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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
• Intra prostatic injection of 200 IU of BONT-A (2 x 100 IU to dilute in 10 cc salted serum), divided into 4 injections, 2 in each prostate lobe for a volume intra injected 2.5 cc per site. Interruption of the medical therapy 1 month after the injection;
Optimization of the medical therapy according to recent guidelines
Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
Aix-en-Provence, France
Service d'Urologie, CHU d'Angers 4, rue Larrey
Angers, France
Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon
Bordeaux, France
Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny
Créteil, France
Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
Limoges, France
Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
Marseille, France
Clinique Mutualiste Beausoleil
Montpellier, France
Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
Paris, France
Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
Paris, France
Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
Pierre-Bénite, France
...and 1 more locations
Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score).
Time frame: 4 months
IPSS question 8 (score 0 to 6)
Time frame: 18 months
Uroflowmetry (Qmax in ml/s)
Time frame: 18 months
• measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage
Time frame: 18 months
measure of prostate volume assessed by endo-rectal ultrasound
Time frame: 18 months
measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score)
Time frame: 18 months
urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score)
Time frame: 18 months
bladder emptying mode (spontaneous or permanent probe)
Time frame: 18 months
specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy)
Time frame: 18 months
Urinary retention
Time frame: 18 months
Surgical treatment
Time frame: 18 months
profile of gene and protein expression on the first urine flow after prostate massage
Time frame: 18 months
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