OBJECTIVES: We compared the applicability and reproducibility of the condom catheter method for noninvasive urodynamics in two Dutch studies. MATERIALS AND METHODS: A longitudinal study of changes in bladder contractility secondary to benign prostatic enlargement is taking place at the Erasmus MC in Rotterdam. Volunteers aged 38-77 years will be studied three times in 5 years. The first series of measurements has been completed in 1,020 men. A randomized controlled trial to test the effect of additional water intake on bladder function has been completed at the University of Maastricht. 184 subjects aged 55-77 years withInternational Prostate Symptom Scores of 8-19 were investigated twice in 6 months. Bladder contractility was measured noninvasively with the condom method. Two consecutive measurements were attempted in each subject. Reproducibility was tested according to Bland and Altman and compared by calculating the normalized standard deviation of the differences by dividing by the difference. RESULTS: The success rate for single measurements was 95% in both studies. The success rates for double measurements varied from 87 to 90%. The normalized standard deviation of the differences between the double measurements was 0.15 for the longitudinal noninvasive study and randomized controlled trial at baseline, and 0.13 for the randomized controlled trial at 6 months. CONCLUSION: Both studies showed good reproducibility of the noninvasive method comparable to invasive urodynamics. (c) 2008 S. Karger AG, Basel.
RCT Entities:
OBJECTIVES: We compared the applicability and reproducibility of the condom catheter method for noninvasive urodynamics in two Dutch studies. MATERIALS AND METHODS: A longitudinal study of changes in bladder contractility secondary to benign prostatic enlargement is taking place at the Erasmus MC in Rotterdam. Volunteers aged 38-77 years will be studied three times in 5 years. The first series of measurements has been completed in 1,020 men. A randomized controlled trial to test the effect of additional water intake on bladder function has been completed at the University of Maastricht. 184 subjects aged 55-77 years with International Prostate Symptom Scores of 8-19 were investigated twice in 6 months. Bladder contractility was measured noninvasively with the condom method. Two consecutive measurements were attempted in each subject. Reproducibility was tested according to Bland and Altman and compared by calculating the normalized standard deviation of the differences by dividing by the difference. RESULTS: The success rate for single measurements was 95% in both studies. The success rates for double measurements varied from 87 to 90%. The normalized standard deviation of the differences between the double measurements was 0.15 for the longitudinal noninvasive study and randomized controlled trial at baseline, and 0.13 for the randomized controlled trial at 6 months. CONCLUSION: Both studies showed good reproducibility of the noninvasive method comparable to invasive urodynamics. (c) 2008 S. Karger AG, Basel.