Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
Condition: Nocturia
MeSH terms: Nocturia
Intervention: Desmopressin; Placebo
Intervention description: Desmopressin orally disintegrating tablets. Female participants took a 25 μg tablet and male participants took a 75 μg tablet one hour prior to bedtime for one month.; Placebo to match the 25 μg tablet of active drug taken by female participants or the 75 μg tablet taken by males. One placebo tablet taken one hour prior to bedtime for one month.
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess psychometric properties (reliability and validity) of
      the Nocturia Impact (NI) diary.

      To assess the association between reduction of number of nocturnal voids and the mean changes
      in NI scores (sensitivity of the NI total score to change in nocturia).

      To assess which NI diary items account for the main difference in change in total NI score in
      treatment versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent prior to performance of any study-related activity

          2. 18 years of age (at the time of written consent) or older

          3. Previous participation in FE992026 CS40 or FE992026 CS41 with a completion ≥ 30 days
             prior to Screening. The subject should have responded to active treatment during
             FE992026 CS40 or FE992026 CS41 or if he/she received placebo during these two studies
             he/she should have been a non-responder.

          4. At least two nocturnal voids every night in two consecutive 3-day periods during the
             screening period (as determined by the two night-time voiding diaries dispensed at
             Visit 1 and collected at Visit 2)

        Exclusion Criteria:

          1. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)

          2. Suspicion of bladder outlet obstruction (BOO) or a urine flow of < 5 mL/s as confirmed
             by uroflowmetry performed after suspicion of BOO

          3. Surgical treatment, including transurethral resection, for BOO or benign prostatic
             hyperplasia (males) within the past six months

          4. Urinary retention or a post void residual volume > 150 mL for females and > 250 mL for
             males as confirmed by bladder ultrasound performed after suspicion of urinary
             retention

          5. Central or nephrogenic diabetes insipidus

          6. Syndrome of inappropriate antidiuretic hormone

          7. Current or a history of urologic malignancies e.g. bladder cancer

          8. Genito-urinary tract pathology e.g. infection or stone in the bladder and urethra
             causing symptoms

          9. Neurogenic detrusor activity (detrusor overactivity)

         10. Suspicion or evidence of cardiac failure

         11. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)

         12. Uncontrolled hypertension

         13. Uncontrolled diabetes mellitus

         14. Hyponatraemia: serum sodium level must be within normal limits

         15. Renal insufficiency: Serum creatinine must be within normal limits and estimated
             glomerular filtration rate must be ≥ 50 mL/min

         16. Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine
             aminotransferase (ALT) levels must not be more than twice the upper limit of normal
             range. Total bilirubin level must not be > 1.5 mg/dL

         17. History of obstructive sleep apnea

         18. Treatment with another investigational product (except desmopressin) within three
             months prior to screening and throughout the study

         19. Concomitant treatment with loop diuretics (furosemide, torsemide, ethacrynic acid)

         20. Pregnancy, breastfeeding, or an intention of becoming pregnant during the period of
             the clinical study. Female subjects of reproductive age must have documentation of a
             reliable method of contraception. All pre-and perimenopausal female subjects have to
             perform pregnancy tests. Amenorrhea of > 12 months duration based on the reported date
             of the last menstrual period is sufficient documentation of post-menopausal status and
             does not require a pregnancy test

         21. Known alcohol or substance abuse

         22. Work or lifestyle that may interfere with regular night-time sleep e.g. shiftworkers
             23. Any other medical condition, laboratory abnormality, psychiatric condition, mental
             incapacity, or language barrier which, in the judgment of the Investigator, would
             impair participation in the study