Voiding DysfunctionPhase 2NCT07822113
A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction
A Phase 2 study testing Silodosin 8 mg in people with Voiding Dysfunction and Female LUTS, run by Jaber Al Ahmad Al Sabah Hospital at 3 sites in Kuwait.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Voiding Dysfunction, Female LUTS
- What is being tested?
- Silodosin 8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesKuwait
- Study dates
- Oct 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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"
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kuwait3 sites
Amiri Hospital
Kuwait City, Kuwait, 00000
Abdullatif E Alterki, MD FRCSC, +96522450005, alterki1@gmail.com
Rehan Khan, MD, +96522450005, doc.rnk@gmail.com
Farwaniya Hospital
Kuwait City, Kuwait, 00000
Faisal M Alhajeri, BMBCh FEBU, +96524888000, falhajry75@gmail.com
Feras T Ajrawi, BMBCh KBU, +96524888000, ferasalajrawi@hotmail.com
Jaber Al Ahmad Al Jaber Al Sobah Hospital
Kuwait City, Kuwait, 00000
Sulaiman M Almazeedi, BMBCh KBGS, +9652530500, jaber.hospital@moh.gov.kh
Ali Lairi, +9652530500, jaber.hospital@moh.gov.kh
About this study
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.
Read more
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.
Read the detailed description
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
- Conditions
- Voiding Dysfunction, Female LUTS
- Being tested
- Silodosin 8 mg, Placebo
- Keywords
- LUTS, Voiding Dysfunction, Alpha Blockers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silodosin 8 mgDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Silodosin 8 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of each 8-week treatment period (Weeks 8 and 18).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaber Al Ahmad Al Sabah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Said Yaiesh, Jaber Al Ahmad Al Sabah Hospital
- Investigators
- Tariq F Al-Shaiji, BMBCh FRCSC, Study chair, Jaber Al Ahmad HospitalSaid M Yaiesh, BMBCh MSurg MSurgEd KBU, Principal investigator, Jaber Al Ahmad HospitalMeshari F Almutairi, BMBCh KBU, Principal investigator, Amiri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822113
- Sponsor's protocol ID
- 2026/3235
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 39765338Sinha 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.
PubMed 41557932Arlandis 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.
PubMed 35181193Perrin 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.
PubMed 37929777Kang 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.
PubMed 34721668Wee 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.
PubMed 39763466
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding Dysfunction
- ClinicalTrials.gov ID
- NCT07822113
- Acronym / sponsor ID
- 2026/3235
- Conditions
- Voiding Dysfunction, Female LUTS
- Keywords
- LUTS, Voiding Dysfunction, Alpha Blockers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jaber Al Ahmad Al Sabah HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silodosin → Placebo | Experimental | Drug: Silodosin 8 mg, Drug: PlaceboParticipants 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: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Active urinary tract infection
- Neurogenic bladder dysfunction
- Significant pelvic organ prolapse requiring intervention
- Previous bladder outlet or urethral surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silodosin 8 mgSilodosin 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. | Drug | Placebo → Silodosin, Silodosin → Placebo |
| PlaceboMatching 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. | Drug | Placebo → Silodosin, Silodosin → Placebo |
Primary outcome
Change in Total International Prostate Symptom Score (IPSS) Following Treatment
Time frame: 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.
7 secondary outcomes
Change in IPSS Voiding Subscore
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)
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Change in Quality-of-Life Score
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
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)
Time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).
Adverse Events
Time frame: Throughout each treatment period and through completion of the 18-week study.
Patient Global Impression of Improvement (PGI-I)
Time frame: End of each 8-week treatment period (Weeks 8 and 18).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- BackgroundAlenezi 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.
- BackgroundSinha 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: PubMed 39765338Jeon 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.
- Background: PubMed 41557932Sinha 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.
- Background: PubMed 35181193Arlandis 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.
- Background: PubMed 37929777Perrin 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.
- Background: PubMed 34721668Kang 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.
- Background: PubMed 39763466Wee 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tariq F Al-Shaiji, BMBCh FRCSC study chair
Jaber Al Ahmad Hospital
Said M Yaiesh, BMBCh MSurg MSurgEd KBU principal investigator
Jaber Al Ahmad Hospital
Meshari F Almutairi, BMBCh KBU principal investigator
Amiri Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Silodosin 8 mg in people with Voiding Dysfunction and Female LUTS, run by Jaber Al Ahmad Al Sabah Hospital at 3 sites in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Said M Yaiesh, BMBCh MSurg MSurgEd KBU (+96597964200, syaiesh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total International Prostate Symptom Score (IPSS) Following Treatment (time frame: Beginning and end of each 8-week treatment period (Weeks 0-8 and Weeks 10-18).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07822113, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.