Joon Chul Kim1, Kang Jun Cho1, Jeong Gu Lee2, Ju Tae Seo3, Duk Yoon Kim4, Seung-June Oh5, Kyu-Sung Lee6, Myung-Soo Choo7, Jeong Zoo Lee8. 1. Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea. 2. Department of Urology, College of Medicine, Korea University, Seoul, Republic of Korea. 3. Department of Urology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Republic of Korea. 4. Department of Urology, Daegu Catholic University College of Medicine, Daegu, Republic of Korea. 5. Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. 6. Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 7. Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 8. Department of Urology, Pusan National University School of Medicine, Busan, Republic of Korea. Electronic address: toohotman@hanmail.net.
Abstract
PURPOSE: We investigated the efficacy and safety of desmopressin add-on therapy for men with persistent nocturia on α-blocker for lower urinary tract symptoms in this placebo controlled study. MATERIALS AND METHODS: The study included men 40 to 65 years old with lower urinary tract symptoms and persistent nocturia despite α-blocker therapy for at least 8 weeks. Patients were randomized to once daily placebo or desmopressin 0.2 mg for 8 weeks. The primary end point was to assess changes in the mean number of nocturia episodes from baseline to the final assessment. Other secondary end points and adverse events were evaluated. RESULTS AND LIMITATION: A total of 86 patients were randomized to treatment, including placebo in 39 and desmopressin 0.2 mg in 47. Baseline characteristics were similar in the 2 groups. The desmopressin add-on group was significantly superior to placebo in terms of the change from baseline in the mean number of nocturia episodes (-1.13 ± 0.92 vs -0.68 ± 0.79, p = 0.034), the changes in nocturnal urine volume (p <0.001), total I-PSS (International Prostate Symptom Score) (p = 0.041), the nocturnal polyuria index (p = 0.001) and ICIQ-N (International Consultation on Incontinence Questionnaire-Nocturia) (p = 0.001), and the willingness to continue (p = 0.025). The incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group. Most adverse events were mild. CONCLUSION:Desmopressin add-on therapy in men 40 to 65 years old with persistent nocturia on α-blocker monotherapy for lower urinary tract symptoms is effective and well tolerated.
RCT Entities:
PURPOSE: We investigated the efficacy and safety of desmopressin add-on therapy for men with persistent nocturia on α-blocker for lower urinary tract symptoms in this placebo controlled study. MATERIALS AND METHODS: The study included men 40 to 65 years old with lower urinary tract symptoms and persistent nocturia despite α-blocker therapy for at least 8 weeks. Patients were randomized to once daily placebo or desmopressin 0.2 mg for 8 weeks. The primary end point was to assess changes in the mean number of nocturia episodes from baseline to the final assessment. Other secondary end points and adverse events were evaluated. RESULTS AND LIMITATION: A total of 86 patients were randomized to treatment, including placebo in 39 and desmopressin 0.2 mg in 47. Baseline characteristics were similar in the 2 groups. The desmopressin add-on group was significantly superior to placebo in terms of the change from baseline in the mean number of nocturia episodes (-1.13 ± 0.92 vs -0.68 ± 0.79, p = 0.034), the changes in nocturnal urine volume (p <0.001), total I-PSS (International Prostate Symptom Score) (p = 0.041), the nocturnal polyuria index (p = 0.001) and ICIQ-N (International Consultation on Incontinence Questionnaire-Nocturia) (p = 0.001), and the willingness to continue (p = 0.025). The incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group. Most adverse events were mild. CONCLUSION: Desmopressin add-on therapy in men 40 to 65 years old with persistent nocturia on α-blocker monotherapy for lower urinary tract symptoms is effective and well tolerated.
Authors: Matthias Oelke; Stefan De Wachter; Marcus J Drake; Antonella Giannantoni; Mike Kirby; Susan Orme; Jonathan Rees; Philip van Kerrebroeck; Karel Everaert Journal: Int J Clin Pract Date: 2017-10-05 Impact factor: 2.503