Role of Dutasteride in Treatment of Chronic Prostatitis

Phase 2

Completed

• Conditions: Category IIIB Chronic Prostatitis; Dutasteride
• Interventions: Drug: Dutasteride 0.5 mg; Drug: Placebo

• Registration Number: NCT04756206
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-09-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-11
• Last Update Submitted: 2021-02-11
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dutasteride	Dutasteride 0.5 mg	Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo.
Placebo	Placebo	same form and color of Dutasteride tablet was given at the same regimen to act as a placebo

Primary Outcome Measures

Name	Time	Method
NIH chronic prostatitis symptom index in study population	assessment was made at 3 months after intervention	scoring system aims to evaluate chronic prostatitis and severity of symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology department - ain shams university; 🇪🇬 Cairo, Egypt