INTRODUCTION & OBJECTIVES: Intravesical resiniferatoxin (RTX) and Botulinum-A toxin (BOTX) injections into the detrusor muscle have been introduced‘as t&atments for neurogenic refractolv detrusor overactivitv. Actuallv. there are no clinical studies conmarine intravesical RTX with Bot&num-A toxin injections. We i&stigated the effectiveness and safety tf intravesical RTX and of BOTX, comparing then clinical and urodynannc effects over long term follow up in patients with neurogenic detmsor overactivity. MATERIAL & METHODS: 25 spinal cord injured patients were randomly assIgned to receive (a) intravesxal administrations of RTX 0.6 nncroM in 50 ml of 0.9% NaCl over 45 min (n=l3). or (b) injections of 300 units of BOTX diluted in 30 ml 0.9% N&l into the detmsor muscle under cystoscopic control (n=12). RTX and BOTX treatments were repeated when there was recurrence of urinary symptoms and/or urodynamic worsening. Frequency of daily incontinence episodes, uninhitxted detrusor contractions (UDC) threshold and maximum pressure, and maximum cystometric bladder capacity were measured at baseline and durmg follow up. Local and/or systemic side effects were noted. RESULTS: RTX arm: mean follow un was 14.8+3 months; the number of instillations/natient was X.611.9 and the mean time between &JO consecutive instillations was 51.6182 days. gOTX arm’ mean follow up was 14.2*3.9months; the number of treatments/ patient was 2.110.7 and the mean time between two consecurwe injections was 6.8h1.5 months. Urodynamic results are showed in the Table. There was a significant increase in UDC threshold (~~0.02) and in maximum bladder capaaty (piO.01) in BOTX arm, as compared to RTX at 6, 12 and 18 mos follow up. We did not observe any local or systemic side effects in both arms. Uninhibited detrusor contraction threshold (ml) RTX Pretreatment 6 mos 12 “10s 18 mos 2OQ69.7 288~84 285+85 213*76 BTX-A Max bladder capacity (ml) 19Ok48.6 1326x81 361*62 406*55 RTX 1 223168 / 329~72 1338+63 1 330*62 BTX-A 211+49 I 370t79 I415*75 1453*48 I CONCLUSIONS: Under the conditions imposed in this study, Botulinurn-A toxin injection into the detrusor muscle is superior to intravesical RTX in terms of urodynamic results and clinical benefits in patients with neurogenic detmsor hyper-reflexia m a long term follow up. While the efferent parasympathetic innerwtion to the detrusor is adequately blocked by 300 units Botilinum-A toxin, the afferent nervous transmission is not completely controlled by the present dose of intravesical RTX.
Intravesical resiniferatoxin versus botulinum A toxin injections for the treatment of neurogenic detrusor overactivity
GIANNANTONI, Antonella;MEARINI, Ettore;COSTANTINI, Elisabetta;PORENA, Massimo
2004
Abstract
INTRODUCTION & OBJECTIVES: Intravesical resiniferatoxin (RTX) and Botulinum-A toxin (BOTX) injections into the detrusor muscle have been introduced‘as t&atments for neurogenic refractolv detrusor overactivitv. Actuallv. there are no clinical studies conmarine intravesical RTX with Bot&num-A toxin injections. We i&stigated the effectiveness and safety tf intravesical RTX and of BOTX, comparing then clinical and urodynannc effects over long term follow up in patients with neurogenic detmsor overactivity. MATERIAL & METHODS: 25 spinal cord injured patients were randomly assIgned to receive (a) intravesxal administrations of RTX 0.6 nncroM in 50 ml of 0.9% NaCl over 45 min (n=l3). or (b) injections of 300 units of BOTX diluted in 30 ml 0.9% N&l into the detmsor muscle under cystoscopic control (n=12). RTX and BOTX treatments were repeated when there was recurrence of urinary symptoms and/or urodynamic worsening. Frequency of daily incontinence episodes, uninhitxted detrusor contractions (UDC) threshold and maximum pressure, and maximum cystometric bladder capacity were measured at baseline and durmg follow up. Local and/or systemic side effects were noted. RESULTS: RTX arm: mean follow un was 14.8+3 months; the number of instillations/natient was X.611.9 and the mean time between &JO consecutive instillations was 51.6182 days. gOTX arm’ mean follow up was 14.2*3.9months; the number of treatments/ patient was 2.110.7 and the mean time between two consecurwe injections was 6.8h1.5 months. Urodynamic results are showed in the Table. There was a significant increase in UDC threshold (~~0.02) and in maximum bladder capaaty (piO.01) in BOTX arm, as compared to RTX at 6, 12 and 18 mos follow up. We did not observe any local or systemic side effects in both arms. Uninhibited detrusor contraction threshold (ml) RTX Pretreatment 6 mos 12 “10s 18 mos 2OQ69.7 288~84 285+85 213*76 BTX-A Max bladder capacity (ml) 19Ok48.6 1326x81 361*62 406*55 RTX 1 223168 / 329~72 1338+63 1 330*62 BTX-A 211+49 I 370t79 I415*75 1453*48 I CONCLUSIONS: Under the conditions imposed in this study, Botulinurn-A toxin injection into the detrusor muscle is superior to intravesical RTX in terms of urodynamic results and clinical benefits in patients with neurogenic detmsor hyper-reflexia m a long term follow up. While the efferent parasympathetic innerwtion to the detrusor is adequately blocked by 300 units Botilinum-A toxin, the afferent nervous transmission is not completely controlled by the present dose of intravesical RTX.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
