Abstract
Aims
In neurourology, the choice of catheter is of paramount importance. At the time of our study, no simple validated questionnaire has been published, evaluating patient satisfaction with the use of urinary catheters. Our objective was to construct and validate a specific tool referred to as the Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), for the purposes of evaluating patient satisfaction with intermittent self-catheterization.
Methods
A simple tool was developed and validated in a neurourology referral centre, with 113 patients affected by a neurological bladder condition, between November 2011 and February 2012. Eight items, separated into four categories (“packaging”, “lubrication”, “catheter itself”, “after catheterization”) were selected. The mean score obtained with the eight-question questionnaire was calculated for each patient. Face validity was evaluated. Reliability based on internal consistency and test-retest reliability using the intraclass correlation coefficient (ICC) was carried out.
Results
The patients’ comprehension and acceptance of the questionnaire were good. The questionnaire appears to have been well designed, with a significant Cronbach’s alpha coefficient, and the ICC demonstrated good test-retest reliability.
Conclusions
The InCaSaQ was found to be a valid tool for the evaluation of patient satisfaction with a urinary catheter. It is thus possible to compare the comfort and effectiveness of different types of catheter, and to objectify the need to change the type of catheter, in cases where patients express their dissatisfaction.
Résumé
Objectif
En neuro-urologie, le choix de la sonde urinaire pour l’autosondage est primordial. Au moment de notre étude, dans la littérature, aucun questionnaire spécifique n’évalue la satisfaction des patients envers leur sonde urinaire. Notre objectif était de construire et valider un outil spécifique d’évaluation de la satisfaction des patients envers leur sonde urinaire : Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ).
Matériel et méthodes
Cent treize patients neurologiques ont été inclus, tous suivis dans un service spécialisé de neuro-urologie, entre novembre 2011 et février 2012. InCaSaQ comportait 8 items regroupés en 4 catégories (« emballage », « lubrification », « sonde elle-même » et « après le sondage »). Le score total moyen obtenu était calculé pour chaque patient. La compréhension, la pertinence et l’acceptabilité (en termes de temps et psychologique) de la formulation des items ont été vérifiées. La validation psychométrique (cohérence interne [Cronbach], reproductibilité [ICC]) a été évaluée.
Résultats
La compréhension et l’acceptation étaient bonnes. La cohérence interne et la reproductibilité sont bonnes.
Conclusion
InCaSaQ est un questionnaire valide permettant d’évaluer la satisfaction des patients envers leur sonde d’autosondage. Il est maintenant possible de comparer, pour chaque patient, le confort et l’efficacité de la sonde urinaire utilisée, et d’objectiver les causes d’insatisfaction, permettant un changement pour une sonde mieux adaptée.
1
English version
1.1
Abbreviations
CISC
clean intermittent self-catheterization
InCaSaQ
Intermittent Catheterization Satisfaction Questionnaire
ICC
intraclass correlation coefficient
1.2
Introduction
Since the publication of Lapides et al. , clean intermittent self-catheterization (CISC) has been considered as the method of choice for the management of voiding dysfunction, typically the result of neurogenic pathology . CISC has contributed to a decrease in the morbidity and mortality of these patients and to an improvement in their quality of life .
As soon as the CISC technique has been learned and acquired, the question of the choice of the catheter is of primary importance, since it affects the patient’s comfort and satisfaction. These are part of the goals of care, influencing the patient’s compliance and long-term adherence to the technique .
In clinical practice, patients sometimes complain of difficulties in catheter handling (with hydrophilic catheters) or pain during catheterization, because of a sticking sensation in the urethra .
Until now, many different catheters have been used for CISC, with different properties in terms of handling and/or packaging and lubrication requirements of the catheter.
Although some authors have compared the tolerance and efficacy of various catheters, as well as patient satisfaction with pre-lubricated versus non-lubricated models , there is no simple, validated questionnaire evaluating patients’ satisfaction with the use of urinary catheters. However, various aspects of the catheterization process have been described: handling of the catheter package, ease of insertion and withdrawal of the catheter, evaluation of catheter lubrication, pain during catheterization .
A pilot study was carried out to design and validate a specific questionnaire, referred to as InCaSaQ, with the aim of evaluating patient satisfaction with intermittent catheterization.
1.3
Materials and methods
1.3.1
Study population
The study inclusion criteria were: 18 years or older, patients using CISC for urinary retention resulting from a neurological disease. The exclusion criteria were: a confused mental state and the inability to read and understand the questionnaire.
