A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: BONT-A intra-prostatic injectionDrug: Optimized medical BPH treatment
- Registration Number
- NCT01275521
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 127
- Patient aged 50 to 85;
- Obstructive or irritative urinary symptomatology linked to a BPH;
- Score IPSS moderate to severe (8-19: moderate; 20-35: severe) or IPSS ≤ 7 in patient medically treated for symptomatic BPH;
- Increase in prostate volume on the rectal touch or ultrasound;
- Free consent, informed and written, dated and signed by the patient and the investigator (at the latest the day inclusion and before any examination requires the study);
- Subject affiliate or beneficiary of a social protection
- stenosis of the urethra confirmed by endoscopic or radiological examination;
- prostate cancer suspicion;
- medical past history of surgery, radiotherapy or pelvic trauma (, breach of the urethra, pubic symphysis disjunction);
- surgical resection of the prostate (adenomecty);
- clinical or paraclinical signs of vesical sphincterial disynergia; chronic urinary retention > 500 ml;
- BPH complications making surgery necessary: effects on the upper urinary tract: dilatation or renal obstructive insufficiency, bladder stones or diverticula.
- patient previously treated by botulic toxin (whatever injection site);
- Persons unable to understand the course of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BONT-A intra-prostatic injection BONT-A intra-prostatic injection - optimized medical BPH treatment Optimized medical BPH treatment -
- Primary Outcome Measures
Name Time Method Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score). 4 months
- Secondary Outcome Measures
Name Time Method Urinary retention 18 months IPSS question 8 (score 0 to 6) 18 months Uroflowmetry (Qmax in ml/s) 18 months • measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage 18 months measure of prostate volume assessed by endo-rectal ultrasound 18 months measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score) 18 months urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score) 18 months bladder emptying mode (spontaneous or permanent probe) 18 months specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy) 18 months Surgical treatment 18 months profile of gene and protein expression on the first urine flow after prostate massage 18 months
Trial Locations
- Locations (11)
Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
🇫🇷Limoges, France
Clinique Mutualiste Beausoleil
🇫🇷Montpellier, 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
🇫🇷Creteil, France
Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
🇫🇷Pierre Benite, France
Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
🇫🇷AIX-en-PROVENCE, France
Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
🇫🇷Marseille, France
Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
🇫🇷Paris, France
Service d'urologie - CHRU Strasbourg - BP 426
🇫🇷Strasbourg, France
Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
🇫🇷Paris, France