Management of Post-operative Urinary Voiding Recovery in the Post-anesthesia Care Unit, Management of Post-opérative Urinary RetentionGEREMISNCT07655713
Postoperative Urinary Retention Management in the Post Anesthesia Care Unit
An observational study of Management of Post-operative Urinary Voiding Recovery in the Post-anesthesia Care Unit, Management of Post-opérative Urinary Retention, run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
Introduction : The post-anesthesia care unit (PACU) admits patients in the immediate post-operative period in order to ensure monitoring, prevention, and management of early complications related to anesthesia and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Management of Post-operative Urinary Voiding Recovery in the Post-anesthesia Care Unit, Management of Post-opérative Urinary Retention
- How many people
- 970 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2026to 29 Aug 2026
- Phase
- Observational
- 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
Study population: Patient admitted to the PACU for post-operative monitoring (excluding outpatient/ambulatory and endoscopy cases)
Who may be able to join
- Patient admitted to the PACU for post-operative monitoring (excluding outpatient/ambulatory and endoscopy cases)
- Standard post-operative monitoring (transfer to a surgical ward after the monitoring period)
- Adult patient (≥18 years)
Who cannot join
- Post-operative care following urological surgery
- History of chronic urinary retention
- Presence of an indwelling urinary drainage system upon arrival in the PACU (urinary catheter, Bricker ileal conduit, suprapubic catheter)
- Chronic renal failure requiring dialysis
- Transfer to intensive care after the PACU monitoring period
- Patient under legal protection (guardianship/conservatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GEstion de la REprise MIctionnelle en Salle de Surveillance Post-interventionnelle/ Management of Postoperative Urinary Void Recovery in the Post-Anesthesia Care Unit
Introduction : The post-anesthesia care unit (PACU) admits patients in the immediate post-operative period in order to ensure monitoring, prevention, and management of early complications related to anesthesia and surgery. Post-operative urinary retention (POUR), inability to urinate despite a full bladder, is a common complication. Its incidence, causes, contributing factors, and complications have been the subject of numerous studies. Although well known, this complication has never had a consensus definition, particularly in terms of bladder volume, and the clinical signs known in urology are not always present post-operatively, notably pain and a feeling of fullness. In the event of POUR, bladder catheterization (intermittent catheterization, indwelling catheter placement, or suprapubic catheter) is often unavoidable, even though some studies have explored the possibility of pharmacological treatment. This procedure is invasive and carries its own risks: infection, trauma, bleeding, pain, discomfort, and loss of privacy/dignity. The challenge is to monitor and manage the onset of POUR while limiting unnecessary catheterization. For this purpose, bladder ultrasound is recommended to measure bladder volume. Previously performed by physicians using medical ultrasound machines, the arrival on the market of portable bladder scanners, which are non-invasive and simple to use, has made it possible to extend this examination to nurses. This diagnostic tool is a valuable aid in cases of suspected POUR (presence of clinical signs) or for patients at risk of obstruction. It helps guide medical decision-making regarding bladder catheterization. These devices, which have been available on the market for about thirty years, have gradually been adopted by care units, likely limited by the cost of investment. The PACUs of our institution have been equipped with this device for less than 7 years, with one of them having acquired it more recently, in 2025. Experienced staff members in the department have reported a sense that the use of the device varies among professionals, and that the number of intermittent catheterizations performed in the PACU has increased since the device was introduced. In this context, we wish to evaluate our practices regarding the management of post-operative urinary voiding recovery, the appropriateness of bladder scanner uses in the PACU, and the appropriateness of bladder catheterization decisions. This project will describe practices regarding the management of urinary voiding recovery, analyze the appropriateness of bladder catheterizations, and help understand the clinical reasoning of healthcare staff. It is part of paramedical research on the evolution of practices with decision-support technologies.
