High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

NCT04031014 | Completed FDA Device

• 1 other identifier: 021-2019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Stress Urinary Incontinence; Urge Incontinence; Urge and Stress; Overactive Bladder

Keywords

Stress urinary incontinence, urge urinary incontinence, overactive bladder

Outcome Measures

Primary Outcomes (1)

• Patient global impression of improvement (PGI-I)

  The PGI comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale. The Patient Global Impression of Improvement (PGI-I) has been validated for use in female patients with urinary incontinence and prolapse. Using this measure we hope to assess for overall improvement in symptoms after treatment. Change from baseline will range from -6 to +6 with higher scores representing better outcomes.

  Baseline, 2 weeks after treatment, 3 months after treatment

Secondary Outcomes (2)

• 24 hour voiding diary

  Baseline, 2 weeks after treatment, 3 months after treatment

• FSFI

  Baseline, 2 weeks after treatment, 3 months after treatment

Study Arms (2)

Active treatment

EXPERIMENTAL

Treatment with the active treatment protocol of the BTL EMSELLA device twice per week for six treatments total

Device: BTL EMSELLA Active treatment

Sham treatment

SHAM COMPARATOR

Treatment with the sham protocol of the BTL EMSELLA device twice per week for six treatments total

Device: BTL EMSELLA Sham Treatment

Interventions

BTL EMSELLA Active treatment DEVICE

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

Active treatment

BTL EMSELLA Sham Treatment DEVICE

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

Sham treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
• Age greater than 18
• Subject has a body mass index (BMI) \< 37 kg/m2
• Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
• Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
• Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
• Subject agrees to comply with the study procedures and visits.

You may not qualify if:

• Subject has used the BTL EMSELLA device previously;
• Subject has any significant pelvic organ prolapse; stage III or greater
• Subject is unwilling to maintain current level of exercise throughout the study;
• Subject planning to have surgery during the study;
• Subject has untreated malignancy;
• Subject is pregnant, planning to get pregnant or within 3 months postpartum;
• Subject has a pacemaker;
• Subject has and implant or IUD containing metal;
• Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
• Subject is using a pessary or other anti-incontinence device
• Subject has implanted defibrillator, implanted neurostimulator
• Subject has metal implants
• Subject has a drug pump

Sponsors & Collaborators

• Boston Urogynecology Associates: lead

Study Sites (1)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two blinded protocols are available on the device, neither investigators, participants or care providers will know the active treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director

Model Details: Active and sham arms 1:1 run in parallel

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 24, 2019
• Study Start: February 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)