A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
Status:
Completed
Trial end date:
2015-04-28
Target enrollment:
Participant gender:
Summary
BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the
prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that
are not fully elucidated. It is the same for symptomatology and urodynamic obstruction
without clear identification of the part which is due to static phenomena (volume increase)
and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and
the difficulty of therapeutic indications between monitoring, medical treatment, and surgical
operation. Experimental studies of BONT-A intra prostatic injection on animal and human
models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the
number of adrenergic α1 receptors.
Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini
invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.
PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A
injection in the treatment of symptomatic BPH.