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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01275521
First received: January 11, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score). [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IPSS question 8 (score 0 to 6) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Uroflowmetry (Qmax in ml/s) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • • measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • measure of prostate volume assessed by endo-rectal ultrasound [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • bladder emptying mode (spontaneous or permanent probe) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Urinary retention [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Surgical treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • profile of gene and protein expression on the first urine flow after prostate massage [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275521

Locations
France
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 Hôpital Saint Louis - 1, avenue Claude-vellefaux
Paris, France, 75475
Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
Paris, France, 75014
Service d'urologie - CHRU Strasbourg - BP 426
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Grégoire ROBERT, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01275521     History of Changes
Other Study ID Numbers: CHUBX 2010/39
Study First Received: January 11, 2011
Last Updated: May 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014