Silodosin vs Placebo in the Treatment of Female LUTS

Sponsor

Mansoura University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06114979

Collaborator

Amiri Hospital (Other)

278

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Drug: Silodosin Drug: Placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

278 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Silodosin Patients will receive 8 mg of Silodosin tablet once daily.	Drug: Silodosin Each patient will receive 8 mg of silodosin tablet once daily.
Placebo Comparator: Placebo Patients will receive placebo pill once daily,	Drug: Placebo Each patient will receive placebo tablet.

Arm

Intervention/Treatment

Active Comparator: Silodosin

Patients will receive 8 mg of Silodosin tablet once daily.

Drug: Silodosin

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

Placebo Comparator: Placebo

Patients will receive placebo pill once daily,

Drug: Placebo

Each patient will receive placebo tablet.

Outcome Measures

Primary Outcome Measures

International Prostate Symptom Score [8 weeks]
International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.
Overactive Bladder Validated 8-question [8 weeks]
Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.

Secondary Outcome Measures

Uroflometry [8 weeks]
Voided volume , Maximum flow, Voiding time, Post void residual
Adverse events [8 weeks]
Side effects of the treatment will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura University
Amiri Hospital

Investigators

Principal Investigator: Tariq F AL-Shaiji, MD, Amiri Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT06114979

Other Study ID Numbers:

Silodosin for female LUTS
937/2018

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mansoura University

Silodosin

LUTS

Female

Additional relevant MeSH terms:

Lower Urinary Tract Symptoms

Silodosin

Study Results

No Results Posted as of Nov 2, 2023