ChiCTR-IPR-15007055进行中（未招募）4 期
利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧口溶片, 每天 60 微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素的研究
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Initial period of undisturbed sleep (i.e. hours of first undisturbed sleep, HUS) at baseline & end of study
研究概览
简要总结
利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧口溶片, 每天 60 微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 40 至 75（—）
- 性别
- Male
入选标准
- •Male subjects who score >=2 ( out of 5 ) in the question 7 of the International Prostate Symptom Scores ( IPSS ) at the time of screening
- •Aged 40 -75
- •Has undergone Transurethral prostate surgery for more than 3 months
- •Willingness and appropriateness to receive desmopressin acetate (oral disintegration formulation) (Minirin Melt?)
- •Willingness to keep a voiding and sleep diary;
- •Willingness to wear a wrist actigraph; and
- •Willingness to make study visits.
排除标准
- •Evidence suggestive of significant bladder outlet obstruction: peak uroflow < 4 mL/sec on a void of >=125 mL, or a PVR of >=300 mL;
- •Use of clean intermittent self-catheterization at home
- •Surgical treatment (e.g. TURP) of bladder outlet obstruction/benign prostate hyperplasia <=3 months before entry into the study
- •Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
- •Having Parkinson's disease with an uncontrolled tremor (as such diseases will invalidate wrist actigraphy);
- •Poorly controlled congestive heart failure as evidenced on physical examination;
- •Poorly controlled diabetes mellitus with either hemoglobin A1c of >=7.5 or a random glucose >=12 mmol/L within last 3 months
- •Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by principal investigator (PI) or Site PI;
- •Allergic to Desmopressin;
- •Previous spinal cord injury;
- •Currently on dialysis or in consideration for dialysis due to end stage renal disease;
- •More than 3 urinary tract infections within the last 12 months;
- •Unstable dose of diuretic within the past 3 months;
- •Has an artificial urinary sphincter;
- •Impaired mental status;
- •Nocturia due to well-defined causes of increased urinary frequency which require specific management, such as multiple sclerosis, diabetes insipidus, or polydipsia.
- •Subjects with history of frequent / repeated hyponatraemia;
- •Subjects with uncontrolled hypertension, clinically relevant cardiac failure, renal or hepatic disease, known alcohol or drug abuse, other investigational drugs taken in the past 30 days;
- •Subjects with any history of clinically relevant psychiatric disorders within the 24 months preceding enrollment in the trial;
- •Subjects with work or lifestyle factors potentially interfering with regular night-time sleep (e.g., shift workers);
- •Subjects who have already received desmopressin for treatment of other conditions e.g. diabetes insipidus;
- •Subjects who have received new (within 3 months of screening) prescription of sedative/hypnotic medications for sleep disorders, selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors;
- •Unable to give informed consent;
- •Currently participating into other investigational research study during the screening and study period.
研究组 & 干预措施
Two groups
Minirin Melt versus placebo, 60mcg before bed, 4 weeks, respectively
结局指标
主要结局
Initial period of undisturbed sleep (i.e. hours of first undisturbed sleep, HUS) at baseline & end of study
Mean number of nocturnal voids (Nocturia episodes) at baseline & end of study; Adverse event, mainly hyponatraemia for the entire study period
次要结局
- diuresis (nocturnal urine volume) at baseline & end of study
- NP index (NPI; nocturnal urine volume/24-hour urine volume [%]) at baseline & end of study
- Sleep quality at baseline & end of study
研究者
研究点 (1)
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