Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)

NCT06217016 | Withdrawn DMC

• 1 other identifier: ICCAUT -2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.

Conditions

Urinary Retention; Rectal Cancer; Urinary Catheterization

Keywords

urinary retention; rectal cancer; bladder training

Outcome Measures

Primary Outcomes (1)

• secondary catheterization owing to urinary retention

  The primary endpoint of this study is the rate of secondary catheterization owing to urinary retention until discharge. Secondary catheterization can be performed by urethral catheter insertion or suprapubic puncture. The decision to perform secondary catheterization is based on the specific criteria determined by the clinician.

  within 7 days after the first time of urethral catheter removal

Secondary Outcomes (6)

• 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

• The residual urine volume after the first voiding

  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

• Voiding function

  on the second day after the first time of urethral catheter removal, and at the 30th day after surgery

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.

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

In this study ,the ICCAUT strategy include intermittent catheter clamping and active urination training. 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. 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, 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.
• Withdrawal Criteria:
• After randomization, patients will be withdrawn from the trial if the following situations occur:

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Urinary Retention; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal 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: CARE PROVIDER, 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 5, 2024
• First Posted: January 22, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

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

Locations

CN (1)