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

Silodosin for female LUTS

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

2023-11-01

2024-10-30

2024-12-30

Not yet recruiting

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 278, 'type': 'ESTIMATED'}}

2023-11-02