Methods: A nursing observational study on care practices, Single-center, mixed-methods study (prospective and retrospective), using data collected as part of routine care for the quantitative analysis and a practice survey by questionnaire addressed to healthcare staff for the qualitative analysis. Data will be collected as part of routine care from medical records (PACU monitoring sheet and electronic patient record) and from a study-specific data collection form for the prospective component, allowing further detail on the modalities of nursing care. Data will be collected over the period between admission to the PACU and the 24 hours following discharge from the PACU. The medical records of 970 patients will be analyzed (485 retrospectively and 485 prospectively). In addition, an anonymous questionnaire will be given to nursing staff working in the PACU, to explore current knowledge and practice habits.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of potentially avoidable urinary catheterizations performed post-operatively in the PACU.
Proportion of catheterizations with an initial drained volume <500 mL among all urinary catheterizations performed in the PACU in included patients
Measured: 24 hours
Secondary outcomes (6)
Evaluate the appropriateness of bladder scanner use
Proportion of patients having had at least one bladder scan measurement in the PACU. Description of urinary volumes measured by bladder scan (median/IQR). Proportion of measurements associated with the presence of clinical signs of urinary retention, and proportion of measurements associated with the presence of factors contributing to retention
Measured: 24 hours
Analyze post-operative urinary voiding recovery and its modalities
Proportion of patients with voiding recovery in the PACU, proportion of patients with voiding recovery upon return to the surgical ward, by modality of voiding recovery: voluntary or prompted by staff (prospective component).
Measured: 24 hours
Measure the rate of intermittent catheterizations and the average volume drained
Proportion of patients who underwent intermittent catheterization in the PACU, proportion of patients who underwent intermittent catheterization upon return to the surgical ward, description of drained volumes (median/IQR).
Measured: 24 hours
Evaluate the decision criteria for intermittent catheterization (prospective component)
Among catheterized patients: proportion of patients with presence/absence of clinical signs of POUR, proportion of patients with a prior bladder scan measurement, description of the median/IQR bladder scan volume
Measured: 24 hours
Evaluate the correlation between the bladder catheterization rate and length of stay in the PACU (prospective component)
Median length of stay in the PACU among patients who required catheterization and among patients who did not require catheterization
Measured: 24 hours
Analyze staff clinical reasoning (questionnaire)
Description of the decision criteria for catheterization, decision criteria for bladder scan use, and management of voiding.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start12 Jun 2026
- Primary completion28 Aug 2026
- Study completion29 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Post-operative Urinary Voiding Recovery in the Post-anesthesia Care Unit, Management of Post-opérative Urinary RetentionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Florence GIMBERT, European Georges Pompidou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655713
- Sponsor's protocol ID
- IRB 00010254 - 2026 - 084
- Acronym
- GEREMIS
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- GEstion de la REprise MIctionnelle en Salle de Surveillance Post-interventionnelle/ Management of Postoperative Urinary Void Recovery in the Post-Anesthesia Care Unit
- ClinicalTrials.gov ID
- NCT07655713
- Acronym / sponsor ID
- GEREMIS / IRB 00010254 - 2026 - 084
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 29 Aug 2026 (actual)
- First posted
- 18 Jun 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.
