The Use of Oxybutynin in Women After Thoracoscopic Sympathectomy and the Effect on Plantar Hyperhidrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- To evaluate the effect of oxybutynin in plantar hyperhidrosis
研究概览
简要总结
A study in which the experimental treatment procedure is compared to a standard (control) treatment, The use of oxybutynin in the late postoperative thoracic sympathectomy for women:
- To Evaluate the effect of oxybutynin on plantar hyperhidrosis.
- To evaluate the effect of oxybutynin in compensatory hyperhidrosis.
- To compare the results of questionnaires on quality of life and specific for hyperhidrosis to the results of TEWL.
详细描述
Sweating is the most important mechanism of the body to regulate body temperature, kept at around 36ºC. The thermoregulatory center in the hypothalamus captures data from the blood that passes through the brain and also the receptors of the skin. Sweat is a response to thermal variation, but may also appear in situations of anxiety and stress. The sweating occurs at rest in ambient temperatures greater than 24ºC.
The sweat glands are in greater numbers are located on the palms, soles, face and underarms. Specifically, these regions, such glands are also influenced by psychological factors, different glands located on the back and abdomen that respond to heat.
The hyperhidrosis is a relatively common disorder, affecting between 0.6 to 1% of the population. It is characterized by increased sweat in certain areas of the body such as hands, face, feet and armpits. More frequent in young adults and adolescents, mostly females. This is not a serious illness as life threatening, but this situation is very uncomfortable, causing deep embarrassment social relationships and psychological disorders in the carrier, which often isolate themselves socially and acquire habits that conceal their problem. Primary hyperhydrosis is the most common indication for the performance of thoracic sympathectomy.
Videothoracoscopic sympathectomy is performed for the treatment of palmar hyperhidrosis, axillary or cranial-facial, with improvement ranging from 80 to 95%. Patients with plantar sweating associated with hyperhidrosis may remain even after the operation. Moreover, the compensatory effect occurs in most patients (70%), with sweat in the abdomen and back, among others.
The plant can alleviate hyperhidrosis after thoracic sympathectomy in 50% of patients, by mechanisms not yet understood. The persistence of this sweat is located a source of frequent complaint postoperatively, spatially specific occasions such as wearing sandals, slippers or going barefoot.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with persistent plantar hyperhidrosis with limitation to their usual activities.
排除标准
- •pregnancy,
- •breastfeeding,
- •glaucoma,
- •use of tricyclic medications,
- •prior use of anticholinergic
- •side effects exacerbated, such as diarrhea, gastritis, constipation or dry mouth.
研究组 & 干预措施
Oxybuynin, hyperhidrosis
干预措施: Oxybutynin 5 mg pills (Drug)
placebo - sugar pill
干预措施: Oxybutynin 5 mg pills (Drug)
结局指标
主要结局
To evaluate the effect of oxybutynin in plantar hyperhidrosis
时间窗: 60 days
Apply the questionnaires of quality of life, specific ones for hyperhidrosis and TEWL before in patients with persistence of plantar sweating after thoracic sympathectomy. After continuous use of oxybutynin for a month, repeated them for comparison.
次要结局
- To evaluate the effect of oxybutynin in compensatory hyperhidrosis(60 days)