A Phase 3 interventional study of BONT-A intra-prostatic injection and Optimized medical BPH treatment in Prostatic Hyperplasia, sponsored by University Hospital, Bordeaux. Completed at 11 sites in France. Open to male participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 127 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BONT-A intra-prostatic injection
Drug: Optimized medical BPH treatment
• 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
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
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux