Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery

NCT07346586 · tracked via the Priya Life Science China tracker

Sponsor

The First Hospital of Jilin University

Phase

Not applicable

Started

2026-03-18

Last updated

2026-09-29

Condition(s) studied

Urinary CathetersRectal CancerUrinary Retention

Investigational drug(s) / intervention(s)

Tamsulosin group24-Hour Removal Group48-Hour Removal Group

Tamsulosin group: 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.

24-Hour Removal Group: 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.

48-Hour Removal Group: 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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients with a preoperative pathological confirmation of rectal malignant tumor. 2. 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). 3. Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME). 4. 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. Exclusion Criteria: 1. 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). 2. History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease. 3. Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy). 4. Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy. 5. 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). 6. Preoperative assessment indicating potential need for lateral pelvic lymph node dissection. 7. Preoperative renal insufficiency (serum creatinine level \>133 μmol/L). 8. Patients undergoing emergency surgery. 9. Male patients with preoperative benign prostatic hyperplasia requiring medication. 10. Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis. 11. Severe lower urinary tract symptoms based on the preoperative International Prostate Symptom Score (IPSS). 12. Previous use of an α1-adrenergic receptor blocker.

Primary outcome measure(s)

Rate of recatheterization within 7 days after the initial catheter removal — 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.

Trial sites (2)

Facility	City	Region	Status
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Not Yet Recruiting
The First Hospital of Jilin University	Changchun	Jilin	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07346586 on ClinicalTrials.gov ↗ ← All trials in China