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

Study Overview
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Brief Summary
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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 Description
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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).

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

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: Oxybutynin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with hyperhidrosis Exclusion Criteria: Glaucoma and pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxybutynin<br>patients will receive in the end of the treatment, 10 mg of oxybutynin a day | Drug: Oxybutynin<br>* 5 mg every 12 hours for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* placebo twice a day for 42 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Quality of life in patients with hyperhidrosis with the use of oxybutynin | Using a Quality of life protocol we will study if patients with hyperhidrosis using oxybutynin have an improvement in their quality of life | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The use of oxybutynin diminishes hyperhidrosis | if the use of oxybutynin diminishes hyperhidrosis | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperhidrosis, oxybutynin