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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.
 
ClinicalTrials.gov Identifier: NCT01275521
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE January 11, 2011
First Posted Date  ICMJE January 12, 2011
Last Update Posted Date August 23, 2017
Actual Study Start Date  ICMJE January 10, 2011
Actual Primary Completion Date April 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score). [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
Official Title  ICMJE Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Hyperplasia
Intervention  ICMJE
  • 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;

  • Drug: Optimized medical BPH treatment
    Optimization of the medical therapy according to recent guidelines
Study Arms  ICMJE
  • Experimental: BONT-A intra-prostatic injection
    Intervention: Drug: BONT-A intra-prostatic injection
  • Active Comparator: optimized medical BPH treatment
    Intervention: Drug: Optimized medical BPH treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2017)
127
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2011)
226
Actual Study Completion Date  ICMJE April 28, 2015
Actual Primary Completion Date April 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01275521
Other Study ID Numbers  ICMJE CHUBX 2010/39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grégoire ROBERT, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP