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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01312259
Eligibility Criteria:
Inclusion Criteria:
* Female with diagnosis of IC/PBS with implanted IPG Interstim.
* Scores \> 8 on the Interstitial Cystitis Symptom index questionnaire (ICSI) and \> 8 on the Interstitial Cystitis Problem Index questionnaire (ICPI).
* Signed Informed Consent.
Exclusion Criteria:
* Progressive neurologic disease or peripheral neuropathy.
* History of bladder surgery.
* Subjects implanted with other neuromodulation device.
* Current or planning pregnancy; Breastfeeding.
* Subjects who are not deemed able to fill questionnaires
* Mental illness or mentally unstable patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01312259
Study Brief:
Protocol Section:
NCT01312259