Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT03969368
Eligibility Criteria:
Inclusion Criteria:
* Female aged 25-70 years
* Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
* Voluntarily signed informed consent form
* Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
* Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study
Exclusion Criteria:
* Use of Botox® in the bladder or pelvic muscles in the last year
* Use of Interstim® or similar device for the treatment of UI
* Suffers from other types of urinary incontinence other than SUI, UUI, MUI
* Pelvic organ prolapse grade 2 and higher
* Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
* Currently lactating
* Cardiac pacemakers
* Implanted defibrillators and/or neurostimulators
* Electronic implants
* Metal implants, including copper IUD
* Drug pumps
* Hemorrhagic conditions
* Anticoagulation therapy
* Fever
* Pregnancy
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Any disorders that the Investigator deems would interfere with study endpoints or subject safety
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
70 Years
Study:
NCT03969368
Study Brief:
Protocol Section:
NCT03969368