MATERIALS AND METHODS: We identified RCTs for SUI interventions published between January 2015 and July 2017. We listed the objective and subjective outcome measures used in eligible trials in the literature search. Using data from our RCT conducted from 2013 to 2016 evaluating pulsed magnetic stimulation for SUI, we analysed the correlation between all measures.
RESULTS: A total of 45 RCTs were included; 28 (62%) involved surgical interventions. The most frequently used objective and subjective measures were the cough stress test and International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), respectively. In all, 24 different validated questionnaires were administered in the 42 studies that used subjective outcome measure. Analyses of measures used in our trial showed that all measures were significantly correlated with each other except for pelvic floor muscle function. The ICIQ-UI SF showed the highest correlation coefficients (0.587-0.733) with all outcome measures.
CONCLUSION: The outcome measures used in recent trials were inconsistent. The ICIQ-UI SF had the highest correlation with all measures in our trial; however, further studies evaluating correlation of measures in other patient cohorts are needed to corroborate our present results. We propose the use of ICIQ-UI SF, as the most relevant outcome measure, in future trials evaluating efficacy of SUI interventions.
METHODS: Permission was obtained to translate the English versions into Malay and subsequently validate them, and to validate the existing Chinese versions. The translated questionnaires were taken for pilot testing. Validation was carried out for the face/content and discriminant validity. Reliability was assessed for test-retest and internal consistency using Cronbach's alpha and intraclass correlation coefficient respectively. The responsiveness was calculated via effect size and standardized response mean.
RESULTS: Ten patients were recruited for the pilot testing. The English and Chinese versions had "substantial" or "almost perfect" agreement as measured by weighted Kappa. 284 participants (139 patients with stress urinary incontinence and 145 healthy volunteers) were included in the subsequent phases. The ICIQ-UI SF and ICIQ-LUTSqol had good discriminant validity. The ICIQ-UI SF had moderate internal consistency although the ICIQ-LUTSqol had good internal consistency. Both questionnaires had high test-retest reliability. Responsiveness was established with a moderate to large effect size and a standardized response mean.
CONCLUSIONS: The English, Chinese, and Malay versions each proved to be valid and reliable in our Malaysian population, thereby enabling more cross-cultural research in this region. Neurourol. Neurourol. Urodynam. 36:438-442, 2017. © 2015 Wiley Periodicals, Inc.
MATERIALS AND METHODS: Data from a randomized clinical trial evaluating efficacy of a nonsurgical intervention in women with stress urinary incontinence were used for analyses. The overall score of ICIQ-UI SF ranges from 0 to 21, with greater values indicating increased severity. The ICIQ-LUTSqol ranges from 19 to 76, with greater values indicating increased impact on quality of life. Instruments used in the anchor-based method were the Patient Global Impression of Improvement, patient satisfaction, 1-hour pad test and the incontinence episode frequency. The distribution-based method used an effect size of 0.5 standard deviation. Triangulation of findings was used to converge on a single value of MCID.
RESULTS: At 12-month post-treatment, 106 (88.3%) participants completed the follow-up and were included in the analysis. Anchor-based MCIDs of the ICIQ-UI SF were between 3.4 and 4.4, while the distribution-based MCID was 1.7. Anchor-based MCIDs of the ICIQ-LUTSqol were between 4.8 and 6.9, while the distribution-based MCID was 5.2. Triangulation of findings showed that MCIDs of 4 for ICIQ-UI SF and 6 for ICIQ-LUTSqol were the most appropriate.
CONCLUSION: For women undergoing nonsurgical treatments for incontinence, reductions of 4 and 6 points in ICIQ-UI SF and ICIQ-LUTSqol, respectively are perceived as clinically meaningful.
METHODS: Women with or without SUI aged ≥21 years old were recruited. Subjects completed the International Consultation of Incontinence-Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation of Incontinence-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), and EQ-5D questionnaires.
RESULTS: A total of 120 women with SUI and 145 controls participated. The ICIQ-LUTSqol total score (mean ± standard deviation) was significantly higher in the SUI group (38.96 ± 10.28) compared with the control group (20.78 ± 2.73) (P