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Abstract
Objective:
Evaluate patient and physician satisfaction with a novel formulation of a once-daily controlled-release (CR) oxybutynin (Uromax
*Uromax is a registered trade-mark of Purdue Pharma, Pickering, Ontario, Canada
) 15-mg tablet as both the initial and maintenance dose in elderly and non-elderly patients with overactive bladder (OAB).Methods:
Patients not on anticholinergic treatment for OAB and experiencing urinary incontinence (≥1 episode/week) and micturition frequency (≥8 episodes/day) or urgency (≥1 episode/week) were enrolled in this 4-week, open-label study. Satisfaction, efficacy, mental status and adverse events were evaluated by urologists, gynecologists, urogynecologists and family practitioners. The analyses compared the outcomes in patients <65 and ≥65 years.
Clinical trial registration:
ISRCTN 19242032.
Results:
A total of 240 patients enrolled; 111 (46%) were ≥65 years of age. Completion rate was 76.0% (<65) and 62.2% (≥65) (p = 0.0204). Medication was rated as tolerable by 75.2% of patients <65 and 58.6% of patients ≥65 (p = 0.0099). Based on overall satisfaction scores 64.2% (patient scores) and 57.1% (physician scores) of patients were considered ‘successfully treated’ (p = 0.0001 & p = 0.0451). There was a significant reduction in incontinence (64.3%; p = 0.0001), nocturia (38.6%; p = 0.0001) and night-time incontinence (39.7%; p = 0.0436) with no difference between age groups. Total continence was achieved by 29.8% and 47.5% of patients <65 and ≥65, respectively (p = 0.0077). No patients clinically experienced confusion or delirium and only six patients ≥65 had a decrease in MMSE score of ≥3 units, which was not statistically different from patients <65 (p = 0.3112). Dry mouth was the most common adverse event reported by 24.8% of patients <65 and 36.0% of patients ≥65 (p = 0.0584). Limitations of the study include a fixed dosing, no control group and 4-week trial.
Conclusion:
Patients and physicians were satisfied with CR oxybutynin 15 mg once-daily. Patients tolerated the CR oxybutynin 15 mg as both the initial and maintenance dose and provided significant reductions in incontinence, nocturia and night-time incontinence without a significant change in cognitive status. Total continence rates were significantly superior in patients ≥65 and there was no difference in dry mouth, cognitive status or efficacy in patients <65 and ≥65.
Transparency
Declaration of funding
The study was funded by Purdue Pharma (Canada) and was conducted under a collaborative research project among the STOP Study group, Context Clinical Research Inc. and Purdue Pharma (Canada).
Declaration of financial/other relationships
L.E.A. and T.J.M are urologists versant with the conduct of clinical research. Accordingly, as Principal Investigators in a study sponsored by a pharmaceutical firm, Purdue Pharma, they contributed both expertise and oversight at their respective sites for the execution of the trial in keeping with the protocol. In support of an at-arms-length relationship in their roles, neither is otherwise affiliated with Purdue Pharma such as involvement in any sponsored activities or as spokespersons for Purdue Pharma or its products. P.J., Senior Consultant, Lynden Hills Research, is an independent research specialist and it was she who had direct involvement with investigative sites. As a former Clinical Research Scientist at Purdue Pharma, she was also versant with the developmental research that had been conducted and, when prospective investigators were considering participation, served as a technical consultant for questions that arose such as requests for web links to previous Uromax studies. J.L.R., Associate Director, Clinical Research, had the lead role in the Department of Scientific Affairs for all clinical research studies at Purdue Pharma on the Uromax formulation which has spanned 13 years. CMRO peer reviewers on this manuscript have no relevant financial relationships to disclose.
Acknowledgments
The authors would like to thank:
Context Clinical Research Inc. for site initiation/closure, monitoring of source documentation and case report forms, data collection and for ensuring Good Clinical Practice and regulatory compliance at the investigational sites.
Dr William Dalziel, gerontologist, for his contribution to the interpretation of the data and assistance with review of the draft manuscript.
Dr Kenneth J. Michalko, Vice President, Scientific Affairs (Purdue Pharma), for providing administrative oversight on adherence to good clinical practices, and other policies and procedures for the ethical conduct of clinical studies. Subsequently he contributed to the interpretation of the data and review of the draft manuscript.
Zoltan Harsanyi, Director, Biostatistics & Data Management (Purdue Pharma), for data management services and execution of the pre-specified statistical analysis.
The STOP Study group:
Dr Lorne Aaron, Greenfield Park, QC; Dr Louis-René Barrette, Chicoutimi, QC; Dr Roger Buckley, Willowdale, ON; Dr Ronald Casselman, St. Catharines, ON; Dr Claudius Che, Fort Erie, ON; Dr Victor Chow, North Vancouver, BC; Dr John Earle, Brockville, ON; Dr Mohammed Elharram, Peterborough, ON; Dr Alan Faiers, Toronto, ON; Dr Stanley Flax, Brampton, ON; Dr Bernard Goldfarb, North Bay, ON; Dr Chander Gupta, Winnipeg, MB; Dr Kenneth Jansz, Burlington, ON; Dr Stephen Kaye, North Vancouver, BC; Dr John Kinahan, Victoria, BC; Dr Rose Kung, Toronto, ON; Dr Jay Lee, Calgary, AB; Dr Robert Luton, London, ON; Dr Alain Maillette, Trois-Rivières, QC; Dr Arun Mathur, Oshawa, ON; Dr Paul Middlebrook, Owen Sound, ON; Dr Brian Morris, Westmount, QC; Dr Thomas Morris, Guelph, ON; Dr Tara Moskalyk, Sudbury, ON; Dr Jeffrey Noakes, Toronto, ON; Dr Jean-Benoit Paradis, Chicoutimi, QC; Dr John Preiner, Newmarket, ON; Dr David Quinlan, Victoria, BC; Dr Krishan Sachdeva, Oshawa, ON; Dr Wayne Samsoondar, Richmond Hill, ON; Dr Jane Schulz, Edmonton, AB; Dr Oluyomi Sobowale, Peterborough, ON; Dr Kolawole Sogbein, North Bay, ON; Dr Jeffrey Spodek, Scarborough, ON; Dr Wallace Tien, Dartmouth, NS; Dr Philippe Walsh, St-Jean-Sur-Richelieu, QC; Dr Leo Winter, Hamilton, ON; Dr Arthur Zilbert, Dartmouth, NS.
Previous presentations: Results of this study were presented at the Canadian Urological Association Meeting, Edmonton, Alberta. June 2008
Notes
*Uromax is a registered trade-mark of Purdue Pharma, Pickering, Ontario, Canada
*Uromax is a registered trade-mark of Purdue Pharma, Pickering, Ontario, Canada