Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University, Hualien, Taiwan.
Pain Physician. 2013 Jan;16(1):E15-23.
Onabotulinumtoxin-A (BoNT-A) is effective for the treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). However, long-term follow-up does not show successful outcome after a single injection.
To evaluate the efficacy and safety of repeated intravesical BoNT-A injections for treatment of IC/PBS and compare the success rates among patient groups receiving different injection numbers.
Prospective interventional study.
Tertiary medical center.
Intravesical injection of 100 U of BoNT-A was performed in 81 patients every 6 months for up to 4 times or until patients' symptoms significantly improved. Patients who received a single injection served as active controls. Measured parameters included O'Leary-Sant symptom indexes (ICSI) and problem indexes (ICPI), visual analogue score (VAS) for pain, voiding diary variables, urodynamic parameters, maximal bladder capacity under anesthesia, glomerulation grade, and global response assessment. Multiple measurements and Kaplan-Meier analysis were used for comparison of consecutive data and success rates among groups.
Among 81 patients, 20 received single injections, 19 received 2 injections, 12 received 3 injections, and 30 received 4 injections. The mean (± standard deviation) of ICSI, ICPI, total scores, VAS, functional bladder capacity, and daytime frequency all showed significant improvement after repeated BoNT-A treatment with different injections. Significantly better success rates were noted in patients who received 4 repeated injections (P = 0.0242) and 3 injections (P = 0.050), compared to those who received a single injection. However, there was no significant difference of long-term success rates among patients who received 2, 3, and 4 injections.
Lack of placebo control group is the main limitation.
Repeated intravesical BoNT-A injections were safe and effective for pain relief and they increased bladder capacity and provided a better long-term success rate than a single injection did for treatment of IC/PBS.
肉毒毒素 A（BoNT-A）对治疗间质性膀胱炎/膀胱疼痛综合征（IC/PBS）有效。然而，长期随访并未显示单次注射后的成功结果。
评估重复膀胱内 BoNT-A 注射治疗 IC/PBS 的疗效和安全性，并比较接受不同注射次数的患者组的成功率。
前瞻性干预研究。
三级医疗中心。
81 例患者每 6 个月接受 100 U 的 BoNT-A 膀胱内注射，最多 4 次，或直至患者症状明显改善。单次注射患者作为活性对照。测量参数包括 O'Leary-Sant 症状指数（ICSI）和问题指数（ICPI）、疼痛视觉模拟评分（VAS）、排尿日记变量、尿动力学参数、麻醉下最大膀胱容量、肾小球分级和整体反应评估。多次测量和 Kaplan-Meier 分析用于比较连续数据和组间成功率。
81 例患者中，20 例接受单次注射，19 例接受 2 次注射，12 例接受 3 次注射，30 例接受 4 次注射。重复 BoNT-A 治疗不同注射次数后，ICSI、ICPI、总分、VAS、功能性膀胱容量和日间频率均有显著改善。接受 4 次重复注射（P = 0.0242）和 3 次注射（P = 0.050）的患者成功率明显更高，而单次注射的患者成功率较低。然而，接受 2、3 和 4 次注射的患者长期成功率无显著差异。
缺乏安慰剂对照组是主要限制。
重复膀胱内 BoNT-A 注射安全有效，可缓解疼痛，增加膀胱容量，并提供比单次注射更好的长期成功率，用于治疗 IC/PBS。
