Botox on Vulvar Vestibulitis
试验速览
- 阶段
- 4 期
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Reduce vulvar pain on a visual analogue scale (VAS).
研究概览
简要总结
The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.
详细描述
Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings.
The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation.
Injection of Botulinum Toxin is tested as a therapeutic option for this condition.
A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Vulvar vestibulitis
- •Safe birth control
排除标准
- •Treated earlier with Botulinum toxin
- •Ongoing vulvar infection
- •Skin disease
- •Pregnancy
- •Myasthenia gravis
- •Amyotrophic lateral sclerosis (ALS)
- •Calcium antagonists;
- •Aminoglycosides;
- •Magnesium sulfate;
- •Systemic steroid treatment
结局指标
主要结局
Reduce vulvar pain on a visual analogue scale (VAS).
次要结局
- Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics