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Completed

NCT Number: NCT04756206

Role of Dutasteride in Treatment of Chronic Prostatitis

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

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Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Urology department - ain shams university

Cairo, 11361, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dutasteride 0.5 mg

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. NIH chronic prostatitis symptom index in study population

    Time frame: assessment was made before treatment

    scoring system aims to evaluate chronic prostatitis and severity of symptoms

  2. NIH chronic prostatitis symptom index in study population

    Time frame: assessment was made at 3 months after intervention

    scoring system aims to evaluate chronic prostatitis and severity of symptoms

Secondary outcomes

  1. change in libido in study population

    Time frame: 3 months after medication

    according to sexual desire inventory -2

  2. Gastritis in study population

    Time frame: 3 months after medication

    side effect of medication (if present or not)

  3. Dizziness in study population

    Time frame: 3 months after medication

    side effect of medication (if present or not)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 16, 2021
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.