Catherine L Gagnon, FNP-BC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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
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 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
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
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

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
At 18 weeks; for sham arm additionally at 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego Sexual Medicine

Investigators

  • Study Director: Sue W Goldstein, BA, Clinical Research Manager

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDSM-2018-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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