1.3.2
Questionnaire
The items in the questionnaire were derived from a full and comprehensive review of the literature (PubMed, 1995–2012; keywords: Intermittent catheterisation; Hydrophilic-coated catheter; Questionnaire; Satisfaction; Acceptance; Compliance; Lower urinary tract dysfunction; Patients’ perception; Quality of life; Clinical evaluation; Difficulties), and from feedback given by a team of healthcare providers who perform more than 400 CISC learning/teaching lessons per year, in an experienced neurourology centre. A specific survey was carried out with this team, involving 6 specialists in neurourology and 11 nurses, in order to check all possible items reported by the patients.
The eight most frequently reported items were selected and sorted into four categories:
- •
packaging:
- ∘
discretion and bulk of the package,
- ∘
hygiene and robustness,
- ∘
opening and possible fixation of the catheter;
- ∘
- •
lubrification: means used for lubrification (spontaneous, gel, water…);
- •
catheter itself:
- ∘
holding, pushing and insertion into the urinary meatus,
- ∘
ease of progression and insertion comfort,
- ∘
ease with which you could void (length of the catheter accessories);
- ∘
- •
after catheterization: ease with which your catheter could be disposed of.
These items were selected to evaluate patient satisfaction with the catheter they were using for self-intermittent catheterization, and were chosen to have wording, which would be simple to understand for all patients.
The individual items were related to discretion, the “hygienic” nature of the catheter, package opening, means of catheter lubrication, ease of catheter insertion and withdrawal, ease of voiding, ease of catheter disposal after use.
The final items and categories of the InCaSaQ are listed in Table 1 (free English translation of our original validated questionnaire written in French).
Question | Not satisfied at all = 0 | Slightly satisfied = 1 | Satisfied = 2 | Extremely satisfied = 3 | |
---|---|---|---|---|---|
Packaging | Concerning discretion and bulk of the package, are you? | 0 | 1 | 2 | 3 |
Concerning hygiene and robustness of the package, are you? | 0 | 1 | 2 | 3 | |
Concerning the opening and possible fixation of the catheter, are you? | 0 | 1 | 2 | 3 | |
Lubrication | Concerning the means used for lubrication (spontaneous, gel, water…), are you? | 0 | 1 | 2 | 3 |
Catheter itself | Concerning holding, pushing and insertion into the urinary meatus, are you? | 0 | 1 | 2 | 3 |
Concerning ease of progression and insertion comfort, are you? | 0 | 1 | 2 | 3 | |
Concerning the ease with which you could void (length of the catheter and catheter accessories), are you? | 0 | 1 | 2 | 3 | |
After catheterization | Concerning the ease with which your catheter could be disposed of, are you? | 0 | 1 | 2 | 3 |
Response options were ranked on a 4-point Likert type scale, with 0 indicating “not at all satisfied” and 3 indicating “extreme satisfaction” with using the catheter ( Table 1 ).
The mean score of the 8 InCaSaQ questions was calculated for each patient.
1.3.3
Methods
From November 2011 until February 2012, the InCaSaQ was then tested in a prospective open study of 113 successive patients, who met all of the inclusion criteria, and none of the exclusion criteria.
All patients had sufficient manual dexterity and mobility to perform CISC, with a Pencil and Paper Test (PP-Test) greater than 10/15 .
For SCI patients included, the higher lesion was C6 knowing that patients with C6 injuries have represented the highest international ASIA (American Spinal Injury Association) level to manage ISC, with a success rate from 20 to 30% .
The patients’ reactions to the InCaSaQ were evaluated, using a sub-sample of 20 participants, complying with the inclusion and exclusion criteria, according to: comprehension, relevance, the patients’ acceptance in terms of time consumption and discretion. These patients answered three questions, with a binary “yes/no” response: “Is the questionnaire relevant?”, “Could you answer the questions easily, in terms of the time needed and its discretion?”, “Are the questions easy to understand?”.
The patients were also given the opportunity to discuss the degree to which they felt the questionnaire dealt with their concerns.
1.3.4
Ethical considerations
French ethics have been requested for this project. Their response was that the validation of a questionnaire was not part of the jurisdiction of the Committee for the Protection of Persons (CPP of Aulnay-sous-Bois, France), but the committee was not opposed to this survey.
Specific local ethics committee approval was obtained for the computerised data reduction and analysis.
1.3.5
Psychometric validation
The psychometric validation of the questionnaire included: face validity in terms of comprehension, relevance, patient acceptance (time consumption and discretion), reliability in terms of internal consistency and test-retest reliability.
Cronbach’s alpha and its confidence interval were used as a measure of internal consistency of the InCaSaQ (α > 0.70 was considered as satisfactory .
