Urinary RetentionNCT04715971
Urinary Retention on an Acute Geriatric Hospitalisation Unit.
An observational study of Urinary Retention and Aged, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Aim: The aim of this observational cohort study was to measure the prevalence of UR in patients aged ≥75 years on admission to an acute geriatric hospitalisation unit and to determine which at risk group would benefit from screening. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Urinary Retention, Aged
- What is being tested?
- portable ultrasound bladder scan
- How many people
- 94 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Oct 2015to 18 Dec 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 75 years or older on admission to an acute geriatric hospitalisation unit.
Who may be able to join
- patients aged 75 years or older
- with or without a urinary catheter
- admitted no more than 72 hours to an acute geriatric hospitalisation unit of the Leuven University Hospitals
Who cannot join
- indwelling urinary catheter for another reason than acute urinary retention
- ascites
- dialysis
- uro- or nephrostomy
- terminally ill
- postoperative
- refusal to participate
- unable to understand and carry out the instructions for the post-void residual volume measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary Retention on an Acute Geriatric Hospitalisation Unit: Prevalence, Risk Factors and the Role of Screening, an Observational Cohort Study
Aim: The aim of this observational cohort study was to measure the prevalence of UR in patients aged ≥75 years on admission to an acute geriatric hospitalisation unit and to determine which at risk group would benefit from screening.
Methods: Post-void residual volumes (PVR) were measured within 3 days of admission with an ultrasound bladder scan. Uni- and multivariable analysis were used to determine risk factors associated with PVR ≥150 and ≥300 millilitres.
Read the detailed description
- Sample and setting An observational cross-sectional cohort study was conducted on the acute geriatric hospitalisation units of the University Hospitals Leuven in Belgium which have a collective capacity of 80 beds. All patients aged 75 years or older admitted with or without an indwelling urinary catheter between October 26 and December 18, 2015 were consecutively screened for inclusion within 72 hours of admission. Patients with urinary catheters for any other reason than UR, patients with ascites, dialysis, uro- or nephrostomy, terminally ill patients, and postoperative patients were not eligible for inclusion. Patients who refused to participate, who were unable to understand and carry out the instructions for the PVR measurement, with a urinary catheter for chronic UR, who were discharged or died during the inclusion process were excluded. The study was approved by the Ethics Committee Research of the University Hospitals Leuven (mp08305). The study nurse (SV) obtained a written informed consent from all patients who agreed to participate in the study, or from a proxy when the patient was incapable to provide written informed consent.
- Procedures Prior to the start of the study, information sessions were organised for the nurses from the acute geriatric hospitalisation units, in which the study nurse (SV) explained the aim of the study and the data collection procedure. In addition, information was given on the use of the portable ultrasound bladder scan and the execution of a bladder scan. The nurses were asked to perform 3 consecutive post-void bladder scans as soon as possible after admission and at the latest within 72 hours of admission as standard of care during the study period. The highest value of the 3 consecutive PVR measurements was recorded. The study nurse (SV) was present on Monday, Wednesday and Friday morning, performed informed consents and performed bladder scanning in patients where this had not yet been done. Before performing the bladder scan, the patients were asked to urinate. Whenever possible, patients had to walk to the toilet in the bathroom, with or without assistance, meanwhile their mobility was assessed. Consecutively, the study nurse performed a bedside assessment. A mini-cog examination was performed and urinary symptoms, defaecation habits, and fall history were assessed by patient or caregiver interview using a structured questionnaire (SV). The demographic and remaining clinical data were collected from the patient's electronic medical records (SV, KH, KF).
