Silodosin vs Placebo in the Treatment of Female LUTS

October 30, 2023 updated by: Mansoura University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

278

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score
Time Frame: 8 weeks
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
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uroflometry
Time Frame: 8 weeks
Voided volume , Maximum flow, Voiding time, Post void residual
8 weeks
Adverse events
Time Frame: 8 weeks
Side effects of the treatment will be recorded
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Collaborators

Amiri Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Silodosin for female LUTS
  • 937/2018 (Registry Identifier: Research Coordination Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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