Health Condition 1: null- patients with frequency, urgency, nocturia with or without urgency urinary incontinence with normal and stable general condition
Conditions
Interventions
Intervention1: Darifenacin 7.5mg: Tab Darifenacin 7.5mg, once daily at night for 14 days
Control Intervention1: Trospium 60mg: Tab Trospium 60mg, once daily, one hour before meals with full glass of w
Sponsors
Dr Manjunatha R self
Eligibility
Inclusion criteria
Inclusion criteria: •Male and female patients aged >18 and •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
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 •Severe hepatic or renal dysfunction •Participation in a clinical trial within 30 days before study entry. •History of alcohol or drug abuse •Currently suffering from serious disease or malignancy •Significant psychiatric problems •Dry eyes, ocular surface disorders, glaucoma, or issues that could affect visual acuity or accommodation (such as cataract, macular degeneration, or history of ocular surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in accommodation amplitude, pupillary diameter, schirmer 1 and 2 tests and tear film break-up time between the two treatment groups.Timepoint: baseline (day 0) and end of study (day 14) | — |
Secondary
| Measure | Time frame |
|---|---|
| change in accommodation amplitude and pupillary diameterTimepoint: baseline (day 0) and end of study (day 14) | — |
Countries
India
Contacts
Public ContactDr Manjunatha R
Kempegowda Institute of Medical Sciences, Bangalore.
Outcome results
None listed