- Variables Outcome variables The PVR was measured using a portable ultrasound bladder scan (Verathon BladdersScan BVI 3000). Jalbani et al. found a high correlation (r²=0.97) between urinary catheterisation (gold standard) and bladder scanning and concluded that the use of the Verathon BladderScan BVI 3000 is as accurate as urinary catheterisations for measuring the PVR. As there are no official definitions or guidelines on what is considered a relevant PVR for UR, in this study we defined UR as a PVR of ≥150 millilitres. In addition, we also included a PVR ≥300 ml as secondary outcome. The cut-offs were chosen for the following reasons: the first bladder-filling sensation is felt at a volume of 150 ml. At a volume of 300 ml, the pressure receptors in the bladder wall will be activated, which creates a sense of fullness of the bladder and a need to urinate. Moreover, in clinical practice a PVR ≥300ml is often considered as threshold for insertion of a urinary catheter. Demographics The following patient characteristics were recorded: age, gender and living situation. Patients living alone at home and together at home were considered as living at home and patients living in an assisted living facility or nursing home were considered as not living at home. Patients living in a convent were considered as not living at home when they were functionally or cognitively impaired. Comorbidities Various comorbidities were retrospectively retrieved from the patient's electronic medical records: neurological, gynaecological and urological history, a history of diabetes type 1 or 2, recurrent falls (more than 1 fall episode in the last 6 months), and chronic kidney disease (CKD). CKD was defined as a glomerular filtration rate (eGFR, calculated using the CKD-EPI formula) of <60 ml/min/1.73 m². An age adjusted definition (<45 ml/min/1.73 m²) was also considered. Clinical evaluation Urinary incontinence was assessed by means of 3 questions: Do you have/does the patient have (1) an urge to urinate and involuntary loss of urine before reaching the toilet? (2) involuntary loss of urine when sneezing, coughing, lifting or moving something? (3) loss of small amounts or drops of urine without urge to urinate or loss of small drops of urine when changing position. Answering positive on these questions was classified as urge, stress or overflow incontinence, respectively. Dysuria was questioned as having a burning sensation or pain when urinating. Urinary frequency was questioned as urinating more often than usual. Voiding difficulty was questioned as straining to void. Subtotal voiding was questioned as the feeling of incomplete bladder emptying. Hypogastric pain was questioned as pain in the lower abdomen. Constipation was defined as the absence of stools for 3 or more days before the PVR measurement, or if patients reported having had less than 3 stools in the last week with a need to strain and mostly hard or lumpy stools, or if the patient had faecal impaction. Faecal impaction was defined as a large mass of compacted faeces in the rectum or colon on clinical or radiographical examination, that could not be spontaneously evacuated. The cognitive status of the patients was evaluated using the Mini-Cog. The Mini-Cog is a brief cognitive test that involves an assessment of an older person's ability to memorise three words, to draw a clock, and to recall the three words. Repeating only 1 or 2 of the 3 words and being unable to draw a clock correctly or not being able to repeat any of the words was considered as cognitive impairment. Mobility was assessed by walking to the bathroom and going to the toilet. All patients were asked to urinate on the toilet prior to the PVR measurements. Patients were considered mobile if they could walk back and forth to the toilet and if they were able to stand up from the toilet independently. The use of mechanical aids was permitted. Needing assistance from another person or not being able to walk was defined as impaired mobility. Laboratory evaluation and urinalysis The patient's renal function was evaluated by serum creatinine level and eGFR (calculated using the CKD-EPI formula). A urinary dipstick test was performed in all patients. In patients with positive leucocyte esterase or positive nitrites on the dipstick test, further urinalysis was performed. An automated leucocyte count of ≥10 leukocytes/mm³ and significant microscopic bacteriuria of >100.000 CFU/ml for which antibiotics were started by the treating physician was considered as UTI in this study. If the patient was taking antibiotics at the time of the urine sample and cultures remained negative, the presence of UTI was determined based on the leucocyte count. Medication For each patient the anticholinergic burden scale (ACB) score was calculated taking into account medication use in the last 24 hours before the PVR measurement. Individual drugs with high anticholinergic properties (ACB score ≥2), such as antipsychotics, antidepressants, as well as detrusor relaxants, were examined separately for their associations with UR. Antiepileptics, histamine H1 receptor antagonists, anti-diarrhoea medications, decongestive drugs, spasmolytics, muscle relaxants, and antiparkinsonian agents with ACB scores ≥2 were not considered individually. Low prevalence of these drugs prohibited statistical analysis. Reason for referral to the hospital The reasons for referral to the hospital were divided into the following categories: confusion, falls or immobility, urinary symptoms, cardiopulmonary symptoms, digestive symptoms, fever or non-specific symptoms with biochemical inflammation (elevated leucocytosis and elevated C-reactive protein) on admission, other. In patients with multiple reasons for admission, each reason was scored separately.
