How the type and size of urinary catheters affect pain and complications during bladder immunotherapy and chemotherapy treatments

Effect of catheter type and size on patient comfort and complications in intravesical BCG and chemotherapy administration: a randomized prospective pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41320163

Enrollment

200

Registered

2025-10-08

Start date

2023-12-12

Completion date

Unknown

Last updated

2025-10-20

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

Conditions

Patients diagnosed with non-muscle-invasive bladder cancer (NMIBC) who are receiving intravesical instillation of Bacillus Calmette–Guérin (BCG) or chemotherapeutic agents as part of their standard treatment. Cancer

Interventions

Participants Eligible patients will be males and females aged =18 years diagnosed with bladder urothelial carcinoma and scheduled for intravesical BCG or chemotherapy instillation. Randomization and

simple randomization, 1:1 ratio). The participants will be randomly allocated into four groups: • Group 1: 12 Fr Foley catheter • Group 2: 8 Fr Foley catheter • Group 3: 12 Fr TAK catheter • Group 4:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with non-muscle-invasive bladder cancer (NMIBC) 2. Receiving intravesical instillation of Bacillus Calmette–Guérin (BCG) or chemotherapeutic agents as part of their standard treatment

Exclusion criteria

Exclusion criteria: 1. Prior diagnosis of anxiety or psychiatric disorder 2. History of urethral trauma associated with catheterization 3. Diagnosis of dementia

Design outcomes

Primary

Measure	Time frame
The following tools were used immediately after catheterization: 1. Anxiety was measured using the Anxiety: Beck Anxiety Inventory (BAI) questionnaire 2. Pain was measured using the Visual Analog Scale (VAS), ranging from 0 (“no pain”) to 10 (“worst imaginable pain”)	—

Secondary

Measure	Time frame
Complications were measured by a urologist who recorded all adverse events for one week post-procedure for complications (e.g., macroscopic hematuria, urinary tract infection, and catheter-induced trauma-false route). Dysuria was defined as painful urination in the absence of bacterial growth in urine culture. Cystitis was defined as the presence of significant bacterial growth in urine culture (>105 CFU/mL), accompanied by symptoms such as urinary frequency, which was defined based on significant bacterial growth in urine culture (>105 CFU/mL) along with symptoms consistent with prostatitis (e.g., pelvic pain, dysuria, and nocturia). Macroscopic hematuria was defined as the presence of visible blood in the urine.	—

Measure

Time frame

Complications were measured by a urologist who recorded all adverse events for one week post-procedure for complications (e.g., macroscopic hematuria, urinary tract infection, and catheter-induced trauma-false route). Dysuria was defined as painful urination in the absence of bacterial growth in urine culture. Cystitis was defined as the presence of significant bacterial growth in urine culture (>105 CFU/mL), accompanied by symptoms such as urinary frequency, which was defined based on significant bacterial growth in urine culture (>105 CFU/mL) along with symptoms consistent with prostatitis (e.g., pelvic pain, dysuria, and nocturia). Macroscopic hematuria was defined as the presence of visible blood in the urine.

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Countries

Türkiye

Contacts

Public ContactFerec Efendioglu

ferec.efendioglu@gulhane.edu.tr+90 (0312) 304 20 00

Outcome results

None listed

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