A clinical trial to study the effects of two drugs, propiverine and oxybutynin in patients with urinary incontinence.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000658
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

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: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified