A randomised controlled trial evaluating the efficacy of an open-ended urinary catheter for catheter-related bladder discomfort

A single-blind, randomised, controlled trial evaluating the efficacy of an open-ended urinary catheter for catheter-related bladder discomfort after urologic surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1062240037

Enrollment

100

Registered

2024-07-24

Start date

2024-08-16

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, renal cell carcinoma, upper truct urothelial carcinoma Non muscle invasive bladder cancer, renal cell carcinoma, upper truct urothelial carcinoma

Interventions

The following research and control instruments will be used in this study. The following study instruments and control instruments will be used in this study: - OEFC and FC: 18Fr. 3-way. Transurethral

OEFC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 18 years and over at the time of obtaining consent. 2) Patients with non muscle invasive bladder cancer, renal cell carcinoma, or upper truct urothelial cancer (renal pelvis or ureter) who will undergo transurethral resection, radical nephroureterectomy, partial nephrectomy or radical nephrectomy with postoperative bladder urinary catheter placement. 3) Patients for whom written consent to participate in the study is obtained from the individual.

Exclusion criteria

Exclusion criteria: 1) Patients who already have a urinary catheter in place before urologic surgery or who are on CIC (clean intermittent catheterization). 2) Patients with spinal cord paralysis or sensory insensitivity below the thoracic spinal cord. 3) Patients scheduled for epidural anaesthesia for post-operative analgesia. 4) Patients with a diagnosis of dementia. 5) Patients on maintenance haemodialysis. 6) Patients with preoperative uncontrolled urinary tract infections. 7) Patients with a history of previous pelvic radiotherapy. 8) Patients with urethral injuries. 9) Patients with allergic symptoms or history of allergy to natural rubber latex. 10) Other patients deemed unsuitable by the principal investigator or a sub-investigator.

Design outcomes

Primary

Measure	Time frame
Percentage of CRBDs at 6 hours post-operatively	—

Secondary

Measure	Time frame
1) Percentage and severity* of CRBD at defined time points (0: no CRBD, 1: mild, 2: moderate, 3: severe). 2) Urethral pain scale* (Wong-Baker face scale) at defined time points 3) Type of drug therapy for CRBD, number of times used 4) Percentage of adverse events The defined time points are 0, 1, 3 and 6 hours postoperatively, plus 24, 48 and 72 hours during catheterisation after 6 hours and up to 72 hours after removal of the catheter during catheterisation. Catheters were left in place for a minimum of 6 hours and removed at any time thereafter.	—

Measure

Time frame

1) Percentage and severity* of CRBD at defined time points (0: no CRBD, 1: mild, 2: moderate, 3: severe). 2) Urethral pain scale* (Wong-Baker face scale) at defined time points 3) Type of drug therapy for CRBD, number of times used 4) Percentage of adverse events The defined time points are 0, 1, 3 and 6 hours postoperatively, plus 24, 48 and 72 hours during catheterisation after 6 hours and up to 72 hours after removal of the catheter during catheterisation. Catheters were left in place for a minimum of 6 hours and removed at any time thereafter.

—

Contacts

Public ContactKohei Kobatake

HIroshima University Hospital

kkobatake@hiroshima-u.ac.jp+81-82-257-5242

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026