The test-retest reliability (agreement between the initial and 2-week scores) was estimated by two successive administrations in patient in stable condition. A questionnaire is reproducible if these two measures provide similar results, which is defined as the calculating intraclass correlation coefficient (ICC). This coefficient measures the correlation for each subject between the two responses. Results were considered unchanged for an ICC > 0.60 .
Wilcoxon test was used to compare the scores for each category with no change.
1.4
Results
1.4.1
Participants
The cohort included 69 females, 44 males, mean age was 50.6 years (range: 18–77). All patients had a neurological disease (multiple sclerosis, spinal cord injury [SCI], cauda equina syndrome, spina bifida, or one of the following: viral myelitis, spinal ependymoma, spinal astrocytoma). The diseases and demographic data of the patients are summarised in Table 2 .
Number | Sex (F/M) | Age (mean ± S.D.) | InCaSaQ (mean ± S.D.) | |
---|---|---|---|---|
Multiple sclerosis | 51 | 35/16 | 51 ± 3.7 | 2.33 ± 0.5 |
Spinal cord injury | 16 | 6/10 | 53 ± 14.4 | 2.11 ± 0.5 |
Cauda equina syndrome | 17 | 12/5 | 52 ± 12.7 | 2.26 ± 0.5 |
Spina bifida | 4 | 4/0 | 49 ± 21.3 | 2.75 ± 0.3 |
Others (viral myelitis, spinal ependymom, spinal astrocystom, hypocontractility) | 25 | 12/13 | 49.6 ± 16.7 | 2.25 ± 0.5 |
Total | 113 | 69/44 | 50.6 ± 13.6 | 2.29 ± 0.5 |
Sixty-eight patients made exclusive use of CISC, 42 patients had spontaneous micturition, associated with the use of CISC, and no data was available in the case of 3 patients. The mean number of CISC per a day was 4.9 (S.D. ± 1.7). The patients had been using CISC for an average period of 60 months (range: 2–324).
1.4.2
Questionnaire
Completion rate was good. Only 2 missing data were observed (0.05%). Missing data were for items dealing with the catheterization itself.
Patients had no difficulties for comprehension and acceptance of the questionnaire.
The mean total score of the InCaSaQ questionnaire was 2.3 (S.D. ± 0.5), and the mean scores for each item and for the four categories of the questionnaire are listed in Table 3 .
Dimensions | Number of patients score = 0 | Number of patients score = 1 | Number of patients score = 2 | Number of patients score = 3 | Mean a ± S.D. | Cronbach’s alpha | Cronbach’s alpha |
---|---|---|---|---|---|---|---|
Packaging | |||||||
P1 | 5 | 6 | 46 | 56 | 2.31 ± 0.7 | 0.76 | 0.88 |
P2 | 0 | 4 | 55 | 54 | |||
P3 | 3 | 16 | 60 | 34 | |||
Lubrication | 2 | 4 | 51 | 56 | 2 ± 1 | – | |
Catheter itself | |||||||
C1 | 2 | 7 | 60 | 44 | 2.35 ± 0.65 | 0.83 | |
C2 | 0 | 6 | 62 | 45 | |||
C3 | 3 | 9 | 49 | 52 | |||
After catheterization | 4 | 30 | 50 | 29 | 1.92 ± 0.81 | – |
a Score from 0 (lower satisfaction) to 3 (higher satisfaction).
No statistical difference was observed between male and female patients, with respect to their age ( P = 0.70) and mean total InCaSaQ score ( P = 0.79).
Cronbach’s alpha was α = 0.88 ( Table 3 ).
Test-retest reliability was evaluated using data from 50 participants who completed the questionnaire for a second time, approximately 2 weeks after the first trial (2.17, range: 1–4). The ICC ranged from 0.56 to 0.67, demonstrating the test-retest reliability of our questionnaire ( Table 4 ). There was however a significant change between day 0 and day 15 for lubrification, catheter itself and after catheterization ( P < 0.05) ( Table 4 ).
Categories | Mean score day D0 | Mean score day D15 | P * | ICC |
---|---|---|---|---|
Packaging | 2.35 ± 0.71 | 2.21 ± 0.68 | 0.07 | 0.64 |
Lubrification | 2.62 ± 0.53 | 2.44 ± 0.54 | 0.01 | 0.61 |
Catheter itself | 2.45 ± 0.60 | 2.30 ± 0.64 | 0.02 | 0.67 |
After catheterization | 2 ± 0.85 | 1.78 ± 0.79 | 0.03 | 0.56 |
1.5
Discussion
CISC is currently considered to be the most suitable treatment for reducing the risk of upper urinary tract alteration in patients with chronic urinary retention . Although, CISC is considered to improve quality of life , little is known about the individual patient’s satisfaction with his/her catheter.