- Statistical analysis Descriptive and comparative statistics were used. Normally distributed continuous variables were reported as means with standard deviations (SD). Not normally distributed continuous variables were reported as medians with interquartile ranges (IQR). Categorical variables were reported as numbers and percentages. Baseline characteristics and clinical variables of patients with a PVR of <150 ml versus ≥150 ml and a PVR of <300 ml versus ≥300 ml were compared using unpaired t-tests for normally distributed continuous variables. Pearson Chi-squared tests or Fisher's exact tests (if ≥1 cell had an expected count of less than 5) were used for dichotomous or nominal variables, and Mann-Whitney U tests for not normally distributed continuous variables or ordinal variables. All tests were 2-tailed, assuming a 5% significance level. Multivariable logistic regression models were used to determine independent predictors for a PVR ≥150 ml and a PVR ≥300 ml. Significant variables in the univariable analysis were considered in a forward stepwise logistic regression procedure. P-values (Likelihood ratios), odds ratios (OR), and 95% confidence intervals (CI) are reported. The software package used was SPSS version 20 (SPSS Inc., Chicago, IL).
- Conditions
- Urinary Retention, Aged
- Being tested
- portable ultrasound bladder scan
- Keywords
- urinary retention, post-void residual volume, bladder scan, prevalence, risk factors, elderly
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable ultrasound bladder scanDiagnostic test
A post-void residual volume was measured using a Verathon BladdersScan BVI 3000.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted ≤72 hours to an acute geriatric hospitalisation unit. | All patients aged ≥75 years, admitted to the acute geriatric hospitalisation units of the University Hospitals Leuven in Belgium, were consecutively screened for inclusion within 72 hours of admission in a 2 month period (between October 26 and December 18, 2015). Receives: Diagnostic Test: portable ultrasound bladder scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-void residual volume
residual volume after urinating measured with a portable ultrasound bladder scan (Verathon BladdersScan BVI 3000)
Measured: measurement within 72 hours of admission to the acute geriatric hospitalisation unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
26 Oct 201518 Dec 2015
- First posted20 Jan 2021
- Study start26 Oct 2015
- Primary completion18 Dec 2015
- Study completion18 Dec 2015
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katleen Fagard, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Johan Flamaing, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715971
- Sponsor's protocol ID
- mp08305
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data are stored on a central secured server for data storage of the University Hospitals Leuven and are available upon contacting the corresponding author after publication, unless the journal asks for publication of the data on a datasharing site.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Retention on an Acute Geriatric Hospitalisation Unit: Prevalence, Risk Factors and the Role of Screening, an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04715971
- Acronym / sponsor ID
- mp08305
- Conditions
- Urinary Retention, Aged
- Keywords
- urinary retention, post-void residual volume, bladder scan, prevalence, risk factors, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 18 Dec 2015 (actual)
- Study completion
- 18 Dec 2015 (actual)
- First posted
- 20 Jan 2021 (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.
Aim: The aim of this observational cohort study was to measure the prevalence of UR in patients aged ≥75 years on admission to an acute geriatric hospitalisation unit and to determine which at risk group would benefit from screening.
Methods: Post-void residual volumes (PVR) were measured within 3 days of admission with an ultrasound bladder scan. Uni- and multivariable analysis were used to determine risk factors associated with PVR ≥150 and ≥300 millilitres.
Detailed description
- Sample and setting An observational cross-sectional cohort study was conducted on the acute geriatric hospitalisation units of the University Hospitals Leuven in Belgium which have a collective capacity of 80 beds. All patients aged 75 years or older admitted with or without an indwelling urinary catheter between October 26 and December 18, 2015 were consecutively screened for inclusion within 72 hours of admission. Patients with urinary catheters for any other reason than UR, patients with ascites, dialysis, uro- or nephrostomy, terminally ill patients, and postoperative patients were not eligible for inclusion. Patients who refused to participate, who were unable to understand and carry out the instructions for the PVR measurement, with a urinary catheter for chronic UR, who were discharged or died during the inclusion process were excluded. The study was approved by the Ethics Committee Research of the University Hospitals Leuven (mp08305). The study nurse (SV) obtained a written informed consent from all patients who agreed to participate in the study, or from a proxy when the patient was incapable to provide written informed consent.
