RECRUITING

Urinary Stress Incontinence and Urgency in Women With EMSELLA

Conditions

Stress Urinary Incontinence Urge Incontinence incontinence stress urgency incontinence EMSELLA

Quick Navigation

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

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.

Official Title

A Double-Blind, Sham Controlled Prospective Pilot Study of Urinary Stress Incontinence and Urgency in Women After 6 Treatments With HIFEM Technology (BTL EMSELLA)

Quick Facts

Study Start:2019-01-11

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03877640

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:21 Years to 80 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. Subject is female; 3. Subject is aged 21-80 years; 4. Subject has a body mass index (BMI) \< 37 kg/m2; 5. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID; 6. Subject is currently sexually active and willing to continue sexual activity throughout the study; 7. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga); 8. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them; 9. 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; 3. Subject has clinically significant findings on physical examination; 4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study; 5. Subject is unwilling to maintain current level of exercise throughout the study; 6. Subject has been diagnosed with overactive bladder or interstitial cystitis; 7. Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI); 8. Subject experiences pain with sexual activity 9. Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI) 10. Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI) 11. Subject planning to have surgery during the study; 12. Subject has untreated malignancy; 13. Subject is pregnant, planning to get pregnant or within 3 months postpartum; 14. Subject has a pacemaker; 15. Subject has and implant or IUD containing metal (e.g. copper 7); 16. Subject has piercing between the waist and knees and is not willing to remove it before each treatment; 17. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week; 18. Subject has received an investigational drug within 30 days prior to signing consent; 19. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Inclusion Criteria

Exclusion Criteria

1. Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
2. Subject is female;
3. Subject is aged 21-80 years;
4. Subject has a body mass index (BMI) \< 37 kg/m2;
5. Subject has stress urinary incontinence, urge incontinence, or mixed urinary incontinence as determined by the QUID;
6. Subject is currently sexually active and willing to continue sexual activity throughout the study;
7. Subject is willing to continue level of core exercise currently being performed or not performed during the study (e.g. gym, Pilates, yoga);
8. Subject is willing to maintain her current prescription and over the counter medications throughout the study without changing them;
9. 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;
3. Subject has clinically significant findings on physical examination;
4. Subject has any chronic medical condition (e.g. neurologic disorder) or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
5. Subject is unwilling to maintain current level of exercise throughout the study;
6. Subject has been diagnosed with overactive bladder or interstitial cystitis;
7. Subject experiences bladder pain or scores above 0 on the pain questions on the O'Leary/Sant Voiding and Pain Indices (ICSI/ICPI);
8. Subject experiences pain with sexual activity
9. Subject answers anything other than "almost never or never" or "a few times" on pain questions 17 or 18 of the Female Sexual Function Index (FSFI)
10. Subject answers anything other than "very low or none at all" or "low" on pain questions 19 of the (FSFI)
11. Subject planning to have surgery during the study;
12. Subject has untreated malignancy;
13. Subject is pregnant, planning to get pregnant or within 3 months postpartum;
14. Subject has a pacemaker;
15. Subject has and implant or IUD containing metal (e.g. copper 7);
16. Subject has piercing between the waist and knees and is not willing to remove it before each treatment;
17. Subject has a history of substance abuse within 12 months prior, or consuming \> 14 alcoholic drinks per week;
18. Subject has received an investigational drug within 30 days prior to signing consent;
19. Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.

Contacts and Locations

Study Contact

Clinical Research Manager

CONTACT

619-265-8865

information@sdsm.info

Wendy Ramirez, AB

CONTACT

6192658865

wramirez@sdsm.info

Principal Investigator

Sue W Goldstein, BA

STUDY_DIRECTOR

Clinical Research Manager

Study Locations (Sites)

San Diego Sexual Medicine

San Diego, California, 92120

United States

Collaborators and Investigators

Sponsor: San Diego Sexual Medicine

Sue W Goldstein, BA, STUDY_DIRECTOR, Clinical Research Manager

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 Date2019-01-11

Study Completion Date2024-06

Study Record Updates

Study Start Date2019-01-11

Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

incontinence
stress urgency incontinence
urge incontinence
EMSELLA

Additional Relevant MeSH Terms

Stress Urinary Incontinence
Urge Incontinence