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Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening (RUC EHPAD)

Primary Purpose

Urinary Retention

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bladder scan
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Retention focused on measuring urinary retention, chronic disease, aged, homes for the aged

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EHPAD du Centre Local Hospitalier de Saint-Joseph
  • EHPAD du Centre Hospitalier de Fougères
  • EHPAD Hôtel-Dieu
  • EHPAD de Saint-Brice-en-Coglès
  • EHPAD de Saint-Georges-de-Reintembault

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Bladder scan

Arm Description

Bladder scan performed on resident in homes for aged

Outcomes

Primary Outcome Measures

Chronic urinary retention
Chronic urinary retention definition : post-void residual urine > 250 mL twice without any clinical argument for acute urinary retention.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2019
Last Updated
April 11, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03828968
Brief Title
Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening
Acronym
RUC EHPAD
Official Title
Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
urinary retention, chronic disease, aged, homes for the aged

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder scan
Arm Type
Other
Arm Description
Bladder scan performed on resident in homes for aged
Intervention Type
Diagnostic Test
Intervention Name(s)
bladder scan
Intervention Description
Measurement of vesical volume by bladder scan
Primary Outcome Measure Information:
Title
Chronic urinary retention
Description
Chronic urinary retention definition : post-void residual urine > 250 mL twice without any clinical argument for acute urinary retention.
Time Frame
4 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaud HONORE, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
EHPAD du Centre Local Hospitalier de Saint-Joseph
City
Combourg
ZIP/Postal Code
35270
Country
France
Facility Name
EHPAD du Centre Hospitalier de Fougères
City
Fougères
ZIP/Postal Code
35300
Country
France
Facility Name
EHPAD Hôtel-Dieu
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
EHPAD de Saint-Brice-en-Coglès
City
Saint-Brice-en-Coglès
ZIP/Postal Code
35460
Country
France
Facility Name
EHPAD de Saint-Georges-de-Reintembault
City
Saint-Georges-de-Reintembault
ZIP/Postal Code
35420
Country
France

12. IPD Sharing Statement

Learn more about this trial

Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening

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