An observational study in Nocturia Associated With Nocturnal Polyuria, sponsored by Ferring Pharmaceuticals. Completed at 140 sites in Germany. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-04-19.
Sponsored by Ferring Pharmaceuticals · Observational
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.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's enrollment of 138 is close to the median of 150 across 21 observational studies indexed under Nocturia.
Browse Nocturia studies →Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Nocturin®
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.
Time frame: Baseline, Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, Week 12
Participants With Treatment Emergent Adverse Events (AEs)
Time frame: Week 1 to Week 12
This was a post marketing, non-randomized surveillance study. The 138 participants were screened from 60 German sites. The study planned for two visits - baseline (week 0 and week 12). Participants could opt for an optional visit between week 0 and week 12 (17 participants did not opt for optional visit).
| Milestone | Desmopressin 0.1 mg |
|---|---|
| Started | 138 |
| Participants who received treatment | 137 |
| Completed | 132 |
| Not completed | 6 |
| Withdrew: Lost to follow-up prior to first visit | 1 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Protocol violation | 1 |
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.
| Number of nocturnal voids | Desmopressin 0.1 mg |
|---|---|
| Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 | -2.01 ± 1.13 |
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.
| ratio | Desmopressin 0.1 mg |
|---|---|
| Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 | -14.0 ± 11.9 |
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.
| Hours | Desmopressin 0.1 mg |
|---|---|
| Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 | 1.69 ± 1.16 |
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.
| Units on a scale | Desmopressin 0.1 mg |
|---|---|
| Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 | -4.86 ± 4.22 |
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).
| Units on a scale | Desmopressin 0.1 mg |
|---|---|
| Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 | -1.56 ± 1.05 |
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.
| Units on a scale | Desmopressin 0.1 mg |
|---|---|
| Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 | -15.1 ± 12.1 |
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).
| Units on a scale | Desmopressin 0.1 mg |
|---|---|
| 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 ± 2.25 |
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).
| Units on a scale | Desmopressin 0.1 mg |
|---|---|
| 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 ± 2.49 |
| Participants | Desmopressin 0.1 mg |
|---|---|
| All Adverse Events | 3 |
| Deaths | 0 |
| Serious Adverse Events | 0 |
| AEs Leading to Discontinuation | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Desmopressin 0.1 mg | — | 0/137 (0%) | 0/137 (0%) |
| Age Continuous(years) | Desmopressin 0.1 mg |
|---|---|
| Mean | 62.6 ± 7.8 |
| Sex: Female, Male(Participants) | Desmopressin 0.1 mg |
|---|---|
| Female | 0 |
| Male | 137 |
| Region of Enrollment(participants) | Desmopressin 0.1 mg |
|---|---|
| Germany | 137 |
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The record gives a start of Feb 2009, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2011, 1 year 1 month after primary completion.
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This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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