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
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 The most common adverse event was dry mouth (10.3%). 5 subjects were withdrawn due to adverse events and all the subjects recovered uneventfully.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.
Department of Urology and Renal Transplantation, SGPGIMS, Rai Bareilly Road, Lucknow - 226 014
|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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