A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction

Background Voiding dysfunction in adult women is a clinically significant condition associated with impaired quality of life and limited evidence-based pharmacological treatment options. Selective α1A-adrenergic antagonists such as silodosin may reduce urethral resistance and improve voiding efficiency; however, robust randomized data in women remain limited. This study addresses the need for high-quality evidence in this population. Objectives To evaluate the efficacy and safety of silodosin compared to placebo in adult women with voiding dysfunction using a randomized cross-over study design. Methods This is a prospective, multicenter, randomized, placebo-controlled cross-over study conducted at Ministry of Health hospitals in Kuwait. Adult women aged 21 years and older with clinically diagnosed voiding dysfunction will be enrolled. Participants will receive silodosin and placebo in a randomized sequence, separated by a washout period. Each participant will serve as her own control. Expected Results / Conclusions The study is expected to clarify the role of silodosin in improving voiding symptoms in adult women and to provide safety data to guide future clinical practice.

Inclusion Criteria: Eligible participants must have clinically significant voiding symptoms including one or more of the following: * Difficulty initiating voiding * Slow urinary stream * Intermittent urinary stream * Straining to void * Sensation of incomplete bladder emptying AND at least one objective parameter suggestive of impaired bladder emptying: * Post-void residual urine volume ≥100 mL * Maximum urinary flow rate (Qmax) \150 mL * Abnormal pressure-flow findings where available" Exclusion Criteria: * Pregnancy or breastfeeding * Active urinary tract infection * Neurogenic bladder dysfunction * Significant pelvic organ prolapse requiring intervention * Previous bladder outlet or urethral surgery * Severe renal or hepatic impairment