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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 Danfeng,
Qu Chuangyu,
Meng Hong,
Ren Jizhong,
Zhu Youhua,
Min Zhilian,
Kong Yuele
Publication year - 2007
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2007.06987.x
Subject(s) - placebo , medicine , crossover study , randomized controlled trial , baclofen , overactive bladder , urinary system , anesthesia , urology , lower urinary tract symptoms , adverse effect , agonist , prostate , alternative medicine , receptor , pathology , cancer
OBJECTIVES To assess the activity of baclofen, a potent γ‐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.