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

Recruiting

Conditions: C67
Malignant neoplasm of bladder

Registration Number: DRKS00017069

Lead Sponsor: d-uo Deutsche Uro-Onkologen (Interessenverband zur Qualitätssicherung in der Uro-Onkologie in Deutschland e.V.)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

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

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• 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.<br>• Exploratory analysis of the administered dose / time unit in connection with the medical outcome (recurrence rate)

Secondary Outcome Measures

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