Lower urinary tract symptoms in male patients with Nocturia Nocturia Prostatic Hyperplasia Melatonin Adrenergic alpha-Antagonists Lower Urinary Tract Symptoms Sleep Disorders Quality of Life
Conditions
Interventions
Participants will receive Circadin 2 mg prolonged-release melatonin tablets. The dosage is one tablet (2 mg) taken orally every night before bedtime for a period of one month.,Participants will receiv
Experimental Drug,Placebo Comparator Drug
Sponsors
Phramongkutklao Hospital
Eligibility
Sex/Gender
Male
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with benign prostatic enlargement, with a prostate size confirmed to be greater than 30 milliliters by imaging. 2. Patients who have been on a stable dose of alpha-blocker medication consistently for three months or more. 3. Patients who wake up from sleep to urinate two or more times per night (nocturia).
Exclusion criteria
Exclusion criteria: 1. Patients who are using other drugs or supplements intended to aid sleep. 2. Patients using medications, other than alpha-blockers, that are known to affect urination. 3. Patients with a known history of allergy to melatonin. 4. Patients who have previously used or are currently using melatonin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the frequency of nocturia episodes Baseline, after 1 month of the first treatment, and after 1 month of the second treatment Number of nightly awakenings to urinate, as recorded by the patient in a bladder diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life related to nocturia Baseline, after 1 month of the first treatment, and after 1 month of the second treatment. Score on the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-Nqol),Change in Lower Urinary Tract Symptoms (LUTS) Baseline, after 1 month of the first treatment, and after 1 month of the second treatment. Score on the International Prostate Symptom Score (IPSS) and The Overactive Bladder Symptom Score (OABSS),Incidence of adverse events Monitored throughout both 1-month treatment periods. Assessed using a side effect record form for melatonin | — |
Countries
Thailand
Contacts
Public ContactNatthawan Simajaruek
Phramongkutklao Hospital
Outcome results
None listed