Silodosin vs Placebo in the Treatment of Female LUTS

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06114979
• Other study ID #: Silodosin for female LUTS
• Secondary ID: 937/2018
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: Majd Alkabbani, MD
• Phone: 0097450322671
• Email: majd.qabbani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 278
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Drug:
• Silodosin
Each patient will receive 8 mg of silodosin tablet once daily.
• Placebo
Each patient will receive placebo tablet.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mansoura University	Amiri Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Uroflometry	Voided volume , Maximum flow, Voiding time, Post void residual	8 weeks
Secondary	Adverse events	Side effects of the treatment will be recorded	8 weeks