Urinary CathetersNCT07346586
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
A study testing Tamsulosin group, 24-Hour Removal Group and 48-Hour Removal Group in people with Urinary Catheters and Rectal Cancer, run by The First Hospital of Jilin University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Catheters, Rectal Cancer, Urinary Retention
- What is being tested?
- Tamsulosin group, 24-Hour Removal Group and 48-Hour Removal Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,545 participants
- Where
- 2 sitesChina
- Study dates
- 18 Mar 2026to 20 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Yuchen Guo Yuchen Guo, +8613630598312, guoyuchen8688@jlu.edu.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Shaopeng Zhang, +86187 4402 1047, 958357004@qq.com
About this study
Official title: 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)
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
- Being tested
- Tamsulosin group, 24-Hour Removal Group, 48-Hour Removal Group
- Keywords
- Urinary Retention, Rectal Cancer, Catheter
- Medical subject headings
- Rectal Neoplasms, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin groupBehavioural
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 GroupBehavioural
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 GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: 48-Hour Removal Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- The PVR volume is >500 mL, or 300-500 mL with accompanying LUTS;
- 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.
Measured: Within 7 days after the initial catheter removal
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start18 Mar 2026
- Primary completion20 Nov 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CathetersStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuchen Guo, Ph.D., The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346586
- Sponsor's protocol ID
- ICCAUT-3
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07346586
- Acronym / sponsor ID
- ICCAUT-3
- Conditions
- Urinary Catheters, Rectal Cancer, Urinary Retention
- Keywords
- Urinary Retention, Rectal Cancer, Catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,545 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 20 Nov 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin Group | Experimental | Behavioral: Tamsulosin groupParticipants 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. |
| 24-Hour Removal Group | Experimental | Behavioral: 24-Hour Removal GroupParticipants 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. |
| 48-Hour Removal Group | Active comparator | Behavioral: 48-Hour Removal GroupParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosin groupTamsulosin 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. | Behavioural | Tamsulosin Group |
| 24-Hour Removal GroupParticipants 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. | Behavioural | 24-Hour Removal Group |
| 48-Hour Removal GroupParticipants 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. | Behavioural | 48-Hour Removal Group |
Primary outcome
Rate of recatheterization within 7 days after the initial catheter removal
Time frame: 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.
5 secondary outcomes
Incidence of Urinary Tract Infection (UTI).
Time frame: Within 7 days after the initial catheter removal
Time to First Successful Voiding after Catheter Removal
Time frame: Within 1 days after the initial catheter removal
Recatheterization rate within 30 days after urinary 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).
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.
Time frame: within 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin group, 24-Hour Removal Group and 48-Hour Removal Group in people with Urinary Catheters and Rectal Cancer, run by The First Hospital of Jilin University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuchen Guo Yuchen Guo (+8613630598312, guoyuchen8688@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recatheterization within 7 days after the initial catheter removal (time frame: Within 7 days after the initial catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.