ObjectiveTo 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).DesignRandomised, double‐blinded clinical trial (January 2020–April 2023).SettingThis multicentre study was conducted at four hospitals in the Netherlands.Population and SampleNinety‐four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled.MethodsParticipants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions.Main Outcomes and MeasuresPrimary 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.ResultsA 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).ConclusionThe results from this study do not support the use of BTA injections in the management of CPP in women.

中文翻译：

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慢性盆腔疼痛患者盆底肌肉注射肉毒杆菌毒素 A 的疗效：一项双盲随机对照试验


目的评价和比较肉毒杆菌毒素 A （BTA） 注射与安慰剂注射联合盆底肌肉疗法 （PFMT） 治疗慢性盆腔疼痛 （CPP） 女性的疗效和安全性。设计随机、双盲临床试验（2020 年 1 月至 2023 年 4 月）。地点这项多中心研究在荷兰的四家医院进行。人群和样本 94 名患有 CPP 且尽管既往接受过 PFMT 但盆底肌张力增加的女性被纳入。方法参与者接受盆底肌 BTA 注射 （100 单位） 或安慰剂注射，然后进行 4 次 PFMT 治疗。主要结局和措施主要结局包括疼痛减轻至少 33% 的妇女人数和报告疼痛（非常）明显改善的妇女人数。次要结局包括生活质量和盆底功能。随访安排在治疗后 4 、 8 、 12 和 26 周。使用重复测量的混合模型进行分析。结果BTA 治疗后 15 名参与者 （33%） 和 9 名参与者 （20%） 报告平均疼痛评分降低 33% 或更多（比值比安慰剂/BTA 1.88;95% CI 0.72-4.90，p = 0.19）。在两组中，8 名女性 （17%） 报告她们的改善（非常）好得多（比值比安慰剂/BTA 0.947;95% CI 0.32-2.80，p = 0.92）。与安慰剂相比，BTA 治疗后盆底静息活动显着降低 （p = 0.001）。结论本研究的结果不支持使用 BTA 注射剂治疗女性 CPP。