NIS EMDA NMIBC High Grade - Non-Interventional Study evaluating the efficacy of adjuvant sequential therapy using Bacillus Calmette-Guerin (BCG) and electromotively assisted Mitomycin-C instillation (EMDA-MMC) versus BCG allone in non-muscular invasive poorly differentiated bladder cancer (NMIBC High Grade) under routine conditions in Germany

NIS EMDA NMIBC High Grade - Non-Interventional Study evaluating the efficacy of adjuvant sequential therapy using Bacillus Calmette-Guerin (BCG) and electromotively assisted Mitomycin-C instillation (EMDA-MMC) versus BCG allone in non-muscular invasive poorly differentiated bladder cancer (NMIBC High Grade) under routine conditions in Germany - NIS EMDA NMIBC High Grade

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017190

Enrollment

Registered

2019-04-24

Start date

2019-06-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C67

Interventions

Group 1: Adjuvant sequential therapy using Bacillus Calmette-Guerin and electromotively assisted mitomycin-C application Group 2: Adjuvant therapy using Bacillus Calmette-Guerin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Signed patient consent form - Eligible women and men> 18 years with urothelial carcinoma - high-risk tumors: pT1G3 ± cis or pT1HG ± cis; N0; M0 - After TUR resection, no remaining pTa/pT1, except Cis (former R0 resection) - First diagnosis of urothelial carcinoma - Multilocalized tumors - Expected life expectancy at least 2 years

Exclusion criteria

Exclusion criteria: - Absence of one or more inclusion criteria - Perforation of the bladder wall intraoperatively - Incompatibilities or contraindications against MMC and / or BCG in study arm receiving sequential therapie; and against BCG in study arm receiving BCG-therapy - Immune disorders, immunosuppressive therapy - Bladder capacity below 150 ml - Secondary tumors outside the bladder - Muscle Invasive Bladder Cancer (MIBC) - Pregnancy, breastfeeding

Design outcomes

Primary

Measure	Time frame
Recurrence rate of histologically proven relapse of a bladder carcinoma after 12 months	—

Secondary

Measure	Time frame
Collection of time to progression (pT2); Recurrence rate after 24 months	—

Countries

Germany

Contacts

Public ContactBenno;Anja Antoni;Rudolph

IQVIA Commercial GmbH & Co. OHG;IQVIA Commercial GmbH & Co. OHG

benno.antoni@iqvia.com;anja.rudolph@iqvia.com+49 89 457 912 6415;+49 170 959 7572

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026