Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)

Study Overview
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Brief Summary
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Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.

Official Title
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Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, Lower Urinary Tract Symptoms (LUTS) and Benign Prostate Syndrome (BPS).

Conditions
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Nocturia Associated With Nocturnal Polyuria

Intervention / Treatment
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* Drug: desmopressin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Therapeutic need according to Summary of Product Characteristics Written informed consent Exclusion Criteria: Contraindications according to Summary of Product Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| desmopressin<br>Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria. Drug given by prescription. | Drug: desmopressin<br>* desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks<br>* Other names: Nocturin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 | The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 | The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here. | Baseline, Week 12 | 
| Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 | Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline. | Baseline, Week 12 | 
| Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 | The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms. | Baseline, Week 12 | 
| Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 | The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL). | Baseline, Week 12 | 
| Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 | The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality. | Baseline, Week 12 | 
| Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) | The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL). | Baseline, Week 12 | 
| Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12 | The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL). | Baseline, Week 12 | 
| Participants With Treatment Emergent Adverse Events (AEs) |  | Week 1 to Week 12 |