Urinary RetentionURICATHORNCT05611255
Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)
A study testing Systematic Intermittent Catheterization and Bladder Scan Guided Catheterization in people with Urinary Retention and Chronic Kidney Infection, run by University Hospital, Montpellier at 1 site in France.
Trial summary
General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Retention, Chronic Kidney Infection, Urinary Infection
- What is being tested?
- Systematic Intermittent Catheterization and Bladder Scan Guided Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2022to 16 Feb 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing scheduled thoracic surgery at the study center
- Be of legal age
- Be eligible for the enhanced recovery after surgery (ERAS) protocol in effect in the department.
Who cannot join
- Non-intubated anesthesia with spontaneous ventilation (NIVATS)
- Already have an indwelling bladder catheter or suprapubic catheter or double J catheter or other urinary drainage device
- Urinary tract infection under treatment or bladder catheterization less than one month old
- Indication of per- or postoperative bladder catheterization for another reason (e.g. monitoring of diuresis in chronic renal failure)
- Known vesico-sphincter disorder with documented post-void residue
- Neurological bladder (spinal cord injury or stroke sequelae)
Show all 14Show fewer
- Documented urinary incontinence
- Chronic renal failure with a glomerular filtration rate (GFR) < 30 ml/min
- Contraindication to bladder catheterization (e.g. stenosis of the urethra)
- Be under legal protection or incapable of giving consent
- Failure to obtain written informed consent after a reflection period
- Not be affiliated to a French social security system or a beneficiary of such a system
- Long-term morphine drugs
- Pregnancy in progress or planned during the study period, Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS): Systematic Intermittent Catheterization Versus Bladder Scan Guided Catheterization in the Post Anesthesia Care Unit: a Prospective Randomized Double-blind Study
General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume > 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.
Read the detailed description
Acute urinary retention (AUR) is clinically defined by the presence of a bladder globe, with complete inability to urinate, sometimes associated with severe suprapubic abdominal pain. It is a urological emergency. An AUR can be complicated by acute renal failure, obstruction lifting syndrome (polyuria), a vacuo hematuria, or a slammed bladder (characterized by the presence of a post-void residue).
Systematic intermittent catheterization (SIC) allows monitoring of diuresis during the per- and post-operative period, and prevents the risk of AUR. It is associated with numerous disadvantages, such as the risk of infection (nosocomial urinary tract infection, bacteriuria, candiduria), which doubles after 2 days of catheterization, the risk of trauma (bleeding from the urethra, hematuria), the delay in mobilization and ambulation, and the psychological impact on the patients (dependence, agitation, confusion). All of these complications are potentially at risk of lengthening the average length of stay, and represent an additional cost for the Health Insurance. Thus, it seems that SIC is an obstacle to enhance recovery after surgery (ERAS), which is why the investigators have eliminated this option in our center. However, even recent American protocols for thoracic ERAS consider that an epidural should be associated with an indwelling catheter.
Bladder catheterization strategies are available for patients undergoing lung surgery. Options include no bladder catheterization, evacuation catheterization, and post anesthesia care unit catheterization guided by ultrasound or bladder scan measurement of bladder volume.
SIC is a strategy that involves draining urine once, in all patients, after surgery (in the operating room). Bladder Scan Guided Catheterization in the post anesthesia care unit (BSGC) is an innovative strategy that consists of a standardized and reproducible assessment of the bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.
To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic ERAS protocol.
The hypothesis is that a SIC strategy is superior to an individualized BSGC strategy in preventing postoperative AUR in thoracic surgery patients entering a ERAS program.
The SIC strategy is a novel idea that is not yet widely used in ERAS programs. The investigators believe that the SIC strategy will significantly decrease the rate of AUR. If this strategy proves to be superior to our current "bladder scan guided" service protocol, it could be incorporated into our ERAS program. Knowing the clinical repercussions, psychological impact, and costs associated with postoperative AUR, the medico-economic prospects of this study are major.
- Being tested
- Systematic Intermittent Catheterization, Bladder Scan Guided Catheterization
- Keywords
- Urinary catheter, Acute urinary retention, Thoracic surgery, Thoracic epidural, Enhanced Recovery After Surgery (ERAS), Perioperative medicine
- Medical subject headings
- Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Intermittent CatheterizationProcedure or surgery
Also called SIC
A strategy that consists of draining urine only once, in all patients, after surgery (in the operating room).
