Silodosin vs Placebo in the Treatment of Female LUTS

Study Overview
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Brief Summary
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This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.

Detailed Description
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The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.

Official Title
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Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Silodosin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females complaining of lower urinary tract symptoms IPSS ≥ 8 or OAB - V8 score ≥ 8 Exclusion Criteria: Patients with documented hypersensitivity to Silodosin. Patients receiving alpha blockers or anticholinergic medications for any other reason. Patients with history of orthostatic hypotension. Pregnant or breastfeeding females. Patients with stress urinary incontinence. Patients with active urinary tract infection. History of previous pelvic surgery or radiation. Patient with diabetes mellitus. Patients diagnosed with bladder cancer. Patients with hepatic impairment (Child-Pugh score >9). Patients with severe renal impairment with creatinine clearance of less than 10 mL/min. Patients planned to undergo any ophthalmic procedure. Patients with history of urinary retention or gastric retention.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silodosin<br>Patients will receive 8 mg of Silodosin tablet once daily. | Drug: Silodosin<br>* Each patient will receive 8 mg of silodosin tablet once daily.<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo pill once daily, | Drug: Placebo<br>* Each patient will receive placebo tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score | International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome. | 8 weeks | 
| Overactive Bladder Validated 8-question | Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uroflometry | Voided volume , Maximum flow, Voiding time, Post void residual | 8 weeks | 
| Adverse events | Side effects of the treatment will be recorded | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silodosin, LUTS, Female