Sung Yong Cho1, Kyu-Sung Lee2, Jang Hwan Kim3, Ju Tae Seo4, Myung-Soo Choo5, Joon Chul Kim6, Jong Bo Choi7, Miho Song5, Ji-Youn Chun5, Seung-June Oh8. 1. Department of Urology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. 2. Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 3. Department of Urology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. 4. Department of Urology, Cheil General Hospital & Women's Healthcare Center, Catholic Kwandong University College of Medicine, Seoul, Korea. 5. Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 6. Department of Urology, Bucheon St. Mary's Hospital, The Catholic University of Korea College of Medicine, Bucheon, Korea. 7. Department of Urology, Ajou University Hospital, Ajou University School of Medicine, Suwon, Korea. 8. Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Abstract
PURPOSE: The aims of this study were to investigate the efficacy of combining the systematized behavioral modification program (SBMP) with desmopressin therapy and to compare this with desmopressin monotherapy in the treatment of nocturnal polyuria (NPU). METHODS: Patients were randomized at 8 centers to receive desmopressin monotherapy (group A) or combination therapy, comprising desmopressin and the SBMP (group B). Nocturia was defined as an average of 2 or more nightly voids. The primary endpoint was a change in the mean number of nocturnal voids from baseline during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters and questionnaires scores, and improvements in self-perception for nocturia. RESULTS:A total of 200 patients were screened and 76 were excluded from the study, because they failed the screening process. A total of 124 patients were randomized to receive treatment, with group A comprising 68 patients and group B comprising 56 patients. The patients' characteristics were similar between the groups. Nocturnal voids showed a greater decline in group B (-1.5) compared with group A (-1.2), a difference that was not statistically significant. Significant differences were observed between groups A and B with respect to the NPU index (0.37 vs. 0.29, P=0.028), the change in the maximal bladder capacity (-41.3 mL vs. 13.3 mL, P<0.001), and the rate of patients lost to follow up (10.3% [7/68] vs. 0% [0/56], P=0.016). Self-perception for nocturia significantly improved in both groups. CONCLUSIONS: Combination treatment did not have any additional benefits in relation to reducing nocturnal voids in patients with NPU; however, combination therapy is helpful because it increases the maximal bladder capacity and decreases the NPI. Furthermore, combination therapy increased the persistence of desmopressin in patients with NPU.
RCT Entities:
PURPOSE: The aims of this study were to investigate the efficacy of combining the systematized behavioral modification program (SBMP) with desmopressin therapy and to compare this with desmopressin monotherapy in the treatment of nocturnal polyuria (NPU). METHODS:Patients were randomized at 8 centers to receive desmopressin monotherapy (group A) or combination therapy, comprising desmopressin and the SBMP (group B). Nocturia was defined as an average of 2 or more nightly voids. The primary endpoint was a change in the mean number of nocturnal voids from baseline during the 3-month treatment period. The secondary endpoints were changes in the bladder diary parameters and questionnaires scores, and improvements in self-perception for nocturia. RESULTS: A total of 200 patients were screened and 76 were excluded from the study, because they failed the screening process. A total of 124 patients were randomized to receive treatment, with group A comprising 68 patients and group B comprising 56 patients. The patients' characteristics were similar between the groups. Nocturnal voids showed a greater decline in group B (-1.5) compared with group A (-1.2), a difference that was not statistically significant. Significant differences were observed between groups A and B with respect to the NPU index (0.37 vs. 0.29, P=0.028), the change in the maximal bladder capacity (-41.3 mL vs. 13.3 mL, P<0.001), and the rate of patients lost to follow up (10.3% [7/68] vs. 0% [0/56], P=0.016). Self-perception for nocturia significantly improved in both groups. CONCLUSIONS: Combination treatment did not have any additional benefits in relation to reducing nocturnal voids in patients with NPU; however, combination therapy is helpful because it increases the maximal bladder capacity and decreases the NPI. Furthermore, combination therapy increased the persistence of desmopressin in patients with NPU.
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