Assessment of Intermittent Self-Catheterization Procedures in Patients with Neurogenic Lower Urinary Tract Dysfunction: Dutch Translation and Validation of the Intermittent Catheterization Satisfaction Questionnaire, Intermittent Catheterization Acceptance Test, Intermittent Self Catheterization Questionnaire and Intermittent Catheterization Difficulty Questionnaire.

BACKGROUND: Intermittent self-catheterization (ISC) is by far the most appealing therapy to achieve a complete bladder emptying in patients with neurogenic lower urinary tract dysfunction (NLUTD). Four questionnaires have been developed in French in order to assess patient's satisfaction, difficulties and acceptance of this technique. OBJECTIVES: The aim of this study was to translate, culturally adapt and validate Dutch versions of the Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), the Intermittent Catheterization Acceptance Test (ICAT), the Intermittent Self Catheterization Questionnaire (ISCQ) and the Intermittent Catheterization Difficulty Questionnaire (ICDQ). METHODS: (1) Translation and cross-cultural adaptation of the questionnaires were performed according to the standardized guidelines. (2) The test of the pre-final version was performed by a group of bilingual lay people by comparing the original version of the questionnaires and the back translated one, assessing the comparability of language and comparability of interpretation. (3) Problematic issues were reviewed for correction. (4) Reliability was examined by intra-class correlation coefficients (ICC) statistics and Cronbach alpha analysis. RESULTS: Pre-test by 45 raters who are fluent in the source language led to an adapted and improved version of the translated questionnaires. Fifty native Dutch-speaking patients performing ISC (>6 months) due to an NLUTD were prospectively included. InCaSaQ, ICAT, ISCQ and ICDQ showed good internal consistency (α respectively (test and re-test): 0.79-0.88, 0.88-0.92, 0.85-0.88, and 0.88-0.86) and reproducibility (ICC respectively 0.77, 0.84, 0.84, and 0.87). CONCLUSION: The translated versions of InCaSaQ, ICAT, ISCQ and ICDQ are reliable and valid, allowing self-reported assessment of satisfaction, acceptance, difficulties and quality of life related to ISC in Dutch-speaking patients with NLUTD.

Cultural adaptation of the female pelvic floor questionnaire (FPFQ) into French.

AIMS: The Female pelvic floor questionnaire (FPFQ) is a self-administered tool on pelvic floor function. Our aim was to carry out a cultural adaptation of the FPFQ into French and to assess its psychometric properties. METHODS: After cross-cultural adaptation into French, acceptability and reliability of the questionnaire were assessed through a sample of 56 women in a test-retest. Discriminative construct validity was evaluated by comparing the results obtained by the FPFQ to those of other validated questionnaires. Longitudinal follow-up of the 282 pregnant women included in the PreNatal Pelvic floor Prevention trial (3PN) was used to analyze responsiveness. RESULTS: The proportion of missing data did not exceed 4% for questions about bladder function, bowel function, and pelvic organ prolapse; 10% for issues related to sexual function. Question 9 was considered difficult to understand by 14% of women. After rewriting, this issue was retested in a new sample of 52 women and presented no further problems. The intra-class correlation coefficient was greater than or equal to 0.7 for all domains during the test-retest. The FPFQ was strongly and significantly correlated (Spearman r > 0.5) with the other validated questionnaires. The French version of FPFQ recorded changes in urinary and sexual symptoms for the women involved in 3PN trial with a standardized response mean equal to 0.83 and 0.44, respectively. CONCLUSION: The French version of the FPFQ is self-administered, reliable, valid, and can detect a change in symptoms during follow-up. Neurourol. Urodynam. 36:253-258, 2017. © 2015 Wiley Periodicals, Inc.

Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial.

OBJECTIVE: Our aim was to assess the usefulness of cranberry extract in multiple sclerosis (MS) patients suffering from urinary disorders. METHODS: In total, 171 adult MS outpatients with urinary disorders presenting at eight centers were randomized (stratification according to center and use of clean intermittent self-catheterization) to cranberry versus placebo in a 1-year, prospective, double-blind study that was analyzed using a sequential method on an intent-to-treat basis. An independent monitoring board analyzed the results of the analyses each time 40 patients were assessed on the main endpoint. Cranberry extract (36 mg proanthocyanidins per day) or a matching placebo was taken by participants twice daily for 1 year. The primary endpoint was the time to first symptomatic urinary tract infection (UTI), subject to validation by a validation committee. RESULTS: The second sequential analyses allowed us to accept the null hypothesis (no difference between cranberry and placebo). There was no difference in time to first symptomatic UTI distribution across 1 year, with an estimated hazard ratio of 0.99, 95% CI [0.61, 1.60] (p = 0.97). Secondary endpoints and tolerance did not differ between groups. CONCLUSION: Taking cranberry extract versus placebo twice a day did not prevent UTI occurrence in MS patients with urinary disorders. Trial Registration NCT00280592.

