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Silodosin vs Placebo in the Treatment of Female LUTS

M

Mansoura University

Status and phase

Not yet enrolling
Phase 3

Conditions

Lower Urinary Tract Symptoms

Treatments

Drug: Silodosin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06114979
937/2018 (Registry Identifier)
Silodosin for female LUTS

Details and patient eligibility

About

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

Full 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.

Enrollment

278 estimated patients

Sex

Female

Ages

21 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

278 participants in 2 patient groups, including a placebo group

Silodosin
Active Comparator group
Description:
Patients will receive 8 mg of Silodosin tablet once daily.
Treatment:
Drug: Silodosin
Placebo
Placebo Comparator group
Description:
Patients will receive placebo pill once daily,
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Central trial contact

Tariq F AL-Shaiji, MD; Majd Alkabbani, MD

Data sourced from clinicaltrials.gov

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