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.
OBJECTIVE: This 12-week pilot study examines the efficacy of applying low frequency sound wave stimulation (between 16-160 Hz) through both hands and feet on relieving pain and improving functional ability in patients with chronic back pain.
METHODS: Twenty-three participants with chronic shoulder (eleven participants) or low back pain (twelve participants) underwent a 12-week vibration therapy program of three sessions per week. A low frequency sound wave device comprising four piezoelectric vibration-type tactile tranducers enclosed in separate 5-cm diameter circular plates, which generate sinusoidal vibratory stimuli at a frequency of 16-160 Hz, was used in this study. Primary outcome measure was pain sensation measured using the Visual Analogue Scale (P-VAS). The secondary outcome measures were pain-related disability measured using the pain disability index (PDI) and quality of life measured using the SF-12.
RESULTS: At week 12, significant reductions in pain sensation and pain-related disability were observed, with mean reductions of 3.5 points in P-VAS and 13.5 points in the PDI scores. Sixty-five percent of the participants had a reduction of at least 3 points on the P-VAS score, while 52% participants showed a decrease of at least 10 points in the PDI score. Significant improvement was observed in the SF-12 physical composite score but not the mental composite score.
CONCLUSIONS: The preliminary findings showed that passive application of low frequency sound wave stimulation therapy through both hands and feet was effective in alleviating pain and improving functional ability in patients with chronic back pain.
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.
METHODS: This study involved 120 female SUI subjects aged ≥21 years old randomized to either active or sham PMS. Treatment involved two PMS sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 7-point reduction in the total score of the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire. Follow-ups were conducted at months 1, 2, 5, 8, and 14.
RESULTS: At 2 months, 35 out of 60 (58%) subjects in the active arm and 21 out of 60 (21%) in the sham arm were treatment responders (≥7-point reduction) (p = 0.006). There was a significant difference in changes in the mean ± SE ICIQ-LUTSqol total score between the active and sham arms (Mdiff = -8.74 ± 1.25 vs -4.10 ± 1.08, p = 0.006). At 1-year post-treatment, regardless of number of PMS sessions (16 or 32 sessions), subjects who received active PMS (63 out of 94, 67%) were more likely to be treatment responders compared with subjects who did not receive any active PMS (3 out of 12, 25%; p
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
METHODS: Women with SUI (n = 120) were randomized to either active or sham PMS for 8 weeks (twice/week). Patients answered seven questions on their perception and acceptability, each measured on a 5-point Likert scale. Treatment satisfaction was assessed using two parameters: (i) the single-item question "Overall, please rate how satisfied you are with the treatment" and (ii) Patient Global Impression of Improvement (PGI-I). All adverse events were documented.
RESULTS: A total of 115 patients completed treatments (active: n = 57, sham: n = 58). There were no significant differences between groups in all parameters regarding perception and acceptability (p > 0.05). In terms of treatment satisfaction, a significantly higher proportion of patients in the active group (n = 47/57, 82.4%) were either mostly or completely satisfied compared with those in the sham group (n = 27/58, 46.6%) ((p = 0.001). Similarly, a statistically significantly higher percentage of patients in the active group (n = 39/57, 68.4%) felt much or very much better compared with patients in the sham group (n = 11/58, 19.0%) as measured using the PGI-I (p
MATERIALS AND METHODS: A cross-sectional survey was conducted involving sexually active women with or without SUI aged at least 21 years old, and their respective partners. Both partners completed the Golombok Rust Inventory of Sexual Satisfaction (GRISS), a 28-item multidimensional measure with separate forms for male and female designed to assess sexual satisfaction of both partners. Spearman rank correlation coefficient was used to analyze bivariate association, whereas multiple regression analysis was used to identify predictors for overall sexual function as measured using GRISS score.
RESULTS: Sixty-six couples with SUI partners and 95 couples with continent partners were recruited. Overall GRISS scores and thus sexual function of men and women were strongly correlated. The correlation coefficient was higher in couples with SUI partners (r = 0.702, P r = 0.629, P
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.