Spruijt Melle A, Klerkx Wenche M, Notten Kim, van Eijndhoven Hugo, Speksnijder Leonie, Kerkhof Manon H, Kluivers Kirsten B
Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, The Netherlands.
BJOG. 2025 Feb;132(3):297-305. doi: 10.1111/1471-0528.17991. Epub 2024 Nov 13.
To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP).
Randomised, double-blinded clinical trial (January 2020-April 2023).
This multicentre study was conducted at four hospitals in the Netherlands.
Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.
Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.
Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis.
A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001).
The results from this study do not support the use of BTA injections in the management of CPP in women.
评估并比较A型肉毒杆菌毒素（BTA）注射与安慰剂注射联合盆底肌肉治疗（PFMT）对慢性盆腔疼痛（CPP）女性的疗效和安全性。
随机双盲临床试验（2020年1月至2023年4月）。
这项多中心研究在荷兰的四家医院进行。
招募了94名患有CPP且尽管先前接受过PFMT但盆底肌肉张力仍增加的女性。
参与者接受盆底肌肉的BTA注射（100单位）或安慰剂注射，随后进行四次PFMT疗程。
主要结局包括疼痛减轻至少33%的女性人数以及报告疼痛（非常）明显改善的女性人数。次要结局包括生活质量和盆底功能。在治疗后4周、8周、12周和26周安排随访。采用重复测量的混合模型进行分析。
BTA治疗后，15名参与者（33%）报告平均疼痛评分降低了33%或更多，安慰剂治疗后有9名参与者（20%）（安慰剂/BTA的比值比为1.88；95%置信区间为0.72 - 4.90，p = 0.19）。两组中，均有8名女性（17%）报告疼痛改善（非常）明显（安慰剂/BTA的比值比为0.947；95%置信区间为0.32 - 2.80，p = 0.92）。与安慰剂相比，BTA治疗后盆底静息活动显著降低（p = 0.001）。
本研究结果不支持使用BTA注射治疗女性CPP。
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