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No Safety Concerns With Tolterodine in Bladder Outlet Obstruction and Symptomatic Detrusor Overactivity: Presented at ICPC

By Jill Stein

PARIS, FRANCE -- June 28, 2005 -- Tolterodine is safe and well tolerated in men with detrusor overactivity and moderate to severe bladder outlet obstruction, researchers reported at the 6^th International Consultation on New Developments in Prostate Cancer and Prostate Diseases (ICPC).

Paul Abrams, MD, consultant urologist, Bristol Urological Institute, Bristol, United Kingdom, presented results here on June 28^th. His study enrolled 221 men with overactive bladder and bladder outlet obstruction randomised to 12 weeks' treatment with tolterodine 2 mg BID or placebo.

While antimuscarinic agents such as tolterodine are used as first-line treatment for overactive bladder, they are often not prescribed to men with bladder outlet obstruction because of concerns that they might aggravate micturition difficulties or cause acute urinary retention, Dr. Abrams said.

Subjects were at least 40 years old and had at least 8 micturitions over 24 hours and urgency, with or without urgency incontinence (at least 1 episode over 24 hours), and urodynamically confirmed detrusor overactivity. They also had bladder outlet obstruction as confirmed by a Bladder Outlet Obstruction Index of 20 or greater.

Results after 12 weeks showed no change in urodynamic measures with tolterodine that might suggest that the agent poses a safety risk.

Changes from baseline in peak urinary flow rate (Qmax) and subtracted voiding pressure (pdet.Qmax) in the tolterodine group were statistically equivalent to those in the placebo group. Estimated differences in median change between groups was Qmax, -0.7 mL/s; pdet.Qmax, -7cmH20.

Median Bladder Outlet Obstruction Index decreased from 49 to 40 in the tolterodine group and remained essentially the same in the placebo group (P <.02).

Significant differences in favour of tolterodine were seen in volume at first detrusor contraction (+59 mL, P =.0026) and maximum cystometric capacity (+67 mL, P =.0001).

Median increase in postvoid residual (PVR) volume was significantly higher in the tolterodine group than in the placebo group (+25 mL vs 0 mL; P =.0038), but this change was not accompanied by an increase in urinary system adverse events (12.8% vs 12.5%, respectively). The rate of increased PVR volume was similar in the 2 groups (3.4% and 2.8%, respectively).

Median voiding efficiency did not change in the placebo group but decreased by 7% in the tolterodine group (P =.0183).

Results also showed a slight increase in Bladder Contractility Index in the placebo group and a slight decrease in the tolterodine group; the treatment difference of -10 was statistically significant (P =.0045).

The frequency of adverse events was similar in the 2 groups; 58.4% of the tolterodine and 51.4% of the placebo group had at least 1 adverse event.

Urinary retention requiring catheterisation occurred in 1 patient in the placebo group and none of the tolterodine patients.

Dr. Abrams emphasised that the results did not support concerns that antimuscarinic agents can aggravate micturition difficulties or cause urinary retention. Thus, tolterodine should be considered for treating overactive bladder symptoms in men with bladder outlet obstruction, he said.

The study was sponsored by Pfizer Inc.


[Presentation title: Safety and Tolerability of Tolterodine in Men With Bladder Outlet Obstruction and Symptomatic Detrusor Overactivity. Abstract 91]

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