COMPLETED

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Conditions

Stress Urinary Incontinence Urge Incontinence Urge and Stress Overactive Bladder Stress urinary incontinence, urge urinary incontinence, overactive bladder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High Intensity Focused Electromagnetic Field Device for Urinary Incontinence

Quick Facts

Study Start:2020-02-01

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04031014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted 2. Age greater than 18 3. Subject has a body mass index (BMI) \< 37 kg/m2 4. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID; 5. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga); 6. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them; 7. Subject agrees to comply with the study procedures and visits.	1. Subject has used the BTL EMSELLA device previously; 2. Subject has any significant pelvic organ prolapse; stage III or greater 3. Subject is unwilling to maintain current level of exercise throughout the study; 4. Subject planning to have surgery during the study; 5. Subject has untreated malignancy; 6. Subject is pregnant, planning to get pregnant or within 3 months postpartum; 7. Subject has a pacemaker; 8. Subject has and implant or IUD containing metal; 9. Subject has piercing between the waist and knees and is not willing to remove it before each treatment; 10. Subject is using a pessary or other anti-incontinence device 11. Subject has implanted defibrillator, implanted neurostimulator 12. Subject has metal implants 13. Subject has a drug pump

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Locations (Sites)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138

United States

Collaborators and Investigators

Sponsor: Boston Urogynecology Associates

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-01

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2020-02-01

Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

Stress urinary incontinence, urge urinary incontinence, overactive bladder

Additional Relevant MeSH Terms

Stress Urinary Incontinence
Urge Incontinence
Urge and Stress
Overactive Bladder