NCT01275521

A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy

Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: Male
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	BONT-A intra-prostatic injection	• 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;
DRUG	Optimized medical BPH treatment	Optimization of the medical therapy according to recent guidelines

Timeline

• Start date: 2011-01-10
• Primary completion: 2015-04-28
• Completion: 2015-04-28
• First posted: 2011-01-12
• Last updated: 2017-08-23

Locations

11 sites across 1 country: France