Bladder Scan Guided CatheterizationProcedure or surgery
Also called BSGC
A strategy of standardized and reproducible assessment of bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.
| Study group | Role | What they receive |
|---|---|---|
| Systematic Intermittent Catheterization (SIC) | Experimental | A bladder catheter will be placed in the operating room, at the end of the operation, in a patient still under general anesthesia. Once the urine has been drained and quantified, the bladder catheter will be removed before the patient is discharged and extubated. Receives: Procedure: Systematic Intermittent Catheterization |
| Bladder Scan Guided Catheterization (BSGC) | Active comparator | No systematic catheterization will be performed, the indication for catheterization will be guided by bladder-scan volume monitoring. Receives: Procedure: Bladder Scan Guided Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
AUR is defined by the absence of voiding recovery in an unprobed patient, with or without pubic pain (pain may be inhibited by epidural or morphine received), associated with a bladder volume > 400 ml on bladder scan.
Measured: 24 hours after thoracic surgery
Secondary outcomes (11)
Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay
Compare the rate of AUR occurring beyond the 24th postoperative hour between the two groups.
Measured: Between Day 1 and Day 5 postoperative
Bladder volume drained
Bladder volume drained the first hour after catheter placement
Measured: The first hour after catheter placement
Total duration of the first bladder catheterization
Total duration of the first bladder catheterization
Measured: During the first bladder catheterization
Total number of bladder catheterizations
Total number of bladder catheterizations
Measured: During the 5 days of post-surgical hospitalization
The rate of complications related to catheterization
Macroscopic hematuria, documented urinary tract infection, suspected urinary tract infection with probabilistic antibiotic treatment.
Measured: During the 5 days of post-surgical hospitalization
The rate of complications related to AUR
Postoperative acute renal failure
Measured: During the 5 days of post-surgical hospitalization
Other postoperative complications
Postoperative hypotension, nausea or vomiting.
Measured: During the 5 days of post-surgical hospitalization
Duration before putting in the chair (in hours)
Duration before putting in the chair (in hours)
Measured: During the 5 days of post-surgical hospitalization
Duration before standing up (in hours)
Duration before standing up (in hours)
Measured: During the 5 days of post-surgical hospitalization
Length of hospital stay
Length of hospital stay
Measured: During the 5 days of post-surgical hospitalization
Estimated cost of stay
Estimated cost of stay
Measured: During the 5 days of post-surgical hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start8 Dec 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Why it stopped: Safety issue : increased occurrence of severe post-micturition residue (emergency urological consultation) for group B. The decision was taken on the advice of a committee of external experts
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 University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611255
- Sponsor's protocol ID
- RECHMPL20_0461
- Acronym
- URICATHOR
- Status last verified
- May 2024
- First submitted
- 10 Oct 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS): Systematic Intermittent Catheterization Versus Bladder Scan Guided Catheterization in the Post Anesthesia Care Unit: a Prospective Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT05611255
- Acronym / sponsor ID
- URICATHOR / RECHMPL20_0461
- Keywords
- Urinary catheter, Acute urinary retention, Thoracic surgery, Thoracic epidural, Enhanced Recovery After Surgery (ERAS), Perioperative medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety issue : increased occurrence of severe post-micturition residue (emergency urological consultation) for group B. The decision was taken on the advice of a committee of external experts
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 10 Nov 2022 (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.
General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume > 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.
Detailed description
Acute urinary retention (AUR) is clinically defined by the presence of a bladder globe, with complete inability to urinate, sometimes associated with severe suprapubic abdominal pain. It is a urological emergency. An AUR can be complicated by acute renal failure, obstruction lifting syndrome (polyuria), a vacuo hematuria, or a slammed bladder (characterized by the presence of a post-void residue).
Systematic intermittent catheterization (SIC) allows monitoring of diuresis during the per- and post-operative period, and prevents the risk of AUR. It is associated with numerous disadvantages, such as the risk of infection (nosocomial urinary tract infection, bacteriuria, candiduria), which doubles after 2 days of catheterization, the risk of trauma (bleeding from the urethra, hematuria), the delay in mobilization and ambulation, and the psychological impact on the patients (dependence, agitation, confusion). All of these complications are potentially at risk of lengthening the average length of stay, and represent an additional cost for the Health Insurance. Thus, it seems that SIC is an obstacle to enhance recovery after surgery (ERAS), which is why the investigators have eliminated this option in our center. However, even recent American protocols for thoracic ERAS consider that an epidural should be associated with an indwelling catheter.
Bladder catheterization strategies are available for patients undergoing lung surgery. Options include no bladder catheterization, evacuation catheterization, and post anesthesia care unit catheterization guided by ultrasound or bladder scan measurement of bladder volume.
