|Silva et al. 2005
|Population: Neurogenic detrusor overactivity. Mean age: 38 yr; Gender: males=15, females=13.
Intervention: Individuals were randomly placed in a treatment group receiving 50nM resiniferatoxin or a placebo group.
Outcome Measures: First detrusor contraction (FDC), maximal cystometric capacity (MCC). Measures were assessed 1 month and 1 week pre-treatment and 1 and 3 months post treatment.
|1. FDC and MCC increased significantly in the treatment group compared to the placebo group (p=0.03, p=0.02).
2. No significant difference was seen in FDC and MCC in the treatment group between month 1 post treatment and month 3.
3. Individuals in the RTX instillation group reported a non-significant increase in discomfort compared to the placebo. Otherwise similar side effects were seen between RTX and placebo.
4. A significant decrease in daily incontinence was seen in the treatment group (p=0.03).
|deSeze et al. 2004
|Population: SCI (n=18); MS (n=21); Mean age: 47 yr; Gender: males=17, females=22; Level of injury: paraplegia=14, tetraplegia=4; Severity of injury: AIS: A, B; Bladder management method: IC=23, reflex or voluntary voiding=8, suprapubic percussion=2, spontaneous voiding=14.
Intervention: 100ml 100nMol/l resiniferatoxin (RTX) in 10% ethanol or 1mmol/l capsaicin (CAP) diluted in glucidic solvent.
Outcome Measures: Clinical: daily voids/catheterization, leakage episodes with urgency/ leakage delay. Primary outcome measure: Maximum Cystometric Capacity (MCC).
|1. No significant difference between groups in MCC (p=0.4): both resulted in clinical and urodynamic improvement at d 90 (Improvement in MCC: 68% of RTX and 86% in CAP groups).
2. Persistent clinical improvement 94% versus 60% in favour of RTX but the difference was not significant.
3. Side effects were similar between groups except clinically tolerable/brief suprapubic pain significantly higher in CAP group (P<0.04).
|Kim et al. 2003
|Population: SCI=20, MS=7, Other=9 with detrusor hyperreflexia and intractable UTIs despite previous anticholinergic drug use; Gender: males=22, females=14.
Intervention: Double-blind dose escalation of single instillation of 100mL intravesical resiniferatoxin (RTX) (0.005, 0.025, 0.05, 0.10, 0.2, 0.5, or 1.0 microM of RTX; n=4/group) or placebo (n=8).
Outcome Measures: A visual analog pain scale (VAPS), bladder diary, mean cystometric bladder capacity (MCC) at wks 1, 3, 6 & 12 posttreatment, adverse events including autonomic dysreflexia (AD).
|1. VAPS: min. to mild discomfort with values of 2.85 and 2.28 for the 0.5-microM and 1.0-microM RTX treatment groups.
2. No statistically significant changes in MCC or incontinence at lower doses of RTX.
3. However in higher doses (0.5-microM & 1.0-microM) of RTX, MCC increased by 53% & 48% respectively at 3 weeks.
4. Incontinence decreased by 51.9% & 52.7% for the 0.5-microM & 1.0-microM RTX.
5. Intravesical RTX is well-tolerated but monitoring for autonomic dysreflexia is required.
|Petersen et al. 1999
|Population: Median age: 45 yr (range 28-68); Gender: males=6, females=6.
Intervention: Individuals were initially randomized to either an intraversical saline (100ml left in the bladder for 30 minutes) or intravesical capsaicin (100 ml 1mmol/L left in the bladder for 30 minutes) group; cross-over to the alternative treatment took place after 4 weeks.
Outcome Measures: Intravesical pressure during DH and bladder capacity, visual analogue scale (VAS).
|1. There were significant changes in the mean values of VAS scores during the study.
2. VAS scores, mean volume and maximum pressure during DH was not significantly different between groups at follow-up.
3. Bladder biopsies taken two weeks post treatment showed pronounced inflammation, superficial hemorrhage, and squamous epithelial metaplasia.
|deSeze et al. 1998
|Population: Age range 20-66 yr; Gender: males=11, females=9; Injury etiology: MS=12, SCI=8; Level of injury: paraplegia=17, tetraplegia=3; Severity of injury: complete=6, incomplete=14; Time post-injury=1-27 yr.
Intervention: 30 mg capsaicin in 100mL 30% ethanol or 100ml 30% ethanol alone.
Outcome Measures: Clinical: voiding diary. Urodynamic: Maximum Cystometric Capacity (MCC), Maximum Detrusor Pressure (MDP).
|30 d after instillation, results favoured capsaicin over placebo:
1. Decrease in 24h voiding freq (p=0.016).
2. Decrease in 24h leakages (p=0.0008).
3. Increase in MCC (p=0.01).
4. Decrease in MDP (p=0.07; not significant).
5. Similar side effects in each group.
|George et al. 2007
Prospective Controlled Trial
|Population: Age range 20-53 yr; Gender: males=17, females=1.
