None listed
Conditions
Interventions
Intervention1: Propiverine Tablets: 15mg twice daily
may be increased to 15 mg three times daily for 4 weeks.
Control Intervention1: Oxybutynin tablet: 5mg two or three times daily for 4 weeks.
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged between 18 - 65 years. 2.Patients with history of urgency or urge incontinence. 3.Patients with UI (≥7 episodes/week) and frequency (≥8 micturition/day). 4.Patients willing to give their informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2.Patients with postvoid residual volume > 100ml. 3.Patients on unstable dosage of any drug with anticholinergics or diuretic/ antidiuretic side effects. 4.Patients with allergy or previous life threatening side effects with anticholinergics/antispasmodic medication. 5.Patients with primary diagnosis of stress urinary incontinence. 6.Patients with conditions wherein anticholinergics are contraindicated. 7.Patients with hepatic/renal diseases. 8.Patients with diagnosed painful bladder syndrome. 9.Patients with uninvestigated voiding difficulty with risk of urinary retention, uninvestigated hematuria, or hematuria secondary to malignant disease. 10.Patents having acute UTIs or history of recurrent UTIs (>3 UTIs/year). 11.Indwelling catheter or bladder training within screening period. 12.Patients with bladder outlet obstruction. 13.Patients suffering from one of the following disorders; Obstruction of the bowel, Significant degree of bladder outflow obstruction where urinary retention may be anticipated, Myasthenia gravis, Severe decreased gastrointestinal motility conditions, Severe ulcerative colitis, Toxic megacolon, Uncontrolled angle closure glaucoma, Moderate or severe hepatic impairment, Tachyarrhythmias, Autonomic neuropathy, Severe congestive heart failure, Prostatic hypertrophy, Hiatus hernia with reflux oesophagitis, Cardiac arrhythmia, Overt cerebral sclerosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of change in ICIQ-SF total scoreTimepoint: week 2 and week 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global evaluation by patients and investigatorTimepoint: week 4 | — |
Countries
India
Contacts
Public ContactDr. Surendra Borgharkar
Outcome results
None listed