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Kim et al. 2003; USA
PEDro = 9
RCT
N=36
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Population: 22 males, 14 females, neurologically impaired patients (20 SCI, 7 multiple sclerosis, 9 other) with urodynamically verified detrusor hyperreflexia
Treatment: Randomized double-blind, placebo-controlled trial. Intravesical instillation of Resiniferatoxin (RTX) 0.005, 0.025, 0.05, 0.10, 0.2, 0.5, or 1.0 microM of RTX (n = 4 each group) or placebo (n=8).
Outcome Measures: incontinence episodes, bladder capacity
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- No statistical significance due to small sample sizes.
- Intravesical RTX administration was well-tolerated. This patient group was refractory to all previous oral pharmacologic therapy, yet some patients responded with improvement in bladder capacity and continence function shortly after RTX administration.
- In some cases, mean cystometric capacity increased up to 500% over baseline.
- Incontinence episodes decreased by over 50% for the 2 highest doses.
- No data available on long term effect of RXT on AD.
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Giannantoni et al. 2002; Italy
PEDro = 6
RCT
N=23
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Population: Refractory detrusor hyperreflexia
Treatment: Randomized two treatments
a) single dose of 2 mM. capsaicin in 30 ml ethanol plus 70 ml 0.9% sodium chloride OR
b) 100 mM. resiniferatoxin in 100 ml 0.9% sodium chloride
Outcome Measures: Urodynamics, frequency of daily catheterizations, incontinence episodes and side effects
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- Capsaicin group showed no significant urodynamic or clinical improvements at 30 and 60 days.
- Resiniferatoxin group demonstrated significant urodynamic improvement at 30 (p<0.05) and 60 days (p<0.001).
- Most patients receiving capsaicin, but none receiving resiniferatoxin developed AD, limb spasms, suprapubic discomfort and hematuria.
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Igawa et al. 2003; Japan
Downs & Black = 13
Pre-post
N=7
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Population: 5 subjects with cervical injuries and 2 subjects with thoracic injuries.
Treatment: bladder instillation with capsaicin solution under general anesthesia.
Outcome Measures: blood pressure, heart rate, serum catecholamines, blood ethanol concentration
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- Capsaicin attenuated elevated BP secondary to bladder distention (empty or full) (p<0.01) post-treatment.
- In all individuals, episodes of AD become negligible and well tolerated > 3 months.
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