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Electromagnetic Field Device

Electromagnetic Therapy for Urinary Incontinence

N/A
Recruiting
Research Sponsored by Boston Urogynecology Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks after treatment, 3 months after treatment
Awards & highlights

Study Summary

This trial will be studying whether or not a new non-invasive treatment for urinary incontinence is effective. The treatment involves a machine that sends electromagnetic waves through the pelvic floor to stimulate muscle contractions.

Who is the study for?
This trial is for adults over 18 with urinary incontinence issues, specifically stress or urge incontinence. Participants must not change their medications during the study and should maintain their current level of core exercise. They can't join if they're pregnant, have metal implants including IUDs, pacemakers, drug pumps, or significant pelvic organ prolapse.Check my eligibility
What is being tested?
The trial tests a High Intensity Focused Electromagnetic (HIFEM) device called BTL EMSELLA that aims to strengthen pelvic floor muscles through intense contractions. It compares an active treatment against a sham (placebo) to see if it effectively treats urinary incontinence.See study design
What are the potential side effects?
Potential side effects are not specified but may include discomfort from the electromagnetic field's effect on pelvic muscles and possible skin irritation where the device is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a type of urinary incontinence.
Select...
I have been diagnosed with a type of urinary incontinence.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks after treatment, 3 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks after treatment, 3 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient global impression of improvement (PGI-I)
Secondary outcome measures
24 hour voiding diary
FSFI

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active treatmentExperimental Treatment1 Intervention
Treatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total
Group II: Sham treatmentPlacebo Group1 Intervention
Treatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total

Find a Location

Who is running the clinical trial?

Boston Urogynecology AssociatesLead Sponsor
9 Previous Clinical Trials
904 Total Patients Enrolled

Media Library

BTL EMSELLA Active treatment (Electromagnetic Field Device) Clinical Trial Eligibility Overview. Trial Name: NCT04031014 — N/A
Stress Incontinence Research Study Groups: Sham treatment, Active treatment
Stress Incontinence Clinical Trial 2023: BTL EMSELLA Active treatment Highlights & Side Effects. Trial Name: NCT04031014 — N/A
BTL EMSELLA Active treatment (Electromagnetic Field Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04031014 — N/A

Frequently Asked Questions

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

Is the opportunity for enrollment in this trial still available?

"Affirmative, the clinicaltrials.gov page reveals that this trial is still inviting participants to participate in their study. This research was initially posted on February 1st 2020 and last revised March 1st 2022 with a recruitment target of 36 individuals from one location."

Answered by AI

Approximately how many individuals are enrolled in this research program?

"Affirmative. According to the recorded information on clinicaltrials.gov, this scientific experiment is still recruiting participants after first being posted in February of 2020 and last updated March 1st 2022; 36 individuals are required at one medical site."

Answered by AI

Does this clinical trial accept participants that are over 35 years of age?

"The stipulated selection parameters for this research endeavour necessitate that the minimum age of enrolment must be 18 and the upper age limit is 100."

Answered by AI

Who qualifies to be included in this clinical examination?

"Urge urinary incontinence and an age range between 18-100 years old are requisite qualifications for potential applicants of this clinical trial. This research requires 36 participants in total."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
South Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
High Intensity Focused Electromagnetic Field Device for Urinary Incontinence
William D. Winkelman 2020. "High Intensity Focused Electromagnetic Field Device for Urinary Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04031014.
All > Overactive Bladder
~7 spots leftby May 2025
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