Prospective

Jenny YIP

Rm 02B06, Main Clinical Block and Trauma Centre, PWH

26321663

siuying@surgery.cuhk.edu.hk

Miss ; The Chinese University of Hong Kong

Hong Kong

CHAN Chi Kwok

4/F, Clinical Science Building, Prince of Wales Hospital

26322211

chanck@surgery.cuhk.edu.hk

Dr. ; Prince of Wales Hospital ; The Chinese University of Hong Kong

Hong Kong

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

Yes

2014-01-09

Joint CUHK-NTEC Clinical Research Ethics Committee

CRE2013.539

Drug

Minirin Melt®

tablet

60mcg

4 weeks

before bed

Placebo

tablet

60mcg

4 weeks

before bed

1. Male subjects who score ≥ 2 ( out of 5 ) in the question 7 of the International Prostate Symptom Scores ( IPSS ) at the time of screening
2. Aged 40 -75
3. Has undergone Transurethral prostate surgery for more than 3 months
4. Willingness and appropriateness to receive desmopressin acetate (oral disintegration formulation) (Minirin Melt®)
5. Willingness to keep a voiding and sleep diary;
6. Willingness to wear a wrist actigraph; and
7. Willingness to make study visits

1. Evidence suggestive of significant bladder outlet obstruction: peak uroflow < 4 mL/sec on a void of ≥ 125 mL, or a PVR of ≥ 300 mL;
2. Use of clean intermittent self-catheterization at home
3. Surgical treatment (e.g. TURP) of bladder outlet obstruction/benign prostate hyperplasia ≤ 3 months before entry into the study
4. Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
5. Having Parkinson's disease with an uncontrolled tremor (as such diseases will invalidate wrist actigraphy);
6. Poorly controlled congestive heart failure as evidenced on physical examination;
7. Poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 7.5 or a random glucose ≥ 12 mmol/L within last 3 months
8. Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by principal investigator (PI) or Site PI;
9. Allergic to Desmopressin;
10. Previous spinal cord injury;
11. Currently on dialysis or in consideration for dialysis due to end stage renal disease;
12. More than 3 urinary tract infections within the last 12 months;
13. Unstable dose of diuretic within the past 3 months;
14. Has an artificial urinary sphincter;
15. Impaired mental status;
16. Nocturia due to well-defined causes of increased urinary frequency which require specific management, such as multiple sclerosis, diabetes insipidus, or polydipsia.
17. Subjects with history of frequent / repeated hyponatraemia;
18. 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;
19. Subjects with any history of clinically relevant psychiatric disorders within the 24 months preceding enrollment in the trial;
20. Subjects with work or lifestyle factors potentially interfering with regular night-time sleep (e.g., shift workers);
21. Subjects who have already received desmopressin for treatment of other conditions e.g. diabetes insipidus;
22. 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;
23. Unable to give informed consent;
24. Currently participating into other investigational research study during the screening and study period.

40

75

Male

Randomized

Randomization number generated

Placebo

Double-blind

Parallel

4

No