Role of Dutasteride in Treatment of Chronic Prostatitis
Condition: Dutasteride; Category IIIB Chronic Prostatitis
MeSH terms: Prostatitis; Chronic Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      this placebo controlled study aims to evaluate the efficacy of Dutasteride in the management
      of Chronic prostatitis type 3.
    

Detailed description: 
      Nonbacterial prostatitis refers to a condition that affects patients who present with
      symptoms of prostatitis without a positive culture for urine or expressed prostate secretions
      (EPS). With time our understanding of prostatitis was evolved to include a different clinical
      phenotype with a variety of voiding presentation and symptomatology rather than just
      inflammation and infection. The two main clinical presentations of prostatitis include pelvic
      pain and LUTS.

      The National Institutes of Health and the National Institute of Diabetes and Digestive and
      Kidney Diseases (NIH-NIDDK) proposed the first classification of prostatitis into 4
      categories in 1995 that was later published in 1998. Bacterial prostatitis represented
      category I and III while nonbacterial prostatitis including chronic prostatitis/chronic
      pelvic pain syndrome (CP/CPPS) was categorized as category III that was further subdivided
      into class IIIa (inflammatory CPPS) and b (non-inflammatory CPPS). Category IV encompasses
      asymptomatic inflammatory prostatitis.

      Shoskes et al, mentioned that inflammation and the upregulation of cytokine expression and
      release in the prostate secondary to an inflammatory process led to the presenting symptoms
      in such a condition. The recently introduced UPOINT phenotype categorization of CP/CPPS
      (Urinary, Psychosocial, Organ-specific, Infection, Neurological/Systemic, Tenderness of the
      skeletal muscles). This categorization shows up to 60% of men have at least prostate organ
      associated symptoms.

      The prostate lies under the hormonal control of dihydrotestosterone (DHT); thus 5
      alpha-reductase inhibitors (5ARIs) might be beneficial in the treatment of prostatitis.
      Dutasteride is a 5α-reductase inhibitor, and hence is a type of anti-androgen. It works by
      decreasing the production of (DHT) in certain parts of the body like the prostate gland. It
      inhibits all three forms of 5α-reductase and can decrease DHT levels in the blood by up to
      98%.

      5ARIs have been previously evaluated on a narrow scale in the management of prostatitis with
      promising results of safety and efficacy.
    

Intervention name(s): Dutasteride 0.5 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.; patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment