Clinical Research Directory

Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:

Objectives of the study The aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients Study center The study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications). Patients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. Laboratory tests of all patients will be performed at the same microbiology laboratory. Study population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study. Study design Double-blind placebo-controlled randomized clinical trial Zero hypothesis (H0) and alternative hypothesis (H1): (H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients. (H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients. Study endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation. Secondary endpoints: * Adverse events rate in all patients during study period. * The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation. * The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation 1. Qmax value 2. Prostate volume 3. Post void residual 4. IIEF-ED score 5. Psa value 6. TNFa, IL 6 values Treatment Visits : Patients accordingly to which group they will be randomized will receive: * Active treatment (Ralivia) Group : 1 pill of Ralivia per os/day for a 3-month period * Placebo Group : 1 placebo pill per os/day for a 3-month period Adverse events will be reported. FU Visit 1: 6 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported. PSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test. FU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported. DRE will be performed . PSA TNFa, IL 6 will be measured through blood test.

Electromagnetic Field Therapy Versus Aerobic Exercise on Prostatic Function in Elderly With Benign Prostatic Hyperplasia

This study will be carried out on seventy five elderly patients with benign prostatic hyperplasia. Their age will range from 60 to 75 years old. They will be recruited from Hoda Talaat Harb geriatric care center, Helwan governorate, Egypt. The aim of this study to investigate the effect of Electromagnetic field versus aerobic exercise on benign prostatic hyperplasia. Benign prostatic hyperplasia is a nonmalignant enlargement of the prostate gland and refers to the stromal and glandular epithelial hyperplasia that occurs in the transition zone of the prostate Clinically, the condition manifests with lower urinary tract symptoms (LUTS) consisting of obstructive (weak urination stream, incomplete bladder emptying, hesitancy) and irritative symptoms (frequency, urgency, nocturia). It is important to note that LUTS can result from a variety of conditions including problems relating to bladder innervation and aging as well as the outflow obstruction caused by BPH. LUTS due to BPH increases with age, BPH was primarily treated surgically for many years, however, in the 1990s this was superseded by the medical approaches that are now the front line therapy. 5α-reductase inhibitors such as finasteride and dutasteride and α-adrenergic blockers such as doxazosin and tamsulosin are used to shrink and relax the organ, respectively. The MTOPS study demonstrated that a combination of the α-blocker Doxazosin and the 5α-reductase inhibitor Finasteride are more effective at reducing LUTS progression than either drug given alone. While these approaches are effective in many patients, a significant proportion, in the range of 35%, showed progressive disease even in the face of the two drug combination,The Electromagnetic field is thought to have the ability to affect the cells that induce different cellular changes , present studies prove that molecular synergies may not remain the unique determinants implicated in the biological interface. EMF possesses numerous well-reported biological effects including inflammation and pain suppression. This therapy is noninvasive, secure, and easy to use for treating the origin of discomfort, damage, and inflammation