Development and psychometric validation of the intermittent self-catheterization questionnaire.

BACKGROUND: Intermittent catheterization, often performed by the users themselves and known as intermittent self-catheterization (ISC), has become the gold standard treatment for people with chronic urinary retention. To date, there are no validated patient-reported outcome measures for individuals who rely on ISC that focus on ISC-related quality of life and can help health care professionals and catheter users to optimize long-term ISC care. OBJECTIVE: The objective of this study was to develop and validate a patient-reported outcome measure, the Intermittent Self-Catheterization Questionnaire (ISC-Q), which evaluates aspects of quality of life specific to the needs of individuals performing ISC. METHODS: This study was divided into 2 phases. The first phase focused on the development of the ISC-Q using 20 interviews and a review of selected literature. In addition, 10 interviews with UK and French individuals who performed ISC were conducted to ensure face and content validity of the ISC-Q. In the second phase of the study, the ISC-Q was administered online in the United Kingdom, France, and Germany to 306 individuals with neurologic urinary retention (including spinal cord injury, multiple sclerosis, and spina bifida), who performed ISC for at least 6 months, and were aged 18 to 85 years. Item reduction, reliability, and validity testing were performed to determine the psychometric properties of the ISC-Q. Responsiveness and minimum important differences were also examined. RESULTS: The initial phase of the study led to the development of a 4-domain instrument focusing on ease of use, convenience, discreetness, and psychological well-being. Various item reduction techniques were used that resulted in the removal of 3 items from the ISC-Q; there were 24 items in the final version. The conceptual framework of the ISC-Q was confirmed with a four-factor solution of the subscales. The ISC-Q was psychometrically robust, with excellent internal consistency, adequate test-retest reliability, and good validity (convergent and known groups validity). Overall, the responsiveness results show the ISC-Q to be sensitive to change, and the total ISC-Q minimum important difference estimates ranged from 4.94 to 8.73. CONCLUSION: The findings illustrate the ISC-Q to be a valid and reliable outcome measure that evaluated aspects of ISC-related quality of life.

Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study.

AIMS: Electrostimulation is an established therapeutic option for neurogenic urinary disorders. The aim of this study was to investigate the efficacy of the noninvasive technique of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with multiple sclerosis (MS) and troublesome symptoms of an overactive bladder (OAB). METHODS: A multicentric study enrolled 70 MS patients, suffering from OAB for a 3-month study period. INTERVENTION: Daily sessions of 20 min of TPTNS were provided. No change of associated treatments during the study period. The primary outcome measurement was Urgency and Frequency reported by bladder diary and symptom score performed before the treatment (Day 0, D0) and at D30 and D90. The secondary outcomes measurements were continence, symptom score, quality of life, psychosocial burden at DO, D30, and D90 and cystometry at baseline, with and without TPTNS and at D90. RESULTS: Clinical improvement of OAB was shown in 82.6% and 83.3% of the patients on D30 and D90, respectively, with significant improvement of primary and secondary outcomes compared to baseline. The initial acute cystometric response to TPTNS was positive in 51.2% of the patients (increase of >30% of cystometric capacity and/or reflex volume), without correlation with TPTNS clinical efficiency. The procedure was well tolerated. CONCLUSIONS: Chronic TPTNS appears to be effective in the management of severe OAB in MS, without compromising bladder emptying or inducing side effect. Treatment may be effective even in the absence of an acute cystometric effect. Additional works are required to demonstrate long-term efficacy of TPTNS.

Italian version of Qualiveen-30: cultural adaptation of a neurogenic urinary disorder-specific instrument.

