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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03828968
Other study ID # 35RC18_3063_RUC EHPAD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2019
Est. completion date May 17, 2019

Study information

Verified date April 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (CUR) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date May 17, 2019
Est. primary completion date May 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
bladder scan
Measurement of vesical volume by bladder scan

Locations

Country Name City State
France EHPAD du Centre Local Hospitalier de Saint-Joseph Combourg
France EHPAD du Centre Hospitalier de Fougères Fougères
France EHPAD Hôtel-Dieu Rennes
France EHPAD de Saint-Brice-en-Coglès Saint-Brice-en-Coglès
France EHPAD de Saint-Georges-de-Reintembault Saint-Georges-de-Reintembault

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic urinary retention Chronic urinary retention definition : post-void residual urine > 250 mL twice without any clinical argument for acute urinary retention. 4 weeks after inclusion
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