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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02452593
Eligibility Criteria:
Inclusion Criteria:
\- Women with Urinary Incontinence of Urgency or Mixed older than 18 years
Exclusion Criteria:
* Presence Of vaginal or urinary infection
* Not understand or sign the informed consent
* Not understand or are unable to perform the proposed treatment
* Pregnancy or the postpartum period covering the period up to 6 months after delivery
* Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
* Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder
* Use of Botox® in the bladder or pelvic muscles in the last year
* Use Interstim® or Bion®
* Use pacemaker or implantable defibrillator
* Current use of TENS in the pelvic region, lower back or legs
* Previous use of percutaneous tibial stimulation
* Drug / experimental devices in the past 4 weeks,
* Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.
* Pelvic radiotherapy;
* Changes in sensibility Lower Limb;
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02452593
Study Brief:
Protocol Section:
NCT02452593