Sung Ryul Shim1, Young Joo Cho2, In-Soo Shin3, Jae Heon Kim4. 1. Institute for Clinical Molecular Biology Research, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Republic of Korea. 2. Department of Epidemiology and Medical Informatics, Korea University, Seoul, Republic of Korea. 3. Department of Education, College of Education, Jeonju University, Jeonju, Republic of Korea. 4. Department of Urology, Soonchunhyang University School of Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, 140-743, Republic of Korea. piacekjh@hanmail.net.
Abstract
PURPOSE: To investigate the overall treatment efficacy and safety of botulinum toxin type A (BoNTA) injections compared with placebo in interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and EMBASE on BoNTA use in IC/BPS. Outcome measures included changes of OLS, ICSI, ICPI, VAS, frequency, nocturia, FBC, Qmax, and PVR from baseline and also included adverse events. RESULTS: A total of five studies were included, with a total sample size of 252 subjects (133 subjects in the experimental group and 119 subjects in the control group). The duration of follow-up ranged from 8 to 12 weeks. The BoNTA dosage was from 50 to 200 U. The pooled overall SMD in the mean change of VAS for the BoNTA group versus the placebo group was -0.49 (95 % CI -0.74, -0.23). There were also significant improvements in ICPI and frequency. The other outcomes (ICSI, nocturia, Qmax, and FBC) were not statistically different between the two groups. CONCLUSION: Although BoNTA is not regulatory approved indication, this first evidence-based systematic review and meta-analysis of BoNTA injection for IC/BPS showed significant differences in efficacy of treatment compared with placebo, especially for pain control, and also showed no differences in the rate of procedure-related adverse events.
PURPOSE: To investigate the overall treatment efficacy and safety of botulinum toxin type A (BoNTA) injections compared with placebo in interstitial cystitis/bladder pain syndrome (IC/BPS). METHODS: We conducted a systematic review and meta-analysis of the published literature in PubMed, Cochrane Library, and EMBASE on BoNTA use in IC/BPS. Outcome measures included changes of OLS, ICSI, ICPI, VAS, frequency, nocturia, FBC, Qmax, and PVR from baseline and also included adverse events. RESULTS: A total of five studies were included, with a total sample size of 252 subjects (133 subjects in the experimental group and 119 subjects in the control group). The duration of follow-up ranged from 8 to 12 weeks. The BoNTA dosage was from 50 to 200 U. The pooled overall SMD in the mean change of VAS for the BoNTA group versus the placebo group was -0.49 (95 % CI -0.74, -0.23). There were also significant improvements in ICPI and frequency. The other outcomes (ICSI, nocturia, Qmax, and FBC) were not statistically different between the two groups. CONCLUSION: Although BoNTA is not regulatory approved indication, this first evidence-based systematic review and meta-analysis of BoNTA injection for IC/BPS showed significant differences in efficacy of treatment compared with placebo, especially for pain control, and also showed no differences in the rate of procedure-related adverse events.
Authors: G R Sant; K J Propert; P M Hanno; D Burks; D Culkin; A C Diokno; C Hardy; J R Landis; R Mayer; R Madigan; E M Messing; K Peters; T C Theoharides; J Warren; A J Wein; W Steers; J W Kusek; L M Nyberg Journal: J Urol Date: 2003-09 Impact factor: 7.450