- Procedures Prior to the start of the study, information sessions were organised for the nurses from the acute geriatric hospitalisation units, in which the study nurse (SV) explained the aim of the study and the data collection procedure. In addition, information was given on the use of the portable ultrasound bladder scan and the execution of a bladder scan. The nurses were asked to perform 3 consecutive post-void bladder scans as soon as possible after admission and at the latest within 72 hours of admission as standard of care during the study period. The highest value of the 3 consecutive PVR measurements was recorded. The study nurse (SV) was present on Monday, Wednesday and Friday morning, performed informed consents and performed bladder scanning in patients where this had not yet been done. Before performing the bladder scan, the patients were asked to urinate. Whenever possible, patients had to walk to the toilet in the bathroom, with or without assistance, meanwhile their mobility was assessed. Consecutively, the study nurse performed a bedside assessment. A mini-cog examination was performed and urinary symptoms, defaecation habits, and fall history were assessed by patient or caregiver interview using a structured questionnaire (SV). The demographic and remaining clinical data were collected from the patient's electronic medical records (SV, KH, KF).
- Variables Outcome variables The PVR was measured using a portable ultrasound bladder scan (Verathon BladdersScan BVI 3000). Jalbani et al. found a high correlation (r²=0.97) between urinary catheterisation (gold standard) and bladder scanning and concluded that the use of the Verathon BladderScan BVI 3000 is as accurate as urinary catheterisations for measuring the PVR. As there are no official definitions or guidelines on what is considered a relevant PVR for UR, in this study we defined UR as a PVR of ≥150 millilitres. In addition, we also included a PVR ≥300 ml as secondary outcome. The cut-offs were chosen for the following reasons: the first bladder-filling sensation is felt at a volume of 150 ml. At a volume of 300 ml, the pressure receptors in the bladder wall will be activated, which creates a sense of fullness of the bladder and a need to urinate. Moreover, in clinical practice a PVR ≥300ml is often considered as threshold for insertion of a urinary catheter. Demographics The following patient characteristics were recorded: age, gender and living situation. Patients living alone at home and together at home were considered as living at home and patients living in an assisted living facility or nursing home were considered as not living at home. Patients living in a convent were considered as not living at home when they were functionally or cognitively impaired. Comorbidities Various comorbidities were retrospectively retrieved from the patient's electronic medical records: neurological, gynaecological and urological history, a history of diabetes type 1 or 2, recurrent falls (more than 1 fall episode in the last 6 months), and chronic kidney disease (CKD). CKD was defined as a glomerular filtration rate (eGFR, calculated using the CKD-EPI formula) of <60 ml/min/1.73 m². An age adjusted definition (<45 ml/min/1.73 m²) was also considered. Clinical evaluation Urinary incontinence was assessed by means of 3 questions: Do you have/does the patient have (1) an urge to urinate and involuntary loss of urine before reaching the toilet? (2) involuntary loss of urine when sneezing, coughing, lifting or moving something? (3) loss of small amounts or drops of urine without urge to urinate or loss of small drops of urine when changing position. Answering positive on these questions was classified as urge, stress or overflow incontinence, respectively. Dysuria was questioned as having a burning sensation or pain when urinating. Urinary frequency was questioned as urinating more often than usual. Voiding difficulty was questioned as straining to void. Subtotal voiding was questioned as the feeling of incomplete bladder emptying. Hypogastric pain was questioned as pain in the lower abdomen. Constipation was defined as the absence of stools for 3 or more days before the PVR measurement, or if patients reported having had less than 3 stools in the last week with a need to strain and mostly hard or lumpy stools, or if the patient had faecal impaction. Faecal impaction was defined as a large mass of compacted faeces in the rectum or colon on clinical or radiographical examination, that could not be spontaneously evacuated. The cognitive status of the patients was evaluated using the Mini-Cog. The Mini-Cog is a brief cognitive test that involves an assessment of an older person's ability to memorise three words, to draw a clock, and to recall the three words. Repeating only 1 or 2 of the 3 words and being unable to draw a clock correctly or not being able to repeat any of the words was considered as cognitive impairment. Mobility was assessed by walking to the bathroom and going to the toilet. All patients were asked to urinate on the toilet prior to the PVR measurements. Patients were considered mobile if they could walk back and forth to the toilet and if they were able to stand up from the toilet independently. The use of mechanical aids was permitted. Needing assistance from another person or not being able to walk was defined as impaired mobility. Laboratory evaluation and urinalysis The patient's renal function was