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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT02657057
Eligibility Criteria:
Inclusion Criteria:
* Female and male
* Age \>18 years
* Complaint urge urinary incontinence (3 or more episodes per week) OR overactive bladder (8 or more voids per day, and/or 2 or more voids per night)
* Urodynamic data of overactive detrusor
* Failed trial of conservative therapy (bladder training, fluid modification, diet modification, caffeine restriction, pelvic floor training)
* Failed trial of anticholinergic either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
* Willing to complete study questionnaires and informed consent study
Exclusion Criteria:
* Presence of bladder obstruction (prostate or prolapse)
* Neurogenic bladder overactivity
* Previous pelvic organ prolapse surgery
* Unwilling and mentally incompetent to participate in study
* Pregnancy or planning to become pregnant during the study
* Presence of urinary fistula
* Recurrent or current urinary tract infection (5 or more infections in the last 12 months)
* Bladder stones
* Bladder cancer or suspected bladder cancer
* Hematuria
* Central or peripheral neurologic disorders such as Multiple Sclerosis, Parkinson's disease, spina bifida, or other spinal cord lesion
* Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (sacrum or ankle/leg).
* Uncontrolled diabetes and diabetes with peripheral nerve involvement
* Anticoagulants treatment
* Current use of anticholinergics or use within the last 4 weeks
* Current use of botox bladder injections or bladder botox injection within the last year
* Current use of interstim therapy or currently implanted interstim device or leads
* Urinary retention or gastric retention
* Painful Bladder Syndrome/Interstitial Cystitis
* Previous PTNS treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02657057
Study Brief:
Protocol Section:
NCT02657057