OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder‐neck dysfunction: Objective and patient‐reported outcomes. Issue 1 (19th July 2013)

• Record Type: Journal Article
• Authors: Sacco, Emilio; Tienforti, Daniele; Bientinesi, Riccardo; D'Addessi, Alessandro; Racioppi, Marco; Pinto, Francesco; Totaro, Angelo; Vittori, Matteo; D'Agostino, Daniele; Bassi, Pierfrancesco
• Is Part Of: Neurourology and urodynamics. Volume 33:Issue 1(2014:Jan.)
• Page Start: 142
• Page End: 146
• Publication Date: 2013-07-19
• Subjects: Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.22393
• Languages: English
• ISSNs: 0733-2467

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="nau22393-sec-0001" sec-type="section"> <title>Objective</title> <p>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).</p> </sec> <sec id="nau22393-sec-0002" sec-type="section"> <title>Materials and Methods</title> <p>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<sup>3</sup>, 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.</p> </sec> <sec id="nau22393-sec-0003" sec-type="section"> <title>Results</title> <p>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 (<italic>P</italic> < 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.</p> </sec> <sec id="nau22393-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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. <italic>Neurourol. Urodynam. 33:142–146, 2014</italic>. © 2013 Wiley Periodicals, Inc.</p> </sec> </abstract>