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

Sponsor
Rennes University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03828968
Collaborator
(none)
200
5
1
3.9
40
10.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: bladder scan
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening
Anticipated Study Start Date :
Feb 3, 2019
Anticipated Primary Completion Date :
May 3, 2019
Anticipated Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Bladder scan

Bladder scan performed on resident in homes for aged

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

Outcome Measures

Primary Outcome Measures

  1. Chronic urinary retention [4 weeks after inclusion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 EHPAD du Centre Local Hospitalier de Saint-Joseph Combourg France 35270
2 EHPAD du Centre Hospitalier de Fougères Fougères France 35300
3 EHPAD Hôtel-Dieu Rennes France 35000
4 EHPAD de Saint-Brice-en-Coglès Saint-Brice-en-Coglès France 35460
5 EHPAD de Saint-Georges-de-Reintembault Saint-Georges-de-Reintembault France 35420

Sponsors and Collaborators

  • Rennes University Hospital

Investigators

  • Principal Investigator: Thibaud HONORE, MD, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT03828968
Other Study ID Numbers:
  • 35RC18_3063_RUC EHPAD
First Posted:
Feb 4, 2019
Last Update Posted:
Feb 4, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rennes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2019