Efficacy and safety of Desmopressin in men with persistent nocturia under alpha blocker monotherapy

Efficacy and safety of Desmopressin “add-on“ therapy in men with persistent nocturia under alpha blocker monotherapy for lower urinary tract symptoms; A randomized, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000271

Enrollment

136

Registered

2011-11-16

Start date

2009-09-02

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : For 8weeks, experimental group is taking Desmopressin acetate 0.2mg, one time daily at bedtime, control group is taking placebo as same manner.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) male patient with lower urinary tract symptoms (LUTS) 2) Previous or current usage of a oral treatment for LUTS, for at least a 8 week duration for alpha blocker 3) Noctuira, more than 2 times per day 4) Nocturia Index scores of =1 (mean nocturnal volume/functional bladder capacity) 5) Written informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1) urine output exceeding 3L/day 2) Diabetes insipidus 3) History of previous prostate surgery within 6 months 4) Cardiac failure 5) serum sodium = 135 mmol/L 6) Clinically significant abnormalities of serum potassium or creatinine 7) Patient has been treated for insomnia 8) Any usage of Minirin therapy within 1 month 9) Uncontrolled hypertension 10)Urge incontinence 11)Clinically significant structural or functional urologic abnormalities 12) Usage of medicatoins which could affect the effect of desmopressin (Diuretics, Tricyclic antidepressants, Indomethacin, Carbamazepine, Cholorpropamide) 13) Usage of anticholinergics 14) Less than 3 months of usage of 5 alpha reductase inhibitors 15) Less than 8 weeks of usage of alpha blockers

Design outcomes

Primary

Measure	Time frame
changes in nocturia on voiding diary	—

Secondary

Measure	Time frame
Voiding diary ( ratio of patients who decreased more than 50% of nocturia, changes in nocturnal urine volume, ratio of nocturnal urine volume to 24 hours urine volume, first sleep duration;International prostate symptom score;changes in nocturnal hesitancy;Quality of life ( changes in bother score in ICIQ-N, changes in quality of life score in IPSS);Patient perception (Benefit, satisfaction, and willingness to continue questions, sleep quality)	—

Measure

Time frame

Voiding diary ( ratio of patients who decreased more than 50% of nocturia, changes in nocturnal urine volume, ratio of nocturnal urine volume to 24 hours urine volume, first sleep duration;International prostate symptom score;changes in nocturnal hesitancy;Quality of life ( changes in bother score in ICIQ-N, changes in quality of life score in IPSS);Patient perception (Benefit, satisfaction, and willingness to continue questions, sleep quality)

—

Countries

Korea, Republic of

Contacts

Public ContactKang Jun Cho

The Catholic University of Korea, Bucheon St. Mary's Hospital

gift928@naver.com+82-32-340-2267

Outcome results