Treatment for radiation cystitis using pentosan polysulfate sodium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of pentosan polysulfate sodium (PPS) compared to a placebo in patients suffering from radiation cystitis following pelvic radiation therapy. It is a randomized controlled trial involving approximately 72 participants who will receive oral PPS for 16 weeks, with a dosage of 100 mg three times a day for the first 8 weeks, followed by 100 mg twice daily for the next 8 weeks. The trial aims to determine whether PPS can alleviate symptoms associated with radiation cystitis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Patients must be ≥20 years of age
3. Patients must have received definitive radiation therapy for cancer in pelvic area.
4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion Criteria:

1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
3. Abnormal coagulation profile with PT/INR higher than normal
4. Thrombocytopenia with platelet counts \< 100,000/μL
5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \>12,000/μL)
7. Patients with known urinary tract infection within 6 months of randomization.
8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
9. Any previous hyperbaric oxygen therapy within 6 months of randomization
10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
11. Has history of thrombocytopenia, hemophilia or bladder cancer
12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
13. Has known history of drug allergy to pentosan polysulfate sodium
14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Chao-Yuan Huang, MD, PhD — National Taiwan University Hospital
• Study coordinator: Chi-Shin Tseng, MD
• Email: clifford1987tcs@gmail.com
• Phone: +886223123456

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hyperbaric oxygen for chronic radiation cystitis

  This project will try hyperbaric oxygen therapy in adults with moderate to severe radiation cystitis to see if symptoms improve and urine inflammatory markers change.

  Recruiting Dartmouth-Hitchcock Medical Center · Lebanon, New Hampshire · NCT07368647

• Gut microbiome in gynecologic cancer patients with pelvic toxicity

  This study looks at whether gut bacteria profiles relate to pelvic toxicity after cancer treatment and how rectal ozone therapy might affect the gut microbiome and symptoms in women with gynecologic tumors.

  Recruiting at 2 sites Hospital Universitario de Gran Canaria Doctor Negrín · Las Palmas de Gran Canaria, Las Palmas and 1 other locations · NCT07259681

• Effects of anticoagulant interruption and left atrial occlusion in patients with bleeding from radiation cystitis and atrial fibrillation

  This study looks at patients who have bleeding from radiation cystitis while on blood thinners for atrial fibrillation to see how these factors affect their treatment and outcomes.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT04701749

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.