Table 49Botulinum toxin type A (Botox) (pre versus post treatment) Adverse events - Clinical study characteristics and clinical summary of findings

No. of studiesDesignTreatment (n)Control (n)ResultsLimitationsInconsistencyIndirectnessImprecisionOther considerationsQuality
Adverse events
1 [A]Prospective observational studyBotulinum toxin type A (Botox)
Mean no. of injections 7.2 (SD 1.3)

Urinary tract infections
Baseline 6.7 (2.1) vs 4 mths 1.6 (1.3) vs 1 yr 3.3 (2.1) vs 3 yrs 1.7 (2.0) vs 6 yrs 1.8 (0.5) baseline vs 6 yr p=0.001
S (i)NNN(ii)NVery low
1 [B]Prospective observational studyBotulinum toxin type A (Botox)
1 to 6 injections

Urinary tract infections
Antibiotics required after 30/327 treatment sessions
Long term antibiotics treatment was required 23/137 (17%)

Exacerbations of MS
8/137 (5.8%)
S (i)NNN(ii)NVery low

S serious N none


Before vs after data


Data at high risk of bias (very low quality), imprecision not assessed


Giannantoni et al (2009) 73


Khan et al (2011) 69

From: 8, Treatment to improve bladder storage

Cover of Urinary Incontinence in Neurological Disease
Urinary Incontinence in Neurological Disease: Management of Lower Urinary Tract Dysfunction in Neurological Disease.
NICE Clinical Guidelines, No. 148.
National Clinical Guideline Centre (UK).
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