Clinical Trial: Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study.

Brief Summary: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Detailed Summary:

Introduction: Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.

Purpose: The objective of this study is to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses comparing to placebo for treating palmar hyperhidrosis.

Methods: This is a prospective, randomized and controlled study. From December 2010 to february 2011, 50 consecutive patients with palmar hyperhidrosis were treated with oxybutynin or placebo. Data were collected from 50 patients, and 5 (10,0%) patients were lost to follow-up. During the first week, patients received 2.5 mg of oxybutynin once a day in the evening. From the 8th to the 42nd day, they received 2.5 mg twice a day, and from the 43rd day to the end of the 12th week, they received 5 mg twice a day. All of the patients underwent 2 evaluations: before and after (12 weeks) the oxybutynin treatment, using a clinical questionnaire; and a clinical protocol for quality of life (QOL).


Sponsor: University of Sao Paulo

Current Primary Outcome: Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin [ Time Frame: 6 weeks ]

Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life


Original Primary Outcome: Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutinin [ Time Frame: 6 weeks ]

Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutinin have an improvement in their quality of life


Current Secondary Outcome: The use of oxybutynin diminishes hyperhidrosis [ Time Frame: 6 weeks ]

if the use of oxybutynin diminishes hyperhidrosis


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: March 7, 2011
Date Started: December 2010
Date Completion:
Last Updated: September 21, 2011
Last Verified: March 2011