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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT07300904
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects aged 22 years or older and,
* Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI),
* Symptoms persisting for at least 3 months, and
* Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and,
* With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries
* Willing and capable of providing informed consent
* Capable of participating in all testing associated with this clinical investigation
Exclusion Criteria:
* Patients with pacemakers or implanted defibrillators or any other implanted electronic device
* Patients prone to excessive bleeding
* Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function
* Patients who are pregnant or planning to become pregnant while using this product
* Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed
* Patients wearing a metal implant near the stimulated area
* Patient with cognitive deficiency
* Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB
* Patients treated with medical therapy OAB treatment washout inferior to 30 days
* Patients with diabetic neuropathy
* Patients with uncontrolled diabetes and HbA1c levels above 7%
* Guillain-Barré syndrome
* Chronic inflammatory demyelinating polyneuropathy (CIDP)
* Multiple sclerosis
* A primary diagnosis of stress urinary incontinence (SUI)
* Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment.
* Currently participating in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07300904
Study Brief:
Protocol Section:
NCT07300904