PURPOSE: Qualiveen-30 is a neurological urinary disorder (UD)-specific health-related quality of life (HRQL) instrument, recommended in the European Association of Urology guideline 2008. The objective is to complete the cultural adaptation of Qualiveen-30 into Italian. MATERIALS AND METHODS: One hundred and twenty eight Italian-speaking spinal cord injury (SCI) patients completed Qualiveen-30 and the SF-12 physical and mental component (PC and MC) at enrollment and 4 weeks later. At follow-up, patients also made global ratings of change (GRC) in urinary HRQL (GRC). RESULTS: Qualiveen-30 proved reliable (intraclass correlation coefficients of four domains: 0.77-0.90). Correlations with SF-12 and GRC were generally consistent with our a priori predictions. Qualiveen-30 domains showed weak-to-moderate cross-sectional correlations with SF-12 scores (0.31-0.45 PC and 0.28-0.45 MC). Correlations between changes in Qualiveen-30 scores and in SF-12-PC scores were weak or absent. Correlations between changes in Qualiveen-30 scores and in SF-12-MC scores were weak to moderate (0.25-0.38). Relationships between change in Qualiveen-30 and GRC were moderate to strong (0.48-0.56). The responsiveness was excellent, similar to the original form (SMR: 1.76-2.31). Minimally important difference values in the four domains varied from 0.34 to 0.47. CONCLUSIONS: Italian Qualiveen-30 is a reliable, valid, and responsive measure of UD-related HRQL in SPI patients. Investigators can be confident of the Qualiveen-30 questionnaire's ability in distinguishing between patients in a cross-sectional survey, as well as in measuring within-subject changes over time in clinical trials in French, English, and Italian.

[Prescribe clean intermittent self-catheterization]. / Prescrire des autosondages intermittents propres.

Clean intermittent self-catheterization is the recommended mode of voiding in patients with urinary retention. CISC is a non-sterile catheterization, done by the patient himself to insure complete emptying of the bladder several times per day. Its prescription rests on well-established recommendations with a sufficient frequency of self-catheterization (minimum 4), collected volumes less than 400 mL and a diuresis higher than 1.5 L. Clean intermittent self-catheterization allows a reduction in complications of infection, protects the upper urinary tract and provides urinary continence for the patient. Asymptomatic bacteriuria is very frequent in patients treated with intermittent catheterization and does not justify antibiotic therapy. Only symptomatic urinary tract infections have to be treated by a short course of antibiotics. Patient education and personalized medical follow-up must ensure adapted management dependant on this voiding mode and its risk factors. A guideline is provided to prescribe clean intermittent self-catheterization with its indications, its advantages and complications, its medical surveillance and treatment of urinary tract infection. This procedure should be well-known to general practitioners who are responsible for the follow up of these patients.

Development and validation of the short form of a urinary quality of life questionnaire: SF-Qualiveen.

PURPOSE: The 30-item Qualiveen is a specific health related quality of life questionnaire for urinary disorders in patients with neurological conditions, such as multiple sclerosis and spinal cord injury. Previous studies have demonstrated the reliability, validity and responsiveness of Qualiveen. However, to address the needs of large clinical trials and long-term monitoring, in which efficiency may compete with precision of measurement, we developed the 8-item self-administered SF-Qualiveen. MATERIALS AND METHODS: A total of 180 English speaking and French speaking outpatients with multiple sclerosis at multiple sclerosis clinics and departments of rehabilitation in Canada and France completed the entire Qualiveen, the Multiple Sclerosis Quality of Life-54 questionnaire or its French version (SEP-59) as well as urinary function assessments at study enrollment and 2 to 10 weeks later. At visit 2 patients also made global ratings of change in urinary health related quality of life. SF-Qualiveen development and testing used this data set. RESULTS: Correlations of SF-Qualiveen with its original form were high (r = 0.70 to 0.92). SF-Qualiveen proved reliable (ICC 0.83 to 0.93). Its responsiveness was similar to that of the long form (SRM 0.75 to 1.62). Correlations with other measures were consistent with our a priori predictions (weighted kappa 0.55 for cross-sectional correlations and 0.66 for correlations of change), supporting the cross-sectional and longitudinal construct validity of SF-Qualiveen. CONCLUSIONS: SF-Qualiveen has excellent measurement properties, similar to those of the long form. The new instrument is likely to perform well in the clinical and research context.

Clinical characteristics and quality of life in a cohort of 621 patients with faecal incontinence.