InCaSaQ was well accepted by patients as seen by the very low rate of missing data. This can be attributed to easy comprehension, and the limited number of items. InCaSaQ is a simple and acceptable questionnaire, which is easy to understand and leads to reproducible results.
It has been validated in a neurological population, with both female and male patients. This sample population were representative of the first population to which CISC was indicated. CISC avoids urological complications in neurogenic bladder (particularly in spinal cord injury and multiple sclerosis) and improves quality of life .
The internal coherence was satisfactory, with a significant Cronbach’s alpha coefficient, reflecting a homogeneous scale.
At the time of our study, it did not exist more traditional or other validated instruments in the same field . Thus, the criterion validity of the questionnaire has not been evaluated.
The questionnaire demonstrated good reproducibility with intraclass correlation coefficient above 0.6 for 3 of the 4 categories. Nevertheless, significant changes in two categories observed between day 0 and day 15 may have resulted from different environment when completing the questionnaire (hospital and patient’s home) or from the impact of the medical visit. This has been observed with other instruments .
The sensibility of the scale to change over time was not evaluated because the small number of patients who changed their urinary catheter during the study was insufficient for statistical analysis.
In the past, various authors have tried to compare patient satisfaction with CISC, for two different sorts of catheter , using a non-validated questionnaire.
It is important to verify patient satisfaction with CISC. Indeed, various catheters can be proposed, some of which the patients may find considerably more comfortable than others. Various types of catheter can be used for CISC : coated (pre-lubricated), hydrophilic-coated or uncoated (separate lubricant). In addition, catheters have different lengths and are gender specific. Some catheters are more compact, and are found to be easier to use and store in a handbag .
The successful teaching of clean intermittent catheterization depends on the patient’s ability to learn, undertake and cope with the procedure. During teaching, the choice of equipment depends not only on the patient’s functional abilities, but also on his/her physical deficiencies or cognitive status. Indeed, general considerations such as ease of opening the package, catheter manipulation, package discretion and catheter gliding properties are often major selection criteria for the patient. Although the patient’s functional and cognitive ability to practice CISC can now be accurately predicted, using a recently described, reliable tool , cost-effectiveness is also an important criterion when choosing a catheter .
In the present study, the patients appeared to be generally satisfied in all of the 4 categories evaluated (“packaging”, “lubrication”, “catheter itself”, “after catheterization”), with high satisfaction scores ( Table 3 ). Maybe the scores would be lower with patients at the beginning of self-catheterization.
In the literature, Sutherland et al. , Stensballe et al. and Hedlund et al. suggested that hydrophilic catheters could be preferable to uncoated catheter, in terms of patient satisfaction. Hydrophilic catheters appear to be preferred by patients with a history of difficult catheterization .
Pascoe and Clovis evaluated two coated catheters in intermittent self-catheterization. These authors concluded that Speedicath ® led to statistically favourable results, in terms of ease and speed of use, but no specific evaluation was made of patient satisfaction.
In 2008, Taskinen et al. evaluated the CISC experience of patients in a paediatric surgery ward, through the use of a questionnaire based on various aspects of the CISC process. They concluded that although the technical properties of hydrophilic catheters were quite similar, the patients had their own personal preferences. However, no psychometric validation was made of this questionnaire.
1.6
Conclusion
In conclusion, this study demonstrates that the InCaSaQ is a simple and valid test for the evaluation of patient satisfaction with the use of urinary catheters. The InCaSaQ can be useful when learning the CISC technique and in patient education. This questionnaire could be integrated into daily clinical practice, following CISC training, in order to adapt, sometimes after a long time of utilisation, the choice of catheter to that providing the best satisfaction for each patient. It could also provide a simple approach to the evaluation of a nurse’s training, and make it possible to provide advice to patients on their choice of catheter. It could also be use as an objective measure to compare for example catheters in trials or new products perhaps. Further studies will be necessary to verify the sensibility of the scale to change over time including patients at the beginning of self-catheterization, with modification in choice of catheters over the time.
Disclosure of interest
The authors declare that they have no conflicts of interest concerning this article.
Acknowledgements
The authors would like to thank the entire team of our neurourology center who included the patients.
2
Version française
2.1
Abréviations
AS
autosondage
InCaSaQ
Intermittent Catheterization Satisfaction Questionnaire
ICC
intraclass correlation coefficient
2.2
Introduction
Depuis la publication princeps de Lapides et al. , l’autosondage (AS) est désormais considéré comme la méthode de choix dans le management des dysfonctions urinaires et particulièrement de la rétention d’urines notamment d’origine neurogénique .
