Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery (ICCAUT-1)

Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Urinary Dysfunction; Urinary Retention Postoperative; Urinary Catheterization
• Intervention / Treatment: Procedure: Free drainage; Procedure: ICCAUT

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 Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuchen Guo, Ph.D.; Phone Number: +8613630598312; Email: guoyuchen8688@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • First Hospital of Jilin University
      • Contact: Yuchen Guo, Ph.D.; Phone Number: +8613630598312; Email: guoyuchen8688@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a confirmed preoperative diagnosis of rectal cancer.
2. Patients with tumors located below the rectosigmoid junction, 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.

Withdrawal Criteria:

After randomization, patients will be withdrawn from the trial if the following situations occur:

1. Inability to remove the urinary catheter within 5 days postoperatively due to various reasons (e.g., impaired consciousness, transfer to the intensive care unit (ICU), Sequential Organ Failure Assessment (SOFA) score ≥2, etc.).
2. Secondary catheterization was performed after catheter removal for reasons other than urinary retention (e.g., secondary surgery, shock, rectal bladder leakage, ureteral leakage, or urethral injury).
3. Patient requests to withdraw from the study at any time during the entire study process.
4. Selective α1-adrenergic receptor blocker is used during the first catheterization of the patient due to medical necessity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 due to inability to urinate.	within 7 days after the first time of urethral catheter removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to first voiding after 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.	within 1 days after the first time of urethral catheter removal
Graded assessment of catheter-related bladder discomfort (CRBD)	CRBD is a questionnaire given to the patients, to investigate the severity of the discomfort of patients to the urinary catheter	within 1 days after the first time of urethral catheter removal
International Consultation on Incontinence Questionnaire-Short Form	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	on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Postoperative complications	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.	within 30 days after the operation
International Prostate Symptom Score	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.	on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Rate of Urinary tract infections	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.	within 1 days after the first time of urethral catheter removal

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Yuchen Guo, Ph.D., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): February 19, 2025
• Study Completion (Estimated): February 19, 2026

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Rectal Cancer; Urinary Retention; Residual Urine Volume; Urinary Dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Urologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Rectal Neoplasms; Urinary Retention
• Other Study ID Numbers: ICCAUT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete our study.
• IPD Sharing Time Frame: after we complete our study.
• IPD Sharing Access Criteria: Researchers can provide valid reasons or demonstrate a need for additional collaboration with us.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No