Efficacy and Safety Evaluating Study to Compare Uritos® (Imidafenacin) and Urotol® (Tolterodine) for Treatment of Overactive Bladder.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Uritos®; Urotol®
Intervention description: film-coated tablets 0.1 mg; film coated tablets, 2 mg
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: overactive bladder; urinary incontinence; frequent urination; urge incontinence; urgency episodes

Summary:

      Objective of this study was confirmation on non-inferiority and validation of similar safety
      profile of new anti-muscarinic medicinal product Uritos® (Imidafenacin) in comparison with
      other product from m-cholinergic antagonists group Urotol® (Tolterodine).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed dated informed consent.

          2. Confirmed overactive bladder (OAB). The OAB diagnosis was made based on characteristic
             symptoms of the patient:

               1. urinary incontinence - 5 or more episodes a week;

               2. frequent urination - 8 or more times a day;

               3. imperative urination urge - 1 or more episodes a day.

          3. The duration of the presence of OAB symptoms is 3 months or more (the assessment is
             based on patient's history and medical records).

          4. Overactive bladder Awareness Tool Questionnaire (OAB Awareness Tool) score 8 and more
             at the screening visit and randomization visit.

          5. Negative result of the urine pregnancy test at the screening and the randomization
             visit before receiving the first dose of the study drug in women of childbearing
             potential.

          6. Female patients of childbearing potential and male patients and their female partners
             should use at least two birth control methods, one of those is barrier, during the
             entire study period and for at least 35 days following administration of the last dose
             of the study product. Acceptable methods of contraception:

               -  oral, transdermal, implantation or injection hormone therapy;

               -  effective intrauterine devices;

               -  double barrier contraceptive methods.

          7. Willingness and ability to follow the study visits schedule, treatment plan,
             laboratory tests and other study procedures.

        Exclusion Criteria:

          1. A history of hypersensitivity or suspected hypersensitivity to tolterodine or
             imidafenacin.

          2. Structural abnormalities of the bladder, including bladder cancer, bladder stones,
             interstitial cystitis.

          3. The volume of residual urine is 100 ml or more with bladder ultrasound.

          4. Documented diagnosis of stress urinary incontinence.

          5. Operative interventions on the bladder or urethra within the previous 6 months or
             indications for surgical treatment for OAB.

          6. Exacerbation of gynecological diseases including endometriosis, uterine leiomyoma
             exceeding 3 cm in diameter.

          7. Prostate cancer.

          8. Prostate diseases with clinically significant urodynamics abnormality (benign
             prostatic hyperplasia, acute and chronic prostatitis, prostatic calculus).

          9. Renal and urinary inflammatory disorders (pyelonephritis, bacterial cystitis,
             urethritis).

         10. For male, the prostatic specific antigen (PSA) level above 4 ng/mL.

         11. Severe liver impairment alanine aminotransferase (ALT) and/or aspartate
             aminotransferase (AST) level 3 and more times exceeding the upper limit of normal
             and/or total bilirubin level 1.5 times exceeding the upper limit of normal.

         12. Moderate or severe renal impairment based on the medical records and/or glomerular
             filtration rate < 50 mL/min determined by Cockroft-Gault formula and/or blood
             creatinine level > 133 μmol/L at screening.

         13. A positive test result for hepatitis B, hepatitis C and human immunodeficiency virus
             (HIV).

         14. Patients suffering from a neoplastic condition without remission at least within 5
             years from the start of administration of the study product.

         15. Vascular dementia, dementia in Alzheimer's disease, dementia in other diseases,
             including organic amnestic syndrome.

         16. Parkinson's disease or secondary parkinsonism.

         17. Nonspecific ulcerative colitis, including severe ulcerative colitis.

         18. Thyroid disorders with hyperthyroidism signs.

         19. Chronic heart insufficiency Stage III-IV by New York Heart Association Chronic heart
             insufficiency classification (NYHA).

         20. Hypotension: systolic blood pressure (SBP) < 90 mm Hg and/or diastolic blood pressure
             (DBP) < 60 mm Hg.

         21. Uncontrolled medically induced hypertension.

         22. Hemodynamically and/or clinically significant heart arrhythmias.

         23. QTc prolongation up to 450 ms and more in men and 470 ms and more in women.

         24. Open-angle glaucoma.

         25. Myasthenia gravis.

         26. Megacolon, paralytic ileus, pyloric part of the stomach/duodenal occlusion and any
             other conditions associated with clinically significant gastric/intestinal obstruction
             or depressed motility.

         27. Necessity of intake and/or intake of prohibited products listed in the Section
             "Acceptable and prohibited recent and concomitant therapy" within 7 days before the
             start of therapy.

         28. Drug abuse, chronic alcoholism, any psychotic disorders.

         29. Participation in other studies within 3 months prior to the beginning of the current
             study and/or during participation in this study.

         30. Pregnancy and/or breastfeeding.

         31. Female patients of childbearing potential, having an unprotected sexual contact with a
             male person non-sterilized by vasectomy during at least 6 months, within 14 days
             before administration of the study product.

         32. Inability to follow protocol procedures.

         33. Any other acute or exacerbation and/or decompensation of chronic diseases at inclusion
             in the study.

         34. Patient's behavior, any safety reasons, clinical and administrative reasons, which,
             according to Investigator's opinion, may potentially affect the study drug
             safety/efficiency assessment.

         35. Other medical and psychiatric conditions or deviations of laboratory parameter which
             may increase patient risk associated with participation in the study or administration
             of the study product, or which can influence the interpretation of the study results
             and, according to Investigator's opinion, make a person ineligible for participation
             in this study.

         36. Patients who are employees of the study site or patients who are employees of the
             Sponsor/Contract Research Organization (CRO), directly involved in this clinical
             trial.