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Study Comparing Desmopressin and Desmopressin Acetate in Children with Bedwetting (Nocturnal Enuresis)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as nocturnal enuresis, which is more commonly referred to as bedwetting. The study involves children who experience this condition. The trial will compare two different treatments that contain the active ingredient desmopressin. The two treatments being compared are called Minirin and Desmopressin "Sandoz". Both of these treatments are designed to help manage bedwetting by affecting how the body concentrates urine.

The purpose of the study is to understand the differences in how these two forms of desmopressin work in the body. This includes looking at how the body absorbs and processes the medication, as well as how effective each treatment is at concentrating urine. The study will involve children taking one of the two medications, and their responses will be monitored over a period of time. The children will take the medication either as an oral lyophilisate, which is a type of tablet that dissolves in the mouth, or as a sublingual tablet, which is placed under the tongue to dissolve.

Throughout the study, researchers will collect information on how the medications affect urine concentration and output. They will also gather feedback on the taste and texture of the medications to understand which one is preferred by the participants. The study aims to provide valuable insights into the best treatment options for children with bedwetting, helping to improve their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, the study team will confirm your eligibility based on the criteria: being aged 8-14 years, having a diagnosis of nocturnal enuresis (bedwetting), experiencing 3 or more wet nights per week, and having completed a 7-day home measurement of urine output and a 2-day fluid intake measurement prior to this visit.

  2. Step 2

    Medication administration

    You will be given one of two formulations of the medication desmopressin: either Minirin or Sandoz. These are sublingual tablets, meaning they dissolve under your tongue. The exact dosage and frequency will be determined by the study team and explained to you during the visit.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, you will be monitored to assess how your body processes the medication. This includes measuring the concentration of the medication in your blood and how well it helps concentrate your urine. You will also be asked about your preferences regarding the taste and texture of the medication.

  4. Step 4

    Completion of study

    The study is expected to end by February 1, 2026. At the end of the study, you will have a final visit where the study team will review your experience and any changes in your condition.

Who can join the trial?

4 criteria

  • Children aged 8 to 14 years.
  • Diagnosis of nocturnal enuresis (bedwetting at night).
  • Experience 3 or more wet nights per week.
  • Complete a 7-day home measurement of urine output and a 2-day fluid intake measurement before the first visit.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing nocturnal enuresis (bedwetting at night) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate.
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Investigated drugs

  • Minirin

    is a medication used in this clinical trial to study how it behaves in the body and how it affects the ability to concentrate urine. It is a form of desmopressin, which is often used to treat conditions like diabetes insipidus and bedwetting by helping the kidneys reduce the amount of urine produced.

  • Sandoz

    is another formulation of desmopressin being tested in this trial. Like Minirin, it is used to help control urine production in the body. The trial aims to compare how Sandoz and Minirin are processed by the body and how effective they are in concentrating urine.

What is already known about the treatment

  • Minirin

    Minirin is a medication administered in the form of a tablet or nasal spray, used to treat nocturnal enuresis, which is bedwetting at night. It is well-established in medical literature and is commonly prescribed for this condition. The main therapeutic indication for Minirin is its ability to reduce urine production at night, helping to prevent bedwetting. At the molecular level, Minirin works by mimicking a natural hormone in the body called vasopressin, which helps the kidneys manage the amount of water in the body. It belongs to the pharmacological class of antidiuretic hormones.

  • Sandoz

    Sandoz is another formulation of desmopressin, similar to Minirin, and is also available as a tablet or nasal spray for the treatment of nocturnal enuresis. It is currently being studied to compare its effectiveness and absorption in the body against Minirin. Like Minirin, Sandoz helps reduce nighttime urine production by acting like the hormone vasopressin, which helps control water balance in the body. It is classified as an antidiuretic hormone, and its use is supported by medical research for managing bedwetting.

Investigated diseases

Nocturnal enuresis – Nocturnal enuresis, commonly known as bedwetting, is a condition characterized by involuntary urination during sleep. It typically occurs in children but can persist into adulthood. The condition is often linked to a delay in the development of bladder control. It may also be associated with a deep sleep pattern where the individual does not wake up when the bladder is full. Over time, many children naturally outgrow nocturnal enuresis as their bladder control improves. The condition can vary in frequency, with some experiencing it nightly and others only occasionally.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521256-29-00Estimated enrolment24 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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