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Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study.
J Urol. 2017 02; 197(2):459-464.JU

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.

Authors+Show Affiliations

Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.Department of Urology, Bucheon St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.Department of Urology, College of Medicine, Korea University, Seoul, Republic of Korea.Department of Urology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Republic of Korea.Department of Urology, Daegu Catholic University College of Medicine, Daegu, Republic of Korea.Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.Department of Urology, Pusan National University School of Medicine, Busan, Republic of Korea. Electronic address: toohotman@hanmail.net.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27622611

Citation

Kim, Joon Chul, et al. "Efficacy and Safety of Desmopressin Add-On Therapy for Men With Persistent Nocturia On α-Blocker Monotherapy for Lower Urinary Tract Symptoms: a Randomized, Double-Blind, Placebo Controlled Study." The Journal of Urology, vol. 197, no. 2, 2017, pp. 459-464.
Kim JC, Cho KJ, Lee JG, et al. Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study. J Urol. 2017;197(2):459-464.
Kim, J. C., Cho, K. J., Lee, J. G., Seo, J. T., Kim, D. Y., Oh, S. J., Lee, K. S., Choo, M. S., & Lee, J. Z. (2017). Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study. The Journal of Urology, 197(2), 459-464. https://doi.org/10.1016/j.juro.2016.08.116
Kim JC, et al. Efficacy and Safety of Desmopressin Add-On Therapy for Men With Persistent Nocturia On α-Blocker Monotherapy for Lower Urinary Tract Symptoms: a Randomized, Double-Blind, Placebo Controlled Study. J Urol. 2017;197(2):459-464. PubMed PMID: 27622611.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo Controlled Study. AU - Kim,Joon Chul, AU - Cho,Kang Jun, AU - Lee,Jeong Gu, AU - Seo,Ju Tae, AU - Kim,Duk Yoon, AU - Oh,Seung-June, AU - Lee,Kyu-Sung, AU - Choo,Myung-Soo, AU - Lee,Jeong Zoo, Y1 - 2016/09/10/ PY - 2016/08/31/accepted PY - 2016/10/25/pubmed PY - 2019/1/29/medline PY - 2016/9/14/entrez KW - adrenergic alpha-antagonists KW - deamino arginine vasopressin KW - lower urinary tract symptoms KW - nocturia KW - urinary bladder SP - 459 EP - 464 JF - The Journal of urology JO - J Urol VL - 197 IS - 2 N2 - 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. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/27622611/Efficacy_and_Safety_of_Desmopressin_Add_On_Therapy_for_Men_with_Persistent_Nocturia_on_α_Blocker_Monotherapy_for_Lower_Urinary_Tract_Symptoms:_A_Randomized_Double_Blind_Placebo_Controlled_Study_ L2 - https://www.jurology.com/doi/10.1016/j.juro.2016.08.116?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -