Szczypior Michał, Połom Wojciech, Wąż Piotr, Matuszewski Marcin
Department of Urology, Medical University of Gdansk, Gdansk, Poland.
Department of Nuclear Medicine, Medical University of Gdansk, Gdansk, Poland.
Wideochir Inne Tech Maloinwazyjne. 2019 Sep;14(3):420-426. doi: 10.5114/wiitm.2019.82763. Epub 2019 Feb 6.
Refractory idiopathic overactive bladder (RIOAB) is a common condition with a significant negative impact on quality of life. Intravesical injection of botulinum toxin A (BTX-A) is widely used as an intervention for these cases. In the standard method the drug solution is colorless. The addition of dye such as methylene blue (MB) facilitates visualization during the procedure and may have a beneficial effect.
To evaluate the injection of BTX-A with the addition of methylene blue (MB) against a standard method in the treatment of RIOAB.
In this 1-center, single-blinded, randomized controlled trial, we recruited 80 patients with RIOAB. A total of 39 were assigned to injection into the bladder wall of 100 U BTX-A with MB (in 9.5 ml normal saline + 0.5 ml MB), and 41 were assigned to BTX-A 100 U alone (in 10 ml normal saline). Cystoscopy with a submucosal injection of the solution was performed systematically, including the bladder triangle. Participants were assessed 6 and 12 weeks after the treatment using a Likert scale and OABSS questionnaire.
Significant improvement was similar (result of 1 or 2 on the Likert scale) and was achieved in 66.7% and 69.2% after 6 weeks and in 63.9% and 64.1% after 12 weeks in the BTX-A + MB group and only-BTX-A group, respectively. There was a significant difference between the two groups (p = 0.049) in the total number of patients with complications: 2 (5.6%) vs. 9 (23.1%).
The addition of MB to BTX for treatment of RIOAB patients does not influence treatment efficacy, while it limits the risk of complications.
难治性特发性膀胱过度活动症（RIOAB）是一种常见病症，对生活质量有重大负面影响。膀胱内注射A型肉毒毒素（BTX-A）被广泛用作这些病例的一种干预措施。在标准方法中，药物溶液是无色的。添加诸如亚甲蓝（MB）之类的染料有助于在操作过程中实现可视化，并且可能具有有益效果。
评估添加亚甲蓝（MB）的BTX-A注射与标准方法相比在治疗RIOAB中的效果。
在这项单中心、单盲、随机对照试验中，我们招募了80例RIOAB患者。总共39例被分配接受将100 U BTX-A与MB（在9.5 ml生理盐水中 + 0.5 ml MB）注射到膀胱壁，41例被分配接受单独的100 U BTX-A（在10 ml生理盐水中）。系统性地进行了溶液的黏膜下注射膀胱镜检查，包括膀胱三角区。在治疗后6周和12周使用李克特量表和膀胱过度活动症症状评分（OABSS）问卷对参与者进行评估。
显著改善情况相似（李克特量表评分为1或2），BTX-A + MB组在6周后和12周后分别有66.7%和63.9%达到，仅BTX-A组在6周后和12周后分别有69.2%和64.1%达到。两组在并发症患者总数上存在显著差异（p = 0.049）：2例（5.6%）对9例（23.1%）。
在治疗RIOAB患者时，在BTX中添加MB不影响治疗效果，同时限制了并发症风险。
