Clinical trial NCT01275521: A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
Official title: Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 127
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score).
timeFrame: 4 months
Secondary outcomes:
measure: IPSS question 8 (score 0 to 6)
timeFrame: 18 months
measure: Uroflowmetry (Qmax in ml/s)
timeFrame: 18 months
measure: • measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage
timeFrame: 18 months
measure: measure of prostate volume assessed by endo-rectal ultrasound
timeFrame: 18 months
measure: measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score)
timeFrame: 18 months
measure: urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score)
timeFrame: 18 months
measure: bladder emptying mode (spontaneous or permanent probe)
timeFrame: 18 months
measure: specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy)
timeFrame: 18 months
measure: Urinary retention
timeFrame: 18 months
measure: Surgical treatment
timeFrame: 18 months
measure: profile of gene and protein expression on the first urine flow after prostate massage
timeFrame: 18 months
Other outcomes:
Locations:
city: AIX-en-PROVENCE
country: France
facility: Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
city: Angers
country: France
facility: Service d'Urologie, CHU d'Angers 4, rue Larrey
city: Bordeaux
country: France
facility: Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon
city: Creteil
country: France
facility: Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny
city: Limoges
country: France
facility: Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
city: Marseille
country: France
facility: Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
city: Montpellier
country: France
facility: Clinique Mutualiste Beausoleil
city: Paris
country: France
facility: Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
city: Paris
country: France
facility: Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
city: Pierre Benite
country: France
facility: Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
city: Strasbourg
country: France
facility: Service d'urologie - CHRU Strasbourg - BP 426
Study officials:
affiliation: University Hospital, Bordeaux
name: Grégoire ROBERT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
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