CTRI/2014/09/004999
Recruiting
Phase 4
A prospective, randomized, single blind study of ocular side effects of darifenacin and trospium in overactive bladder.
Dr Manjunatha R self0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dr Manjunatha R self
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients aged \>18 and \<80 years
- •Patients with a baseline score for urinary urgency of \>\=2 points, day time frequency \>1 point and a total OABSS of \>\=3 points, with or without urgency urinary incontinence (UUI) episodes
- •Symptoms of OAB for at least 4 weeks
- •Patients with stable doses of alpha blockers or 5\-alpha\-reductase inhibitors for patients with benign prostatic hyperplasia were permitted with the limitation that a specific drug was used without a change in dosage and administration and was not replaced with another drug during the study period (observation and treatment phase).
Exclusion Criteria
- •Serious heart disease,
- •Untreated angle\-closure glaucoma,
- •Myasthenia gravis,
- •Gastric outlet and intestinal obstruction, paralytic ileus, gastric and intestinal atony or risk of urinary or gastric retention.
- •Residual urine volume \>\=100 mL (determined by abdominal sonography)
- •Strong possibility of prostate and bladder cancer
- •Acute active urinary tract infection
- •Women of childbearing age were required not to be pregnant or nursing, and to be using acceptable methods of contraception.
- •Concomitant treatments known to affect urinary bladder function like anticholinergics, antispasmodics, serotonin\-noradrenaline\-reuptake\-inhibitors, TCA, first generation antihistaminics, cholinergic agonists, cholinesterase inhibitors (e.g. bethanecol, donepezil and rivastigmine), potent inhibitors of cytochrome CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), potent P\-glycoprotein inhibitors (e.g. cyclosporine and verapamil), aluminum antacids, antiparkinson and antipsychotic drugs, Calcium channel blockers, opioids, muscle relaxants, angiotensin\-converting enzyme inhibitors, anticoagulants.
- •Patients on digoxin or metformin
Outcomes
Primary Outcomes
Not specified
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