A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy (PROTOX)

University Hospital of Bordeaux

Status and phase

Completed

Phase 3

Conditions

Prostatic Hyperplasia

Treatments

Drug: BONT-A intra-prostatic injection

Drug: Optimized medical BPH treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01275521

CHUBX 2010/39

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

Male

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.