Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

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/A

Clinical Study ID

NCT05245591
202108161MIPD
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the informed consent form and in the studyprotocol.
  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 6months.
  5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion

Exclusion Criteria:

  1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 timeshigher 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 upto 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 ofrandomization
  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

Study Design

Total Participants: 72
Study Start date:
April 29, 2022
Estimated Completion Date:
November 01, 2029

Study Description

RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region.

Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).

Connect with a study center

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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