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

NCT07822113 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026/3235
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Voiding Dysfunction; Female LUTS

Keywords

LUTS; Voiding Dysfunction; Alpha Blockers

Outcome Measures

Primary Outcomes (1)

• 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.

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

Secondary Outcomes (7)

• Change in IPSS Voiding Subscore

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

• Change in Overactive Bladder Symptom Score (OABSS)

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

• Change in Quality-of-Life Score

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

• Change in Post-Void Residual Urine Volume

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

• Change in Maximum Urinary Flow Rate (Qmax)

  Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).

Study Arms (2)

Silodosin → Placebo

EXPERIMENTAL

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

Placebo → Silodosin

EXPERIMENTAL

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

Interventions

Silodosin 8 mg DRUG

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 → Silodosin; Silodosin → Placebo

Placebo DRUG

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.

Placebo → Silodosin; Silodosin → Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaber Al Ahmad Al Sabah Hospital: lead

Study Sites (3)

Amiri Hospital

Kuwait City, Kuwait, 00000, Kuwait

Location

Farwaniya Hospital

Kuwait City, Kuwait, 00000, Kuwait

Location

Jaber Al Ahmad Al Jaber Al Sobah Hospital

Kuwait City, Kuwait, 00000, Kuwait

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 39765338 BACKGROUND

• 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.

  PMID: 41557932 BACKGROUND

• 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.

  PMID: 35181193 BACKGROUND

• 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.

  PMID: 37929777 BACKGROUND

• 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.

  PMID: 34721668 BACKGROUND

• 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.

  PMID: 39763466 BACKGROUND

Related Links

• International Continence Society (ICS). ICS Standards 2023: Terminology and definitions relevant to lower urinary tract dysfunction, including female bladder outlet obstruction. International Continence Society; 2023.

MeSH Terms

Interventions

silodosin

Study Officials

• Tariq F Al-Shaiji, BMBCh FRCSC

  Jaber Al Ahmad Hospital

  STUDY CHAIR

• Said M Yaiesh, BMBCh MSurg MSurgEd KBU

  Jaber Al Ahmad Hospital

  PRINCIPAL INVESTIGATOR

• Meshari F Almutairi, BMBCh KBU

  Amiri Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Said M Yaiesh, BMBCh MSurg MSurgEd KBU

CONTACT

+96597964200; syaiesh@hotmail.com

Tariq F Al-Shaiji, BMBCh FRCSC

CONTACT

+96599773789; tshaiji@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Urologist

Model Details: Randomized, double-blind, placebo-controlled, two-period crossover design. Participants will be randomized to receive silodosin 8 mg or matching placebo for 8 weeks, followed by a 2-week washout period, then crossover to the alternate treatment for a further 8 weeks. Each participant will therefore receive both interventions during the 18-week study period.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KU (3)