Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol.

BACKGROUND

Urinary catheter placement is routinely performed after proctectomy. However, there is uncertainty regarding the need for bladder training before catheter removal. This trial aims to examine the effect of intermittent catheter clamping combined with active urination training (ICCAUT) on urinary retention and secondary catheterisation after proctectomy.

METHODS AND ANALYSIS

Eligible patients will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage (FD) group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter combined with active urination training before its removal, whereas the patients in the FD group will not receive any specific training. The urinary catheter will be removed on postoperative day 2 in both groups after emptying the bladder. The primary end point is the incidence of urinary dysfunction. Secondary end points include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality and urinary function within 30 days.

ETHICS AND DISSEMINATION

This trial was approved by the Ethics Review Committee of the First Hospital of Jilin University (24K047-001). Written informed consent will be obtained before performing any study procedures. All primary and secondary outcomes will be reported in peer-reviewed publications and at conference presentations.

TRIAL REGISTRATION NUMBER

The trial was registered at ClinicalTrials.gov website, NCT06241703.