Urinary Nerve Growth Factor (NGF), Prostaglandin E2 (PGE2)and Adenosine Triphosphate (ATP): Potential Biomarkers in Overactive Bladder Patients

This is an interventional other trial for Overactive Bladder Read More

Inclusion Criteria:

• Male or female aged 18 or over 18 years who had no history of antimuscarinic treatment or stopped antimuscarinics at least 3 months prior to the screening visit

• Verified by 3-day bladder diary as below

  • Urgency episode of 2 or over 2 times/24 hours (defined as a level of 3 to 5 in a 5 point urgency scale at baseline)
  • Urinary frequency of 8 or over 8 times/24 hours
• Symptom duration of 3 or over 3 months.
• Ability and willingness to correctly complete the micturition diary and questionnaire
• Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

• Clinically significant stress incontinence as determined by the investigators and confirmed for female patients by a cough provocation test.
• Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine
• Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
• Symptomatic acute urinary tract infection (UTI) during the run-in period
• Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
• Diagnosed or suspected interstitial cystitis
• Uninvestigated hematuria or hematuria secondary to malignant disease.
• Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
• Patients with marked cystocele or other clinically significant pelvic prolapse.

• Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with:

  • Any anticholinergic drugs other than randomized trial drug
  • Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed.
• On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
• Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
• An indwelling catheter or practicing intermittent self-catheterization
• Use of any investigational drug within 2 months preceding the start of the study
• Patients with chronic constipation or history of severe constipation
• Pregnant or nursing women
• Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
• Patients who have bladder cancer or prostate cancer
• Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole).
• Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion