Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
- Registration Number
- NCT00902265
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 138
- Therapeutic need according to Summary of Product Characteristics
- Written informed consent
- Contraindications according to Summary of Product Characteristics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description desmopressin desmopressin Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria. Drug given by prescription.
- Primary Outcome Measures
Name Time Method Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 Baseline, 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.
Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 Baseline, 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.
Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 Baseline, 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.
Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 Baseline, 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).
Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 Baseline, 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.
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) Baseline, 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 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).
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 Baseline, 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).
Participants With Treatment Emergent Adverse Events (AEs) Week 1 to Week 12
Trial Locations
- Locations (66)
Investigational Site - Kurfürstendamm 33
🇩🇪Berlin, Germany
Investigational Site - Marburger Straße 12/13
🇩🇪Berlin, Germany
Investigational Site - Mehrower Allee 22
🇩🇪Berlin, Germany
Investigational Site - Schnellerstraße 123
🇩🇪Berlin, Germany
Investigational Site - Ginnheimer Landstraße 88
🇩🇪Frankfurt /Main, Germany
Investigational Site - Eschersheimer Landstr. 544
🇩🇪Frankfurt a.M., Germany
Investigational Site - Nimeyerstraße 23
🇩🇪Halle, Germany
Investigational Site - Möllner Landstraße 27
🇩🇪Hamburg, Germany
Investigational Site - Dornburger Straße 17a
🇩🇪Jena, Germany
Investigational Site - Ernst-Abbe-Platz 3-4
🇩🇪Jena, Germany
Investigational Site - Hohenstaufenring 59
🇩🇪Köln, Germany
Investigational Site - Wilhelm-Ewald-Weg 1
🇩🇪Köln, Germany
Investigational Site - Zeppelinstraße 1
🇩🇪Köln, Germany
Investigational Site - Bahnhofstraße 8
🇩🇪Nordhausen, Germany
Investigational Site - Karl-Gerharts-Straße 2
🇩🇪Schwerte, Germany
Investigational Site - Langerfelder Straße 115
🇩🇪Wuppertal, Germany
Investigational Site - Morianstraße 10
🇩🇪Wuppertal, Germany
Investigational Site - Friedrich-Wilhelm-Str. 43/44
🇩🇪Braunschweig, Germany
Investigational Site - Neumarkt 1d
🇩🇪Celle, Germany
Investigational Site - Rüttenscheider Stern 5
🇩🇪Essen, Germany
Investigational Site - Florastraße 44
🇩🇪Berlin, Germany
Investigational Site - Britzer Damm 63
🇩🇪Berlin, Germany
Investigational Site - Pauwelsstraße 30
🇩🇪Aachen, Germany
Investigational Site
🇩🇪Witten, Germany
Investigational Site - Heerstraße 435
🇩🇪Berlin, Germany
Investigational Site - Fritz-Reuter-Straße 6-8
🇩🇪Berlin, Germany
Investigational Site - Sanatoriumstraße 10
🇩🇪Aachen, Germany
Investigational Site - Breite Straße 37
🇩🇪Berlin, Germany
Investigational Site - Kaiserdamm 12
🇩🇪Berlin, Germany
Investigational Site - Küchenstraße 10
🇩🇪Braunschweig, Germany
Investigational Site - Ritterbrunnen 7
🇩🇪Braunschweig, Germany
Investigational Site - Dr.-Franz-Mertens-Str. 8
🇩🇪Bremerhaven, Germany
Investigational Site - Wittbräucker Str. 2
🇩🇪Dortmund, Germany
Investigational Site - Humannstraße 3
🇩🇪Essen, Germany
Investigational Site - Zitzmannstraße 2
🇩🇪Jena, Germany
Investigational Site - Großer Plan 11
🇩🇪Celle, Germany
Investigational Site - Hansastraße 14-16
🇩🇪Dortmund, Germany
Investigational Site - Gerichtsstraße 32
🇩🇪Essen, Germany
Investigational Site - Markt 4
🇩🇪Dortmund, Germany
Investigational Site - Bologarostraße 131
🇩🇪Frankfurt a.M., Germany
Investigational Site - Oeder Weg 72
🇩🇪Frankfurt a.M., Germany
Investigational Site - Zum Ehrenmal 21
🇩🇪Gelsenkirchen, Germany
Investigational Site - Diesterwegstraße 39
🇩🇪Halle, Germany
Investigational Site - August-Bebel-Platz 33-34
🇩🇪Nordhausen, Germany
Investigational Site - Allee nach Sanssouci 7
🇩🇪Potsdam, Germany
Investigational Site - Großbeerenstraße 301
🇩🇪Potsdam, Germany
Investigational Site - Materialhofstraße 9-11
🇩🇪Rendsburg, Germany
Investigational Site - Berliner Promenade 15
🇩🇪Saarbrücken, Germany
Investigational Site - Heckenstraße 10
🇩🇪Salzgitter, Germany
Investigational Site - In den Blumentriften 62
🇩🇪Salzgitter, Germany
Investigational Site - Am Ostentor 5
🇩🇪Schwerte, Germany
Investigational Site - Fleischstraße 20
🇩🇪Trier, Germany
Investigational Site - Georgstraße 44
🇩🇪Bremerhaven, Germany
Investigational Site - Kutzbachstraße 7
🇩🇪Trier, Germany
Investigational Site - Einsteinstraße 59
🇩🇪Ulm, Germany
Investigational Site - Olgastraße 103
🇩🇪Ulm, Germany
Investigational Site - Olgastraße 139
🇩🇪Ulm, Germany
Investigational Site - Rüdesheimer Straße 43
🇩🇪Berlin, Germany
Investigational Site - Tempelhofer Damm 214
🇩🇪Berlin, Germany
Investigational Site - Turmstraße 82
🇩🇪Berlin, Germany
Investigational Site - Güldenstraße 19-20
🇩🇪Braunschweig, Germany
Investigational Site - Humboldtstraße 4
🇩🇪Braunschweig, Germany
Investigational Site - Altessener Str. 400a
🇩🇪Essen, Germany
Investigational Site - Grindelberg 3
🇩🇪Hamburg, Germany
Investigational Site - Bahnhofstraße 17
🇩🇪Nordhausen, Germany
Investigational Site - Kaiserslauterer Str. 26
🇩🇪Saarbrücken, Germany