AIM: The aim of this study was to study a cohort of patients with faecal incontinence (FI) to gain a better insight into the clinical and epidemiological characteristics of this pathology and its repercussions on quality of life (QL). MATERIALS AND METHODS: Consecutive patients with FI seen at tertiary centres filled in a self-questionnaire. The severity of FI, constipation and urinary incontinence (UI) was evaluated, respectively, by the Jorge and Wexner score, the Knowles-Eccersley-Scott Symptom score and the Urological Distress Inventory score. ROME II criteria were used to assess the existence of an associated irritable bowel syndrome. The repercussion on QL was evaluated by the Gastrointestinal Quality of Life index score and the Ditrovie score. The psychological status was assessed by the Hospital Anxiety and Depression scale. RESULTS: Six hundred twenty-one patients (114 men), mean age 58 +/- 15 years (range: 20-92), with FI, filled in the questionnaire. The mean Jorge and Wexner score was 11 +/- 4. Twenty-seven presented with an irritable bowel syndrome. Thirty-eight percent had an associated constipation. A UI was associated in 48% women and 25% men. QL was significantly altered, and anxiety and depression were frequent. CONCLUSIONS: FI symptoms are frequently severe, QL very altered and anxiety and depression common. FI is frequently associated with other digestive and perineal symptoms, which argue in favour of a multi-disciplinary management of FI.

Qualiveen, a urinary-disorder specific instrument: 0.5 corresponds to the minimal important difference.

OBJECTIVE: This study assessed the interpretability of changes in Qualiveen, a specific health-related quality-of-life (HRQOL) questionnaire for urinary disorders (UD) in multiple sclerosis (MS) patients. Qualiveen has 30 items focusing on four aspects of patients' lives related to their urinary problems: bother with limitations (nine items), frequency of limitations (eight items), fears (eight items), and feelings (five items). Response options are framed as 5-point Likert-type scales, and scores on each domain range from 0 to 4. STUDY DESIGN AND SETTING: One hundred twenty-one MS patients with UD completed Qualiveen at baseline and 2-10 weeks later. At the second visit, patients also made global ratings of change in urinary HRQOL (GRC) with a 15-point scale from -7 to +7. We addressed the validity of GRC by examining its relationships with pre- and post-Qualiveen scores and determined the mean change in score on each Qualiveen domain associated with small, moderate, and large changes in the corresponding GRC. RESULTS: The correlation of the change score with the corresponding GRC was substantially stronger than the correlation with either pre- or post-Qualiveen score, establishing the validity of the GRC. In all domains, a within-patient change in Qualiveen score of approximately 0.5 (range: 0.36-0.72) represents the minimal important difference. A change in score of approximately 0.7 corresponds to a moderate change in quality of life (range: 0.55-0.86). CONCLUSIONS: These estimates will help in interpreting the results of subsequent studies that use Qualiveen to examine the impact of interventions designed to improve urinary-specific HRQOL.

Qualiveen: a urinary disorder-specific instrument for use in clinical trials in multiple sclerosis.

OBJECTIVE: To examine the longitudinal construct validity and the responsiveness of the English and French versions of Qualiveen in multiple sclerosis (MS) patients with urinary disorders. DESIGN: Cohort study. SETTING: MS clinics and departments of rehabilitation in Canada and France. PARTICIPANTS: One hundred eighty English-speaking and French-speaking outpatients who, at enrollment, were classified as "stable" if they had no urinary disorders requiring change in medicine, or "anticipated improvement" if they had troubling urinary disorders that mandated intensified treatment. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We tested predictions about the relation between changes in other questionnaires (Multiple Sclerosis Quality of Life-54 questionnaire or its French version, the SEP-59, and a global rating of change) and changes in the Qualiveen domains. A paired t test in the anticipated improvement group comparing scores before and after the intervention, and the magnitude of the standardized response mean (SRM) provided measures of responsiveness. RESULTS: Consistent with a priori predictions (weighted kappa=.71), changes in Qualiveen score correlated with changes in other questionnaires. All Qualiveen domains detected changes in patients in the anticipated improvement group (P<.001) and differentiated these patients from "stable" patients (P<.001);all SRMs were large (>.75). CONCLUSIONS: Valid and responsive, both English and French versions are useful for MS studies into urinary disorders.

[Comparative study of the acceptability of the SpeediCath Set and Actreen set catheterization sets in patients performing self-catheterization]. / Etude d'acceptabilité du set de sondage SpeediCath Set comparativement à Actreen Set chez des patients pratiquant l'autosondage.

