Silodosin vs Placebo in the Treatment of Female LUTS

NCT ID: NCT06114979

Last Updated: 2023-11-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Silodosin

Patients will receive 8 mg of Silodosin tablet once daily.

Group Type ACTIVE_COMPARATOR

Silodosin

Intervention Type DRUG

Each patient will receive 8 mg of silodosin tablet once daily.

Placebo

Patients will receive placebo pill once daily,

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Each patient will receive placebo tablet.

Interventions

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Silodosin

Each patient will receive 8 mg of silodosin tablet once daily.

Intervention Type DRUG

Placebo

Each patient will receive placebo tablet.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amiri Hospital

OTHER_GOV

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tariq F AL-Shaiji, MD

Role: PRINCIPAL_INVESTIGATOR

Amiri Hospital

Central Contacts

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Majd Alkabbani, MD

Role: CONTACT

0097450322671

Tariq F AL-Shaiji, MD

Role: CONTACT

0096599099915

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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