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 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT03547518
Eligibility Criteria:
Inclusion Criteria:
* Women and men \> 18 years of age
* Self-reported failed conservative care of behavioral modifications and/or oral medications
* An above normal urinary frequency as recorded on initial 3-day voiding diary
* Self-reported bladder symptoms greater than or equal to 3 months
* On a stable dose of antimuscarinics/beta-3 agonists for greater than or equal to 4 weeks, and willing to remain on the medication for the duration of the study OR discontinued antimuscarinics/beta-3 agonists for greater than or equal to 2 weeks
* Capable of giving informed consent
* Ambulatory and able to use toilet independently without difficulty
* Capable and willing to follow all study-related procedures
Exclusion Criteria:
* Pregnant or planning to become pregnant during study duration
* Diagnosis of neurogenic bladder
* Botox use in bladder or pelvic floor muscles within past 12 months
* Pacemakers or implantable defibrillators
* Current urinary tract infection
* Active use of neuromodulation in any other form. If patient has InterStim, must be turned off for 2 weeks for a washout period and remain off during the entirety of the study.
* Current use of Transcutaneous Electrical Nerve Stimulation (TENS) in pelvic region, back or legs
* Previous PTNS treatment who received greater than 6 treatments. Those who have received less than 6 treatments will be allowed to screen if the last treatment was at least 6 months prior to screening.
* Use of investigational drug/device therapy within past 4 weeks
* Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
* Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results
Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03547518
Study Brief:
Protocol Section:
NCT03547518