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Exploratory Study on the Efficacy of a Small-Caliber, Large-Lumen Catheter for Early Postoperative Urinary Incontinence

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Prostate cancer
Date of first enrollment	13/02/2026
Target sample size	100
Countries of recruitment
Study type	Interventional
Intervention(s)	After obtaining informed consent preoperatively and confirming eligibility, the patient will be enrolled. At the time of enrollment, randomization will be performed to assign either a 20 Fr FC or a 14 Fr LLC. The subject will not be informed of the allocated catheter type. For eligible cases, either a 20 Fr FC or a 14 Fr LLC will be placed intraoperatively. The standard indwelling period is 4-6 days postoperatively, but extension of the indwelling period is allowed at the discretion of the attending physician. During the indwelling period, CRBD and urethral pain scales will be evaluated at predefined time points, and adverse events will be monitored. In addition, the total amount of urinary incontinence on the day after catheter removal and the number of incontinence pad changes at 1 month postoperatively will be assessed.

Outcome(s)

Primary Outcome

The total amount of urinary incontinence on the day after catheter removal (from 0:00 to 24:00).

Secondary Outcome

1) Number of urinary pad changes at 1 month after surgery 2) Incidence and severity of CRBD (catheter-related bladder discomfort) during catheterization at the specified time points* (0: no CRBD, 1: mild, 2: moderate, 3: severe) 3) Incidence and severity of urethral pain during catheterization at the specified time points*, evaluated using the Wong-Baker Faces Pain Scale 4) Incidence of adverse events** *The specified time points are defined as immediately upon return to the ward (postoperative 0 hours), and at 6, 24, 48, and 72 hours postoperatively. **Adverse events will be collected up to the day after catheter removal. However, events that are clearly attributable to catheter insertion occurring after the day following catheter removal will continue to be collected.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Male
Include criteria	Patients aged 18 years or older at the time of obtaining informed consent. Patients diagnosed with prostate cancer who are scheduled to undergo RARP. The presence or absence of pelvic lymph node dissection during surgery is not restricted. Patients who can provide written informed consent for participation in this study.
Exclude criteria	Patients who already have an indwelling bladder catheter or are performing intermittent self-catheterization preoperatively. Patients with a history of urethral injury or urethral stricture. Patients with spinal cord paralysis below the thoracic level or sensory impairment. Patients scheduled to receive epidural anesthesia for postoperative analgesia. Patients diagnosed with dementia. Patients undergoing maintenance hemodialysis. Patients with uncontrolled urinary tract infection prior to surgery. Patients with a history of pelvic radiation therapy. Patients with current or past allergic reactions to natural rubber latex. Patients undergoing Retzius-sparing technique or choosing a retroperitoneal approach. Patients deemed inappropriate for participation by the principal investigator or sub-investigators.