Urinary RetentionNCT06217016
Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
A study testing ICCAUT and Free drainage in people with Urinary Retention and Rectal Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Retention, Rectal Cancer, Urinary Catheterization
- What is being tested?
- ICCAUT and Free drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 confirmed preoperative diagnosis of rectal cancer.
- Patients with tumors located below the rectosigmoid junction, as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
- Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.
Who cannot join
- History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
- History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
- Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
- Presence of urinary tract infection preoperatively.
- Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
- Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
Show all 19Show fewer
- Lateral lymph node dissection for rectal cancer.
- Injury to the ureter, bladder, or urethra during the perioperative period.
- Preoperative renal dysfunction (serum creatinine level >133 μmol/L).
- Emergency surgery.
- Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
- Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
- Conversion to open surgery.
- Withdrawal Criteria:
- After randomization, patients will be withdrawn from the trial if the following situations occur:
- Inability to remove the urinary catheter within 5 days postoperatively due to various reasons (e.g., impaired consciousness, transfer to the intensive care unit (ICU), Sequential Organ Failure Assessment (SOFA) score ≥2, etc.).
- Secondary catheterization was performed after catheter removal for reasons other than urinary retention (e.g., secondary surgery, shock, rectal bladder leakage, ureteral leakage, or urethral injury).
- Patient requests to withdraw from the study at any time during the entire study process.
- Selective α1-adrenergic receptor blocker is used during the first catheterization of the patient due to medical necessity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Re-catheterization Secondary to Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Read the detailed description
Urinary catheter placement is a standard procedure before proctectomy. However, the necessity of bladder training prior to catheter removal remains uncertain. The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
- Conditions
- Urinary Retention, Rectal Cancer, Urinary Catheterization
- Being tested
- ICCAUT, Free drainage
- Keywords
- urinary retention, rectal cancer, bladder training
- Medical subject headings
- Urinary Retention, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICCAUTProcedure or surgery
In this study ,the ICCAUT strategy include intermittent catheter clamping and active urination training. For patients in the ICCAUT group, intermittent catheter clamping will be initiated at 9:00 AM. The catheter will be clamped for 3 h, followed by a 5-minute release, which is one cycle. The next cycle will begin after the cycle was completed. Catheter training is to conclude at 10:00 PM on the first postoperative day, and the catheter is left open during the night. At 6:00 AM on the second postoperative day, another cycle of catheter training will be performed, with the catheter removed at 9:00 AM. During the training period, if the patient experiences a strong urge to urinate before the 3-hour clamping time is over, the clamping can be released in advance for 5 min, allowing the patient to proceed to the next cycle of bladder training. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.
Free drainageProcedure or surgery
For patients in the free draining group, no intervention will be performed on the catheter during this period. The catheter will be removed at 9:00 AM on postoperative day two.
| Study group | Role | What they receive |
|---|---|---|
| ICCAUT Group | Experimental | Patients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training. The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy. The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day. Receives: Procedure: ICCAUT |
| Free Drainage Group | Other | Patients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day. Receives: Procedure: Free drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary catheterization owing to urinary retention
The primary endpoint of this study is the rate of secondary catheterization owing to urinary retention until discharge. Secondary catheterization can be performed by urethral catheter insertion or suprapubic puncture. The decision to perform secondary catheterization is based on the specific criteria determined by the clinician.
Measured: within 7 days after the first time of urethral catheter removal
Secondary outcomes (6)
Urinary tract infections
A urinary tract infection is characterized by an inflammatory response in the urinary tract epithelium resulting from bacterial invasion. To diagnose a urinary tract infection, the following criteria must be met simultaneously: 1) urinalysis indicating a bacterial count above the upper limit of normal and 2) positive urine culture.
Measured: within 1 days after the first time of urethral catheter removal
The time to first voiding after catheter removal
The time to first voiding after catheter removal refers to the duration, measured in hours, from the moment the catheter was removed until the patient spontaneously voids for the first time.
Measured: within 1 days after the first time of urethral catheter removal
The residual urine volume after the first voiding
The residual urine volume after the first voiding is determined by assessing the volume of urine remaining in the bladder immediately after the patient's initial voiding following catheter removal using bladder ultrasonography.
