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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT06059066
Eligibility Criteria:
Inclusion Criteria:
* Adult men and women (\>18 years of age) with a diagnosis of neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, or traumatic brain injury longer than 6 months prior to treatment.
* Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms.
* Participants must be able to provide informed consent, as well as understand and be willing to undergo.
follow-up procedures and completion of all questionnaires provided during the study.
Exclusion Criteria:
* Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline.
* Diagnosis of bladder pain syndrome or other chronic pain syndrome including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia.
* Untreated bladder malignancy.
* Women who are currently pregnant or breast feeding.
* Contraindications to intradetrusor BTX-A injections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06059066
Study Brief:
Protocol Section:
NCT06059066