Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
278 participants
INTERVENTIONAL
2023-11-01
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Silodosin
Patients will receive 8 mg of Silodosin tablet once daily.
Silodosin
Each patient will receive 8 mg of silodosin tablet once daily.
Placebo
Patients will receive placebo pill once daily,
Placebo
Each patient will receive placebo tablet.
Interventions
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Silodosin
Each patient will receive 8 mg of silodosin tablet once daily.
Placebo
Each patient will receive placebo tablet.
Eligibility Criteria
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Inclusion Criteria
* IPSS ≥ 8 or OAB - V8 score ≥ 8
Exclusion Criteria
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.
21 Years
75 Years
FEMALE
No
Sponsors
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Amiri Hospital
OTHER_GOV
Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Tariq F AL-Shaiji, MD
Role: PRINCIPAL_INVESTIGATOR
Amiri Hospital
Central Contacts
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Other Identifiers
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937/2018
Identifier Type: REGISTRY
Identifier Source: secondary_id
Silodosin for female LUTS
Identifier Type: -
Identifier Source: org_study_id
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