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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT05309993
Eligibility Criteria:
Inclusion Criteria:
* Female Subjects ≥18 years of age
* OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence
* Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training) -Failed trial of at least one pharmacologic treatment (anticholinergics, β3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
* Willing to complete study questionnaires
* Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm
* No contraindication to undergoing PTNS or TENS therapy
Exclusion Criteria:
* Age \< 18 years
* Presence of urinary fistula
* Male genital anatomy
* Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 months or 3 or more infections in the last 12 months) or current urinary tract infection
* Current Bladder stones
* Bladder cancer or suspected bladder cancer
* Gross Hematuria
* Pregnancy or planning to become pregnant during the study
* Cognitive impairment
* Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc.
* Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg)
* Uncontrolled diabetes
* Diabetes with peripheral nerve involvement
* Current use of anticoagulants (excluding aspirin)
* 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 (12 months)
* Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads
* Bladder outlet obstruction
* Urinary retention or gastric retention
* Painful Bladder Syndrome/Interstitial Cystitis
* Unable to be contacted for follow up by telephone
* Inability to speak/read/understand English or Spanish
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05309993
Study Brief:
Protocol Section:
NCT05309993