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Urinary Stress Incontinence and Urgency in Women With EMSELLA

NCT03877640 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Stress Urinary Incontinence
  • Urge Incontinence

Interventions

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.

Sponsors & Collaborators

  • San Diego Sexual Medicine

    lead OTHER

Principal Investigators

  • Sue W Goldstein, BA · Clinical Research Manager

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03877640 on ClinicalTrials.gov