Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Taiwan72 participantsStarted 2022-04-29
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
. 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 6 months.
. Radiation cystitis with lower urinary tract symptoms or hematuria.
Exclusion criteria
. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of complete remission in lower urinary tract symptoms and hematuria
Timeframe: From date of randomization throughout the treatment period up to 5 years
2
Time to complete remission
Timeframe: From date of randomization to study completion up to 5 years
3
Time to hematuria recurrence
Timeframe: From date of randomization to study completion up to 5 years
4
Assessment of quality of life
Timeframe: From date of randomization to study completion up to 5 years
5
Assessment of symptoms
Timeframe: From date of randomization to study completion up to 5 years