Non-interventional prospective research study by d-uo on intravesical instillation of mitomycin C in non-muscle invasive bladder cancer

Non-interventional prospective research study by d-uo on intravesical instillation of mitomycin C in non-muscle invasive bladder cancer - THUROC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017069

Enrollment

500

Registered

2019-04-01

Start date

2019-07-30

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: Documentation of therapy with Urocin and the quality of life of treated patients

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age> = 18 years 2. gender: male or female 3. Written consent and consent to the processing of personal data given 4. Patients with histologically confirmed, non-muscle-invasive urothelial carcinoma of the bladder ("typical bladder cancer") 5. Patients with planned or performed TUR-B 6. Patients with planned instillation therapy with mitomycin C (Urocin®)

Exclusion criteria

Exclusion criteria: 1. Presence of a bladder wall perforation 2. Other histological subtype as urothelial carcinoma (e.g., urinary bladder adenocarcinoma, squamous cell carcinoma of bladder) 3. cystitis 4. Hypersensitivity to mitomycin C or another component of Urocin® according to the SmPC 5. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
• Determination of the recurrence rate after mitomycin C (Urocin®) instillation therapy in patients with non-muscle invasive bladder urothelial cancer at 6, 12 and 24 months and the time to relapse. • Exploratory analysis of the administered dose / time unit in connection with the medical outcome (recurrence rate)	—

Secondary

Measure	Time frame
1. Description of the use of mitomycin C (Urocin®) in doses of 20 mg and 40 mg 2. Description of the use of mitomycin C (Urocin®) 20 mg and 40 mg in early instillation after TUR-B 3. Analysis of possible relationships between tumor stage / grading / risk classification and dosage 4. Description of the user safety of mitomycin C (Urocin®) 5. Determination of side effects 6. Determination of the disease-specific quality of life of affected patients 7. Determination of guideline adherence by the treating physician	—

Measure

Time frame

1. Description of the use of mitomycin C (Urocin®) in doses of 20 mg and 40 mg 2. Description of the use of mitomycin C (Urocin®) 20 mg and 40 mg in early instillation after TUR-B 3. Analysis of possible relationships between tumor stage / grading / risk classification and dosage 4. Description of the user safety of mitomycin C (Urocin®) 5. Determination of side effects 6. Determination of the disease-specific quality of life of affected patients 7. Determination of guideline adherence by the treating physician

—

Countries

Germany

Contacts

Public ContactChristoph Trusch

d-uo Service GmbH

info@smgf.de+493028445005

Outcome results

None listed

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