Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery

NCT07346586 | Recruiting DMC

• 1 other identifier: ICCAUT-3
• Study Type: interventional
• Target: 1,545
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to systematically evaluate the safety and efficacy of different early urinary catheter removal strategies following radical resection of mid-low rectal cancer. Current clinical practice faces controversy regarding the optimal timing of catheter removal (24 hours vs. 48 hours) and lacks precise preventive measures for patients at high risk of postoperative acute urinary retention (AUR). To address these issues, this study is designed as a three-arm randomized controlled trial, directly comparing three management protocols: catheter removal at 24 hours postoperatively, catheter removal at 48 hours postoperatively, and urinary catheter removal within 24 hours combined with prophylactic tamsulosin. The primary endpoint is the rate of recatheterization within 7 days after the initial removal, with secondary endpoints comprehensively assessing urinary tract infections, voiding function, and postoperative complications. The ultimate goal is to provide high-quality evidence-based medical evidence to establish a precise and standardized clinical pathway for postoperative catheter management.

Conditions

Urinary Catheters; Rectal Cancer; Urinary Retention

Keywords

Urinary Retention; Rectal Cancer; Catheter

Outcome Measures

Primary Outcomes (1)

• Rate of recatheterization within 7 days after the initial catheter removal

  If a patient had not urinated spontaneously by 10 h after catheter removal and had a bladder extending above the pubic symphysis on percussion, or was able to void but had lower urinary tract symptoms (LUTS), and these conditions persisted despite oral tamsulosin, bladder ultrasonography was performed to measure the post-void residual (PVR) urine volume. Recatheterization will be performed if: 1. The PVR volume is \>500 mL, or 300-500 mL with accompanying LUTS; 2. The PVR volume is 300-500 mL without LUTS or ≤300 mL. In these cases, patients are observed for an additional 2-4 h, and recatheterization is performed if no spontaneous voiding occurs or symptoms worsen.

  Within 7 days after the initial catheter removal

Secondary Outcomes (5)

• Incidence of Urinary Tract Infection (UTI).

  Within 7 days after the initial catheter removal

• Time to First Successful Voiding after Catheter Removal

  Within 1 days after the initial catheter removal

• Recatheterization rate within 30 days after urinary catheter removal

  Within 30 days after the initial catheter removal

• The incidence of events triggering oral tamsulosin after catheter removal (24-Hour Removal Group and 48-Hour Removal Group) or triggering early oral tamsulosin administration (Tamsulosin Group).

  Within 7 days after the initial catheter removal

• Incidence, types, and severity (graded by Clavien-Dindo classification) of postoperative complications within 30 days.

  within 30 days postoperatively

Study Arms (3)

Tamsulosin Group

EXPERIMENTAL

Participants assigned to this arm underwent urinary catheter removal at 04:00 AM on postoperative day 1 and received prophylactic oral tamsulosin 0.4 mg once daily from one day before surgery through postoperative day 7.

Behavioral: Tamsulosin group

24-Hour Removal Group

EXPERIMENTAL

Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.

Behavioral: 24-Hour Removal Group

48-Hour Removal Group

ACTIVE COMPARATOR

Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.

Behavioral: 48-Hour Removal Group

Interventions

24-Hour Removal Group BEHAVIORAL

Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.

24-Hour Removal Group

48-Hour Removal Group BEHAVIORAL

Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2. For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.

48-Hour Removal Group

Tamsulosin group BEHAVIORAL

Tamsulosin regimen: Tamsulosin 0.4 mg was administered orally once daily at 18:00 from the day before surgery to postoperative day 7. On the day of surgery, if the patient had not returned to the ward by 18:00, the dose was given after return to the ward and recovery from anesthesia. On postoperative day 1, if the patient had not voided within 6 hours after catheter removal or developed lower urinary tract symptoms, the daily dose was administered early and was not repeated at 18:00. Catheter removal: The urinary catheter was removed at 04:00 on postoperative day 1.

Tamsulosin 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 preoperative pathological confirmation of rectal malignant tumor.
• Preoperative colorectal CT or rectal MRI confirming that the lower edge of the tumor is located in the rectum within 10 cm from the anal verge (including rectal and anal canal lesions).
• Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME).
• Patients with a most recent preoperative clinical stage, including restaging after neoadjuvant therapy, of cT0 (clinical complete response \[cCR\]) to cT4 and cN0-N2 were eligible. For cT4 disease, tumor invasion was limited to the levator ani muscle or external anal sphincter.

You may not qualify if:

• History of previous abdominal surgery involving the rectum/sigmoid colon/left colon, bladder resection or partial resection, prostate surgery (in males), or hysterectomy (in females).
• History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease.
• Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy).
• Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy.
• Preoperative assessment indicating potential need for combined resection of other pelvic organs during surgery, including the bladder, prostate, uterus and cervix, or vagina (excluding simple adnexectomy in females).
• Preoperative assessment indicating potential need for lateral pelvic lymph node dissection.
• Preoperative renal insufficiency (serum creatinine level \>133 μmol/L).
• Patients undergoing emergency surgery.
• Male patients with preoperative benign prostatic hyperplasia requiring medication.
• Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis.
• Severe lower urinary tract symptoms based on the preoperative International Prostate Symptom Score (IPSS).
• Previous use of an α1-adrenergic receptor blocker.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

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

Central Study Contacts

Yuchen Guo Yuchen Guo

CONTACT

+8613630598312; guoyuchen8688@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, the sonographers performing bladder post-void residual volume measurements and data analysts were blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 16, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): November 20, 2029
• Study Completion (Estimated): December 20, 2029
• Last Updated: September 29, 2026

Record last verified: 2026-09

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 may provide legitimate justification and supporting documentation.

Locations

CN (2)