Intervention: Oxybutynin, propantheline, and capsaicin solution were instilled intravesically. Oxybutynin and propantheline were administered 3 times daily by a double blind method with a 6 d washout period between each drug. Individuals receiving propantheline or oxybutynin had urodynamic studies done before and 3 hours after the instillation of the third dose. The capsaicin instillation was not possible to blind and urodynamic studies were repeated 1 and 2 weeks after instillation of the drug.
Outcome Measures: Reflex volume, detrusor leak point pressure, cystometric capacity, and urine leak frequency.
|1. Overall capsaicin treatment resulted in significant change in:
· Reflex volume (p=0.018).
· Cystometric capacity (p=0.0440).
· Leak volume (p=0.000).
· Leak frequency (p=0.009).
2. Pre and post responses between intravesical oxybutynin, propantheline and capsaicin showed significant differences at 2 weeks with respect to leak volume (p=0.017) and leak frequency (p=0.003).
|Shin et al. 2006
|Population: Mean age: 27.2 yr; Gender: males=11, females=4; Severity of injury: AIS Impairment Score: A=10; B=5.
Intervention: Conventional and ice provocative urodynamic studies were performed. Seven days later, 100 ml of resiniferatoxin solution (RTX; 100 nM) diluted in 10% ethanol was instilled into the bladder at an infusion rate of 30mL/min.
Outcome Measures: Involuntary detrusor activity, reflex volume, maximal bladder capacity, compliance, DPmax, and reflex volume. Urodynamic changes were examined 30 days after the instillation.
|1. Intravesical RTX instillation resulted in a significant increased reflex volume ratio (p<0.05).
2. No significant change was found after intravesical RTX instillation in:
· Maximum bladder capacity.
· Maximal detrusor pressure.
3. Three cases showed complete suppression and 9 cases showed partial suppression of the unmyelinated C-fiber activities.
|Watanabe et al. 2004
|Population: Group 1: Individuals with NDO from SCI (n=7) or transverse myelitis (n=1): Mean age: 30.9 yr (range19-53); Gender: males=6, females=2.
Group 2: Individuals with NDO from SCI (n=7) or cerebral palsy (n=1); Mean age: 28.1 yr (range 19-46); Gender: males=7, females=1.
Intervention: Intravesical resiniferatoxin (RTX) (30 mL of 500 nM in protocol 1, 100ml of 1um in protocol 2).
Outcome Measures: Incontinence, bladder capacity.
|1. 6/8 individuals (75%) reported improvements in their incontinence grades and symptoms.
2. The mean bladder capacity increased significantly in both protocol groups (protocol 1: 138ml to 227.3ml, protocol 2:133.1ml to 247 ml, p<0.05).
|Lazzeri et al. 1998
|Population: SCI individuals with detrusor hyperreflexia currently being treated with itnravesical instillation of capsaicin: Mean age: 32.85 yr (range 19-54); Gender: males=2, females=5.
Intervention: Resiniferatoxin (RTX) saline solution (30ml at 10-5 M) instilled into the bladders of all individuals and left for 30 minutes.
Outcome Measures: Mean cystomanometric capacity (MCC); mean maximum bladder detrusor pressure (MDP), incontinence.
|1. 15 days post-treatment: MCC significantly increased (190ml to 407.14 ml, p<0.01) and MDP decreased significantly.
2. Four weeks after RTX instillation, MCC remained significantly increased from its baseline value (421.66 ml, p value).
3. Incontinence was improved in 6/7 individuals (85.7%): improvements in their frequency, urgency and nocturia (n=3) or remained completely dry (n=3) post-treatment.
|Dasgupta et al. 1998
|Population: MS, SCI: Age range 40-70 yr; Gender: males=9, females=11.
Intervention: Intravesical capsaicin.
Outcome Measures: Histopathological examination of bladder biopsies, urodynamics to assess bladder capacity, cystoscopy in 2 individuals.
|1. All biopsies were benign. Some reflected chronic inflammation (cystoscopy: 2 males with TM – transient inflammatory reaction to treatment).
2. Bladder capacity improvement at 6 weeks.
|Das et al. 1996
|Population: Mixed group: Age range 23-52 yr.
Intervention: Intravesical capsaicin treatment: 100uM, 500uM, 1mM, 2mM.
Outcome Measures: Symptomatic improvement, bladder capacity.
|1. Symptomatic improvement: 3/5 completers.
2. Mean urodynamic bladder capacity increased (p<0.05).