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Intravesical instillation therapy for high-risk non-muscle-invasive transitional cell carcinoma of the bladder: Does the strain of Bacillus Calmette-Guerin (BCG) matter?

Assessment of intravesical instillation therapy with two different strains of Bacillus Calmette-Guerin (BCG) in patients with high-risk non-muscle-invasive transitional cell carcinoma of the bladder in terms of recurrence and survival.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000204943
Acronym
nil
Enrollment
149
Registered
2011-02-22
Start date
1986-08-06
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

After completed transurethral resection of a bladder tumor (TURBT), patients diagnosed with high-risk non-muscle-invasive transitional cell carcinoma of the bladder, which qualify for a maintenance BCG therapy, are prospectively included in the trial. Patients are randomized into 2 groups: One group will use the strain BCG-Connaught (dose 1.5-5x10E8 CFU, intravesical), the other group the strain BCG-Tice (dose 5x10E8 CFU, intravesical) for the bladder instillation. Within 2 weeks after the TURBT

After completed transurethral resection of a bladder tumor (TURBT), patients diagnosed with high-risk non-muscle-invasive transitional cell carcinoma of the bladder, which qualify for a maintenance BCG therapy, are prospectively included in the trial. Patients are randomized into 2 groups: One group will use the strain BCG-Connaught (dose 1.5-5x10E8 CFU, intravesical), the other group the strain BCG-Tice (dose 5x10E8 CFU, intravesical) for the bladder instillation. Within 2 weeks after the TURBT the BCG instillation therapy is begun. A total of 6 bladder instillations are performed in weekly intervals. For the bladder instillation BCG is injected into the bladder by a single use urethral catheter. Intravesical therapy duration is 2 hours. Regular follow-up controls with cystoscopy and urine cytology are performed every 3 months during the first 3 years and then every 6 months until at least 5 years postoperatively.

Sponsors

Department of Urology, Inselspital Bern
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

High-risk non-muscle-invasive transitional cell carcinoma of the bladder requiring BCG-therapy, complete resection of bladder tumors by TURBT.

Exclusion criteria

Muscle-invasive transitional cell carcinoma of the bladder, incomplete resection of tumor by TURBT.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026