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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Said M Yaiesh, BMBCh MSurg MSurgEd KBU
- 電話番号：+96597964200
- メール：syaiesh@hotmail.com
研究連絡先のバックアップ
- 名前：Tariq F Al-Shaiji, BMBCh FRCSC
- 電話番号：+96599773789
- メール：tshaiji@gmail.com
研究場所
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Kuwait
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Kuwait City、Kuwait、クウェート、00000
- Amiri Hospital
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コンタクト：
- Abdullatif E Alterki, MD FRCSC
- 電話番号：+96522450005
- メール：alterki1@gmail.com
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コンタクト：
- Rehan Khan, MD
- 電話番号：+96522450005
- メール：doc.rnk@gmail.com
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主任研究者：
- Meshari F Almutairi, BMBCh KBU
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Kuwait City、Kuwait、クウェート、00000
- Farwaniya Hospital
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コンタクト：
- Faisal M Alhajeri, BMBCh FEBU
- 電話番号：+96524888000
- メール：falhajry75@gmail.com
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コンタクト：
- Feras T Ajrawi, BMBCh KBU
- 電話番号：+96524888000
- メール：ferasalajrawi@hotmail.com
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主任研究者：
- Awad Thahir, MD KBU
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Kuwait City、Kuwait、クウェート、00000
- Jaber Al Ahmad Al Jaber Al Sobah Hospital
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コンタクト：
- Sulaiman M Almazeedi, BMBCh KBGS
- 電話番号：+9652530500
- メール：jaber.hospital@moh.gov.kh
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コンタクト：
- Ali Lairi
- 電話番号：+9652530500
- メール：jaber.hospital@moh.gov.kh
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主任研究者：
- Said M Yaiesh, BMBCh
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Silodosin → 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.
|
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.
|
|
実験的：Placebo → Silodosin
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Total International Prostate Symptom Score (IPSS) Following Treatment
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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.
|
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in IPSS Voiding Subscore
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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.
|
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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Change in Overactive Bladder Symptom Score (OABSS)
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
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Change in total OABSS from the beginning to the end of each 8-week treatment period.
Higher scores indicate greater overactive bladder symptom severity.
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Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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Change in Quality-of-Life Score
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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.
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Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
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Change in Post-Void Residual Urine Volume
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
Change in post-void residual urine volume, measured in milliliters, from the beginning to the end of each treatment period.
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Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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Change in Maximum Urinary Flow Rate (Qmax)
時間枠：Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
Change in maximum urinary flow rate, measured by uroflowmetry in mL/second, from the beginning to the end of each treatment period.
|
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
|
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Adverse Events
時間枠：Throughout each treatment period and through completion of the 18-week study.
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Incidence and nature of adverse events occurring during treatment with silodosin and placebo, including assessment of severity and relationship to study treatment.
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Throughout each treatment period and through completion of the 18-week study.
|
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Patient Global Impression of Improvement (PGI-I)
時間枠：End of each 8-week treatment period (Weeks 8 and 18).
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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.
|
End of each 8-week treatment period (Weeks 8 and 18).
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協力者と研究者
捜査官
- スタディチェア：Tariq F Al-Shaiji, BMBCh FRCSC、Jaber Al Ahmad Hospital
- 主任研究者：Said M Yaiesh, BMBCh MSurg MSurgEd KBU、Jaber Al Ahmad Hospital
- 主任研究者：Meshari F Almutairi, BMBCh KBU、Amiri Hospital
出版物と役立つリンク
一般刊行物
- Alenezi A, Salem S, Taleb S, Almazeedi A, Alfahad M, Alkabbani M, Alyousef R, Al-Terki A, Al-Shaiji T. Silodosin in Females with Voiding Dysfunction: Safety and Efficacy, A Pilot Study. International Continence Society Annual Congress 2023; Abstract 382.
- Sinha S, Yang CC, Arlandis S, Goldman HB. Female voiding dysfunction: A review of clinical presentation, urodynamic diagnosis and management. Continence. 2023;6:100578. doi:10.1016/j.cont.2023.100578
- Jeon BJ, Chang HK, Tae BS, Park JY, Yoon DK, Bae JH. Efficacy of Combined Therapy With Silodosin and Solifenacin in Females With Overactive Bladder. Int Neurourol J. 2024 Dec;28(4):264-269. doi: 10.5213/inj.2448374.187. Epub 2024 Dec 31.
- Sinha A, Tuttle B, Weidner A. Non-neurogenic Voiding Dysfunction in Pediatric Patients and Female Adults: Review of Current Clinical Trials. Obstet Gynecol Surv. 2026 Jan 1;81(1):29-38. doi: 10.1097/OGX.0000000000001467. Epub 2026 Jan 19.
- Arlandis S, Bo K, Cobussen-Boekhorst H, Costantini E, de Heide M, Farag F, Groen J, Karavitakis M, Lapitan MC, Manso M, Arteaga SM, Nambiar AK, Riogh ANA, O'Connor E, Omar MI, Peyronnet B, Phe V, Sakalis VI, Sihra N, Tzelves L, van Poelgeest-Pomfret ML, van den Bos TWL, van der Vaart H, Harding CK. European Association of Urology Guidelines on the Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 2: Underactive Bladder, Bladder Outlet Obstruction, and Nocturia. Eur Urol. 2022 Jul;82(1):60-70. doi: 10.1016/j.eururo.2022.01.044. Epub 2022 Feb 16.
- Perrin A, Corcos J. Nonneurogenic female bladder outlet obstruction: Conservative and medical management. Neurourol Urodyn. 2025 Jan;44(1):37-43. doi: 10.1002/nau.25318. Epub 2023 Nov 6.
- Kang TW, Kim SJ, Chang KD, Kim MH, Chung HC. Effect of the symptom-based alpha-blocker treatment on lower urinary tract symptoms in women: systematic review and meta-analysis. Ther Adv Urol. 2021 Oct 26;13:17562872211053679. doi: 10.1177/17562872211053679. eCollection 2021 Jan-Dec.
- Wee CB, Kim TH, Tae JH, Choi SY. Efficacy and Safety of Silodosin for the Treatment of Female LUTS: A 12-Week Prospective, Single-Center Study. Low Urin Tract Symptoms. 2025 Jan;17(1):e70005. doi: 10.1111/luts.70005.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
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