Treatment of Chronic Bacterial Prostatitis
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|ClinicalTrials.gov Identifier: NCT02130713|
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : May 5, 2014
Background - bacterial prostatitis (BP) is a common condition accounting responsible for about 5-10% of all prostatitis cases; chronic bacterial prostatitis (CBP) classified as type II, are less common but is a condition that significantly hampers the quality of life, (QoL) because not only is it a physical condition but also a psychological distress. Commonly patients are treated with antibiotics alone, and in particular fluoroquinolones are suggested by the European Urology guidelines. This approach, although recommended, may not be enough. Thus, a multimodal approach to the prolonged antibiotic therapy may be helpful.
Methods - 210 patients affected by chronic bacterial prostatitis were enrolled in the study. All patients were positive to Meares-Stamey test and symptoms duration was > 3 months. The purpose of the study was to evaluate the efficacy of a long lasting therapy with a fluoroquinolone in association with a nutraceutical supplement (prulifloxacin 600 mg for 21 days and an association of Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg for 30 days). Patients were randomized in two groups (A and B) receiving respectively antibiotic alone and an association of antibiotic plus supplement.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Bacterial Prostatitis||Drug: Third generation fluoroquinolone Dietary Supplement: Nutritional supplement + third generation fluoroquinolone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Bacterial Prostatitis: Efficacy of Short-lasting Antibiotic Therapy With Prulifloxacin (Unidrox®) in Association With Saw Palmetto Extract, Lactobacillus Sporogens and Arbutin (Lactorepens®)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
Active Comparator: Group A, antibiotics
Prulifloxacin 600 mg
Drug: Third generation fluoroquinolone
Prulifloxacin 600 mg
Active Comparator: Group B, antibiotics plus nutraceuticals
Prulifoxacin plus Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg
Dietary Supplement: Nutritional supplement + third generation fluoroquinolone
Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg
- Meares-Stamey evaluation [ Time Frame: up to 6 months ]The Meares-Stamey test, also known as 4-glass test, is the standard method of assessing inflammation and presence of bacteria in the lower urinary tract of men presenting CBP. The test has been performed on each patient before and after the therapy. The Meares-Stamey evaluation allows the collection of four samples: first voided urine (VB1) that represents urethra, mid-stream urine (VB2) that represents bladder, expressed prostatic secretion (EPS) and post-prostatic massage urine (VB3) that represent the prostate. It is considered positive when we have urophathogen colony-forming units (CFU)/mL ≥103.
- NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) [ Time Frame: up to 6 months ]The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) is a questionnaire with 13 questions developed to evaluate symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Every question has a score differing by the answer, and the questionnaire has a total score ranging from 0 to 43. The score is divided by three subscales: pain (score range 0-21), urinary symptoms (score range 0-10) and quality of life (QoL) (score range 0-12). The sum of all single scores is the total score. The reason every item has a different maximum score is because they have a different potential. NIH-CPSI characteristics are: good reliability, validity, and responsiveness to change. It has been used in many large-scale trials regarding CP/CPPS as the primary outcome variable .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130713
|policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences|
|Roma, Italy, 00161|
|Study Director:||Ettore De Berardinis, Professor||Policlinico Umberto I - Department of Gynecological-Obstetrics Sciences and Urological Sciences|