Silodosin vs Placebo in the Treatment of Female LUTS

NCT06114979 | Unknown Phase 3

• 2 other identifiers: Silodosin for female LUTS937/2018
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lower Urinary Tract Symptoms

Keywords

Silodosin; LUTS; Female

Outcome Measures

Primary Outcomes (2)

• International Prostate Symptom Score

  International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.

  8 weeks

• Overactive Bladder Validated 8-question

  Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.

  8 weeks

Secondary Outcomes (2)

• Uroflometry

  8 weeks

• Adverse events

  8 weeks

Study Arms (2)

Silodosin

ACTIVE COMPARATOR

Patients will receive 8 mg of Silodosin tablet once daily.

Drug: Silodosin

Placebo

PLACEBO COMPARATOR

Patients will receive placebo pill once daily,

Drug: Placebo

Interventions

Silodosin DRUG

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

Silodosin

Placebo DRUG

Each patient will receive placebo tablet.

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females complaining of lower urinary tract symptoms
• IPSS ≥ 8 or OAB - V8 score ≥ 8

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead
• Amiri Hospital: collaborator

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

silodosin

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tariq F AL-Shaiji, MD

  Amiri Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Majd Alkabbani, MD

CONTACT

0097450322671; majd.qabbani@gmail.com

Tariq F AL-Shaiji, MD

CONTACT

0096599099915; tshaiji@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share