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

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ClinicalTrials.gov Identifier: NCT00902265
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : April 11, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment
Nocturia Associated With Nocturnal Polyuria Drug: desmopressin

Study Design
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Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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).
Study Start Date : February 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Groups and Cohorts
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Group/Cohort Intervention/treatment
desmopressin

Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.

Drug given by prescription.

 Drug: desmopressin
desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
Other Name: Nocturin®


Outcome Measures
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Primary Outcome Measures :
  1. Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 [ Time Frame: 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 :
  1. Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 [ Time Frame: 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.

  2. Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 [ Time Frame: 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.

  3. Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: 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.

  4. Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 [ Time Frame: 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).

  5. Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 [ Time Frame: 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.

  6. 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) [ Time Frame: 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).

  7. 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 [ Time Frame: 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).

  8. Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 1 to Week 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
private practices
Criteria

Inclusion Criteria:

  • Therapeutic need according to Summary of Product Characteristics
  • Written informed consent

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902265


Locations
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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00902265    
Other Study ID Numbers: FE992026 CS33
First Posted: May 15, 2009    Key Record Dates
Results First Posted: April 11, 2011
Last Update Posted: April 19, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Polyuria
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Urination Disorders
Urologic Diseases
 Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs