Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, Lower Urinary Tract Symptoms (LUTS) and Benign Prostate Syndrome (BPS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 66
- 主要终点
- Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
研究概览
简要总结
Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Therapeutic need according to Summary of Product Characteristics
- •Written informed consent
排除标准
- •Contraindications according to Summary of Product Characteristics
研究组 & 干预措施
desmopressin
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription.
干预措施: desmopressin (Drug)
结局指标
主要结局
Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
时间窗: Baseline, Week 12
The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.
次要结局
- Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12(Baseline, Week 12)
- Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12(Baseline, Week 12)
- Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12(Baseline, Week 12)
- Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12(Baseline, Week 12)
- Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)(Baseline, Week 12)
- Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12(Baseline, Week 12)
- Participants With Treatment Emergent Adverse Events (AEs)(Week 1 to Week 12)