Silodosin vs Placebo in the Treatment of Female LUTS

Mansoura University (Other)
Overall Status
Not yet recruiting ID
Amiri Hospital (Other)

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
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:
Anticipated Enrollment :
278 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. Uroflometry [8 weeks]

    Voided volume , Maximum flow, Voiding time, Post void residual

  2. Adverse events [8 weeks]

    Side effects of the treatment will be recorded

Eligibility Criteria


Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Mansoura University
  • Amiri Hospital


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Mansoura University Identifier:
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2023