Indian Journal of Urology
ORIGINAL ARTICLE
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


Anant Kumar 
 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
India

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«SQ» per­ception of treatment benefit. Efficacy was evaluated from patients«SQ» 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«SQ» 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 The most common adverse event was dry mouth (10.3%). 5 sub­jects were withdrawn due to adverse events and all the subjects recovered uneventfully.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.


How to cite this article:
Kumar A. Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study.Indian J Urol 2002;19:73-78


How to cite this URL:
Kumar A. Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study. Indian J Urol [serial online] 2002 [cited 2020 Nov 28 ];19:73-78
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