臨床研究等提出・公開システム

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

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

100

A total of 100 patients were enrolled in this study; however, 6 patients were excluded from the full analysis set (FAS), resulting in 94 patients included in the final analysis. Baseline characteristics of the FAS population were as follows: The median age was 71.5 years in the FC group and 73.8 years in the OEFC group.The male-to-female ratio was 38:9 in the FC group and 36:11 in the OEFC group. The types of surgical procedures performed were as follows (TURBT/RANU/RAPN/RARN): FC group: 22/4/21/0 patients; OEFC group: 22/7/17/1 patients.

The first patient provided informed consent on August 16, 2024, and the final observation for the 100th patient was completed on April 30, 2025, marking the end of the study.

No severe adverse events or device malfunctions were reported that were deemed to be causally related to the protocol treatment.

Primary Endpoint Incidence of CRBD at 6 Hours Postoperatively: At 6 hours postoperatively, the incidence of CRBD was significantly lower in the OEFC group than in the FC group (42.5% vs. 68.1%; odds ratio, 0.35; 95% confidence interval, 0.15-0.80; p < 0.05). Secondary Endpoints: Incidence and Severity of CRBD at Predefined Time Points: At 6 hours postoperatively, both the incidence and severity of CRBD were consistently and significantly lower in the OEFC group compared to the FC group. No significant differences were observed between groups after the 6-hour time point. Urethral Pain Scores at Predefined Time Points: No significant differences were observed between the two groups. Type and Frequency of Pharmacological Interventions for CRBD During Catheterization: No significant differences were observed between the two groups. Incidence of Adverse Events: Aside from CRBD and urethral pain, no other catheter-related adverse events were reported in either group.

OEFC was considered to be a feasible and safe approach for reducing CRBD in postoperative patients.

Oct. 01, 2025

Sept. 14, 2025

https://pubmed.ncbi.nlm.nih.gov/40947576/

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT1062240037

Hinata Nobuyuki

Hiroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan

kkobatake@hiroshima-u.ac.jp

Kobatake Kohei

HIroshima University Hospital

1-2-3, Kasumi, Minami-ku, Hiroshima city, Hiroshima, Japan

+81-82-257-5242

kkobatake@hiroshima-u.ac.jp

Complete

July. 24, 2024

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

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.

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.

Both

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

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).

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

OEFC

D000093284, D002292, D002295

Percentage of CRBDs at 6 hours post-operatively

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.

+81-82-257-1551

July. 17, 2024

None