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Dysfunctional voiding confirmed by transdermal perineal electromyography, and its effective treatment with baclofen in women with lower urinary tract symptoms: a randomized double-blind placebo-controlled crossover trial.

Author(s): Xu D, Qu C, Meng H, Ren J, Zhu Y, Min Z, Kong Y

Affiliation(s): Departments of Urology, Changzheng Hospital, and Health Statistics, Second Military Medical University, Shanghai, China.

Publication date & source: 2007-09, BJU Int., 100(3):588-92. Epub 2007 May 19.

OBJECTIVES To assess the activity of baclofen, a potent gamma-aminobutyric acid-ergic agonist, against dysfunctional voiding (DV) and lower urinary tract symptoms (LUTS) in a clinical trial, as DV is a leading cause of LUTS in women, but there is no effective treatment. PATIENTS AND METHODS We conducted a randomized double-blind placebo-controlled crossover trial in 60 women with DV and LUTS between January 2003 and January 2006; patients were randomly assigned either baclofen 10 mg three times daily, then matching placebo for 4 weeks, or matching placebo then baclofen 10 mg three times daily for 4 weeks, separated by a 2-week washout period. Voiding diaries and multichannel urodynamics (at baseline, 4 and 10 weeks) were used to record the changes of voids/24 h and urodynamic variables. The primary efficacy endpoint was the change in voids/24 h, and the TL value (log[T/L]), a new electromyographic variables showing the extent of DV. Efficacy outcomes at 4 and 10 weeks were compared with the baseline data, using a crossover-designed analysis of variance model. RESULTS The efficacy analysis of the treatment showed that baclofen was associated with significantly fewer voids/24 h than placebo (mean difference from baseline 5.53 vs 2.70; P = 0.001) and a significant increase in TL (mean difference from baseline -1.78 vs 0.01, P = 0.001). No significant adverse events were reported. CONCLUSIONS A 4-week course of baclofen significantly reduced the number of voids/24 h and increased the TL value in women with DV confirmed by transdermal perineal electromyography. These encouraging results suggest that baclofen could be used for treating DV in women.

Page last updated: 2007-08-04

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