Prospective randomized trial of 100u vs 200u botox in the treatment of idiopathic overactive bladder

Abstract

Aim:To evaluate the clinical outcomes of two different doses of BTX-A in patients with refractory idiopathic overactive bladder.Patients and Methods:Thirty nine patients with refractory idiopathic overactive bladder from 1/1/2008 till 30/3/2009 were evaluated in a tertiary care hospital. Patients were evaluated using urodynamic studies, voiding diary, UDI-6 and IIQ-7 questionnaires prior to being prospectively randomized (alternate randomization) to the BTX-A applications and three months after treatment. Voiding diary and residual volume were followed two weeks later. All patients received intradetrusorial injections of BTX-A (Botox, Allergan, Irvine, CA) of 100u or 200u under cystoscopic control on an outpatient basis. The primary endpoint was assessed for the improvement of urodynamic parameters and adverse events at three months after the initial treatment. Secondary end points included urinary frequency, urgency and UUI episodes as assessed by voiding diary and QoL.Results:Eleven patients were enrolled to each arm of the study. There were no significant differences in demographic characteristics between the two groups. Urodynamic assessment at the end of the third month showed significant improvement in urodynamic variables in both groups. There was no statistically significant difference in urodynamic parameters and in the voiding diary between the two groups. QOL was significantly improved in both groups with no statistically significant difference between the different doses. Only three patients developed acute urinary retention.Conclusion:BTX-A at 100u and 200u appears to improve symptoms, urodynamic parameters and QoL with no statistical significance between the two groups.

Botulinum Toxin-A Injections for Idiopathic Overactive Bladder: A Systematic Review and Meta-Analysis

“…In Denys et al's study [11], quality of life improvements were maintained for up to 6 months and generally lasted longer than clinical and urodynamic improvements. Quality of life was significantly improved in Altaweel et al's study [21] in both groups, with no statistically significant difference between 100 and 200 U at month 3. There were also no differences noted in Cohen et al's study [22] between those receiving 100 and 150 U botulinum toxin-A regarding improvement in quality of life (p > 0.05) at week 12.…”

“…No statistically significant difference was seen in Cohen et al's study [22] in the reduction of daily voiding frequency between patients receiving 100 U (p > 0.05) and 150 U (p > 0.05) botulinum toxin-A at week 12. Altaweel et al [21] found no statistically significant difference in voiding diary between 100 and 200 U (p > 0.05) at any time point.…”

“…Compared to 50 U, significant improvements were observed in Denys et al [11] at month 3 after 150 U botulinum toxin-A treatments for all measured volumes (voided volume, volume at first contraction, volume at first desire to void) and for MCC. Altaweel et al [21] found no statistically significant difference in urodynamic parameters between 100 and 200 U (p > 0.05) at month 3. No significant differences in PVR, MCC, maximum detrusor pressure or maximum urinary flow rate were noted by Cohen et al between the 100 and 150 U groups at any time point after injection [22].…”

“…Few patients need clean intermittent self-catheterization (CIC) (3/21 with 50 U, 1/22 with 100 U, 4/27 with 150 U). Dysuria and urinary retention occurred more often in Altaweel et al's study with 200 U compared with 100 U botulinum toxin-A injection [21]. …”

“…Different doses of botulinum toxin-A were compared in four trials [7,8,10,11,18,21,22]. A total of 478 patients were included; 18 patients were lost to follow-up.…”