- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828968
Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening (RUC EHPAD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main goal of this study is to assess the prevalence of CUR in elderly living in homes for the aged, the secondary ones are to evaluate the risk factors and complications of CUR.
We will carry out this prevalence study in 5 centres whit a draw of 40 residents per centre. Following an information and a non-opposition of the patients, we will collect datas in their medical file (age, medical history and comorbidities, current treatments, anticholinergic score according to the ADS (Anticholinergic Drug Scale), GIR score according to the AGGIR scale (Autonomie Gérontologique Groupes Iso Ressources), FAC modified score (Functional Ambulation Classification modified), MMSE score (Mini Mental State Examination), communicative capacity, notion of fall and date of last fall, knowledge of urinary incontinence, knowledge of constipation, knowledge of previous urinary screening by bladder scan and previous urological consulting, last urinalysis and its results, last analysis of creatinemia and creatinine clearance according to CKD-EPI) and we will perform up to 3 measurements of vesical volume by bladder scan.
The expected results are a prevalence of CUR between 10 and 20 % among people living in homes for the aged with more urinary tract infections, renal insufficiency and falls in the CUR group showing the interest of screening for CUR by bladder scan in elderly people living in nursing homes according to risk groups based on the risk factors found.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: kristell COAT
- Phone Number: 33 2 99 28 25 55
- Email: kristell.coat@chu-rennes.fr
Study Contact Backup
- Name: Direction de la Recherche
- Phone Number: 33 2 99 28 25 55
- Email: drc@chu-rennes.fr
Study Locations
-
-
-
Combourg, France, 35270
- EHPAD du Centre Local Hospitalier de Saint-Joseph
-
Contact:
- Karine BREGAIN, MD
- Phone Number: 2 99 73 05 34
-
Principal Investigator:
- Karine BREGAIN, MD
-
Fougères, France, 35300
- EHPAD du Centre Hospitalier de Fougères
-
Contact:
- Didier MARCHAND, MD
- Phone Number: 33 2 99 17 70 90
-
Principal Investigator:
- Didier MARCHAND, MD
-
Rennes, France, 35000
- EHPAD Hôtel-Dieu
-
Contact:
- Frederique BRILLANT, MD
- Phone Number: 33 2 99 27 30 01
- Email: frederique.brillant@chu-rennes.fr
-
Principal Investigator:
- Frederique BRILLANT, MD
-
Saint-Brice-en-Coglès, France, 35460
- EHPAD de Saint-Brice-en-Coglès
-
Contact:
- Mohammed BRAHIMI, MD
- Phone Number: 33 2 99 98 68 00
-
Principal Investigator:
- Mohammed BRAHIMI, MD
-
Saint-Georges-de-Reintembault, France, 35420
- EHPAD de Saint-Georges-de-Reintembault
-
Principal Investigator:
- Mohammed BRAHIMI, MD
-
Contact:
- Mohammed BRAHIMI
- Phone Number: 33 2 99 97 03 10
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult people
- Residents in a participating nursing home
Exclusion Criteria:
- Resident with indwelling urinary catheter or regular urinary catheterisation
- Resident or legal representative opposing participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Bladder scan
Bladder scan performed on resident in homes for aged
|
Measurement of vesical volume by bladder scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic urinary retention
Time Frame: 4 weeks after inclusion
|
Chronic urinary retention definition : post-void residual urine > 250 mL twice without any clinical argument for acute urinary retention.
|
4 weeks after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thibaud HONORE, MD, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC18_3063_RUC EHPAD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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