title: OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes.
abstract: OBJECTIVE
  To determine efficacy and safety of OnabotulinumtoxinA (BoNT-A) injection therapy in medically refractory patients with lower urinary tract symptoms (LUTS) due to primary bladder-neck dysfunction (PBND).
  
  
  METHODS
  Thirty-five consecutive ambulatory males diagnosed with PBND and refractory to medical therapy, with IPSS > 15, Qmax < 15 ml/sec, and total prostate volume < 30 cm(3), were screened from January 2010 to December 2011. Eligible patients underwent transurethral bladder-neck injection of BoNT-A (200 U, 50 U/ml × 4 sites) and were assessed at baseline, 2-, 6-, 9-, and 12-month postprocedure and until duration of clinical response. The primary outcome was the change from baseline in total IPSS, and secondary outcome were storage- and voiding-IPSS, QoL score, Qmax, and postvoiding residual volume (PVR), patient-reported outcomes. Adverse effects were also recorded, including ejaculatory dysfunctions.
  
  
  RESULTS
  Of 30 enrolled patients (mean age 33.8 years), 29 (96.7%) completed the study. A statistically significant improvement of total IPSS was observed from 21.9 at baseline, to 7.8, 10.3, and 16.6 at 2, 6, and 9 months, respectively (P < 0.000). Statistically significant improvements from baseline of storage- and voiding-IPSS, QoL score, Qmax, and PVR were also observed until 9-month postprocedure. The proportion of patients with overall satisfaction was favorable although decreasing from 80% at 2 months, to 44.8% at 12 months. No significant adverse effects or ejaculatory dysfunctions were noted.
  
  
  CONCLUSIONS
  BoNT-A injection therapy appears effective and safe in medically refractory men with PBND, although repeated procedures are required for long-term sustained benefit. Randomized controlled trials are warranted in order to corroborate these results.
authors.affiliation: Urologic Clinic, Department of Surgical Sciences, "Agostino Gemelli" Hospital, Catholic University School of Medicine, Rome, Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Sacco
authors.forename: Daniele
authors.initials: D
authors.lastname: Tienforti
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bientinesi
authors.forename: Alessandro
authors.initials: A
authors.lastname: D'Addessi
authors.forename: Marco
authors.initials: M
authors.lastname: Racioppi
authors.forename: Francesco
authors.initials: F
authors.lastname: Pinto
authors.forename: Angelo
authors.initials: A
authors.lastname: Totaro
authors.forename: Matteo
authors.initials: M
authors.lastname: Vittori
authors.forename: Daniele
authors.initials: D
authors.lastname: D'Agostino
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Bassi
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D059411:Lower Urinary Tract Symptoms / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D001748:Urinary Bladder Neck Obstruction / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects; D064804:Urological Agents / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D064804:Urological Agents; D019274:Botulinum Toxins, Type A
keywords: lower urinary tract symptoms; onabotulinumtoxina; primary bladder-neck dysfunction; urinary bladder-neck obstruction