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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT07091266
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 years or older.
* Diagnosis of refractory Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) according to AUA/SUFU guidelines, confirmed by cystoscopy with hydrodistention and glomerulations, and/or Hunner's lesions.
* Failure of at least two prior therapies (e.g., oral medications, intravesical instillations, pelvic floor physical therapy).
* Willingness to provide written informed consent.
Exclusion Criteria:
* Presence of urinary tract malignancies, pelvic organ prolapse ≥ stage III, or urethral stricture.
* Low-compliance bladder (\<10 mL/cm H₂O), organic bladder outlet obstruction, or active urinary tract infection.
* Contraindications to surgery (e.g., coagulopathy, existing pacemaker) or HBOT (e.g., untreated pneumothorax).
* Pregnancy.
* Presence of psychiatric disorders or inability to comply with follow-up protocols.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07091266
Study Brief:
Protocol Section:
NCT07091266