The effectiveness of Botulinum toxin on persistent pelvic pain in women with endometriosis

慢性盆腔疼痛与子宫内膜异位症是知之甚少。 一些患有慢性盆腔疼痛的女性会出现盆腔肌肉痉挛。肌肉痉挛可能是子宫内膜异位症和其他类型慢性盆腔疼痛女性疼痛的重要组成部分。 肉毒杆菌毒素注射被广泛用于治疗与过度肌肉活动和痉挛相关的疾病。肉毒杆菌毒素注射到骨盆疼痛的妇女的骨盆肌肉的研究表明，减少疼痛和痉挛，但太少的妇女进行了研究，以得出其有效性。我们希望能证明肉毒杆菌毒素注射在盆腔疼痛的妇女将减轻他们的盆腔疼痛。 合格的受试者是患有慢性盆腔疼痛和子宫内膜异位症病史的健康女性。受试者将随机接受肉毒杆菌毒素注射或安慰剂（盐水）注射。一个月后，我们将评估疼痛的存在，并为所有女性提供肉毒杆菌毒素注射。我们还将评估是否需要重新注入。 本研究的目的是确定肉毒杆菌毒素注射到骨盆底的肌肉是否可以缓解慢性盆腔疼痛的妇女盆腔肌肉痉挛。经过多次行政延误后，与Allergan，Inc.实施了CTA，完成研究启动访视，并于2014年7月开始招募。 这项研究现正全面展开。 在入组开始后的一年中，我们取得了良好的进展，有9名入组受试者，3名女性进入了研究的预筛选阶段，另有4名女性表示有兴趣。

Chronic pelvic pain associated with endometriosis is poorly understood. Some women with chronic pelvic pain have muscle spasm of their pelvic muscles. Muscle spasm may be a significant part of pain in women with endometriosis and other types of chronic pelvic pain. Botulinum toxin injection is widely used to treat conditions associated with excessive muscle activity and spasm. Studies of botulinum toxin injected into pelvic muscles of women with pelvic pain have shown a decrease pain and spasm, but too few women have been studied to conclude its effectiveness. We expect to show that botulinum toxin injection in women with pelvic pain will relieve some of their pelvic pain. Eligible subjects are otherwise healthy women who have chronic pelvic pain and a history of endometriosis. Subjects will be randomized to either botulinum toxin injection or placebo (salt water) injection. After one month, we will evaluate the presence of the pain and all women will be offered botulinum toxin injection. We will also evaluate the need for reinjection. The purpose of this study is to determine if botulinum toxin injections into the muscles of the pelvic floor can relieve chronic pelvic pain in women with pelvic muscle spasm. After a number of administrative delays, a CTA was implemented with Allergan, Inc., a study initiation visit was completed and enrollment began in July 2014. The study is now fully underway. In the year since enrollment started, we have made good progress with 9 enrolled participants, 3 women who have entered the pre-screening phase of the study, and another 4 who have expressed interest.