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 @ 1:55 PM
Ignite Modification Date:
2025-12-24 @ 1:55 PM
NCT ID:
NCT00928395
Eligibility Criteria:
Inclusion Criteria:
* Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
* Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
* Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
* Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
* Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
* Subjects must remain off all antimuscarinics throughout participation in trial
* Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
* Capable of giving informed consent
* Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years
Exclusion Criteria:
* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
* Subjects who were not able or willing to follow original SUmiT Trial study schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00928395
Study Brief:
Protocol Section:
NCT00928395