Intermittent Urethral CatheterizationNCT04095871
Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
An observational study of Intermittent Urethral Catheterization and Lower Urinary Tract Symptoms, run by Gérard Amarenco at 1 site in France.
Trial summary
Clean Intermittent Self-Catheterization (CISC) is a procedure of regularly emptying the bladder by introducing a single-use urinary catheter through the urethra. CISC are indicated in several situations in patients with neurological pathologies but also with urological or functional disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Urethral Catheterization, Lower Urinary Tract Symptoms, Treatment Adherence
- What is being tested?
- Observational study
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 30 Oct 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: patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.
Who may be able to join
- patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.
Who cannot join
- patients with an inability to comply with protocol instructions (severe cognitive disorders, language barrier, assistance with AS)
Trial locations and contacts
1 site in 1 country.
About this study
Clean Intermittent Self-Catheterization (CISC) is a procedure of regularly emptying the bladder by introducing a single-use urinary catheter through the urethra. CISC are indicated in several situations in patients with neurological pathologies but also with urological or functional disorders.
The announcement of the indication of CISC is often difficult and the acceptance of this therapy remains complicated, due to the invasive side, the dependence on a material and the time required to perform CISC.
Read more
A few studies have assessed patient satisfaction and adherence to self-catheterization through quality of life questionnaires, but none have examined the impact of this technique on daily life through the duration of CISC.
Primary aim is to evaluate the impact of time to perform CISC on patient adherence and satisfaction.
Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.
History and treatment, age, professional activity, visuals disorders, technical aids for walking and the history of CISC with the date of initiation, the type of catheter, the carrier, the number of CISC per 24 hours, the position of realization, the use of a mirror and urethral sensitivity are recorded. Cognitive disorders, fatigue, psychological state, impact on quality of life are assessed on the day of the patient's consultation. The grip of the upper limbs is explored by Box and Block and Nine Hole Peg Test. The validated questionnaires,Intermittent Catheterization Satisfaction Questionnaire ( InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) are completed.
At home, patients have to complete one calendar on the specific duration of a 24-hour self-catheterization and the next day a second calendar on the total duration of CISC
Primary outcome is specific time of self-catheterization described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
Secondary outcome is total time of self-catheterization described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity.
Influence of age, Expanded Disability Status Scale (EDSS), American Spinal Injury Association (ASIA), Montreal Cognitive Assessment (Moca), Fatigue Impact Scale (FIS), Box and Block and Nine Hole Peg Test, Hospital Anxiety and Depression Scale (HADS), Qualiveen Total,Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) on time of self-catheterization are analysis.
- Conditions
- Intermittent Urethral Catheterization, Lower Urinary Tract Symptoms, Treatment Adherence, Patient Satisfaction
- Being tested
- Observational study
- Keywords
- Intermittent urethral catheterization, Treatment adherence and compliance, Lower urinary tract symptoms, Urinary retention, Patient satisfaction
- Medical subject headings
- Lower Urinary Tract Symptoms, Treatment Adherence and Compliance, Patient Satisfaction, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Also called no intervention
No intervention, patients record the time of CISC
| Study group | Role | What they receive |
|---|---|---|
| Patients included | Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.
At home, patients have to complete one diary on the specific duration of a 24-hour CISC and the next day a second diary on the total duration of CISC.
The specific time of CISC described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
The total time of CISC described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific time of CISC
described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
Measured: 1 Day
Secondary outcomes (1)
total time of CISC
described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity
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 posted19 Sep 2019
- Study start1 Jul 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095871
- Sponsor's protocol ID
- GRC -- 01GREEN
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leroux C, Turmel N, Chesnel C, Grasland M, Le Breton F, Amarenco G, Hentzen C. Determinants and impact of the time to perform clean intermittent self-catheterization on patient adherence and quality of life: A prospective observational study. Neurourol Urodyn. 2021 Apr;40(4):1027-1034. doi: 10.1002/nau.24662. Epub 2021 Mar 26.
PubMed 33769589
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
- ClinicalTrials.gov ID
- NCT04095871
- Acronym / sponsor ID
- GRC -- 01GREEN
- Conditions
- Intermittent Urethral Catheterization, Lower Urinary Tract Symptoms, Treatment Adherence, Patient Satisfaction
- Keywords
- Intermittent urethral catheterization, Treatment adherence and compliance, Lower urinary tract symptoms, Urinary retention, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 19 Sep 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.
Clean Intermittent Self-Catheterization (CISC) is a procedure of regularly emptying the bladder by introducing a single-use urinary catheter through the urethra. CISC are indicated in several situations in patients with neurological pathologies but also with urological or functional disorders.
The announcement of the indication of CISC is often difficult and the acceptance of this therapy remains complicated, due to the invasive side, the dependence on a material and the time required to perform CISC.
A few studies have assessed patient satisfaction and adherence to self-catheterization through quality of life questionnaires, but none have examined the impact of this technique on daily life through the duration of CISC.
Primary aim is to evaluate the impact of time to perform CISC on patient adherence and satisfaction.
Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.
History and treatment, age, professional activity, visuals disorders, technical aids for walking and the history of CISC with the date of initiation, the type of catheter, the carrier, the number of CISC per 24 hours, the position of realization, the use of a mirror and urethral sensitivity are recorded. Cognitive disorders, fatigue, psychological state, impact on quality of life are assessed on the day of the patient's consultation. The grip of the upper limbs is explored by Box and Block and Nine Hole Peg Test. The validated questionnaires,Intermittent Catheterization Satisfaction Questionnaire ( InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) are completed.
At home, patients have to complete one calendar on the specific duration of a 24-hour self-catheterization and the next day a second calendar on the total duration of CISC
Primary outcome is specific time of self-catheterization described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
Secondary outcome is total time of self-catheterization described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity.
Influence of age, Expanded Disability Status Scale (EDSS), American Spinal Injury Association (ASIA), Montreal Cognitive Assessment (Moca), Fatigue Impact Scale (FIS), Box and Block and Nine Hole Peg Test, Hospital Anxiety and Depression Scale (HADS), Qualiveen Total,Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) on time of self-catheterization are analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included | – | Other: Observational studyPatients over 18 years old performed CISC for more than 1 month, exclusive or not, are included. At home, patients have to complete one diary on the specific duration of a 24-hour CISC and the next day a second diary on the total duration of CISC. The specific time of CISC described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment. The total time of CISC described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.
Key inclusion criteria (1 listed)
- patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.
Key exclusion criteria (1 listed)
- patients with an inability to comply with protocol instructions (severe cognitive disorders, language barrier, assistance with AS)
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 |
|---|---|---|
| Observational studyAlso: no interventionNo intervention, patients record the time of CISC | Other | Patients included |
Primary outcome
specific time of CISC
Time frame: 1 Day
described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.
1 secondary outcome
total time of CISC
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 18 Feb 2022.
- Derived from this study: PubMed 33769589Leroux C, Turmel N, Chesnel C, Grasland M, Le Breton F, Amarenco G, Hentzen C. Determinants and impact of the time to perform clean intermittent self-catheterization on patient adherence and quality of life: A prospective observational study. Neurourol Urodyn. 2021 Apr;40(4):1027-1034. doi: 10.1002/nau.24662. Epub 2021 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Lower Urinary Tract Symptoms, 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 1 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 18 Feb 2022. 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?
specific time of CISC (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095871, which also lists 1 linked publication.
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 18 Feb 2022.