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High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

NCT04031014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-05

No results posted yet for this study

Summary

High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercise over 28 minutes, with the intention of increasing neuromuscular tone of the pelvic floor. This study will have looking at treatment of the two of the most common pelvic floor disorders: stress or stress predominant urinary incontinence and urge or urge predominant urinary incontinence.

Conditions

Interventions

DEVICE

BTL EMSELLA Active treatment

BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 100% for active treatment

DEVICE

BTL EMSELLA Sham Treatment

BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 5% for sham treatment

Sponsors & Collaborators

  • Boston Urogynecology Associates

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031014 on ClinicalTrials.gov