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

10. September 2026 aktualisiert von: Said Yaiesh, Jaber Al Ahmad Al Sabah Hospital

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Said M Yaiesh, BMBCh MSurg MSurgEd KBU
  • Telefonnummer: +96597964200
  • E-Mail: syaiesh@hotmail.com

Studieren Sie die Kontaktsicherung

  • Name: Tariq F Al-Shaiji, BMBCh FRCSC
  • Telefonnummer: +96599773789
  • E-Mail: tshaiji@gmail.com

Studienorte

  • Kuwait
    • Kuwait
      • Kuwait City, Kuwait, Kuwait, 00000
        • Amiri Hospital
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Meshari F Almutairi, BMBCh KBU
      • Kuwait City, Kuwait, Kuwait, 00000
        • Farwaniya Hospital
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Awad Thahir, MD KBU
      • Kuwait City, Kuwait, Kuwait, 00000
        • Jaber Al Ahmad Al Jaber Al Sobah Hospital
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Said M Yaiesh, BMBCh

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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.
Arzneimittel: 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.
Experimental: 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.
Arzneimittel: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Total International Prostate Symptom Score (IPSS) Following Treatment
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in IPSS Voiding Subscore
Zeitfenster: 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).
Change in Overactive Bladder Symptom Score (OABSS)
Zeitfenster: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in total OABSS from the beginning to the end of each 8-week treatment period. Higher scores indicate greater overactive bladder symptom severity.
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Quality-of-Life Score
Zeitfenster: 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.
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Post-Void Residual Urine Volume
Zeitfenster: 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.
Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Maximum Urinary Flow Rate (Qmax)
Zeitfenster: 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).
Adverse Events
Zeitfenster: Throughout each treatment period and through completion of the 18-week study.
Incidence and nature of adverse events occurring during treatment with silodosin and placebo, including assessment of severity and relationship to study treatment.
Throughout each treatment period and through completion of the 18-week study.
Patient Global Impression of Improvement (PGI-I)
Zeitfenster: End of each 8-week treatment period (Weeks 8 and 18).
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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Jaber Al Ahmad Al Sabah Hospital

Ermittler

  • Studienstuhl: Tariq F Al-Shaiji, BMBCh FRCSC, Jaber Al Ahmad Hospital
  • Hauptermittler: Said M Yaiesh, BMBCh MSurg MSurgEd KBU, Jaber Al Ahmad Hospital
  • Hauptermittler: Meshari F Almutairi, BMBCh KBU, Amiri Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

10. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. September 2026

Zuerst gepostet (Tatsächlich)

16. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026/3235

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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