SIC is a strategy that involves draining urine once, in all patients, after surgery (in the operating room). Bladder Scan Guided Catheterization in the post anesthesia care unit (BSGC) is an innovative strategy that consists of a standardized and reproducible assessment of the bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it.
To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic ERAS protocol.
The hypothesis is that a SIC strategy is superior to an individualized BSGC strategy in preventing postoperative AUR in thoracic surgery patients entering a ERAS program.
The SIC strategy is a novel idea that is not yet widely used in ERAS programs. The investigators believe that the SIC strategy will significantly decrease the rate of AUR. If this strategy proves to be superior to our current "bladder scan guided" service protocol, it could be incorporated into our ERAS program. Knowing the clinical repercussions, psychological impact, and costs associated with postoperative AUR, the medico-economic prospects of this study are major.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic Intermittent Catheterization (SIC) | Experimental | Procedure: Systematic Intermittent CatheterizationA bladder catheter will be placed in the operating room, at the end of the operation, in a patient still under general anesthesia. Once the urine has been drained and quantified, the bladder catheter will be removed before the patient is discharged and extubated. |
| Bladder Scan Guided Catheterization (BSGC) | Active comparator | Procedure: Bladder Scan Guided CatheterizationNo systematic catheterization will be performed, the indication for catheterization will be guided by bladder-scan volume monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing scheduled thoracic surgery at the study center
- Be of legal age
- Be eligible for the enhanced recovery after surgery (ERAS) protocol in effect in the department.
Key exclusion criteria (14 listed)
- Non-intubated anesthesia with spontaneous ventilation (NIVATS)
- Already have an indwelling bladder catheter or suprapubic catheter or double J catheter or other urinary drainage device
- Urinary tract infection under treatment or bladder catheterization less than one month old
- Indication of per- or postoperative bladder catheterization for another reason (e.g. monitoring of diuresis in chronic renal failure)
- Known vesico-sphincter disorder with documented post-void residue
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 |
|---|---|---|
| Systematic Intermittent CatheterizationAlso: SICA strategy that consists of draining urine only once, in all patients, after surgery (in the operating room). | Procedure or surgery | Systematic Intermittent Catheterization (SIC) |
| Bladder Scan Guided CatheterizationAlso: BSGCA strategy of standardized and reproducible assessment of bladder volume before discharge from the post anesthesia care unit, and draining urine only in patients who require it. | Procedure or surgery | Bladder Scan Guided Catheterization (BSGC) |
Primary outcome
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively
Time frame: 24 hours after thoracic surgery
AUR is defined by the absence of voiding recovery in an unprobed patient, with or without pubic pain (pain may be inhibited by epidural or morphine received), associated with a bladder volume > 400 ml on bladder scan.
11 secondary outcomes
Occurrence of acute urinary retention (AUR) after Day 1 and during the first 5 days after surgery or during the hospital stay
Time frame: Between Day 1 and Day 5 postoperative
Bladder volume drained
Time frame: The first hour after catheter placement
Total duration of the first bladder catheterization
Time frame: During the first bladder catheterization
Total number of bladder catheterizations
Time frame: During the 5 days of post-surgical hospitalization
The rate of complications related to catheterization
Time frame: During the 5 days of post-surgical hospitalization
The rate of complications related to AUR
Time frame: During the 5 days of post-surgical hospitalization
Other postoperative complications
Time frame: During the 5 days of post-surgical hospitalization
Duration before putting in the chair (in hours)
Time frame: During the 5 days of post-surgical hospitalization
Duration before standing up (in hours)
Time frame: During the 5 days of post-surgical hospitalization
Length of hospital stay
Time frame: During the 5 days of post-surgical hospitalization
Estimated cost of stay
Time frame: During the 5 days of post-surgical hospitalization
Results and safety
The study was stopped early (reason given: Safety issue : increased occurrence of severe post-micturition residue (emergency urological consultation) for group B. The decision was taken on the advice of a committee of external experts). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic Intermittent Catheterization and Bladder Scan Guided Catheterization in people with Urinary Retention and Chronic Kidney Infection, run by University Hospital, Montpellier at 1 site in France.
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 14 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: stopped early, as of the sponsor's last update on 26 Oct 2024. 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 France. 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 stopped early (reason given: Safety issue : increased occurrence of severe post-micturition residue (emergency urological consultation) for group B. The decision was taken on the advice of a committee of external experts). Results are not available in the source record.
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?
Occurrence of acute urinary retention (AUR) within 24 hours postoperatively (time frame: 24 hours after thoracic surgery). 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 26 Oct 2024.