This trial is active, not recruiting.

Condition prostatic hyperplasia
Treatments bont-a intra-prostatic injection, optimized medical bph treatment
Phase phase 3
Sponsor University Hospital, Bordeaux
Start date January 2011
End date July 2015
Trial size 226 participants
Trial identifier NCT01275521, CHUBX 2010/39


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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;
(Active Comparator)
optimized medical bph treatment
Optimization of the medical therapy according to recent guidelines

Primary Outcomes

Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score).
time frame: 4 months

Secondary Outcomes

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

Eligibility Criteria

Male participants from 50 years up to 85 years old.

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.

Additional Information

Official title Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.
Principal investigator Grégoire ROBERT, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University Hospital, Bordeaux.