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

Not Applicable

Completed

• Conditions: Rectal Cancer; Urinary Catheterization; Urinary Dysfunction; Urinary Retention Postoperative

• Registration Number: NCT06241703
• Lead Sponsor: The First Hospital of Jilin University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-05
• Study Start: 2024-03-20
• Primary Completion: 2025-06-27
• Status Verified: 2025-07
• Study Completion: 2025-07-20
• Last Update Submitted: 2025-07-20
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients with a confirmed preoperative diagnosis of rectal cancer.
2. Patients with tumors located below the rectosigmoid junction (12 cm from the anal verge), as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
3. Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.

Exclusion Criteria

1. History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
2. History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
3. Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
4. Presence of urinary tract infection preoperatively.
5. Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
6. Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
7. Lateral lymph node dissection for rectal cancer.
8. Injury to the ureter, bladder, or urethra during the perioperative period.
9. Preoperative renal dysfunction (serum creatinine level >133 μmol/L).
10. Emergency surgery.
11. Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
12. Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
13. Conversion to open surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of urinary dysfunction	within 7 days after the first time of urethral catheter removal	Urinary dysfunction is defined as the presence of residual urine volume greater than 100ml, as estimated by bladder ultrasound, after the first voiding following catheter removal, or the need for a second catheterization.

Secondary Outcome Measures

Name	Time	Method
Rate of Urinary tract infections	within 1 days after the first time of urethral catheter removal	A urinary tract infection is characterized by an inflammatory response in the urinary tract epithelium resulting from bacterial invasion. To diagnose a urinary tract infection, the following criteria must be met simultaneously: 1) urinalysis indicating a bacterial count above the upper limit of normal and 2) positive urine culture.
The time to first voiding after catheter removal	within 1 days after the first time of urethral catheter removal	The time to first voiding after catheter removal refers to the duration, measured in hours, from the moment the catheter was removed until the patient spontaneously voids for the first time.
Graded assessment of catheter-related bladder discomfort (CRBD)	within 1 days after the first time of urethral catheter removal	CRBD is a questionnaire given to the patients, to investigate the severity of the discomfort of patients to the urinary catheter
International Consultation on Incontinence Questionnaire-Short Form	on the second day after the first time of urethral catheter removal, and at the 30th day after surgery	International Consultation on Incontinence Questionnaire-Short Form is used to evaluate the incontinence of voiding. The minimum value is 0 and maximum value is 21. A higher score means a worse outcome
Postoperative complications	within 30 days after the operation	Complications that occur within 30 days after the operation will be evaluated and documented according to the Clavien-Dindo classification. Complications of grade II or higher were analyzed.
International Prostate Symptom Score	on the second day after the first time of urethral catheter removal, and at the 30th day after surgery	International Prostate Symptom Score is used to evaluate the severity of urinary difficulties. The scoring range ranges from 0 to 35 points for asymptomatic to severe symptoms. There are three levels of severity: 0-7 is mild, 8-19 is moderate, and 20-35 is severe.
Incidence rate of residual urine volume greater than 200 ml after the first voiding	within 1 days after the first time of urethral catheter removal	Incidence rate of residual urine volume greater than 200 ml after the first voiding

Trial Locations

Locations (2)

Firs Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China