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

Primary Purpose

Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
BONT-A intra-prostatic injection
Optimized medical BPH treatment
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
  • Service d'Urologie, CHU d'Angers 4, rue Larrey
  • Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon
  • Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny
  • Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
  • Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
  • Clinique Mutualiste Beausoleil
  • Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
  • Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
  • Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
  • Service d'urologie - CHRU Strasbourg - BP 426

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BONT-A intra-prostatic injection

optimized medical BPH treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2011
Last Updated
August 22, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01275521
Brief Title
A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy
Acronym
PROTOX
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2011 (Actual)
Primary Completion Date
April 28, 2015 (Actual)
Study Completion Date
April 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BONT-A intra-prostatic injection
Arm Type
Experimental
Arm Title
optimized medical BPH treatment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BONT-A intra-prostatic injection
Intervention Description
• 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;
Intervention Type
Drug
Intervention Name(s)
Optimized medical BPH treatment
Intervention Description
Optimization of the medical therapy according to recent guidelines
Primary Outcome Measure Information:
Title
Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
IPSS question 8 (score 0 to 6)
Time Frame
18 months
Title
Uroflowmetry (Qmax in ml/s)
Time Frame
18 months
Title
• measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage
Time Frame
18 months
Title
measure of prostate volume assessed by endo-rectal ultrasound
Time Frame
18 months
Title
measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score)
Time Frame
18 months
Title
urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score)
Time Frame
18 months
Title
bladder emptying mode (spontaneous or permanent probe)
Time Frame
18 months
Title
specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy)
Time Frame
18 months
Title
Urinary retention
Time Frame
18 months
Title
Surgical treatment
Time Frame
18 months
Title
profile of gene and protein expression on the first urine flow after prostate massage
Time Frame
18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grégoire ROBERT, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris
City
AIX-en-PROVENCE
ZIP/Postal Code
13616
Country
France
Facility Name
Service d'Urologie, CHU d'Angers 4, rue Larrey
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King
City
Limoges
ZIP/Postal Code
87052
Country
France
Facility Name
Service d'urologie - Hôpital de la Conception - 147 boulevard Baille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Clinique Mutualiste Beausoleil
City
Montpellier
ZIP/Postal Code
33070
Country
France
Facility Name
Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Service d'urologie - CHRU Strasbourg - BP 426
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

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A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy

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