N/A
N=138
Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Nocturia Associated With Nocturnal Polyuria
Bottom Line
View on ClinicalTrials.gov: NCT00902265 ↗Enrolled (actual)
138
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 — -2.01 Number of nocturnal voids
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- desmopressin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 |
-2.01 | — |
| SECONDARY Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 |
-14.0 | — |
| SECONDARY Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 |
1.69 | — |
| SECONDARY Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 |
-4.86 | — |
| SECONDARY Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 |
-1.56 | — |
| SECONDARY Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 |
-15.1 | — |
| SECONDARY 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) |
-2.25 | — |
| SECONDARY 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 |
-4.00 | — |
| SECONDARY Participants With Treatment Emergent Adverse Events (AEs) |
3; 0; 0; 2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Therapeutic need according to Summary of Product Characteristics
- Written informed consent
Exclusion Criteria
- Contraindications according to Summary of Product Characteristics
Data sourced from ClinicalTrials.gov (NCT00902265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.