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NCT Number: NCT01275521

A-botulinic Toxin for Symptomatic Benign Prostate Hypertrophy

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BONT-A intra-prostatic injection

Drug
  • 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;

Optimized medical BPH treatment

Drug

Optimization of the medical therapy according to recent guidelines

Primary outcomes

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

    Time frame: 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.

Acronym: PROTOX

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2011
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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