Last updated: May 2, 2022
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting
Phase
2/3
Condition
Urinary Tract Infections
Bladder Disorders
Urinary Incontinence
Treatment
N/AClinical Study ID
NCT05245591
202108161MIPD
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form and in the studyprotocol.
- Patients must be ≥20 years of age
- Patients must have received definitive radiation therapy for cancer in pelvic area.
- Time from the end of radiation therapy to radiation cystitis must be longer than 6months.
- Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion
Exclusion Criteria:
- Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 timeshigher than normal
- Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
- Abnormal coagulation profile with PT/INR higher than normal
- Thrombocytopenia with platelet counts < 100,000/μL
- Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
- Patients who have systemic inflammatory symptoms during screening period (ie, fever upto 38℃ or WBC counts >12,000/μL)
- Patients with known urinary tract infection within 6 months of randomization.
- Any previous intravesical instillation within 6 months of randomization (ie,hyaluronic acid instillation)
- Any previous hyperbaric oxygen therapy within 6 months of randomization
- Any previous treatment with pentosan polysulfate sodium within 6 months ofrandomization
- Has history of thrombocytopenia, hemophilia or bladder cancer
- Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
- Has known history of drug allergy to pentosan polysulfate sodium
- Has hematuria caused by clinically active urolithiasis or urothelial carcinoma
Study Design
Total Participants: 72
Study Start date:
April 29, 2022
Estimated Completion Date:
November 01, 2029
Study Description
Connect with a study center
National Taiwan University Hospital
Taipei,
TaiwanActive - Recruiting
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