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Efficacy and safety of modify maintenance instillation Bacillus- calmette-guerin (BCG) in bladder cancer

Efficacy and safety evaluation of modify maintenance instillation Bacillus- calmette-guerin (BCG) in , with stage Ta high grade and/or multiple and/or large and T1 bladder cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220302054165N1
Enrollment
64
Registered
2022-07-02
Start date
2013-05-22
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Bladder Cancer. Malignant neoplasm of bladder

Interventions

Intervention 1: Intervention group: A group of randomly selected patients received an intravesical injection of Bacillus-Calmette-Guerin (BCG) every week for up to 6 weeks and then a monthly intravesi

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with non-muscle invasive bladder cancer (stage Ta and T1). Have a history of transurethral resection of tumor (TURT) one month before Bacillus-calmette-guerin (BCG) therapy. Have no previous history of BCG instillation. Do not have contraindications to BCG instillation.

Exclusion criteria

Exclusion criteria: Patients with muscle invasive bladder cancer Have a history of transurethral resection of tumor (TURT) more than one month before Bacillus-calmette-guerin (BCG) therapy. Have previous history of BCG instillation. Have contraindications to BCG instillation.

Design outcomes

Primary

MeasureTime frame
Acceptance rate by patients. Timepoint: After induction dose and then every month for up to 6 months. Method of measurement: Visit and follow up the patients.;Complications. Timepoint: After induction dose and then every month for up to 6 months. Method of measurement: Patient symptoms and complaints.

Secondary

MeasureTime frame
Recurrence rate. Timepoint: Every 3 months to 2 years. Method of measurement: laboratory tests , cytology and cystoscopy.;Progress rate. Timepoint: Every 3 months to 2 years. Method of measurement: laboratory tests , cytology and cystoscopy.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasser Shakhssalim

Shahid Beheshti University of Medical Sciences

shakhssalim@sbmu.ac.ir+98 21 2277 0954

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 10, 2026