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Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life

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ClinicalTrials.gov Identifier: NCT04095871
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Gérard Amarenco, Pierre and Marie Curie University

Brief 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.

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.


Condition or disease Intervention/treatment
Intermittent Urethral Catheterization Lower Urinary Tract Symptoms Treatment Adherence Patient Satisfaction Other: Observational study

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Group/Cohort Intervention/treatment
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.

Other: Observational study
No intervention, patients record the time of CISC
Other Name: no intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. total time of CISC [ Time Frame: 1 Day ]
    described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.
Criteria

Inclusion Criteria:

  • patients >18 years of age perform sel-catheterization since more than 1 month (they could keep spontaneous voiding associated with CISC.

Exclusion Criteria:

  • patients with an inability to comply with protocol instructions (severe cognitive disorders, language barrier, assistance with AS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095871


Contacts
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Contact: Camille LEROUX, Resident +33156017040 greengrc01@gmail.com
Contact: Gérard AMARENCO, PhD +33156017040 greengrc01@gmail.com

Locations
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France
Department of Neuro-Urology, Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Camille LEROUX, Resident    +33156017040    greengrc01@gmail.com   
Contact: Gérard AMARENCO, PhD    +33156017040    greengrc01@gmail.com   
Sponsors and Collaborators
Gérard Amarenco

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Responsible Party: Gérard Amarenco, Head of Neuro-Urology department, Tenon Hospital, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT04095871    
Other Study ID Numbers: GRC -- 01GREEN
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérard Amarenco, Pierre and Marie Curie University:
Intermittent urethral catheterization
Treatment adherence and compliance
Lower urinary tract symptoms
Urinary retention
Patient satisfaction
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms