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Year : 2002  |  Volume : 19  |  Issue : 1  |  Page : 73-78

Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study

Department of Urology and Renal Transplantation, SGPGIMS, Lucknow, India

Correspondence Address:
Anant Kumar
Department of Urology and Renal Transplantation, SGPGIMS, Rai Bareilly Road, Lucknow - 226 014
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Source of Support: None, Conflict of Interest: None

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Objective: To evaluate the clinical efficacy and safety of Tolterodine 2 mg twice daily in Indian subjects with symptoms of overactive bladder including frequency, ur­gency with or without urge incontinence. Methods: This multicentric open-label, noncompara­tive, prospective study was conducted at 7 centers across India. Eligible patients were assigned to treatment with Tab. Tolterodine 2 mg twice daily for 8 weeks. Subjects were seen at visit ](day 3 to 10), visit 2 (day 1) and after 8 weeks of treatment. Micturition charts were completed prior to visit 2 and visit 3. Efficacy variables included change, from baseline to 8 weeks of treatment in the mean number of micturitions, incontinence episodes/24 hours, mean volume voided per micturition and subjects' per­ception of treatment benefit. Efficacy was evaluated from patients' micturition diaries. Patients were also assessed for adverse events during the treatment. Results: A total of 127 subjects with symptoms of overactive bladder were enrolled. 8 weeks' treatment with Tolterodine resulted in improvement in assessment of all symptoms of overactive bladder Significant decreases from baseline in both the frequency of micturition (mean ± SD of -2.5 ± 5.0 per 24 hours, p=0.0001) and the number of incontinence episodes per 24 hours (-1.5±3.8, p=0.0051) and a significant increase in mean volume voided per mic­turition (+26±55 ml, p=0.0001) were obtained. Treatment was well tolerated and most subjects (71.4%) did not ex­perience any adverse events during the study. The most common adverse event was dry mouth (10.3%). 5 sub­jects were withdrawn due to adverse events and all the subjects recovered uneventfully. Conclusions: Treatment with Tolterodine 2 mg twice daily was effective and safe in Indian subjects with the symptoms of overactive bladder as assessed by both objective and subjective criteria.

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