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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT02034604
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 20 years old and above (upper limit of age: 80 years old)
2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
3. a+b
1. IPSS ≥ 12 and QoL ≥ 3
2. Maximum Flow Rate \<15 mL/s (Voiding volume) ≥ 120mL)
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
1. In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
2. In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
3. In female, the history of anti-incontinence operation.
4. Patients with cancer of any type including cancer of the prostate or bladder
5. Patients with urethral stricture or bladder neck contracture
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT02034604
Study Brief:
Protocol Section:
NCT02034604