| Registry | NCT07822113 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: quadruple, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Jaber Al Ahmad Al Sabah Hospital (Other) |
| Conditions | Voiding Dysfunction, Female LUTS |
| Interventions | Silodosin 8 mg, Placebo (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-09-16, last updated 2026-09-16 |
| Locations | 3 sites in Kuwait |
Related Papers Related Patents Related Grants Related Experts
All trials for Voiding Dysfunction All trials for Female LUTS All trials of Silodosin 8 mg All trials of Placebo
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:
* To compare voiding symptoms during silodosin and placebo treatment periods
* To assess patient-reported symptom improvement
* To evaluate the safety and tolerability of silodosin
* To compare outcomes between treatment sequences
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Silodosin → Placebo | Experimental | Drug: Silodosin 8 mg; Drug: Placebo | 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. |
| Placebo → Silodosin | Experimental | 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. |
Sex: Female, ages: 18 Years to any
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) <15 mL/sec with voided volume >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
| Facility | City | Country | Status |
|---|---|---|---|
| Amiri Hospital | Kuwait City, Kuwait | Kuwait | |
| Farwaniya Hospital | Kuwait City, Kuwait | Kuwait | |
| Jaber Al Ahmad Al Jaber Al Sobah Hospital | Kuwait City, Kuwait | Kuwait |