GYNAECOLOGY
Efficacy of Botulinum Toxin A Intradetrusor Injections for Non-neurogenic Urinary Urge Incontinence: A Randomized Double-Blind Controlled Trial

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Abstract

Objective

To determine the efficacy of intradetrusor injections of botulinum toxin A for non-neurogenic urinary urge incontinence.

Methods

We conducted a six-month, randomized, double-blind controlled trial involving women with urinary urge incontinence. Participants received intradetrusor injections of either botulinum toxin (100U in 10 mL) via cystoscopy or a placebo control (saline injection). The primary outcome was maximum bladder capacity at cystoscopy. Secondary outcomes included quality-of-life measures, 24-hour leakage rate, patients' subjective assessment, and safety data.

Results

There were 21 participants: 11 in the botulinum toxin (treated) group and 10 in the placebo (control) group. There were no significant differences between the groups at baseline. After six months the mean maximum bladder capacity at cystoscopy was 161.6 mL greater in the treated group than in the control group (P = 0.018). There were no differences in diary data or quality-of- life measures. The 24-hour pad test (a measure of leakage) after three months showed significant improvement in the treated group (difference 272.12 g, P = 0.016); treated subjects also showed subjective benefit at three months (difference 1.29, P = 0.007) and at six months (difference 1.16, P = 0.01). There was no significant difference in rates of urinary tract infection between groups. There was one serious adverse event (a perioperative cardiac event) in the botulinum toxin group.

Conclusion

Botulinum toxin increased bladder capacity at cystoscopy and reduced urinary incontinence on 24-hour pad testing in adult females with urinary urge incontinence. There was one adverse event in the group treated with botulinum toxin.

Résumé

Objectif

Déterminer l'efficacité des injections intradétrusoriennes de toxine botulinique A dans la prise en charge de l'incontinence par impériosité non neurogène.

Méthodes

Nous avons mené un essai comparatif randomisé à double insu d'une durée de six mois auprès de femmes présentant une incontinence par impériosité. Les participantes ont reçu des injections intradétrusoriennes de toxine botulinique (100 U dans 10 ml) par cystoscopie ou des injections de placebo (solution saline). Le critère d'évaluation principal était la capacité vésicale maximale telle que déterminée par cystoscopie. Parmi les critères d'évaluation secondaires, on trouvait les mesures de la qualité de vie, le taux de fuite sur 24 heures, l'évaluation subjective des patientes et les données sur la sûreté.

Résultats

L'essai comptait 21 participantes : 11 dans le groupe traité à la toxine botulinique (groupe « traitement ») et 10 dans le groupe traité au placebo (groupe « témoin »). Aucune différence significative n'a été constatée entre les groupes au point de départ. Après six mois, la capacité vésicale maximale moyenne telle que déterminée par cystoscopie était supérieure de 161,6 ml au sein du groupe « traitement », par comparaison avec le groupe « témoin » (P = 0,018). Aucune différence n'a été constatée en ce qui a trait aux données issues des journaux tenus par les participantes ou aux mesures de la qualité de vie. Le test de 24 heures au moyen d'une serviette hygiénique (une mesure des fuites) mené après trois mois a indiqué une amélioration significative au sein du groupe « traitement » (différence : 272,12 g, P = 0,016); les participantes du groupe « traitement » présentaient également un avantage subjectif à trois mois (différence : 1,29, P = 0,007) et à six mois (différence : 1,16, P = 0,01). Aucune différence significative n'a été constatée entre les groupes en matière de taux d'infection des voies urinaires. Un événement indésirable grave (un incident cardiaque périopératoire) a été constaté dans le groupe « traitement ».

Conclusion

L'utilisation de la toxine botulinique a entraîné l'augmentation de la capacité vésicale (telle que déterminée par cystoscopie) et l'atténuation de l'incontinence urinaire (baisse constatée grâce au test de 24 heures au moyen d'une serviette hygiénique) chez des femmes adultes présentant une incontinence par impériosité. Un événement indésirable a été constaté dans le groupe traité à la toxine botulinique.

Section snippets

INTRODUCTION

Overactive bladder is a condition characterized by urgency with or without urinary urge incontinence.1 It causes individuals to feel an urgent need to urinate because of involuntary bladder contractions and is a common quality-of-life disorder that becomes more prevalent with age.1 Standard treatment for urinary urge incontinence includes behaviour modification, pelvic floor exercises, anticholinergic medication, and, less commonly, sacral neuromodulation.2 Unfortunately, anticholinergic

METHODS

We conducted a single-institution, six-month randomized, double-blind controlled trial of botulinum toxin in patients with idiopathic urge incontinence recruited from the practice of a single urogynaecologist (C.J.). Subjects in the placebo group were offered botulinum toxin after the six-month follow-up visit.

Women over 18 years of age with a confirmed diagnosis of idiopathic urge incontinence refractory to anticholinergic treatment were considered eligible for inclusion. The diagnosis was

RESULTS

Eleven participants were randomized to the treatment group (botulinum toxin) and 10 to the control group between February 2008 and September 2009. Recruitment was stopped at 21 subjects because of slow accrual; this was attributed to the introduction of two new anticholinergic medications following initiation of the study. The flow of patients through the study is shown in Figure 1. All subjects received their assigned treatment and no subjects were lost to follow-up. Patient characteristics

DISCUSSION

In this study, based on both objective and subjective endpoints, 100 U of botulinum toxin was somewhat effective at improving urinary urge incontinence symptoms. The treatment group had a significant increase in the primary outcome, maximum bladder capacity at cystoscopy, with a 14% increase from baseline to six months. At three months, 55% of the treatment group had a dry pad test. There was also a significant difference in the groups’ subjective assessment of benefit from treatment, with 55%

CONCLUSION

Intradetrusor injections of 100 U of botulinum toxin A were well tolerated and resulted in improvement in adult women with non-neurogenic urinary urge incontinence resistant to anticholinergic medication. A total injection dose of 100 U appears to be an optimal initial dose and can be repeated after six months. Most participants did not require or want sedation for this procedure, improving the availability of botulinum toxin treatment and reducing wait times. The technique of botulinum toxin

ACKNOWLEDGEMENT

Allergan Inc. (Markham, Ontario) provided an honorarium for a urologist experienced in the use of botulinum toxin to be the first author’s preceptor. Allergan Inc. also provided eight vials of botulinum toxin for the day of training. There was no financial support for this study.

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Competing interests: None declared.

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