OBJECTIVE: To compare SpeediCath Set to Actreen Set in terms of performance, acceptability and safety, in patients performing self-catheterization. MATERIAL AND METHODS: Four questionnaires were completed during this multicentre, randomized, crossover study: initial, after having tested each of the two products and patient preference at the end of the study. RESULTS: Analysis was based on 29 men performing self-catheterization. The SpeediCath Set was found to be superior to the Actreen Set in terms of ease of introduction (p=0.0055), ease of emptying (p=0.0157), quality of lubricant (p<0.0001), urethral tolerance and possibility of catheterization in bed (p= 0.0157). The patients 'global assessment was clearly in favour of SpeediCath Set (70 +/- 2.3 versus 5.7 +/- 2.5; p=0.0156) and 65.5% of patients preferred to use SpeediCath Set in the future. CONCLUSION: SpeediCath Set facilitates catheterization and improves the urethral tolerance compared to Actreen Set, with a marked patient preference in favour of SpeediCath Set.

[Choosing a quality-of-life questionnaire]. / Choisir un questionnaire de qualité de vie.

UNLABELLED: Define the objective of the questionnaire: Discrimination: do you want a questionnaire to enable you to describe the quality of life of patients or to compare the quality of life between groups of patients, for example, to determine who has improved and who has gotten worse? ASSESSMENT: do you want a questionnaire to help you measure changes over time (improvement or aggravation) in your patients? Determine the properties of instruments necessary for this objective: If the objective is discrimination, analyze: construct validity, reliability. If the objective is assessment, analyze construct validity, sensitivity to changes. Choose the general category of questionnaire: generic questionnaire, specific questionnaire.

Quality of life in multiple sclerosis patients with urinary disorders: discriminative validation of the English version of Qualiveen.

UNLABELLED: The Qualiveen questionnaire is a urinary disorder (UD)-specific health related quality of life (HRQL) instrument. Recent data suggests Qualiveen has excellent validity in French-speaking multiple sclerosis (MS) patients. AIM: To assess discriminative measurement properties of the English version of Qualiveen. METHODS: Fifty-five Canadian MS out-patients completed a set of questionnaires, including Qualiveen, MSQOL-54, a MS-specific HRQL questionnaire, urinary function assessments and the Expanded Disability Status Scale (EDSS) twice at an interval of two to four weeks. RESULTS: Qualiveen proved internally consistent (Cronbach's alpha coefficients 0.73 to 0.90 for the four Qualiveen domains) and test-retest reliable (intraclass correlation coefficients 0.88 to 0.94). Consistent with a priori predictions, we found a strong association between overall Qualiveen score and the degree of incontinence (0.63), a moderate correlation with the type of urinary symptoms (0.49), a weak association with manner of voiding (0.28) and weak or absent correlations with MSQOL-54 domains, EDSS bladder/bowel and global EDSS. Predictions proved generally accurate (weighted kappa = 0.65). CONCLUSION: The internal consistency, test-retest reliability and cross-sectional construct validity of the English version of Qualiveen are excellent, and similar to the original French version. Further studies should explore Qualiveen's longitudinal validity and responsiveness.

Measuring quality of life in multiple sclerosis patients with urinary disorders using the Qualiveen questionnaire.

OBJECTIVES: To assess the impact of urinary disorders on multiple sclerosis (MS) patients' health-related quality of life and to examine the cross-sectional construct validity of Qualiveen, a questionnaire originally developed for spinal cord injury patients with urinary disorders, in patients with MS. DESIGN: Cohort study. SETTING: Neurourodynamic units in 3 French university hospitals. PARTICIPANTS: Patients with MS (N=197). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We tested predictions about the relationships among clinical features, the French version of the Multiple Sclerosis Quality of Life questionnaire (SEP-59), the Expanded Disability Status Scale (EDSS), and the 4 domains of the 30-item Qualiveen. RESULTS: Cross-sectional correlations among the 4 Qualiveen domains and type (range, .36-.54), number of symptoms (range, .23-.50), and severity of incontinence (.39-.68) were generally moderate to strong. The SEP-59 bowel and bladder function domain showed moderate to strong relationships with the Qualiveen (range, .39-.59). Relationships with other SEP-59 domains were generally weak (range, .22-.35), and with the EDSS they were very weak. Predictions proved generally accurate (weighted kappa=.61). CONCLUSIONS: Our data supported the Qualiveen's validity as a discriminative instrument for use with patients with MS. Further studies should explore the Qualiveen's longitudinal validity and responsiveness.