Study of Pentosan Polysulfate Sodium Capsules for Treating Radiation-Induced Cystitis After Pelvic Radiation Therapy

What this Trial Is About

Researchers are studying radiation cystitis in patients who have received radiation therapy in the pelvic area. This trial evaluates the safety and effectiveness of pentosan polysulfate sodium PPS compared to a placebo. The study is a phase IIIII randomized controlled trial aiming to provide clearer evidence on treatment options for this condition. Participants are randomly assigned to receive either PPS or a matching placebo. The medication is taken orally for 16 weeks, starting with 300 mg three times daily for the first 8 weeks, followed by 200 mg twice daily for the next 8 weeks. Both groups follow the same dosing schedule to compare the effects accurately. During the study, participants will undergo regular assessments to monitor symptoms, quality of life, and the presence of hematuria blood in urine. The main outcomes measured include the rate and timing of symptom remission and hematuria recurrence, monitored over up to 5 years. Safety is also tracked by recording adverse events, hospitalizations, and invasive procedures throughout the study period.

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial