Department of Urology/Female Pelvic Health, Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, USA.
Can J Urol. 2020 Feb;27(1):10125-10129.
Botulinum toxin A (BTX-A) is currently used as a fourth-line therapeutic option for interstitial cystitis/bladder pain syndrome (IC/BPS) management. The purpose of this study was to determine if BTX-A injection can mitigate pain and if injection location (i.e. trigone-including versus trigone-sparing injection template) impacts treatment efficacy and/or treatment complications profile.
Female IC/BPS patients refractory to conservative management strategies were prospectively enrolled and asked to complete a baseline history and physical exam, post-void residual (PVR) urine volume determination, O'Leary Sant (OLS) questionnaire, and Pelvic Pain and Urgency/Frequency Symptom Scale (PUF) questionnaire. Participants were randomly assigned to one of two treatment groups and received either: 1) a trigone-including BTX-A injection template or 2) a trigone-sparing injection template. Following therapy, patients were examined in clinic at 30 and 90 day post-treatment with symptom re-assessment via repeat questionnaires and for evidence of post-procedural complications.
Compared to baseline, patients in both treatment groups experienced significant improvement in OLS and PUF scores at both 30 and 90 days post-treatment with BTX-A, regardless of which injection template was used (p < 0.05). Complications resulting from BTX-A were minimal (most commonly urinary tract infection (UTI) and urinary retention) and not significantly different between the treatment groups (p > 0.05). No distant spread of BTX-A was observed in any patient in either treatment group.
BTX-A treatment using either a trigone-sparing or trigone-including injection template resulted in significant, but not location-dependent, improvement in IC/BPS symptom scores at 30 and 90 day points post-procedure with no significant difference in post-treatment complication profiles.
肉毒杆菌毒素 A(BTX-A)目前被用作间质性膀胱炎/膀胱疼痛综合征(IC/BPS)管理的第四线治疗选择。本研究的目的是确定 BTX-A 注射是否可以减轻疼痛,以及注射部位(即包括三角区与不包括三角区的注射模板)是否会影响治疗效果和/或治疗并发症的特征。
对经过保守治疗策略治疗无效的女性 IC/BPS 患者进行前瞻性登记,并要求其完成基线病史和体检、残余尿量(PVR)测定、O'Leary Sant(OLS)问卷、盆腔疼痛和急迫/频率症状量表(PUF)问卷。参与者被随机分配到两个治疗组之一,并接受以下治疗:1)包括三角区的 BTX-A 注射模板或 2)不包括三角区的注射模板。治疗后,患者在治疗后 30 天和 90 天在诊所接受检查,通过重复问卷评估症状,并评估是否存在治疗后并发症。
与基线相比,两组治疗组的 OLS 和 PUF 评分在 BTX-A 治疗后 30 天和 90 天均显著改善,无论使用哪种注射模板(p < 0.05)。BTX-A 引起的并发症很少见(最常见的是尿路感染(UTI)和尿潴留),且两组之间无显著差异(p > 0.05)。在任何治疗组的患者中均未观察到 BTX-A 的远处扩散。
使用包括三角区或不包括三角区的注射模板进行 BTX-A 治疗,在治疗后 30 天和 90 天,IC/BPS 症状评分均显著改善,但与注射部位无关,且治疗后并发症的特征无显著差异。