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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BONT-A intra-prostatic injection | Experimental |
| |
| optimized medical BPH treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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; |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the patient with auto-questionnaire IPSS urinary symptomatology: questions 1 to 7 (0 to 35 score). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| IPSS question 8 (score 0 to 6) | 18 months | |
| Uroflowmetry (Qmax in ml/s) | 18 months | |
| • measure the post-voiding residue assessed by supra pubic ultrasound or urinary drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grégoire ROBERT, MD | University Hospital, Bordeaux | Principal Investigator |
| Antoine BENARD, MD | University Hospital, Bordeaux | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris | Aix-en-Provence | 13616 | France | |||
| Service d'Urologie, CHU d'Angers 4, rue Larrey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15098749 | Background | Costa P, Ben Naoum K, Boukaram M, Wagner L, Louis JF. [Benign prostatic hyperplasia (BPH): prevalence in general practice and practical approach of French general practitioners. Results of a study based on 17,953 patients]. Prog Urol. 2004 Feb;14(1):33-9. French. | |
| 10367833 | Background | Rhodes PR, Krogh RH, Bruskewitz RC. Impact of drug therapy on benign prostatic hyperplasia-specific quality of life. Urology. 1999 Jun;53(6):1090-8. doi: 10.1016/s0090-4295(99)00041-2. |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| Optimized medical BPH treatment | Drug | Optimization of the medical therapy according to recent guidelines |
|
| 18 months |
| measure of prostate volume assessed by endo-rectal ultrasound | 18 months |
| measurement of the erectile function by auto questionnaire IIEF-5 (0 to 24 score) | 18 months |
| urinary continence Evaluation by ICS 1 (0 to 23 score) and ICS 2 (0 to 12 score) | 18 months |
| bladder emptying mode (spontaneous or permanent probe) | 18 months |
| specific treatment for BPH (alpha blocking, 5 alpha reductase inhibitor and/or phytotherapy) | 18 months |
| Urinary retention | 18 months |
| Surgical treatment | 18 months |
| profile of gene and protein expression on the first urine flow after prostate massage | 18 months |
| Angers |
| 49933 |
| France |
| Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon | Bordeaux | 33076 | France |
| Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny | Créteil | 94000 | France |
| Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King | Limoges | 87052 | France |
| Service d'urologie - Hôpital de la Conception - 147 boulevard Baille | Marseille | 13005 | France |
| Clinique Mutualiste Beausoleil | Montpellier | 33070 | France |
| Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques | Paris | 75014 | France |
| Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux | Paris | 75475 | France |
| Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet | Pierre-Bénite | 69495 | France |
| Service d'urologie - CHRU Strasbourg - BP 426 | Strasbourg | 67091 | France |
| 2482772 | Background | Isaacs JT, Coffey DS. Etiology and disease process of benign prostatic hyperplasia. Prostate Suppl. 1989;2:33-50. doi: 10.1002/pros.2990150506. |
| 1722154 | Background | Chute CG, Stephenson WP, Guess HA, Lieber M. Benign prostatic hyperplasia: a population-based study. Eur Urol. 1991;20 Suppl 1:11-7. doi: 10.1159/000471739. |
| 1722791 | Background | McConnell JD. The pathophysiology of benign prostatic hyperplasia. J Androl. 1991 Nov-Dec;12(6):356-63. |
| 6186370 | Background | Barrack ER, Bujnovszky P, Walsh PC. Subcellular distribution of androgen receptors in human normal, benign hyperplastic, and malignant prostatic tissues: characterization of nuclear salt-resistant receptors. Cancer Res. 1983 Mar;43(3):1107-16. |
| 10893637 | Background | Marcelli M, Shao TC, Li X, Yin H, Marani M, Denner L, Teng B, Cunningham GR. Induction of apoptosis in BPH stromal cells by adenoviral-mediated overexpression of caspase-7. J Urol. 2000 Aug;164(2):518-25. |
| 9772874 | Background | Colombel M, Vacherot F, Diez SG, Fontaine E, Buttyan R, Chopin D. Zonal variation of apoptosis and proliferation in the normal prostate and in benign prostatic hyperplasia. Br J Urol. 1998 Sep;82(3):380-5. doi: 10.1046/j.1464-410x.1998.00752.x. |
| 8876703 | Background | Radlmaier A, Eickenberg HU, Fletcher MS, Fourcade RO, Reis Santos JM, van Aubel OG, Bono AV. Estrogen reduction by aromatase inhibition for benign prostatic hyperplasia: results of a double-blind, placebo-controlled, randomized clinical trial using two doses of the aromatase-inhibitor atamestane. Atamestane Study Group. Prostate. 1996 Oct;29(4):199-208. doi: 10.1002/(SICI)1097-0045(199610)29:43.0.CO;2-7. |
| 8767399 | Background | Frick J. [Pathophysiology of benign prostatic hyperplasia]. Wien Med Wochenschr. 1996;146(8):158-60. German. |
| 2428671 | Background | Hieble JP, Boyce AJ, Caine M. Comparison of the alpha-adrenoceptor characteristics in human and canine prostate. Fed Proc. 1986 Oct;45(11):2609-14. |
| 8880886 | Background | Hieble JP, Ruffolo RR Jr. The use of alpha-adrenoceptor antagonists in the pharmacological management of benign prostatic hypertrophy: an overview. Pharmacol Res. 1996 Mar;33(3):145-60. doi: 10.1006/phrs.1996.0022. |
| 15474261 | Background | Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54. doi: 10.1016/j.eururo.2004.07.016. |
| 11276294 | Background | Wilt TJ, Ishani A, Rutks I, MacDonald R. Phytotherapy for benign prostatic hyperplasia. Public Health Nutr. 2000 Dec;3(4A):459-72. doi: 10.1017/s1368980000000549. |
| 9820264 | Background | Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. doi: 10.1001/jama.280.18.1604. |
| 19250191 | Background | Zhu YS, Imperato-McGinley JL. 5alpha-reductase isozymes and androgen actions in the prostate. Ann N Y Acad Sci. 2009 Feb;1155:43-56. doi: 10.1111/j.1749-6632.2009.04115.x. |
| 16516013 | Background | Crawford ED, Wilson SS, McConnell JD, Slawin KM, Lieber MC, Smith JA, Meehan AG, Bautista OM, Noble WR, Kusek JW, Nyberg LM, Roehrborn CG; MTOPS RESEARCH Group. Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol. 2006 Apr;175(4):1422-6; discussion 1426-7. doi: 10.1016/S0022-5347(05)00708-1. |
| 8804493 | Background | Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology. 1996 Sep;48(3):398-405. doi: 10.1016/s0090-4295(96)00353-6. |
| 15651487 | Background | Desgrandchamps F. [Combination therapy in benign prostatic hyperplasia (BPH)]. Ann Urol (Paris). 2004 Dec;38 Suppl 2:S24-8. doi: 10.1016/s0003-4401(04)80003-2. French. |
| 10492184 | Background | Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6. |
| 29383480 | Derived | Robert G, Descazeaud A, Karsenty G, Saussine C, Azzouzi AR, de la Taille A, Desgrandchamps F, Faix A, Fourmarier M, Georget A, Benard A, Barry Delongchamps N. Prostatic injection of botulinum toxin is not inferior to optimized medical therapy in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a randomized clinical trial. World J Urol. 2018 Jun;36(6):921-929. doi: 10.1007/s00345-018-2193-y. Epub 2018 Jan 30. |
| D052801 |
| Male Urogenital Diseases |