An interventional study of Tamsulosin group and 24-Hour Removal Group in Urinary Catheters, Rectal Cancer and Urinary Retention, sponsored by The First Hospital of Jilin University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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
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
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
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.
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.
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.
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.
Time frame: Within 7 days after the initial catheter removal
Incidence of Urinary Tract Infection (UTI).
Urinary Tract Infection is defined as the inflammatory response of the urinary tract epithelium to bacterial invasion. The diagnosis must simultaneously satisfy the following two criteria: 1) Urinalysis indicates that the urinary bacterial count exceeds the upper limit of the normal range, and 2) Urine culture is positive. Incidence of UTI is calculated as a ratio: UTI cases occurring after first catheter removal divided by the total number of enrolled participants.
Time frame: Within 7 days after the initial catheter removal
Time to First Successful Voiding after Catheter Removal
The time to first void after catheter removal is defined as the period from the time of catheter removal to the time when the patient voids spontaneously, measured in hours.
Time frame: Within 1 days after the initial catheter removal
Recatheterization rate within 30 days after urinary catheter removal
Recatheterization within 30 days was defined as reinsertion of a urinary catheter for any reason after initial catheter removal.
Time frame: 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).
Tamsulosin administration is triggered by either of the following: (1) failure to void spontaneously within 6 hours after urinary catheter removal; or (2) the occurrence of lower urinary tract symptoms at any time, including a sensation of incomplete bladder emptying, urinary urgency, urinary frequency, intermittent urine flow, straining to void, bladder pain or distension, urgency urinary incontinence, or suspected overflow incontinence. For participants in Tamsulosin Group, if any of the above conditions occurs before the scheduled 18:00 dose, that day's dose is administered immediately, is not repeated at 18:00, and the event is recorded as a trigger for early oral tamsulosin.
Time frame: Within 7 days after the initial catheter removal
Incidence, types, and severity (graded by Clavien-Dindo classification) of postoperative complications within 30 days.
The Clavien-Dindo classification includes, but is not limited to, intra-abdominal hemorrhage, gastrointestinal bleeding, anastomotic leakage, chyle leakage, surgical site infection (intra-abdominal infection and incisional infection), intestinal obstruction, postoperative diarrhea, pulmonary infection, urinary tract infection, cardiovascular accident, cerebrovascular accident, and thrombotic diseases.
Time frame: within 30 days postoperatively
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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The First Hospital of Jilin University