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

Joon Chul Kim, Kang Jun Cho, Jeong Gu Lee, Ju Tae Seo, Duk Yoon Kim, Seung June Oh, Kyu Sung Lee, Myung Soo Choo, Jeong Zoo Lee

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)459-464
Number of pages6
JournalJournal of Urology
Volume197
Issue number2
DOIs
Publication statusPublished - 2017 Feb 1

Fingerprint

Nocturia
Deamino Arginine Vasopressin
Lower Urinary Tract Symptoms
Placebos
Safety
Therapeutics
Polyuria
Prostate
Referral and Consultation
Urine
Incidence

Keywords

  • adrenergic alpha-antagonists
  • deamino arginine vasopressin
  • lower urinary tract symptoms
  • nocturia
  • urinary bladder

ASJC Scopus subject areas

  • Urology

Cite this

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. / Kim, Joon Chul; Cho, Kang Jun; Lee, Jeong Gu; Seo, Ju Tae; Kim, Duk Yoon; Oh, Seung June; Lee, Kyu Sung; Choo, Myung Soo; Lee, Jeong Zoo.

In: Journal of Urology, Vol. 197, No. 2, 01.02.2017, p. 459-464.

Research output: Contribution to journalArticle

Kim, Joon Chul ; Cho, Kang Jun ; Lee, Jeong Gu ; Seo, Ju Tae ; Kim, Duk Yoon ; Oh, Seung June ; Lee, Kyu Sung ; Choo, Myung Soo ; Lee, Jeong Zoo. / 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. In: Journal of Urology. 2017 ; Vol. 197, No. 2. pp. 459-464.
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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.",
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T1 - Efficacy and Safety of Desmopressin Add-On Therapy for Men with Persistent Nocturia on α-Blocker Monotherapy for Lower Urinary Tract Symptoms

T2 - 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

PY - 2017/2/1

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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.

AB - 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.

KW - adrenergic alpha-antagonists

KW - deamino arginine vasopressin

KW - lower urinary tract symptoms

KW - nocturia

KW - urinary bladder

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