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

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00902265
First received: May 14, 2009
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

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 Intervention
Nocturia Associated With Nocturnal Polyuria
Drug: desmopressin

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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:
  • Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 1 to Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 138
Study Start Date: February 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00902265

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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00902265     History of Changes
Other Study ID Numbers: FE992026 CS33
Study First Received: May 14, 2009
Results First Received: March 15, 2011
Last Updated: April 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Nocturia
Polyuria
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014