Iniezione intracervicale di OnabotulinotossinaA per il trattamento dell'ostruzione primitiva del collo vescicale refrattaria alla terapia medica. Una nuova opzione terapeutica

[Autom. eng. transl.] Aim: To evaluate the safety and efficacy of the intracervical injection of OnabotulinotoxinaA (BoNTA) as a new therapeutic option of primary bladder neck obstruction (PBNO). Materials and methods: Inclusion criteria: from January 2008 to September 2012, consecutive patients with low urinary tract symptoms (LUTS) with IPSS ≥15, Qmax≤15 ml / sec and video-urodynamic diagnosis of PBNO, not responsive to alpha-lytic ± anticholinergic therapy. Exclusion criteria: benign prostatic hypertrophy, stenosing sclerosis of the bladder neck, previous urethral or prostatic surgery, neuropathies. Treatment: each patient was injected with 200 IU BoNTA (BOTOX®, Allergan) diluted in 4 ml of physiological solution (50 U / ml) on the bladder neck, trans-urethral way. Evaluation: Patients were assessed at baseline and at 2, 6 and 12 months via total IPSS, storage (S-IPSS) and voiding (V-IPSS) IPSS subscores, IPSS-QoL score, uroflowmetry with evaluation of post-voiding residue ( RPM), and a Patient Reported Outcomes (PROs) questionnaire including satisfaction questions (patient global impression of satisfaction, PGI-S; range 0-5). Results: Of the 37 consecutive eligible patients, four were excluded. Table 1 shows the main characteristics of treated patient patients. No systemic adverse effects were recorded, while 20 patients (60.6%) reported autolimitant local side effects, related to the procedure: 16 (48.5%) hematuria, 17 (51.5%) stranguria, 5 (15, 2%) transient urinary retention. No patient reported ejaculatory dysfunctions. Figure 1 shows the average percentage reduction of the values detected by the IPSS. A statistically significant reduction in the average IPSS was observed from 21.3 ± 8.1 to 8.2 • ± 6 (-61.5%; p <0.0001) at 2 months, at 11.5 • ± 7, 0 (-46.0%; p <0.0001) at 6 months, but not after 12 months (-15.6%, p = 0.166). The mean reductions in the IPSS-QoL score were -53% (p <0.0001) at 2 months, -49% (p <0.0001) at 6 months and -10% (p = 0.066) at 12 months. Figure 2 shows the average percentage changes of Qmax and RPM. Qmax increased from 8.0 ± 3.8 to 16.1 ± 4.9 ml / s at 2 months (p <0.0001), then decreased to 10.1 ± 3.9 at 12 months (p = 0.151). Figure 3 shows the percentages of patients satisfied with the treatment. 81% of patients expressed satisfaction with treatment (PGI-S score≥3) at 2 months, but only 54.5% at 12 months.