Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery — ICCAUT-1  

Rectal Cancer Clinical Trial

Official title: Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)

Status Recruiting

Clinical Trial Summary

In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.

Clinical Trial Description

Urinary catheter placement is a routine procedure performed in proctectomy. Nevertheless, there is uncertainty regarding the need for bladder training before catheter removal. The purpose of this trial is to examine the impact of bladder training on the urinary retention and secondary catheterization following proctectomy.

In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While the participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.

This trial aims to investigate whether ICCAUT strategy, achieved through intermittent clamping of the catheter combined with active urination training in patients undergoing rectal cancer surgery, can impact the rate of urinary dysfunction compared to direct catheter removal. The findings from this study will provide valuable evidence regarding the manipulation of urinary catheters and help guide clinical practice. ;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Urinary Catheterization
• Urinary Retention
• Urinary Retention Postoperative

• NCT number: NCT06241703
• Study type: Interventional
• Source: The First Hospital of Jilin University
• Contact: Yuchen Guo, Ph.D.
• Phone: +8613630598312
• Email: guoyuchen8688@jlu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Completion date: February 19, 2026