How the type and size of urinary catheters affect pain and complications during bladder immunotherapy and chemotherapy treatments
| ISRCTN | ISRCTN41320163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41320163 |
- Submission date
- 06/10/2025
- Registration date
- 08/10/2025
- Last edited
- 08/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study explores whether the type and size of urinary catheters affect how comfortable patients feel during bladder treatments for non-muscle-invasive bladder cancer (NMIBC). These treatments involve putting medicine, such as BCG or chemotherapy, directly into the bladder through a catheter. Although this is a common procedure, many patients experience pain or anxiety during catheterization.
Who can participate?
Adult patients (men and women aged 18 years or older) with bladder urothelial carcinoma.
What does the study involve?
Participants were randomly assigned to one of four groups, depending on the type and size of catheter used:
12 French (Fr) Foley catheter
8 Fr Foley catheter
12 Fr TAK (silicone) catheter
8 Fr TAK (silicone) catheter
All treatments were performed by a urologist. Before catheter insertion, a 2% lidocaine gel was applied to reduce discomfort. After a short wait, the assigned catheter was inserted, and the bladder medicine was given. The catheter was removed immediately after the drug was instilled.
Pain and anxiety were measured right after the procedure using standard scales. Patients were also followed for one week to record any side effects, such as bleeding, infection, or catheter-related injury.
What are the possible benefits and risks of participating?
The study aims to identify which catheter type and size causes less pain and anxiety and leads to fewer complications, helping doctors choose the most comfortable and safest option for future bladder treatments.
There are minimal risks. Possible mild discomfort may occur during catheterization, but no serious or long-term complications are expected.
Where is the study run from?
Lokman Hekim University, Türkiye.
When is the study starting and how long is it expected to run for?
December 2023 to March 2025
Who is funding the study?
Lokman Hekim University, Türkiye.
Who is the main contact?
Dr Ferec Efendioğlu, Gülhane Training and Research Hospital, Department of Urology, ferec.efendioglu@gulhane.edu.tr, ferecefendiyev@mail.com
Contact information
Public, Scientific, Principal investigator
Etlik, Gen. Dr. Tevfik Sağlam Cd No:1
Ankara
06010
Türkiye
 ORCID ID |
0000-0002-4824-1271 |
|---|---|
| Phone | +90 (0312) 304 20 00 |
| ferec.efendioglu@gulhane.edu.tr |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory, Training facility/simulation, University/medical school/dental school |
| Study type | Quality of life, Safety, Efficacy |
| Participant information sheet | Not available web format,please use contact details to reguest a participant information sheet |
| Scientific title | Effect of catheter type and size on patient comfort and complications in intravesical BCG and chemotherapy administration: a randomized prospective pilot study |
| Study objectives | To evaluate whether catheter type and size influence patient-reported pain, anxiety, and adverse events during intravesical therapy, recognizing that intravesical instillation of Bacillus Calmette-Guérin (BCG) or chemotherapeutic agents requires urethral catheterization, which may cause pain, anxiety, and complications. |
| Ethics approval(s) |
Approved 07/12/2023, Scientific Research Ethics Committee of Lokman Hekim University (Söğütözü, 9 Eylül Cd No:6, Ankara, 06530, Türkiye; +90-444 8 548; info@lokmanhekim.edu.tr), ref: Approval Code: 2023232, date: 2023/241 |
| Health condition(s) or problem(s) studied | 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. |
| Intervention | 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 Blinding An assistant head nurse will perform randomization using a computer-based program (www.randomizer.org; 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: 8 Fr TAK catheter The allocation sequence will be concealed using the sealed envelope method, which will be managed by the nurse. Both the participants and outcome assessors will be blinded to group allocation. The randomization process will be illustrated in the CONSORT flow diagram. Intervention Intravesical drug instillations will be performed by a urologist using either a rubber Foley catheter (Rüsch) or a silicone catheter (TAK) (Homecath), with sizes of 8 Fr or 12 Fr, as per group assignment. Before catheterization, a 2% lidocaine gel will be administered to the urethra via the external meatus. After a 1-minute wait, the appropriate catheter will be inserted, and the pre-prepared BCG or chemotherapeutic agent will be instilled into the bladder. The catheter will be removed immediately after drug administration. Statistical Analysis All statistical analyses will be performed using IBM SPSS Statistics for Windows, Version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be expressed as mean ± standard deviation (SD) or median with interquartile range (IQR), and categorical variables will be expressed as frequency and percentage. Normality will be assessed using the Shapiro–Wilk test and Q–Q plots, while homogeneity of variances will be evaluated using Levene’s test. Nonparametric tests will be applied when parametric assumptions are not met. Group comparisons will be conducted using one-way ANOVA or the Kruskal–Wallis test, as appropriate. Categorical variables will be compared using the chi-squared test or Fisher’s exact test. Independent predictors of the VAS pain scores will be identified using multiple linear regression analysis, adjusting for age, sex, catheter type, anxiety, and complications. Ordinal logistic regression will be performed to evaluate the factors influencing anxiety severity. Results will be presented as odds ratios (ORs) with 95% confidence intervals (CIs). Statistical significance will be defined as a two-sided p-value of < 0.05. Participants (continued) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 01/12/2023 |
| Completion date | 12/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 97 Years |
| Sex | All |
| Target number of participants | 200 |
| Total final enrolment | 179 |
| Key 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 |
| Key exclusion criteria | 1. Prior diagnosis of anxiety or psychiatric disorder 2. History of urethral trauma associated with catheterization 3. Diagnosis of dementia |
| Date of first enrolment | 12/12/2023 |
| Date of final enrolment | 12/03/2025 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Aankara
06530
Türkiye
Sponsor information
University/education
Söğütözü Mh. 2179 Cd. No: 6 Çankaya
Ankara
06510
Türkiye
| Phone | +90 0312-444 8 548 |
|---|---|
| helal@lokmanhekim.edu.tr | |
| Website | https://www.lokmanhekim.edu.tr/ |
"ROR" |
https://ror.org/04v8ap992 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 12/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this research will be published in scientific journals and presented at medical conferences so that doctors and patients can benefit from the findings. The results will also be added to the ISRCTN and ClinicalTrials.gov websites within one year after the study finishes. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ferec Efendioğlu, Gülhane Training and Research Hospital, Department of Urology, ferec.efendioglu@gulhane.edu.tr, ferecefendiyev@mail.com. Description: De-identified individual participant data (IPD) that support the findings of this study will be made available to qualified researchers upon reasonable request. The shared dataset will include variables related to patient demographics, catheter type and size, pain scores (VAS), anxiety scores (BAI), and recorded complications. Data will be anonymized in accordance with data protection regulations (GDPR and national ethics guidelines). No information that could identify a participant will be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/10/2025 | No | No |
Additional files
Editorial Notes
07/10/2025: Study's existence confirmed by the Scientific Research Ethics Committee of Lokman Hekim University, Türkiye.
