Silodosin vs Placebo in the Treatment of Female LUTS

Mansoura University

Status and phase: Not yet enrolling; Phase 3

Conditions: Lower Urinary Tract Symptoms

Treatments: Drug: Silodosin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06114979

937/2018 (Registry Identifier)

Silodosin for female LUTS

Details and patient eligibility

About

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

Full 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.

Enrollment: 278 estimated patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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278 participants in 2 patient groups, including a placebo group

Silodosin

Active Comparator group

Description:

Patients will receive 8 mg of Silodosin tablet once daily.

Treatment:

Drug: Silodosin

Placebo

Placebo Comparator group

Description:

Patients will receive placebo pill once daily,

Treatment:

Drug: Placebo