Nocturia Associated With Nocturnal Polyuria
Conditions
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.
Interventions
DRUGdesmopressin
desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Therapeutic need according to Summary of Product Characteristics * Written informed consent
Exclusion criteria
* Contraindications according to Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 | — |
| 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. |
Countries
Germany
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Desmopressin 0.1 mg Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.
Drug given by prescription. | 137 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up Prior to First Visit | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Desmopressin 0.1 mg |
|---|---|
| Age Continuous | 62.6 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment Germany | 137 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 137 |
| serious Total, serious adverse events | 0 / 137 |
Outcome results
Primary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 | -2.01 Number of nocturnal voids | Standard Deviation 1.13 |
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)
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 Units on a scale | Standard Deviation 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
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 Units on a scale | Standard Deviation 2.49 |
Secondary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 | 1.69 Hours | Standard Deviation 1.16 |
Secondary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 | -14.0 ratio | Standard Deviation 11.9 |
Secondary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 | -1.56 Units on a scale | Standard Deviation 1.05 |
Secondary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 | -15.1 Units on a scale | Standard Deviation 12.1 |
Secondary
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
Population: Intent to treat (ITT) population --All participants who received at least one dose of study drug and provided at least one primary efficacy measure (i.e., number of nocturnal voids)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desmopressin 0.1 mg | Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 | -4.86 Units on a scale | Standard Deviation 4.22 |
Secondary
Participants With Treatment Emergent Adverse Events (AEs)
Time frame: Week 1 to Week 12
Population: Safety Population, consisting of participants who took at least one dose of desmopressin
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desmopressin 0.1 mg | Participants With Treatment Emergent Adverse Events (AEs) | All Adverse Events | 3 Participants |
| Desmopressin 0.1 mg | Participants With Treatment Emergent Adverse Events (AEs) | Deaths | 0 Participants |
| Desmopressin 0.1 mg | Participants With Treatment Emergent Adverse Events (AEs) | Serious Adverse Events | 0 Participants |
| Desmopressin 0.1 mg | Participants With Treatment Emergent Adverse Events (AEs) | AEs Leading to Discontinuation | 2 Participants |