Serenoa repens, cucurbita pepo, lycopene and selenium as an adjunct to the treatment of chronic bacterial prostatitis with antibiotics
Completed
- Conditions
- Chronic bacterial prostatitis and lower urinary tract symptom (LUTS)Urological and Genital DiseasesChronic prostatitis
- Registration Number
- ISRCTN10248199
- Lead Sponsor
- Synapse Hellenic Pharmaceuticals & Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 128
Inclusion Criteria
Adult patients with chronic bacterial prostatitis
Exclusion Criteria
1. Patients who are immediately diagnosed during their visit with acute bacterial prostatitis (NIH Category I)
2. Patients who receive treatment with an a-blocker (Terazosin, Doxazosin, Tamsulosin, Alfuzosin)
3. Patients who have been under treatment with antibiotics through the last 6 months
4. Patients who are under treatment with immunosuppressant drugs
5. Patients who are under treatment with drugs containing cortisone
6. Patents who are allergic to corn or cucurbita pepo
7. Patents who suffer from diabetes mellitus
8. Patients who had a history of urethral stricture or neurogenic bladder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Prostatitis symptoms assessed using the National Institute of Health's Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) at baseline, 1, 3, 6 and 12 months<br>2. Qmax measured using specific uroflowmetry techniques at baseline, 3, 6 and 12 months<br>3. Residual volume after urination and prostate volume measured by the urologist using ultrasound at baseline, 3, 6 and 12 months
- Secondary Outcome Measures
Name Time Method Bacterial reinfection, assessed using Meares - Stamey Test and microbiological testing at baseline, 3, 6 and 12 months