prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer

prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer - prospective study of whether residual urine volume will affect adverse events of BCG instillation therapy for non-muscle invasive bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035176

Enrollment

100

Registered

2018-12-10

Start date

2018-06-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

non-muscle invasive bladder cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with non-muscle invasive bladder cancer 1)Age: over 20 years old, gender does not matter 2)Patients with ECOG PS 0 or 1 3)Patients who are expected to survive for more than 2 years 4)Patient with document informed consent 5)Patients who are not taking other treatments for bladder cancer

Exclusion criteria

Exclusion criteria: 1)The case with serious complications 2)The case with active double cancer 3)The case with pregnancy,lactation or possibility of pregnancy 4)The case with drug allergy for BCG 5)The case with History of HIV infection, patients with active chronic hepatitis by hepatitis B or C virus 6)Patients with active infection (grade 3 or higher according to CTCAE Version 4.0) 7)The case without the selection criteria

Design outcomes

Primary

Measure	Time frame
The primary end point was adverse events and quality of life during enforcement. We assessed QOL using the EORTC QLQ-C30 before start of BCG, after completion or dropout.	—

Secondary

Measure	Time frame
The secondary endpoints are complications, enforcement frequency and recurrence.	—

Countries

Japan

Contacts

Public ContactYoichiro Kato

Iwate Medical University Urology

j2c789@bma.biglobe.ne.jp0196515111

Outcome results