Intravesical Resiniferatoxin for the Treatment of Storage Lower Urinary Tract Symptoms in Patients with Either Interstitial Cystitis or Detrusor Overactivity: A Meta-Analysis

<div><p>Background</p><p>While Resin­iferatoxin (RTX) has been widely used for patients with storage lower urinary tract symptoms (LUTS), its clinical efficiency hasn't yet been well evaluated. A meta-analysis was performed to evaluate the exact roles of intravesical RTX for the treatment of storage LUTS in patients with either interstitial cystitis (IC) or detrusor overactivity (DO).</p><p>Methods</p><p>A meta-analysis of RTX treatment was performed through a comprehensive search of the literature. In total, 2,332 records were initially recruited, 1,907 from Elsevier, 207 from Medline and 218 from the Web of Science. No records were retrieved from the Embase or Cochrane Library. Seven trials with 355 patients were included and one trial was excluded because of the lack of extractable data. The analyses were all performed using RevMan 5.1 and MIX 2.0.</p><p>Results</p><p>Bladder pain was significantly reduced after RTX therapy in patients with either IC or DO. The average decrease of the visual an alogue pain scale was 0.42 after RTX treatment (p = 0.02). The maximum cystometric capacity (MCC) was significantly increased in patients with DO (MCC increase, 53.36 ml, p = 0.006) but not in those with IC (MCC increase, −19.1 ml, p = 0.35). No significant improvement in urinary frequency, nocturia, incontinence or the first involuntary detrusor contraction (FDC) was noted after RTX therapy (p = 0.06, p = 0.52, p = 0.19 and p = 0.41, respectively).</p><p>Conclusions</p><p>RTX could significantly reduce bladder pain in patients with either IC or DO, and increase MCC in patients with DO; however, no significant improvement was observed in frequency, nocturia, incontinence or FDC. Given the limitations in the small patient size and risk of bias in the included trials, great caution should be taken when intravesical RTX is used before a large, multicenter, well-designed random control trial with a long-term follow-up is carried out to further assess the clinical efficacy of RTX in in patients with storage LUTS.</p></div

Nocturia changes in all the patients (A; mean difference −0.16, 95% CI −0.64 to 0.33, p = 0.52) and subgroup analyses of nocturia in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (B; mean difference for IC −0.25, 95% CI −1.00 to 0.49, p = 0.51; mean difference for DO −0.09, 95% CI −0.73 to 0.55, p = 0.78). Incontinence changes in all the patients (C; mean difference −2.26, 95% CI −5.68 to 1.15, p = 0.19).

<p>Nocturia changes in all the patients (A; mean difference −0.16, 95% CI −0.64 to 0.33, p = 0.52) and subgroup analyses of nocturia in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (B; mean difference for IC −0.25, 95% CI −1.00 to 0.49, p = 0.51; mean difference for DO −0.09, 95% CI −0.73 to 0.55, p = 0.78). Incontinence changes in all the patients (C; mean difference −2.26, 95% CI −5.68 to 1.15, p = 0.19).</p

Visual an­alogue scale (VAS) score changes for bladder pain in all the patients (A; average decrease of VAS score 0.42, 95% CI 0.07 to 0.76, p = 0.02) and subgroup analyses in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (B; average decrease of VAS score for IC 0.35, 95% CI 0 to 0.7, p = 0.05; average decrease of VAS score for DO 1.4, 95% CI 0.03 to 2.77, p = 0.05).

<p>Visual an­alogue scale (VAS) score changes for bladder pain in all the patients (A; average decrease of VAS score 0.42, 95% CI 0.07 to 0.76, p = 0.02) and subgroup analyses in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (B; average decrease of VAS score for IC 0.35, 95% CI 0 to 0.7, p = 0.05; average decrease of VAS score for DO 1.4, 95% CI 0.03 to 2.77, p = 0.05).</p

Flowchart of literature searches and results.

<p>In this meta-analysis, eight studies were selected for qualitative analysis. Of these eight studies, seven eligible controlled trials with 355 patients were included in our meta-analysis while the remaining one trial was excluded because of the lack of extractable data.</p

FDC (A; mean difference −16.56 ml, 95% CI −55.79 to 22.67 ml, p = 0.41) and MCC (B; mean difference 34ml, 95% CI -16.54 to 84.53ml, p = 0.19) changes in all the patients and subgroup analyses of MCC in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (C; MCC mean difference for IC −19.10 ml, 95% CI −59.37 to 21.17 ml, p = 0.35; MCC mean difference for DO 53.36 ml, 95%CI 15.42 to 91.29 ml, p = 0.006).

<p>FDC (A; mean difference −16.56 ml, 95% CI −55.79 to 22.67 ml, p = 0.41) and MCC (B; mean difference 34ml, 95% CI -16.54 to 84.53ml, p = 0.19) changes in all the patients and subgroup analyses of MCC in patients with either interstitial cystitis (IC) or detrusor overactivity (DO) (C; MCC mean difference for IC −19.10 ml, 95% CI −59.37 to 21.17 ml, p = 0.35; MCC mean difference for DO 53.36 ml, 95%CI 15.42 to 91.29 ml, p = 0.006).</p

Characteristics of included trials.

<p>R = patients treated with RTX, N =  controls, B =  the baseline symptom, P =  the post-treatment symptom.</p><p>“*” =  No. of incontinence episodes/3-day voiding diary, “−” =  data unavailable.</p><p>Data are expressed by mean ± standard deviation.</p

Quality assessment in this meta-analysis demonstrated a low risk of bias in five studies (Rios 2007, Kuo 2006, Payne 2005, Silva 2005 and Chen 2005) and a relatively high risk of bias in the remaining two studies (Ham 2012 and Lazzeri 2000).

<p>Quality assessment in this meta-analysis demonstrated a low risk of bias in five studies (Rios 2007, Kuo 2006, Payne 2005, Silva 2005 and Chen 2005) and a relatively high risk of bias in the remaining two studies (Ham 2012 and Lazzeri 2000).</p