A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain improvement
研究概览
简要总结
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
- •Negative screening test results
- •Notified associated factors
- •Menopause, surgically sterilized women or women using effective contraceptive method
- •Good understanding and predictable adherence to the protocol
- •beneficiary/affiliated to French social security/social healthcare
- •signed Informed Consent Form
排除标准
- •Predictable poor adherence
- •Pregnant or breastfeeding women
- •Myasthenia
- •Treatment with aminoglycosides
- •Major mental disorders
- •Underlying etiology
- •Vulnerable subjects (particularly adults under guardianship)
- •Any reason deemed relevant by the investigator
- •Current or former (in the last 3 months) participation to another clinical trial
研究组 & 干预措施
Botulinum toxin
Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total).
First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
干预措施: Botulinum Toxin Type A (Drug)
Botulinum toxin
Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total).
First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
干预措施: Indexes (Other)
Saline solution
Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
干预措施: Saline solution (Other)
Saline solution
Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
干预措施: Indexes (Other)
结局指标
主要结局
Pain improvement
时间窗: 3 months
Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale
次要结局
未报告次要终点