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Study · Randomized controlled trial · n = 261 · 2013

8 results

Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study.

Sand PK, Dmochowski RR, Reddy J, van der Meulen EA

The Journal of urology20 Feb 2013Cited by 57 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In women with nocturia, desmopressin reduced nocturnal voids versus placebo by 0.22 (p = 0.028).

    In plain wordsIn women with nocturia, desmopressin reduced nightly urination more than placebo.

    Outcome
    DecreaseNocturnal voids
    Study

    n = 261

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Measurements

    Change in mean number of nocturnal voids versus placebo
    −0.22 voids
    desmopressin 25 μg, longitudinal analysis, 3 months

    Source sentences

    Summary
    Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (-0.22, p = 0.028 and OR 1.85, p = 0.006, respectively).
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In women with nocturia, desmopressin increased odds of at least 33% response versus placebo (OR 1.85, p = 0.006).

    In plain wordsIn women with nocturia, desmopressin increased response odds compared with placebo.

    Outcome
    IncreaseAt least 33% response
    Study

    n = 261

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Measurements

    Odds ratio for at least 33% reduction in nocturnal voids versus placebo
    1.85 odds ratio
    desmopressin 25 μg, longitudinal analysis, 3 months

    Source sentences

    Summary
    Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (-0.22, p = 0.028 and OR 1.85, p = 0.006, respectively).
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In women with nocturia, desmopressin delayed first nocturnal void by 49 minutes versus placebo (p = 0.003).

    In plain wordsIn women with nocturia, desmopressin delayed first urination by 49 minutes compared with placebo.

    Outcome
    IncreaseTime to first nocturnal void
    Study

    n = 261

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Measurements

    Increase in mean time to first nocturnal void versus placebo
    49 minutes
    desmopressin 25 μg, at 3 months

    Source sentences

    Summary
    Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p = 0.003).
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In women with nocturia, desmopressin significantly improved health-related quality of life compared with placebo.

    In plain wordsIn women with nocturia, desmopressin improved quality of life compared with placebo.

    Outcome
    IncreaseHealth-related quality of life
    Study

    n = 261

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases in health related quality of life and sleep quality were observed compared to placebo.
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women with nocturia, desmopressin significantly improved sleep quality compared with placebo.

    In plain wordsIn women with nocturia, desmopressin improved sleep quality compared with placebo.

    Outcome
    IncreaseSleep quality
    Study

    n = 261

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Significant increases in health related quality of life and sleep quality were observed compared to placebo.
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  6. 06HumanNon-randomized trialEfficacy outcome

    In women with nocturia, desmopressin response appeared by week 1 and persisted throughout the trial.

    In plain wordsIn women with nocturia, desmopressin response appeared by week 1 and persisted throughout the trial.

    Outcome
    Not applicableResponse onset and persistence
    Study

    n = 261

    Outcome group
    Nocturia · Kidney and urinary
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Measurements

    Week by which response was seen
    ≤ 1 week
    desmopressin 25 μg

    Source sentences

    Summary
    The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial.
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  7. 07HumanNon-randomized trialSafety outcome

    In women with nocturia, desmopressin was well tolerated.

    In plain wordsIn women with nocturia, desmopressin was well tolerated.

    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Source sentences

    Summary
    Desmopressin was well tolerated.
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).
  8. 08HumanNon-randomized trialSafety outcome

    In the women's desmopressin trial, sodium remained above 125 mmol/L, with 3 transient decreases below 130 mmol/L.

    In plain wordsIn the women's desmopressin trial, sodium stayed above 125 mmol/L, with 3 temporary decreases below 130 mmol/L.

    Outcome
    Not applicableSerum sodium
    Study

    n: not reported in source

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    25 μg once daily · oral · 3 monthsAs given in this study (human).

    Measurements

    Serum sodium level maintained
    > 125 mmol/L
    desmopressin 25 μg, throughout the trial
    Transient decreases in serum sodium to <130 mmol/L
    3 transient decreases
    desmopressin 25 μg

    Source sentences

    Summary
    Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded.
    2 context sentences
    Summary · context
    In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids).
    Summary · context
    The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01223937

Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

Ferring Pharmaceuticalsn = 268Nov 2010 to Nov 2011

Nocturia

Trial pageClinicalTrials.govUpdated 15 Oct 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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