evaluated by serum creatinine level and eGFR (calculated using the CKD-EPI formula). A urinary dipstick test was performed in all patients. In patients with positive leucocyte esterase or positive nitrites on the dipstick test, further urinalysis was performed. An automated leucocyte count of ≥10 leukocytes/mm³ and significant microscopic bacteriuria of >100.000 CFU/ml for which antibiotics were started by the treating physician was considered as UTI in this study. If the patient was taking antibiotics at the time of the urine sample and cultures remained negative, the presence of UTI was determined based on the leucocyte count. Medication For each patient the anticholinergic burden scale (ACB) score was calculated taking into account medication use in the last 24 hours before the PVR measurement. Individual drugs with high anticholinergic properties (ACB score ≥2), such as antipsychotics, antidepressants, as well as detrusor relaxants, were examined separately for their associations with UR. Antiepileptics, histamine H1 receptor antagonists, anti-diarrhoea medications, decongestive drugs, spasmolytics, muscle relaxants, and antiparkinsonian agents with ACB scores ≥2 were not considered individually. Low prevalence of these drugs prohibited statistical analysis. Reason for referral to the hospital The reasons for referral to the hospital were divided into the following categories: confusion, falls or immobility, urinary symptoms, cardiopulmonary symptoms, digestive symptoms, fever or non-specific symptoms with biochemical inflammation (elevated leucocytosis and elevated C-reactive protein) on admission, other. In patients with multiple reasons for admission, each reason was scored separately.
- Statistical analysis Descriptive and comparative statistics were used. Normally distributed continuous variables were reported as means with standard deviations (SD). Not normally distributed continuous variables were reported as medians with interquartile ranges (IQR). Categorical variables were reported as numbers and percentages. Baseline characteristics and clinical variables of patients with a PVR of <150 ml versus ≥150 ml and a PVR of <300 ml versus ≥300 ml were compared using unpaired t-tests for normally distributed continuous variables. Pearson Chi-squared tests or Fisher's exact tests (if ≥1 cell had an expected count of less than 5) were used for dichotomous or nominal variables, and Mann-Whitney U tests for not normally distributed continuous variables or ordinal variables. All tests were 2-tailed, assuming a 5% significance level. Multivariable logistic regression models were used to determine independent predictors for a PVR ≥150 ml and a PVR ≥300 ml. Significant variables in the univariable analysis were considered in a forward stepwise logistic regression procedure. P-values (Likelihood ratios), odds ratios (OR), and 95% confidence intervals (CI) are reported. The software package used was SPSS version 20 (SPSS Inc., Chicago, IL).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted ≤72 hours to an acute geriatric hospitalisation unit. | – | Diagnostic Test: portable ultrasound bladder scanAll patients aged ≥75 years, admitted to the acute geriatric hospitalisation units of the University Hospitals Leuven in Belgium, were consecutively screened for inclusion within 72 hours of admission in a 2 month period (between October 26 and December 18, 2015). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 75 years or older on admission to an acute geriatric hospitalisation unit.
Key inclusion criteria (3 listed)
- patients aged 75 years or older
- with or without a urinary catheter
- admitted no more than 72 hours to an acute geriatric hospitalisation unit of the Leuven University Hospitals
Key exclusion criteria (8 listed)
- indwelling urinary catheter for another reason than acute urinary retention
- ascites
- dialysis
- uro- or nephrostomy
- terminally ill
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 |
|---|---|---|
| portable ultrasound bladder scanA post-void residual volume was measured using a Verathon BladdersScan BVI 3000. | Diagnostic test | Patients admitted ≤72 hours to an acute geriatric hospitalisation unit. |
Primary outcome
post-void residual volume
Time frame: measurement within 72 hours of admission to the acute geriatric hospitalisation unit
residual volume after urinating measured with a portable ultrasound bladder scan (Verathon BladdersScan BVI 3000)
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 25 Jan 2021.
- Individual participant dataSharing planned: Undecided. Data are stored on a central secured server for data storage of the University Hospitals Leuven and are available upon contacting the corresponding author after publication, unless the journal asks for publication of the data on a datasharing site.
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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.
Johan Flamaing, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Urinary Retention and Aged, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 8 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 25 Jan 2021. 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 Belgium. 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?
post-void residual volume (time frame: measurement within 72 hours of admission to the acute geriatric hospitalisation unit). 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 25 Jan 2021.