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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06349694
Eligibility Criteria:
Inclusion Criteria:
* Women over the age of 18 with clinical diagnosis of idiopathic OAB
* Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
* Able to understand the procedures, advantages and possible side effects
* Willing and able to complate the voiding diary and QoL questionnaire
* The strength of PFM 3/5 and more
Exclusion Criteria:
* Women with stress urinary incontinence
* History of conservative therapy (BT, T-MPNS and TTNS/PTNS) within 6 months
* Pregnancy or intention to become pregnant during the study
* Current vulvovaginitis or urinary tract infections or malignancy
* Anatomic or posttraumatic malformations/skin disorders of medial plantar/tibial nerve region on inner foot/ankle that cannot allow to apply the electrodes
* More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
* Cardiac pacemaker, implanted defibrillator
* Previous urogyneceological surgery within 3 months
* Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
* Ultrasonographic evidence of PVR volume more than 100 ml
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06349694
Study Brief:
Protocol Section:
NCT06349694