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Trial record 2 of 2 for:    TAMARIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01275521
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : August 23, 2017
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: BONT-A intra-prostatic injection Drug: Optimized medical BPH treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.
Actual Study Start Date : January 10, 2011
Actual Primary Completion Date : April 28, 2015
Actual Study Completion Date : April 28, 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BONT-A intra-prostatic injection 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;

Active Comparator: optimized medical BPH treatment Drug: Optimized medical BPH treatment
Optimization of the medical therapy according to recent guidelines

Primary Outcome Measures :
  1. Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score). [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. IPSS question 8 (score 0 to 6) [ Time Frame: 18 months ]
  2. Uroflowmetry (Qmax in ml/s) [ Time Frame: 18 months ]
  3. • measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage [ Time Frame: 18 months ]
  4. measure of prostate volume assessed by endo-rectal ultrasound [ Time Frame: 18 months ]
  5. measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score) [ Time Frame: 18 months ]
  6. urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score) [ Time Frame: 18 months ]
  7. bladder emptying mode (spontaneous or permanent probe) [ Time Frame: 18 months ]
  8. specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy) [ Time Frame: 18 months ]
  9. Urinary retention [ Time Frame: 18 months ]
  10. Surgical treatment [ Time Frame: 18 months ]
  11. profile of gene and protein expression on the first urine flow after prostate massage [ Time Frame: 18 months ]

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01275521

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Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
AIX-en-PROVENCE, France, 13616
Service d'Urologie, CHU d'Angers 4, rue Larrey
Angers, France, 49933
Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon
Bordeaux, France, 33076
Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny
Creteil, France, 94000
Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
Limoges, France, 87052
Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
Marseille, France, 13005
Clinique Mutualiste Beausoleil
Montpellier, France, 33070
Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
Paris, France, 75014
Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
Paris, France, 75475
Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
Pierre Benite, France, 69495
Service d'urologie - CHRU Strasbourg - BP 426
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Grégoire ROBERT, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Bordeaux Identifier: NCT01275521    
Other Study ID Numbers: CHUBX 2010/39
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Pathological Conditions, Anatomical
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents