A research study to explore the occurrence of side effects of darifenacin and trospium on eye, the two drugs used in the treatment of patients with increased frequency of urination, urgency, nocturia with or without urinary leakage

Phase 4

• Conditions: Health Condition 1: null- patients with frequency, urgency, nocturia with or without urgency urinary incontinence with normal and stable general condition

• Registration Number: CTRI/2014/09/004999
• Lead Sponsor: Dr Manjunatha R self

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 30

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

•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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified