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NCT07346586From ClinicalTrials.govRecruiting

Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery

Safety and Efficacy of Oral Tamsulosin in Facilitating Early Urinary Catheter Removal After Surgery for Mid- and Low Rectal Cancer: A Randomized Controlled Trial (ICCAUT-3)

  • Urinary Catheters
  • Rectal Cancer
  • Urinary Retention

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
The First Hospital of Jilin University
Enrolment target
1,545
Started
18 March 2026
Main results due
20 November 2029
Study sites
2
Registry updated
29 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

    Not yet recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, China

    Recruiting

Showing 2 of 2 sites. 1 of the 2 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07346586. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery | Trialion