A Clinical multi-center, randomized, open-label, blank control trial of Cystistat in combination with THP by co-perfusion to reduce complications induced by THP-chemotherapy

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2010
INTERVENTION: Group B:30mg THP diluted with 50ml water for injection, after routine disinfection, place catheters in the bladder and empty the bladder, then give THP perfusion, by injecting a small amount of air to prevent THP residues, then remove the catheter, Make patients to change their positions every 8 minutes, and 32 minutes later make THP discharged from the bladder ;Group A:30mg THP diluted with 50ml water for injection. After routine disinfection, place catheters in the bladder and empty the bladder then give THP perfusion, by injecting a small amount of air to prevent THP residues, and then keep urethral catheter in under the condition of occlusion. Make patients to change their positions every 8 minutes. 32 minutes later, make THP discharged from the catheter and empty the bladder, then give Cystistat perfusion instantly (40mg/50ml/ bottle for each perfuse; CONDITION: complications induced by THP instillation/non‐muscle invasive tumor PRIMARY OUTCOME: VAS score for bladder pain; SECONDARY OUTCOME: Urine routine examination;Bladder tumor recurrence rate in first year and second year;The case proportion in each group on completion of THP perfusion weekly;WHO toxicity assessment on hematuria and bladder irritation; INCLUSION CRITERIA: 1. Newly diagnosed patients or patients with relapse bladder tumor more than one year; 2. Treated with THP instillation after TUR‐BT surgery; 3. 18 to 75 years old; 4. Pathologically diagnosed as primary non‐invasive bladder cancer, TNM staging of T1, Ta or Tis.
Epistemonikos ID: bfe561d391a7b7c438b9eca37ed8b3556cddd3f9
First added on: Aug 22, 2024