NCT03828968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2019

Last Update Submit

April 11, 2023

Conditions

Urinary Retention

Keywords

urinary retentionchronic diseaseagedhomes for the aged

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Bladder scan

OTHER

Bladder scan performed on resident in homes for aged

Diagnostic Test: bladder scan

Interventions

bladder scanDIAGNOSTIC_TEST

Measurement of vesical volume by bladder scan

Bladder scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult people
  • Residents in a participating nursing home

You may not qualify if:

  • Resident with indwelling urinary catheter or regular urinary catheterisation
  • Resident or legal representative opposing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

EHPAD du Centre Local Hospitalier de Saint-Joseph

Combourg, 35270, France

Location

EHPAD du Centre Hospitalier de Fougères

Fougères, 35300, France

Location

EHPAD Hôtel-Dieu

Rennes, 35000, France

Location

EHPAD de Saint-Brice-en-Coglès

Saint-Brice-en-Coglès, 35460, France

Location

EHPAD de Saint-Georges-de-Reintembault

Saint-Georges-de-Reintembault, 35420, France

Location

MeSH Terms

Conditions

Urinary RetentionChronic Disease

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thibaud HONORE, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 4, 2019

Study Start

February 2, 2019

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(5)