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A prospective randomized clinical trial comparing two doses of AbobotulinumtoxinA for idiophatic overactive bladder

Abstract: PD54-06
Sources of Funding: none

Introduction

Cystoscopic administration of BoNT-A has been reported to be effective for patients with idiopathic overactive bladder refractory. Most of studies ranging doses have reported OnabotulinumtoxinA. The purpose of our study was to compare 300U versus 500U of AbobotulinumtoxinA in this patients.

Methods

This is a prospective, randomized, blind study. Adult female patients, with symptoms of OAB, who had failed conservative treatment or discontinued pharmacotherapy due to intolerability or contraindications were included. Patients who had any neurological disease, tumors, pelvic abnormalities or voiding dysfunction were excluded. Detrusor overactivity was not required for inclusion. They were assessed at 4,12 and 24 weeks after injection. Treatment consisted of 30 injections distribuited into the detrusor muscle, avoiding trigone. The primary outcome was change in clinical status, including urinary frequency, urgency and urinary urgency incontinence (UUI) episodes. Secondary outcomes were changes in maximum cystometric capacity (MCC), volume at first desire to void (FDV) and post-void residual (PVR). Quality of life (QoL) was assessed using a visual analogue scale (VAS,0-10) and a patient global impression of improvement (PGI-I).Urinary retention, urinary tract infection (UTI) and required clean intermitent catheterization (CIC) were adverse events.

Results

A total of 22 patients were randomized to either 300U (n=11) or 500U (n=11) groups. Baseline demographics characteristics were comparable for both groups. All 21 patients reported urgency, with 90% of UUI before treatment. At 12 w, an important reduction in daily UUI episodes was observed in two groups, with 90% of them being dry. Decrease in mean episodes of nocturia and urinary frequency, increase FDV and CCM and a mean reduction in total ICIQ-OAB were observed. At 24 w, episodes of UUI had returned in 50% (300U) and 0% (500U) (p=0,013). Patients had an impression of significant improvement in 70% (300U) and 88,9% (500U) at 12w; and 50% (300U) and 100% (500U),at 24w. Score of VAS was manteined higher in 500U group. There was a significant increase in mean PVR after treatment (4w) in both groups. Our incidence of UTI was 36,7% (300U) and 34,6% (500U). One patient (500U) required CIC for 2 weeks.

Conclusions

Data from this study suggest 500U improves symptoms and quality of life for longer time than 300U. However, results are not significantly differents to determine which dose is safer. As far we know this is the first study to compare two doses of AbobotulinumtoxinA for refractory idiophatic OAB._x000D_ _x000D_

Funding

none

Authors
Danielle de Sa Dantas Bezerra
Luis Gustavo Morato Toledo
Jose Eduardo Vetorazzo Filho
Antonio Pedro Flores Auge
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