title: Botulinum neurotoxin type A for the treatment of benign prostatic hyperplasia: randomized study comparing two doses.
abstract: OBJECTIVE
  To assess the efficacy and safety of intraprostatic injection of two botulinum neurotoxin type A (BoNT-A) doses for the treatment of benign prostatic hyperplasia (BPH).
  
  
  METHODS
  Men with symptomatic BPH who failed medical treatment were randomized to receive 100 U or 200 U of BoNT-A into the prostate. The International Prostatic Symptom Score (IPSS), maximum flow rate (Q(max)), post-void residual volume (PVR), PSA levels and prostate volume before injection and after 3 and 6 months were evaluated. Adverse events were compared between the groups.
  
  
  RESULTS
  Thirty four patients were evaluated, including 17 in the BoNT-A 100 U group and 17 in the BoNT-A 200 U group. Baseline characteristics were similar in both groups. Both doses produced significant improvements in IPSS, Q(max) and PVR after 3 and 6 months and both doses promoted comparable effects. Prostate volume was affected by 200 U BoNT-A injection only after 6 months of treatment. PSA levels were significantly affected in the 100 U group only after 6 months of treatment. In the 200 U group, PSA levels were significantly decreased after 3 and 6 months. The complication rate was similar in both groups.
  
  
  CONCLUSIONS
  Efficacy and safety of both BoNT-A doses are similar for BPH treatment in the short term followup.
authors.affiliation: Department of Urology, Dr. Carlos Arvelo Military Hospital, 1060 Caracas, Miranda, Venezuela.
authors.forename: René
authors.initials: R
authors.lastname: Arnouk
authors.forename: Carlos Henrique
authors.initials: CH
authors.lastname: Suzuki Bellucci
authors.forename: Roberto
authors.initials: R
authors.lastname: Benatuil Stull
authors.forename: José
authors.initials: J
authors.lastname: de Bessa
authors.forename: Cesar Augusto
authors.initials: CA
authors.lastname: Malave
authors.forename: Cristiano
authors.initials: C
authors.lastname: Mendes Gomes
mesh_terms: D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D007267:Injections / Q000379:methods; D007610:Kallikreins / Q000032:analysis; D008297:Male; D008875:Middle Aged; D009929:Organ Size; D011446:Prospective Studies; D011467:Prostate / Q000187:drug effects / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000032:analysis; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D016482:Urinalysis / Q000379:methods
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA