Silodosin vs Placebo in the Treatment of Female LUTS

Phase 3

Not yet recruiting

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Drug: Placebo; Drug: Silodosin

• Registration Number: NCT06114979
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study Start: 2023-11-01
• Study First Posted: 2023-11-02
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 278

Inclusion Criteria

• Females complaining of lower urinary tract symptoms
• IPSS ≥ 8 or OAB - V8 score ≥ 8

Exclusion Criteria

1. Patients with documented hypersensitivity to Silodosin.
2. Patients receiving alpha blockers or anticholinergic medications for any other reason.
3. Patients with history of orthostatic hypotension.
4. Pregnant or breastfeeding females.
5. Patients with stress urinary incontinence.
6. Patients with active urinary tract infection.
7. History of previous pelvic surgery or radiation.
8. Patient with diabetes mellitus.
9. Patients diagnosed with bladder cancer.
10. Patients with hepatic impairment (Child-Pugh score >9).
11. Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
12. Patients planned to undergo any ophthalmic procedure.
13. Patients with history of urinary retention or gastric retention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive placebo pill once daily,
Silodosin	Silodosin	Patients will receive 8 mg of Silodosin tablet once daily.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Uroflometry	8 weeks	Voided volume , Maximum flow, Voiding time, Post void residual
Adverse events	8 weeks	Side effects of the treatment will be recorded