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Electromagnetic Therapy

EMSELLA for Urinary Incontinence

N/A

Recruiting

Research Sponsored by San Diego Sexual Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is female

Subject is aged 21-80 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 weeks; for sham arm additionally at 32 weeks

Awards & highlights

Study Summary

This trial looks at whether a new electromagnetic treatment is safe and effective for stress or urge incontinence in women, and whether it has any benefits for sexual health.

Who is the study for?

This trial is for women aged 21-80 with stress, urge, or mixed urinary incontinence who are sexually active and not planning to change their exercise or medication routines. They must have a BMI under 37 kg/m2 and cannot be pregnant, postpartum within 3 months, have metal implants including IUDs with metal, pacemakers, significant pelvic organ prolapse, untreated malignancy or substance abuse history.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of BTL EMSELLA's high intensity focused electromagnetic technology on women with different types of urinary incontinence. It also examines potential sexual health benefits from this treatment.See study design

What are the potential side effects?

While specific side effects are not listed here for BTL EMSELLA treatment, it generally involves non-invasive electromagnetic stimulation which may cause discomfort or muscle contractions during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am female.

Select...

I am between 21 and 80 years old.

Select...

I have been diagnosed with a type of urinary incontinence.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 weeks; for sham arm additionally at 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 weeks; for sham arm additionally at 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 weeks; for sham arm additionally at 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

QUID (Questionnaire for Urinary Incontinence Diagnosis)

Secondary outcome measures

FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm)

FSFI (Female Sexual Function Index)

FSFI (Female Sexual Function Index) Orgasm Domain

+2 more

Other outcome measures

PGI-I (Patient global impression of improvement)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active EMSELLA treatmentActive Control1 Intervention

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

Group II: Sham EMSELLA treatmentPlacebo Group1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Diego Sexual MedicineLead Sponsor

3 Previous Clinical Trials

71 Total Patients Enrolled

Sue W Goldstein, BAStudy DirectorClinical Research Manager

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I a viable candidate for inclusion in this medical experiment?

"Participants with urinary urge incontinence between 21 and 80 years old are encouraged to apply for this medical study. Currently, the trial is looking to accept a total of 21 patients."

Answered by AI

Are there still opportunities for individuals to enroll in this study?

"Affirmative. Clinicaltrials.gov reveals that this medical experiment was first advertised on the 11th of January 2019 and is actively seeking 21 volunteers from a single clinical site as indicated in its most recent update on 8th June 2022."

Answered by AI

What is the key aim of this research endeavor?

"This clinical trial's primary outcome is to be evaluated using the QUID (Questionnaire for Urinary Incontinence Diagnosis) and this assessment will occur over a period of up to 18 weeks in the active arm, and 32 weeks in the placebo arm. Secondary outcomes include changes on FSDS-DAO (Female Sexual Distress Score-Desire, Arousal, Orgasm), which runs from 0-60 with lower results representing better health; FSFI (Female Sexual Function Index) Orgasm Domain running from 0-6 where higher scores indicate an improved condition; as well as modified Oxford Scale measuring pelvic floor strength"

Answered by AI

Are applicants aged 45 or above eligible for participation in the trial?

"This clinical trial requires individuals be between 21 and 80 years old. Separately, there are 17 trials for minors under 18 and 140 research programs available to those 65 or older."

Answered by AI

How many participants are being admitted to participate in this trial?

"Indeed, according to the information on clinicaltrials.gov this trial is currently enrolling patients. It was initially posted in January 11th 2019 and updated last June 8th 2022; they are recruiting 21 people from one medical site."

Answered by AI

Recent research and studies

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

Journal of UrologyJournal

Pelvic Floor Electrical Stimulation in the Treatment of Stress Incontinence: An Investigational Study and A Placebo Controlled Double-blind Trial

Yamanishi, Tomonori, Kosaku Yasuda, Ryuuji Sakakibara, Takamichi Hattori, Haruo Ito, and Shino Murakami. 1997. “Pelvic Floor Electrical Stimulation in the Treatment of Stress Incontinence: An Investigational Study and A Placebo Controlled Double-blind Trial”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0022-5347(01)68176-x.

Medical & Biological Engineering & ComputingJournal

Development of a Non-invasive Treatment System for Urinary Incontinence Using a Functional Continuous Magnetic Stimulator (FCMS)

Ishikawa, N., S. Suda, T. Sasaki, T. Yamanishi, H. Hosaka, K. Yasuda, and H. Ito. 1998. “Development of a Non-invasive Treatment System for Urinary Incontinence Using a Functional Continuous Magnetic Stimulator (FCMS)”. Medical & Biological Engineering & Computing. Springer Science and Business Media LLC. doi:10.1007/bf02518872.

Tissue Engineering Part B: ReviewsJournal