Measured: within 1 days after the first time of urethral catheter removal
Graded assessment of catheter-related bladder discomfort (CRBD)
CRBD is a questionnaire given to the patients, to investigate the severity of the discomfort of patients to the urinary catheter
Measured: within 1 days after the first time of urethral catheter removal
Voiding function
Voiding function is evaluated by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and International Prostate Symptom Score (IPSS).
Measured: on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Postoperative complications
Complications that occur within 30 days after the operation will be evaluated and documented according to the Clavien-Dindo classification (19). Complications of grade II or higher were analyzed.
Measured: within 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start21 Mar 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Why it stopped: The ICCAUT-1 trial failed to demonstrate the superiority of the ICCAUT strategy in urinary dysfunction. Therefore, there is no need to conduct subsequent trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
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
- Investigators
- Yuchen Guo, Ph.D, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217016
- Sponsor's protocol ID
- ICCAUT -2
- Status last verified
- Aug 2025
- First submitted
- 5 Jan 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete ours study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Re-catheterization Secondary to Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
- ClinicalTrials.gov ID
- NCT06217016
- Acronym / sponsor ID
- ICCAUT -2
- Conditions
- Urinary Retention, Rectal Cancer, Urinary Catheterization
- Keywords
- urinary retention, rectal cancer, bladder training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The ICCAUT-1 trial failed to demonstrate the superiority of the ICCAUT strategy in urinary dysfunction. Therefore, there is no need to conduct subsequent trials.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 22 Jan 2024 (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.
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Detailed description
Urinary catheter placement is a standard procedure before proctectomy. However, the necessity of bladder training prior to catheter removal remains uncertain. The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICCAUT Group | Experimental | Procedure: ICCAUTPatients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training. The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy. The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day. |
| Free Drainage Group | Other | Procedure: Free drainagePatients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a confirmed preoperative diagnosis of rectal cancer.
- Patients with tumors located below the rectosigmoid junction, as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
- Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.
Key exclusion criteria (19 listed)
- History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
- History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
- Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
- Presence of urinary tract infection preoperatively.
- Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
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 |
|---|---|---|
| ICCAUTIn this study ,the ICCAUT strategy include intermittent catheter clamping and active urination training. For patients in the ICCAUT group, intermittent catheter clamping will be initiated at 9:00 AM. The catheter will be clamped for 3 h, followed by a 5-minute release, which is one cycle. The next cycle will begin after the cycle was completed. Catheter training is to conclude at 10:00 PM on the first postoperative day, and the catheter is left open during the night. At 6:00 AM on the second postoperative day, another cycle of catheter training will be performed, with the catheter removed at 9:00 AM. During the training period, if the patient experiences a strong urge to urinate before the 3-hour clamping time is over, the clamping can be released in advance for 5 min, allowing the patient to proceed to the next cycle of bladder training. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. | Procedure or surgery | ICCAUT Group |
| Free drainageFor patients in the free draining group, no intervention will be performed on the catheter during this period. The catheter will be removed at 9:00 AM on postoperative day two. | Procedure or surgery | Free Drainage Group |
Primary outcome
secondary catheterization owing to urinary retention
Time frame: within 7 days after the first time of urethral catheter removal
The primary endpoint of this study is the rate of secondary catheterization owing to urinary retention until discharge. Secondary catheterization can be performed by urethral catheter insertion or suprapubic puncture. The decision to perform secondary catheterization is based on the specific criteria determined by the clinician.
6 secondary outcomes
Urinary tract infections
Time frame: within 1 days after the first time of urethral catheter removal
The time to first voiding after catheter removal
Time frame: within 1 days after the first time of urethral catheter removal
The residual urine volume after the first voiding
Time frame: within 1 days after the first time of urethral catheter removal
Graded assessment of catheter-related bladder discomfort (CRBD)
Time frame: within 1 days after the first time of urethral catheter removal
Voiding function
Time frame: on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Postoperative complications
Time frame: within 30 days after the operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete ours study.
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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. This study is not recruiting at the moment.
Yuchen Guo, Ph.D principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICCAUT and Free drainage in people with Urinary Retention and Rectal Cancer, run by The First Hospital of Jilin University at 1 site 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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secondary catheterization owing to urinary retention (time frame: within 7 days after the first time of urethral 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 28 Aug 2025.