Clinical Trial: A Study to Compare Oxybutynin to a Placebo in Women and the Effect on Plantar Hyperhidrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Use of Oxybutynin in Women After Thoracoscopic Sympathectomy and the Effect on Plantar Hyperhidrosis
Brief Summary:
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.
Detailed Summary:
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
Sponsor: Federal University of São Paulo
Current Primary Outcome: To evaluate the effect of oxybutynin in plantar hyperhidrosis [ Time Frame: 60 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To evaluate the effect of oxybutynin in compensatory hyperhidrosis [ Time Frame: 60 days ]
Original Secondary Outcome: Same as current
Information By: Federal University of São Paulo
Dates:
Date Received: March 29, 2011
Date Started: March 2010
Date Completion:
Last Updated: April 1, 2011
Last Verified: November 2010
