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A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction
Sponsor: Jaber Al Ahmad Al Sabah Hospital
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-10
Completion Date
2027-12
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Silodosin 8 mg
Silodosin 8 mg oral capsule administered once daily for 8 weeks. In the crossover design, participants will receive silodosin during one treatment period and matching placebo during the alternate treatment period, separated by a 2-week washout period.
Placebo
Matching placebo oral capsule administered once daily for 8 weeks. The placebo will be identical in appearance and packaging to silodosin to maintain masking. Participants will receive placebo during one treatment period and silodosin during the alternate treatment period, separated by a 2-week washout period.
Locations (3)
Amiri Hospital
Kuwait City, Kuwait, Kuwait
Farwaniya Hospital
Kuwait City, Kuwait, Kuwait
Jaber Al Ahmad Al Jaber Al Sobah Hospital
Kuwait City, Kuwait, Kuwait