Introduction : The post-anesthesia care unit (PACU) admits patients in the immediate post-operative period in order to ensure monitoring, prevention, and management of early complications related to anesthesia and surgery. Post-operative urinary retention (POUR), inability to urinate despite a full bladder, is a common complication. Its incidence, causes, contributing factors, and complications have been the subject of numerous studies. Although well known, this complication has never had a consensus definition, particularly in terms of bladder volume, and the clinical signs known in urology are not always present post-operatively, notably pain and a feeling of fullness. In the event of POUR, bladder catheterization (intermittent catheterization, indwelling catheter placement, or suprapubic catheter) is often unavoidable, even though some studies have explored the possibility of pharmacological treatment. This procedure is invasive and carries its own risks: infection, trauma, bleeding, pain, discomfort, and loss of privacy/dignity. The challenge is to monitor and manage the onset of POUR while limiting unnecessary catheterization. For this purpose, bladder ultrasound is recommended to measure bladder volume. Previously performed by physicians using medical ultrasound machines, the arrival on the market of portable bladder scanners, which are non-invasive and simple to use, has made it possible to extend this examination to nurses. This diagnostic tool is a valuable aid in cases of suspected POUR (presence of clinical signs) or for patients at risk of obstruction. It helps guide medical decision-making regarding bladder catheterization. These devices, which have been available on the market for about thirty years, have gradually been adopted by care units, likely limited by the cost of investment. The PACUs of our institution have been equipped with this device for less than 7 years, with one of them having acquired it more recently, in 2025. Experienced staff members in the department have reported a sense that the use of the device varies among professionals, and that the number of intermittent catheterizations performed in the PACU has increased since the device was introduced. In this context, we wish to evaluate our practices regarding the management of post-operative urinary voiding recovery, the appropriateness of bladder scanner uses in the PACU, and the appropriateness of bladder catheterization decisions. This project will describe practices regarding the management of urinary voiding recovery, analyze the appropriateness of bladder catheterizations, and help understand the clinical reasoning of healthcare staff. It is part of paramedical research on the evolution of practices with decision-support technologies.
Methods: A nursing observational study on care practices, Single-center, mixed-methods study (prospective and retrospective), using data collected as part of routine care for the quantitative analysis and a practice survey by questionnaire addressed to healthcare staff for the qualitative analysis. Data will be collected as part of routine care from medical records (PACU monitoring sheet and electronic patient record) and from a study-specific data collection form for the prospective component, allowing further detail on the modalities of nursing care. Data will be collected over the period between admission to the PACU and the 24 hours following discharge from the PACU. The medical records of 970 patients will be analyzed (485 retrospectively and 485 prospectively). In addition, an anonymous questionnaire will be given to nursing staff working in the PACU, to explore current knowledge and practice habits.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to the PACU for post-operative monitoring (excluding outpatient/ambulatory and endoscopy cases)
Key inclusion criteria (3 listed)
- Patient admitted to the PACU for post-operative monitoring (excluding outpatient/ambulatory and endoscopy cases)
- Standard post-operative monitoring (transfer to a surgical ward after the monitoring period)
- Adult patient (≥18 years)
Key exclusion criteria (6 listed)
- Post-operative care following urological surgery
- History of chronic urinary retention
- Presence of an indwelling urinary drainage system upon arrival in the PACU (urinary catheter, Bricker ileal conduit, suprapubic catheter)
- Chronic renal failure requiring dialysis
- Transfer to intensive care after the PACU monitoring period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the incidence of potentially avoidable urinary catheterizations performed post-operatively in the PACU.
Time frame: 24 hours
Proportion of catheterizations with an initial drained volume <500 mL among all urinary catheterizations performed in the PACU in included patients
6 secondary outcomes
Evaluate the appropriateness of bladder scanner use
Time frame: 24 hours
Analyze post-operative urinary voiding recovery and its modalities
Time frame: 24 hours
Measure the rate of intermittent catheterizations and the average volume drained
Time frame: 24 hours
Evaluate the decision criteria for intermittent catheterization (prospective component)
Time frame: 24 hours
Evaluate the correlation between the bladder catheterization rate and length of stay in the PACU (prospective component)
Time frame: 24 hours
Analyze staff clinical reasoning (questionnaire)
Time frame: 24 hours
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 29 Sep 2026.
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?
An observational study of Management of Post-operative Urinary Voiding Recovery in the Post-anesthesia Care Unit, Management of Post-opérative Urinary Retention, run by European Georges Pompidou Hospital 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 6 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 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 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 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?
Evaluate the incidence of potentially avoidable urinary catheterizations performed post-operatively in the PACU. (time frame: 24 hours). 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.