A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

Inclusion Criteria: * Adults ≥18 years of age (at the time of written consent) * Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1 * ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2 * The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2 * Nocturnal polyuria, defined as Nocturnal Polyuria index \>33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2 * ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3 Exclusion Criteria: * Current diagnosis of Obstructive Sleep Apnoea (OSA) * Restless Legs Syndrome (RLS) * Bladder Outlet Obstruction (BOO) or urine flow \<5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2 * Urinary incontinence defined as an average of \>1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary) * Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures * Geni…