Noctura
Conditions
Interventions
Two groups:Minirin Melt versus placebo, 60mcg before bed, 4 weeks, respectively
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Evidence suggestive of significant bladder outlet obstruction: peak uroflow =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 =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactCHAN Chi Kwok
Prince of Wales Hospital; The Chinese University of Hong Kong
Outcome results
None listed