Lower Urinary Tract Symptoms
Conditions
Keywords
Silodosin, LUTS, Female
Brief summary
This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.
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.
Interventions
DRUGSilodosin
Each patient will receive 8 mg of silodosin tablet once daily.
DRUGPlacebo
Each patient will receive placebo tablet.
Sponsors
Amiri Hospital
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Uroflometry | 8 weeks | Voided volume , Maximum flow, Voiding time, Post void residual |
| Adverse events | 8 weeks | Side effects of the treatment will be recorded |
Contacts
Primary ContactMajd Alkabbani, MD
Backup ContactTariq F AL-Shaiji, MD
Outcome results
None listed