Health Condition 1: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: NA MMC: Patients will receive one intravesical instillation of MMC (40 mg/40 ml saline) on day: -1 and one on day: 0 + adjuvant installation of MMC after TUR resection based on guidelin
Sponsors
AIIMS bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: All patients with recurrent NMIBC
Exclusion criteria
Exclusion criteria: 1) Non-UC of the bladder 2) T2 and above tumours 3) Suspicion or presence of CIS 4) Pregnancy 5) Urinary incontinence 6) MIBC or benign disease 7) Variant histology 8) Prior intravesical MMC instillation for NMIBC within 3 y (intravesical MMC instillation within 3 y prior to study entry) 9)Prior hypersensitivity reaction history to MMC 10) Prior BCG treatment within the past 24 months 11) Neurogenic bladder 12) Untreated urinary tract infection 13) Prior systemic chemotherapy for any malignancy within 6 months 14) Any factors that would preclude study participation. 15) Withdrawal of consent at any time during the clinical trial • No outpatient follow-up examination within 3 mo-1 y after TURBT • Failed intravesical MMC instillation before TURBT even once due to some reasons • Not eligible single intravesical chemotherapy instillation immediately after TURBT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of neoadjuvant MMC treatment in reducing the recurrence rate of BC calculated as the proportion of patients who achieve a complete response (no evidence of BC after 3, 6, 12 and 24 months).Timepoint: 3 months 6 months 12 months 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| to analyse the stage progression to MIBC in case of recurrence. • To look for the grade of progressTimepoint: 2 weeks 3 weeks 4 weeks | — |
Countries
India
Contacts
Public ContactPrasanna Ram
AIIMS Bhubaneswar
Outcome results
None listed