Role of Dutasteride in Treatment of Chronic Prostatitis

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

Detailed Description
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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.

Official Title
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Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)

Conditions
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Dutasteride, Category IIIB Chronic Prostatitis

Intervention / Treatment
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* Drug: Dutasteride 0.5 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged between 40 and 70 years old, diagnosed with chronic prostatitis based on the presence of pelvic pain for ≥3 months of the preceding 6 months Exclusion Criteria: Patients with bacterial prostatitis documented site of infection along the urinary tract, urinary bladder tumors prostate cancer previous history of pelvic radiation or chemotherapy were excluded from our study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dutasteride<br>Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. | Drug: Dutasteride 0.5 mg<br>* 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.<br>|
| Placebo Comparator: Placebo<br>same form and color of Dutasteride tablet was given at the same regimen to act as a placebo | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH chronic prostatitis symptom index in study population | scoring system aims to evaluate chronic prostatitis and severity of symptoms | assessment was made before treatment | 
| NIH chronic prostatitis symptom index in study population | scoring system aims to evaluate chronic prostatitis and severity of symptoms | assessment was made at 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in libido in study population | according to sexual desire inventory -2 | 3 months after medication | 
| Gastritis in study population | side effect of medication (if present or not) | 3 months after medication | 
| Dizziness in study population | side effect of medication (if present or not) | 3 months after medication |