Intermittent Urethral CatheterizationNCT04033913
What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter
An observational study of Intermittent Urethral Catheterization, run by Gérard Amarenco at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Urethral Catheterization
- What is being tested?
- Self questionnaire
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department
Who may be able to join
- Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department
Who cannot join
- patient who does not speak French
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Management of voiding dysfunction has been revolutionized by the practice of clean intermittent self-catheterization (CISC) described by Lapides. It is nowadays the gold standard for the treatment of urinary retention in neurogenic bladders. But increasingly, CISC is prescribed to patients with non-neurogenic lower urinary tract symptoms (LUTS). Several studies have demonstrated an improvement in quality of life in patients under CISC. There are several indications for CISC in older adults, either in neurological condition (myelopathy following neck osteoarthritis, lumbar spinal stenosis, multiple sclerosis (MS), etc…) or not (bladder outlet obstruction, underactive detrusor, etc…).
The arrival of hydrophilic catheters has revolutionized management, reducing the risk of traumatic and infectious complications and facilitating their use. Many catheters are now available, and the choice of catheter may depend on different factors: grip disorder, ease of use, design and packaging, discomfort or pain when testing a specific material, specific anatomical conditions (male Tiemann or olive tip), longer catheter length in case of imperfect emptying, explanations given on how to use the catheter... Thus, if the doctor and the nurse involved in the patient's therapeutic education in self-catheterization will guide the choice of the catheter according to medical criteria and the patient's physical capacities, the patient remains an active participant in the choice of the model. Making the patient an actor and decision-maker can also improve adherence to treatment.
The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient.
In this study, the investigators develop a questionnaire based on expert meetings and literature review of the criteria that guide the choice of the catheter.
Five areas are explored: catheter design, catheter length, comfort of using the catheter, nurse's explanations, easy to transport and dispose of the catheter.
The importance of each criterion is rated by a 4-level likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) and patient have to report the most important criterion for the choice of the catheter.
Number of types of catheter showed and tried are reported, and if they chose the first, second, are two types of catheter. The questionnaire is completed at the end of a day hospital to learn to perform CISC
Data collected are:
- Age
- Sex
- Etiology of urinary disorders
- Score of the Pencil and Paper Test
- Functional Independence Measure score
- Nine Hold Peg Test over 18
- "Tinetti Mobility Test" score
- sensory hand problems assessed by Weber test
Statistical analyses will be performed with the R software for Windows (Rx64 3.2.3, R Foundation for Statistical Computing, Vienna, Austria). Descriptive data will be presented as means with standard deviation for continuous data and as medians with range for ordinal data and data not normally distributed.
Differences between the choosing criterion and the patients' characteristics will be assessed using analysis of variance or Chi2 tests. A p value of less than 0.05 will be considered statistically significant.
This study was approved by the local ethics review board.
- Conditions
- Intermittent Urethral Catheterization
- Being tested
- Self questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self questionnaireOther
Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Self questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
the importance of each criterion (catheter design; catheter length; comfort to handle the catheter; nurse's explanations; discretion for transport and disposal of the catheter) is rated by a 4-level likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start12 Nov 2018
- Primary completion10 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent Urethral CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérard Amarenco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PhD, Principal investigator, Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033913
- Sponsor's protocol ID
- GRC-01 GREEN
- Status last verified
- Nov 2019
- First submitted
- 20 Jul 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Criteria for the Patient's Choice of Sel-catheterization Catheter
- ClinicalTrials.gov ID
- NCT04033913
- Acronym / sponsor ID
- GRC-01 GREEN
- Conditions
- Intermittent Urethral Catheterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Management of voiding dysfunction has been revolutionized by the practice of clean intermittent self-catheterization (CISC) described by Lapides. It is nowadays the gold standard for the treatment of urinary retention in neurogenic bladders. But increasingly, CISC is prescribed to patients with non-neurogenic lower urinary tract symptoms (LUTS). Several studies have demonstrated an improvement in quality of life in patients under CISC. There are several indications for CISC in older adults, either in neurological condition (myelopathy following neck osteoarthritis, lumbar spinal stenosis, multiple sclerosis (MS), etc…) or not (bladder outlet obstruction, underactive detrusor, etc…).
The arrival of hydrophilic catheters has revolutionized management, reducing the risk of traumatic and infectious complications and facilitating their use. Many catheters are now available, and the choice of catheter may depend on different factors: grip disorder, ease of use, design and packaging, discomfort or pain when testing a specific material, specific anatomical conditions (male Tiemann or olive tip), longer catheter length in case of imperfect emptying, explanations given on how to use the catheter... Thus, if the doctor and the nurse involved in the patient's therapeutic education in self-catheterization will guide the choice of the catheter according to medical criteria and the patient's physical capacities, the patient remains an active participant in the choice of the model. Making the patient an actor and decision-maker can also improve adherence to treatment.
The aim of this study is to evaluate which are the most important criteria guiding the choice of the catheter for the patient.
In this study, the investigators develop a questionnaire based on expert meetings and literature review of the criteria that guide the choice of the catheter.
Five areas are explored: catheter design, catheter length, comfort of using the catheter, nurse's explanations, easy to transport and dispose of the catheter.
The importance of each criterion is rated by a 4-level likert scale (strongly disagree, somewhat disagree, somewhat agree, strongly agree) and patient have to report the most important criterion for the choice of the catheter.
Number of types of catheter showed and tried are reported, and if they chose the first, second, are two types of catheter. The questionnaire is completed at the end of a day hospital to learn to perform CISC
Data collected are:
- Age
- Sex
- Etiology of urinary disorders
- Score of the Pencil and Paper Test
- Functional Independence Measure score
- Nine Hold Peg Test over 18
- "Tinetti Mobility Test" score
- sensory hand problems assessed by Weber test
Statistical analyses will be performed with the R software for Windows (Rx64 3.2.3, R Foundation for Statistical Computing, Vienna, Austria). Descriptive data will be presented as means with standard deviation for continuous data and as medians with range for ordinal data and data not normally distributed.
Differences between the choosing criterion and the patients' characteristics will be assessed using analysis of variance or Chi2 tests. A p value of less than 0.05 will be considered statistically significant.
This study was approved by the local ethics review board.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patient learning self-catheterization | – | Other: Self questionnairePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department
Key inclusion criteria (1 listed)
- Adults patients who have successfully perform self-catheterization during a day hospital in a neuro-urology department
Key exclusion criteria (2 listed)
- patient who does not speak French
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self questionnairePatients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made. | Other | Adult patient learning self-catheterization |
Primary outcome
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)
Time frame: 1 day
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 secondary outcome
Importance for the choice of catheter of each of the 5 criteria of the questionnaire created, using a 4-level likert scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gérard Amarenco, PhD principal investigator
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Urethral Catheterization, run by Gérard Amarenco at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.