Urinary DysfunctionICCAUT-1NCT06241703
Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery
A study testing ICCAUT and Free drainage in people with Urinary Dysfunction and Rectal Cancer, run by The First Hospital of Jilin University at 2 sites in China.
Trial summary
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Dysfunction, 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
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 20 Mar 2024to 20 Jul 2025
- 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 (12 cm from the anal verge), 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Firs Hospital of Jilin University
Changchun, Jilin, 130021
First Hospital of Jilin University
Changchun, Jilin, 130021
About this study
Official title: Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
Read the detailed description
Urinary catheter placement is a routine procedure performed in proctectomy. Nevertheless, there is uncertainty regarding the need for bladder training before catheter removal. The purpose of this trial is to examine the impact of bladder training on the urinary retention and secondary catheterization following proctectomy.
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While the participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
This trial aims to investigate whether ICCAUT strategy, achieved through intermittent clamping of the catheter combined with active urination training in patients undergoing rectal cancer surgery, can impact the rate of urinary dysfunction compared to direct catheter removal. The findings from this study will provide valuable evidence regarding the manipulation of urinary catheters and help guide clinical practice.
- Conditions
- Urinary Dysfunction, Rectal Cancer, Urinary Catheterization, Urinary Retention Postoperative
- Being tested
- ICCAUT, Free drainage
- Keywords
- Residual Urine Volume, Urinary Retention, Urinary Dysfunction, Rectal Cancer
- 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.
ICCAUTProcedure or surgery
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 after the bladder is empty. 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 after the bladder is empty. 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.
Rate of urinary dysfunction
Urinary dysfunction is defined as the presence of residual urine volume greater than 100ml, as estimated by bladder ultrasound, after the first voiding following catheter removal, or the need for a second catheterization.
Measured: within 7 days after the first time of urethral catheter removal
Secondary outcomes (7)
Rate of 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
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
International Consultation on Incontinence Questionnaire-Short Form
International Consultation on Incontinence Questionnaire-Short Form is used to evaluate the incontinence of voiding. The minimum value is 0 and maximum value is 21. A higher score means a worse outcome
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. Complications of grade II or higher were analyzed.
Measured: within 30 days after the operation
International Prostate Symptom Score
International Prostate Symptom Score is used to evaluate the severity of urinary difficulties. The scoring range ranges from 0 to 35 points for asymptomatic to severe symptoms. There are three levels of severity: 0-7 is mild, 8-19 is moderate, and 20-35 is severe.
Measured: on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Incidence rate of residual urine volume greater than 200 ml after the first voiding
Incidence rate of residual urine volume greater than 200 ml after the first voiding
Measured: within 1 days after the first time of urethral catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Mar 2024
- Primary completion27 Jun 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary DysfunctionStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 400 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
- NCT06241703
- Sponsor's protocol ID
- ICCAUT-1
- Acronym
- ICCAUT-1
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2024
- Last updated
- 30 Jan 2026
- 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 our study.
Publications
He T, Liang S, Guan Y, Sun J, Hu H, Wang Q, Guo Y. Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol. BMJ Open. 2025 Feb 5;15(2):e095217. doi: 10.1136/bmjopen-2024-095217.
PubMed 39909516
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. 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 Urinary Dysfunction After Radical Rectal Cancer Surgery: a Single-Center Randomized Controlled Trial (ICCAUT-1)
- ClinicalTrials.gov ID
- NCT06241703
- Acronym / sponsor ID
- ICCAUT-1 / ICCAUT-1
- Conditions
- Urinary Dysfunction, Rectal Cancer, Urinary Catheterization, Urinary Retention Postoperative
- Keywords
- Residual Urine Volume, Urinary Retention, Urinary Dysfunction, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 5 Feb 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.
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
Detailed description
Urinary catheter placement is a routine procedure performed in proctectomy. Nevertheless, there is uncertainty regarding the need for bladder training before catheter removal. The purpose of this trial is to examine the impact of bladder training on the urinary retention and secondary catheterization following proctectomy.
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While the participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
This trial aims to investigate whether ICCAUT strategy, achieved through intermittent clamping of the catheter combined with active urination training in patients undergoing rectal cancer surgery, can impact the rate of urinary dysfunction compared to direct catheter removal. The findings from this study will provide valuable evidence regarding the manipulation of urinary catheters and help guide clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, 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 after the bladder is empty. |
| 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 (12 cm from the anal verge), 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 (13 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 |
|---|---|---|
| ICCAUTFor 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 after the bladder is empty. 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
Rate of urinary dysfunction
Time frame: within 7 days after the first time of urethral catheter removal
Urinary dysfunction is defined as the presence of residual urine volume greater than 100ml, as estimated by bladder ultrasound, after the first voiding following catheter removal, or the need for a second catheterization.
7 secondary outcomes
Rate of 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
Graded assessment of catheter-related bladder discomfort (CRBD)
Time frame: within 1 days after the first time of urethral catheter removal
International Consultation on Incontinence Questionnaire-Short Form
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
International Prostate Symptom Score
Time frame: on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
Incidence rate of residual urine volume greater than 200 ml after the first voiding
Time frame: within 1 days after the first time of urethral catheter removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 39909516He T, Liang S, Guan Y, Sun J, Hu H, Wang Q, Guo Y. Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary dysfunction after radical rectal cancer surgery: single-centre randomised controlled trial (ICCAUT -1) study protocol. BMJ Open. 2025 Feb 5;15(2):e095217. doi: 10.1136/bmjopen-2024-095217.
- 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 our 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
2 sites 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 Dysfunction 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of urinary dysfunction (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?
On the ClinicalTrials.gov record for NCT06241703, which also lists 1 linked publication.
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 30 Jan 2026.