Iniezione transuretrale intracervicale di tossina botulinica tipo A nel trattamento della dissinergia del collo vescicale refrattaria a terapia medica

[Autom. eng. transl.] Objectives: To evaluate the long-term efficacy and safety of treatment of bladder neck disease refractory to medical therapy by intracervical injection of botulinum toxin type A (BTA). Materials: Cohort study, prospective, uncontrolled. From January 2008 to January 2012, patients suffering from low urinary tract symptoms (LUTS) with video-urodynamic diagnosis of bladder neck dyssynergia (BND) were enrolled, with an IPSS score≥15 and Qmax≤15 ml / sec and non-responsive to alpha-lithic therapy. Patients who had undergone previous surgery of the low urinary tract, with benign prostatic hypertrophy (BPH) and with neurological pathologies were excluded from the study. Each patient, after signing the informed consent, was injected with 200 IU BTA (BOTOX®, Allergan) diluted in 4 ml of physiological solution (50 U / ml) on the bladder neck (in 4 points, 1 ml per point ), trans-urethral using a 22 Fr rigid caliber cystoscope, under general anesthesia (Propofol). The use of a Foley-type bladder catheter was necessary only in patients who presented an episode of acute urinary retention after the procedure. All patients were discharged the day after the treatment, after urinating without problems. Methods: Patients were evaluated at baseline and at 2, 6 and 12 months after surgery by uroflowmetry with evaluation of post-voiding residue (PVR), IPSS-QoL questionnaires and a Patient Reported Outcomes (PROs) questionnaire, which includes questions on the subjective perception of global improvement of the symptomatology (patient global impression of improvement, PGI-I; range 1-7), on satisfaction (patient global impression of satisfaction, PGI-S; range 0-5) and on the perception of efficacy of the procedure (patient global impression of efficacy, PGI-E; range 0-5), with a higher score indicating a better result. A reduction in IPSS> 50% compared to baseline was considered a primary outcome. Secondary outcomes were considered the maximum urinary flow (Qmax), the post-voiding residue (PVR), the IPSS-QoL score, the PROs questionnaire and the incidence of adverse effects. Results: Of the 36 consecutive enrollable patients, 4 were excluded (two for signs of BPH at cystoscopy, one for scars on the bladder neck and one for not having consented to enrollment). For the final analysis, therefore, 32 patients were considered, with an average age of 34 years (range 18-50) and average duration of LUTS of 4.9 years. The average duration of the procedure was 14 minutes. No systemic adverse effects were recorded, while 19 patients (59.3%) reported autolimitant local side effects, related to the procedure: 15 (46.9%) hematuria, 17 (54.4%) stranguria, 5 (16, 6%) post-procedure urinary retention that required transient catheterization. A statistically significant reduction in the average IPSS score was observed, after 2 months of follow-up from 21.7 ± 8.6 to 7.8 ± 5.9 (-63.4%; p <0.0001) and after 6 months of follow-up from 10 .7 ± 6.8 (-50.9%; p <0.0001), but not after 12 months (-17.6%, p = 0.145), although the IPSS values did not reach the pre-treatment values. The primary outcome was achieved by 23 (73.6%) patients at 2 months, 21 (65.6%) patients at 6 months, and 3 (9.3%) patients at 12 months. The mean reductions of S-IPSS, V-IPSS and IPSS-QoL scores were -45% (p = 0.0083), -74.8% (p <0.0001) and -54.2% (p <0.0001) at 2 months, -43.9% (p = 0.0081), -53% (p <0.0001) and -48% (p <0.0001) at 6 months and -13.4% (p = 0.39), -17.9% (p = 0.108) and -20% (p = 0.005) at 12 months. The mean value of Qmax increased from 7.8 to 17.3 ml / s at 2 months (p <0.0001), and then decreased to 15.2 ml / s at 6 months (p <0.0001) and 10.7 at 12 months (p = 0.0087). The average PVR value decreased by 35.4% at 2 months (p = 0.0061), by 34.1%