Role of Dutasteride in Treatment of Chronic Prostatitis

Category IIIB Chronic Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756206
• Other study ID #: R21/2020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Category IIIB Chronic Prostatitis
• Chronic Disease
• Dutasteride
• Prostatitis

Intervention

Drug:
• Dutasteride 0.5 mg
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
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.

Locations

Country	Name	City	State
Egypt	Urology department - ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH chronic prostatitis symptom index in study population	scoring system aims to evaluate chronic prostatitis and severity of symptoms	assessment was made before treatment
Primary	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	change in libido in study population	according to sexual desire inventory -2	3 months after medication
Secondary	Gastritis in study population	side effect of medication (if present or not)	3 months after medication
Secondary	Dizziness in study population	side effect of medication (if present or not)	3 months after medication