NCT04033913

Brief Summary

The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient to perform clean intermittent self catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 12, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

July 20, 2019

Last Update Submit

November 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • The criterion of the created questionnaire for the choice of the catheter designated by the patient as the most important (rate of patients who identified each criterion as the most important)

    patients must identify the most important criterion among the 5 proposed in the questionnaire created: catheter design; catheter length; comfort to handle the catheter; nurse's explanations; discretion for transport and disposal of the catheter. Only one answer is accepted.

    1 day

Secondary Outcomes (1)

  • Importance for the choice of catheter of each of the 5 criteria of the questionnaire created, using a 4-level likert scale

    1 day

Study Arms (1)

Adult patient learning self-catheterization

Patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department complete a questionnaire validated by experts on the different criteria that guided the final choice of the catheter

Other: Self questionnaire

Interventions

Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.

Adult patient learning self-catheterization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department

You may qualify if:

  • Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department

You may not qualify if:

  • patient who does not speak French
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of Neuro-Urology, Hôpital Teno

Paris, 75020, France

Location

Study Officials

  • Gérard Amarenco, PhD

    Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Neuro-Urology department, Tenon Hospital

Study Record Dates

First Submitted

July 20, 2019

First Posted

July 26, 2019

Study Start

November 12, 2018

Primary Completion

August 10, 2019

Study Completion

September 30, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Locations