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

NCT06241703 | Completed DMC

• 1 other identifier: ICCAUT-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Residual Urine Volume; Urinary Retention; Urinary Dysfunction; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of urinary dysfunction

  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.

  within 7 days after the first time of urethral catheter removal

Secondary Outcomes (7)

• Rate of Urinary tract infections

  within 1 days after the first time of urethral catheter removal

• The time to first voiding after catheter removal

  within 1 days after the first time of urethral catheter removal

• Graded assessment of catheter-related bladder discomfort (CRBD)

  within 1 days after the first time of urethral catheter removal

• 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

• Postoperative complications

  within 30 days after the operation

Study Arms (2)

ICCAUT Group

EXPERIMENTAL

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.

Procedure: ICCAUT

Free Drainage Group

OTHER

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.

Procedure: Free drainage

Interventions

ICCAUT 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.

ICCAUT Group

Free drainage 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.

Free Drainage Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed preoperative diagnosis of rectal cancer.
• 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).
• Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (2)

Firs Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 39909516 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Urinary Retention

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yuchen Guo, Ph.D.

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients and bedside nurses cannot be blinded, but the attending physicians and the medical ultrasound doctor will be blinded. The medical team will ensure that the patients and bedside nurses keep the group assignment confidential from the attending physicians and the medical ultrasound doctor. Unblinding will occur when the patient is discharged, and any instances of premature unblinding will be recorded. Additionally, the data analysts involved in this study will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 5, 2024
• Study Start: March 20, 2024
• Primary Completion: June 27, 2025
• Study Completion: July 20, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after we complete our study.
• Access Criteria: Researchers can provide valid reasons or demonstrate a need for additional collaboration with us.

Locations

CN (2)