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

JRCT ID: jRCT1062240037

Registered date:24/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non muscle invasive bladder cancer, renal cell carcinoma, upper truct urothelial carcinoma
• Date of first enrollment: 16/08/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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 resection of bladder tumours: 18Fr. 3-way
Other techniques (total nephroureterectomy, nephrectomy, partial nephrectomy): 14Fr. 2-way (14Fr does not have a 3-way)
FC: Round tip Foley catheter
OEFC: Short tip tip opening Foley catheter
In both cases, the tip of the catheter can be easily implanted (fixed) in the bladder by inflating the balloon after insertion, and urine in the bladder is continuously guided (discharged) out of the body through the lumen of this product by implantation. The product can be easily removed (replaced) by deflating the balloon in the bladder (aspirating balloon inflation water from the valve).

Outcome(s)

• Primary Outcome: Percentage of CRBDs at 6 hours post-operatively

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hinata Nobuyuki