Status:
UNKNOWN
Silodosin vs Placebo in the Treatment of Female LUTS
Lead Sponsor:
Mansoura University
Collaborating Sponsors:
Amiri Hospital
Conditions:
Lower Urinary Tract Symptoms
Eligibility:
FEMALE
21-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Females complaining of lower urinary tract symptoms
- IPSS ≥ 8 or OAB - V8 score ≥ 8
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT06114979
Start Date
November 1 2023
End Date
December 30 2024
Last Update
November 2 2023
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