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

NCT ID: NCT06241703

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-07-20

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.

Conditions

Urinary Dysfunction; Rectal Cancer; Urinary Catheterization; Urinary Retention Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ICCAUT Group

Patients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training. The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy. The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day after the bladder is empty.

Group Type: EXPERIMENTAL

ICCAUT

Intervention Type: PROCEDURE

For patients in the ICCAUT group, intermittent catheter clamping will be initiated at 9:00 AM. The catheter will be clamped for 3 h, followed by a 5-minute release, which is one cycle. The next cycle will begin after the cycle was completed. Catheter training is to conclude at 10:00 PM on the first postoperative day, and the catheter is left open during the night. At 6:00 AM on the second postoperative day, another cycle of catheter training will be performed, with the catheter removed at 9:00 AM after the bladder is empty. During the training period, if the patient experiences a strong urge to urinate before the 3-hour clamping time is over, the clamping can be released in advance for 5 min, allowing the patient to proceed to the next cycle of bladder training. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.

Free Drainage Group

Patients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day.

Group Type: OTHER

Free drainage

Intervention Type: PROCEDURE

For patients in the free draining group, no intervention will be performed on the catheter during this period. The catheter will be removed at 9:00 AM on postoperative day two.

Interventions

ICCAUT

For patients in the ICCAUT group, intermittent catheter clamping will be initiated at 9:00 AM. The catheter will be clamped for 3 h, followed by a 5-minute release, which is one cycle. The next cycle will begin after the cycle was completed. Catheter training is to conclude at 10:00 PM on the first postoperative day, and the catheter is left open during the night. At 6:00 AM on the second postoperative day, another cycle of catheter training will be performed, with the catheter removed at 9:00 AM after the bladder is empty. During the training period, if the patient experiences a strong urge to urinate before the 3-hour clamping time is over, the clamping can be released in advance for 5 min, allowing the patient to proceed to the next cycle of bladder training. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.

Intervention Type: PROCEDURE

Free drainage

For patients in the free draining group, no intervention will be performed on the catheter during this period. The catheter will be removed at 9:00 AM on postoperative day two.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Yuchen Guo, Ph.D.

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuchen Guo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

Firs Hospital of Jilin University

Changchun, Jilin, China

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

References

He T, Liang S, Guan Y, Sun J, Hu H, Wang Q, Guo Y. 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. BMJ Open. 2025 Feb 5;15(2):e095217. doi: 10.1136/bmjopen-2024-095217.

Reference Type: DERIVED

PMID: 39909516 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ICCAUT-1

Identifier Type: -

Identifier Source: org_study_id