A Phase 2 interventional study of Silodosin 8 mg and Placebo in Voiding Dysfunction and Female LUTS, sponsored by Jaber Al Ahmad Al Sabah Hospital. Not yet recruiting at 3 sites in Kuwait. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Jaber Al Ahmad Al Sabah Hospital · Phase 2, Interventional, and Treatment
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.
Background:
Female voiding dysfunction and non-neurogenic lower urinary tract symptoms (LUTS) represent a common yet under-recognized clinical problem that significantly impacts quality of life. Symptoms may include hesitancy, straining, weak urinary stream, prolonged voiding time, and a sensation of incomplete bladder emptying. Despite their prevalence, diagnostic pathways and management strategies in women remain heterogeneous and less well standardized compared to male populations. Current international guidance highlights the complexity of female LUTS and emphasizes the need for better characterization and evidence-based treatment strategies, particularly for voiding-predominant symptoms and functional bladder outlet obstruction [1].
The European Association of Urology (EAU) guidelines on female non-neurogenic LUTS underscore that female voiding dysfunction is multifactorial and often underdiagnosed, with limited high-quality evidence guiding pharmacological management [1]. Similarly, contemporary reviews and International Continence Society (ICS) discussions have highlighted substantial gaps in clinical trials addressing female voiding dysfunction, particularly interventional studies evaluating medical therapies targeting urethral and bladder outlet mechanisms [2,3].
Alpha-adrenergic receptors, particularly the α1A subtype, play an important role in urethral smooth muscle tone. Pharmacological blockade of these receptors has a well-established role in male lower urinary tract symptoms. In women, emerging evidence suggests that alpha-blockers may reduce functional urethral resistance and improve voiding efficiency; however, available data remain limited and heterogeneous. A systematic review and meta-analysis evaluating alpha-blocker use in women with LUTS demonstrated potential symptom improvement but emphasized variability in study design, patient selection, and outcome measures, reinforcing the need for well-designed randomized trials [4]. Additional systematic reviews have similarly reported modest benefits of alpha-blockers in selected female populations, while calling for higher-quality evidence to guide routine clinical use [5].
Non-neurogenic female bladder outlet obstruction and voiding dysfunction remain challenging clinical entities, with recent reviews highlighting the lack of standardized therapeutic pathways and the reliance on extrapolated evidence from male studies [6]. These reviews consistently identify selective alpha-blockade as a promising but insufficiently studied therapeutic option, particularly in women without overt anatomical obstruction.
Silodosin is a highly selective α1A-adrenergic receptor antagonist with a favorable pharmacological profile and established safety record. Recent prospective studies have explored the use of silodosin in women with lower urinary tract and voiding symptoms, suggesting potential improvements in symptom scores and voiding parameters, with acceptable tolerability [7]. Additional studies evaluating silodosin, either alone or in combination with other agents, have further supported its potential role in female LUTS management, though these studies remain limited by sample size, study design, or focus on storage-predominant symptoms [8]. Emerging abstracts and presentations at international continence meetings have continued to highlight growing clinical interest in silodosin for female voiding dysfunction, while reinforcing the need for rigorous randomized controlled trials [7-11].
Given the persistent evidence gaps, the absence of standardized pharmacological treatment for female voiding dysfunction, and the promising yet inconclusive data surrounding selective alpha-blockade, there is a clear need for a well-designed randomized clinical study. A randomized cross-over, placebo-controlled design allows each participant to serve as her own control, minimizing inter-individual variability and reducing unnecessary drug exposure. This approach is particularly well suited for functional voiding disorders and aligns with ethical principles of participant safety and scientific rigor.
This multicenter randomized cross-over study aims to address these gaps by evaluating the efficacy and safety of silodosin in adult women with voiding dysfunction, thereby contributing robust evidence to inform clinical practice and future guideline development.
Aim \& Objectives:
Aim: To assess the efficacy and safety of silodosin in adult women with voiding dysfunction.
Objectives:
This is the only study on the registry with Jaber Al Ahmad Al Sabah Hospital as lead sponsor.
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Eligible participants must have voiding symptoms including one or more of the following:
AND at least one objective parameter suggestive of impaired bladder emptying:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive silodosin 8 mg orally once daily for 8 weeks, followed by a 2-week washout period, then matching placebo once daily for 8 weeks.
Drug: Silodosin 8 mg · Drug: Placebo
Participants will receive matching placebo orally once daily for 8 weeks, followed by a 2-week washout period, then silodosin 8 mg orally once daily for 8 weeks.
Drug: Silodosin 8 mg · Drug: Placebo
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.
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.
Change in Total International Prostate Symptom Score (IPSS) Following Treatment
Change in total International Prostate Symptom Score (IPSS) from the beginning to the end of each 8-week treatment period. The IPSS consists of 7 symptom questions, each scored from 0 to 5, giving a total score ranging from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The treatment effect of silodosin will be compared with that of placebo within the crossover design.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in IPSS Voiding Subscore
Change in the International Prostate Symptom Score (IPSS) voiding subscore from the beginning to the end of each 8-week treatment period. The voiding subscore comprises the IPSS items relating to incomplete emptying, intermittency, weak stream, and straining; higher scores indicate greater symptom severity.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Overactive Bladder Symptom Score (OABSS)
Change in total OABSS from the beginning to the end of each 8-week treatment period. Higher scores indicate greater overactive bladder symptom severity.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Quality-of-Life Score
Change in the IPSS quality-of-life score from the beginning to the end of each 8-week treatment period. The score ranges from 0 (delighted) to 6 (terrible), with higher scores indicating worse urinary symptom-related quality of life.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Post-Void Residual Urine Volume
Change in post-void residual urine volume, measured in milliliters, from the beginning to the end of each treatment period.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Maximum Urinary Flow Rate (Qmax)
Change in maximum urinary flow rate, measured by uroflowmetry in mL/second, from the beginning to the end of each treatment period.
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Adverse Events
Incidence and nature of adverse events occurring during treatment with silodosin and placebo, including assessment of severity and relationship to study treatment.
Time frame: Throughout each treatment period and through completion of the 18-week study.
Patient Global Impression of Improvement (PGI-I)
Patient-reported overall improvement in urinary symptoms assessed using the Patient Global Impression of Improvement (PGI-I) scale at the end of each treatment period. The PGI-I is a 7-point scale ranging from 1 (very much better) to 7 (very much worse), with lower scores indicating greater perceived improvement.
Time frame: End of each 8-week treatment period (Weeks 8 and 18).
Plan to share: No — Individual participant data are not currently planned for public sharing because of participant confidentiality, institutional data-governance requirements, and the absence of an approved data-sharing framework across participating study sites. Aggregate study results will be reported through scientific publication and presentation.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
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Studies of the drug tested here: Silodosin