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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT04696666
Eligibility Criteria:
Inclusion Criteria:
* Males and females, at least 18 years,
* Patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form,
* Patients with diagnosis of Hemorrhagic Cystitis,
* Patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at least one other urinary symptom (need to urinate right away (urgency), often (frequency), or both).
Exclusion Criteria:
* Patients with Post-void residual (PVR) urine volume \> 200ml,
* Patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans),
* Patients receiving HyperBaric Oxygen Therapy (HBOT),
* Patients with neurogenic bladder,
* Patients treated with neuromodulation techniques within the last six months,
* Patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with BCG or with Mitomycin-C,
* Patients suffering from lower urinary infections (UTIs),
* Patients with unstable cardiovascular disease,
* Patients with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04696666
Study Brief:
Protocol Section:
NCT04696666