Conflicts of interest: none.
Original Clinical Article
Article first published online: 30 SEP 2010
Copyright © 2010 Wiley-Liss, Inc.
Neurourology and Urodynamics
Volume 30, Issue 1, pages 75–82, January 2011
How to Cite
Marencak, J., Cossons, N. H., Darekar, A. and Mills, I. W. (2011), Investigation of the clinical efficacy and safety of pregabalin alone or combined with tolterodine in female subjects with idiopathic overactive bladder. Neurourol. Urodyn., 30: 75–82. doi: 10.1002/nau.20928
Roger Dmochowski led the review process.
- Issue published online: 22 DEC 2010
- Article first published online: 30 SEP 2010
- Manuscript Accepted: 5 MAR 2010
- Manuscript Received: 18 JAN 2010
- lower urinary tract symptoms;
- overactive bladder;
To assess the efficacy and safety of pregabalin alone or in combination with tolterodine extended release (ER) in subjects with idiopathic OAB.
This 26-week, multicenter, randomized, double-blind, placebo-controlled, three-period crossover study enrolled women aged ≥18 years that were diagnosed with OAB and reported ≥8 micturitions/24 hr and ≥4 urgency episodes/week on 5-day bladder diary at baseline. Subjects were randomized to 1 of 10 treatment sequences and received three of five treatments, each for 4 weeks with 4-week washout periods: standard-dose pregabalin/tolterodine ER (150 mg twice daily [BID]/4 mg once daily [QD], n = 102), pregabalin alone (150 mg BID, n = 105), tolterodine ER alone (4 mg QD, n = 104), low-dose pregabalin/tolterodine ER (75 mg BID/2 mg QD, n = 105), and placebo (n = 103). Subjects completed 5-day diaries at the end of treatment and washout periods. The primary endpoint was change from baseline to week 4 in mean voided volume (MVV) per micturition. The primary comparison was standard-dose pregabalin/tolterodine ER versus tolterodine ER alone; secondary comparisons were pregabalin alone versus tolterodine ER alone and versus placebo.
Baseline-adjusted changes in MVV were significantly greater after treatment with standard-dose pregabalin/tolterodine ER (39.5 ml) versus tolterodine ER alone (15.5 ml; P < 0.0001), and with pregabalin alone (27.4 ml) versus tolterodine ER alone (P = 0.005) and placebo (11.9 ml; P = 0.0006). Treatments were generally well tolerated; discontinuation rates due to adverse events were 4%, 2%, 5%, 0%, and 1% with standard- and low-dose pregabalin/tolterodine ER, pregabalin, tolterodine ER, and placebo, respectively.
Pregabalin, alone or with tolterodine ER may offer an alternative treatment option for idiopathic OAB in women. Neurourol. Urodynam. 30:75–82, 2011. © 2010 Wiley-Liss, Inc.