Efficacy of an Alpha-Blocker for the Treatment of Nonneurogenic Voiding Dysfunction in Women: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

PurposeTo evaluate the efficacy of an alpha-1 adrenergic receptor (α1-AR) blocker for the treatment of female voiding dysfunction (FVD) through a pressure-flow study.MethodsThis was a randomized, double-blind, placebo-controlled trial. Women aged ≥18 years with voiding symptoms, as defined by an American Urological Association symptom score (AUA-SS) ≥15 and a maximum flow rate (Qmax) <15 mL/sec with a voided volume of >100 mL and/or a postvoid residual (PVR) volume >150 mL, were randomly allocated to either the alfuzosin or placebo group. After 8 weeks of treatment, changes in the AUA-SS, Bristol female lower urinary tract symptoms (BFLUTS) questionnaire, Qmax/PVR, and voiding diary were compared between groups. Patients’ satisfaction with the treatment was compared. Patients were categorized into 3 groups according to the Blaivas-Groutz bladder outlet obstruction (BOO) nomogram: none, mild, and moderate to severe. Subgroup comparisons were also made.ResultsOf a total of 187 women, 154 (79 alfuzosin, 75 placebo) were included in the analysis. After 8 weeks of treatment, the AUA-SS decreased by 7.0 in the alfuzosin group and by 8.0 in the placebo group. Changes in AUA-SS subscores, BFLUTS (except the I-sum), the voiding diary, and Qmax/PVR were not significantly different between groups. Approximately 54% of the alfuzosin group and 62% of the placebo group were satisfied with the treatment. No significant difference was observed between groups according to the presence or grade of BOO.ConclusionsAlfuzosin might not be more effective than placebo for treating FVD. The presence or the grade of BOO did not affect the results. A further study with sufficient power is needed to determine the efficacy of α1-AR blockers for the treatment of FVD.

Alpha-1 Adrenergic Receptor Blockers for the Treatment of Lower Urinary Tract Symptoms in Women: A Systematic Review and Meta-Analysis

“…The authors in the present study compared adverse event rates between α1-blockers and placebo in the studies that reported safety outcomes for the α1-blockers and found no statistically significant difference in the adverse event rate of the α1-blockers compared to placebo [5,6,25,26]. The side effects of α1-blockers reported in the studies were dizziness, headache, asthenia, GI discomfort, and edema.…”

“…Subsequently, title and abstract review eliminated 377 articles, with only trials published in English included in the present study. An analysis of the remaining full-text articles with respect to the inclusion criteria resulted in the final selection of 14 studies (Table 1) with a total of 1,319 patients [5,6,16-27]. Of these studies, 6 were RCTs and 8 were open-label prospective studies.…”

“…Thus, many clinicians have prescribed similar treatments to women with LUTS based on the assumption that α1-blockers will similarly affect the female bladder neck. Some open-label prospective trials [16-19,21,23,24,27] and RCTs [5,6,20,22,25,26] have examined the effect of α1-blockers on female voiding dysfunction. However, the outcomes of these studies have not been consistent.…”

“…Changes in LUTS outcomes were measured by IPSS or AUASS, Qmax, and PVR urine volume values, which were recorded as continuous data. Mean and SD values were extracted from all studies except for that published by Lee et al [5], which presented the results as median and interquartile range. The authors in the present study subsequently calculated the mean and SD values using a known statistical method [13,14].…”

“…However, considering the present lack of standardized diagnostic criteria and clinical guidelines, female LUTS is likely overlooked and underestimated. Moreover, the pathophysiological mechanism of female LUTS remains unclear [5].…”