L’AS a ainsi permis de contribuer à la diminution de la morbidité et de la mortalité de ces patients ainsi que d’une manière subséquente à l’amélioration de leur qualité de vie .
Dès l’instant où la technique de l’autosondage a été apprise et acquise par le patient, la question du choix du cathéter est d’une grande importance puisqu’elle affecte le confort général du patient et sa satisfaction.
Il y a plusieurs buts dans cet apprentissage et les différentes modalités peuvent influencer la compliance du patient et l’adhérence sur le long terme à la technique .
En pratique clinique, certains patients se plaignent parfois de difficultés à la manipulation du cathéter (tout particulièrement avec les sondes hydrophiles à faible friction) ou de douleurs pendant la cathétérisation en raison d’une sensation de striction douloureuse urétrale .
Différents types de cathéters ont pu être utilisés pour les AS, chaque cathéter ayant des propriétés, avantages et inconvénients spécifiques quant à leur manipulation et à leur environnement en termes de procédés de conservation ou de lubrification.
Alors que quelques travaux ont été effectués comparant la tolérance et l’efficacité des différents cathéters ainsi que la comparaison de la satisfaction du patient entre l’utilisation de cathéters prélubrifiés et non lubrifiés , il n’y a pas de questionnaire validé évaluant la satisfaction du patient lors de l’utilisation de leur propre cathéter.
Cependant, différents aspects du processus d’autosondages ont pu être décrits pouvant impacter la satisfaction comme la manipulation de l’enveloppe du cathéter, comme la facilité d’insertion ou pour retirer la sonde, comme la qualité de la lubrification du cathéter ou la douleur pouvant éventuellement survenir pendant cet autosondage .
Une étude pilote a ainsi été réalisée pour élaborer et valider un questionnaire spécifique nommé InCaSaQ dans le but d’évaluer la satisfaction du patient avec l’utilisation de son cathéter pour l’AS.
2.3
Matériels et méthodes
2.3.1
Population étudiée
Les critères d’inclusion pour cette étude étaient : âge supérieur à 18 ans, patient utilisant les AS pour des rétentions urinaires secondaires à une atteinte neurologique. Les critères d’exclusion étaient : un état de confusion mentale, une impossibilité de lire et de comprendre le questionnaire.
2.3.2
Questionnaire
Les items du questionnaire étaient issus d’une revue exhaustive de la littérature (PubMed de 1995 à 2012 utilisant les mots clés : Intermittent catheterization ; Hydrophilic-coated catheter ; Questionnaire ; Satisfaction ; Acceptance ; Compliance ; Lower urinary tract dysfunction ; Patients’ perception ; Quality of life ; Clinical evaluation ; Difficulties ), ainsi que par une analyse de l’expérience donnée par une équipe d’infirmières très spécialisées dans l’apprentissage des AS (plus de 400 apprentissages par an dans un centre de neuro-urologie spécialisé).
Une étude spécifique a été conduite intéressant six spécialistes de neuro-urologie et 11 infirmières en dehors de l’équipe initiale dans le but de vérifier l’exhaustivité des items qui avaient été préalablement listés et reportés par les patients.
Les huit items les plus fréquemment reportés ont été sélectionnés et ont été classés dans les quatre catégories suivantes :
- •
enveloppe ( packaging ) :
- ∘
discrétion et solidité de l’enrobement,
- ∘
son hygiène et sa robustesse,
- ∘
les facilités d’ouverture et les possibilités de fixation du cathéter ;
- ∘
- •
lubrification : les modalités utilisées pour la lubrification (spontanée, gel, eau…) ;
- •
le cathéter lui-même :
- ∘
la manière de le tenir, de l’introduire, de l’insérer à travers le méat urétral,
- ∘
la facilité de progression et le confort d’insertion,
- ∘
la facilité avec laquelle les urines pouvaient s’écouler ;
- ∘
- •
après la cathérisation : la facilité avec laquelle le cathéter pouvait être jeté.
Ces items ont été sélectionnés pour évaluer la satisfaction du patient avec le cathéter d’AS d’une manière qu’il puisse être simple et facilement compris par toutes les catégories de patients.
Les items spécifiques reliés à la discrétion, au caractère sécuritaire et hygiénique du cathéter, de l’ouverture de l’enrobement, les moyens de lubrification, la facilité d’insertion et pour retirer le cathéter, la facilité de la miction et la facilité de jeter le cathéter.
Les items définitifs et les catégories d’InCaSaQ sont listés dans le Tableau 1 .