Use of Oxybutynin to Treat Axillary Hyperhidrosis
Study Details
Study Description
Brief Summary
The objective of this study was to evaluate the effectiveness and patient satisfaction with the use of oxybutynin at low doses for treating axillary hyperhidrosis in a large series of patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oxybutynin Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled. |
Drug: Oxybutynin
Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
|
| Placebo Comparator: Placebo Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled. |
Drug: Placebo
Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
|
Outcome Measures
Primary Outcome Measures
- Effectiveness of treatment by a clinical questionnaire [6 weeks of treatment]
These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire, published at 2003: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91
- Effectiveness of treatment using a clinical questionnaire [After 12 weeks of treatment]
These evaluations were used to assess (1) the patients' clinical improvement in axillary hyperhidrosis, using a clinical questionnaire: de Campos JR, Kauffman P, Werebe Ede C, Andrade Filho LO, Kusniek S, Wolosker N, Jatene FB.Quality of life, before and after thoracic sympathectomy: report on 378 operated patients.Ann Thorac Surg. 2003 Sep;76(3):886-91
Secondary Outcome Measures
- Treatment of hyperhidrosis at other sites [6 weeks]
These evaluations were used to assess (1) the patients' clinical improvement in hyperhidrosis at other sites, using a clinical questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients with axillary hyperhidrosis
Exclusion Criteria:
- glaucoma and micturition disorders, pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clinicas da FMUSP | Sao Paulo | Brazil | 04534000 |
Sponsors and Collaborators
- Grupo de Cirurgia Vascular
Investigators
- Principal Investigator: Nelson Wolosker, MD, PhD, Hospital das Clinicas, University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
- de Campos JR, Wolosker N, Yazbek G, Munia MA, Kauffman P, Puech-Leao P, Jatene FB. Comparison of pain severity following video-assisted thoracoscopic sympathectomy: electric versus harmonic scalpels. Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):919-22. doi: 10.1510/icvts.2009.225383. Epub 2010 Mar 16.
- Munia MA, Wolosker N, Kauffman P, de Campos JR, Puech-Leão P. A randomized trial of T3-T4 versus T4 sympathectomy for isolated axillary hyperhidrosis. J Vasc Surg. 2007 Jan;45(1):130-3.
- Munia MA, Wolosker N, Kaufmann P, de Campos JR, Puech-Leão P. Sustained benefit lasting one year from T4 instead of T3-T4 sympathectomy for isolated axillary hyperhidrosis. Clinics (Sao Paulo). 2008 Dec;63(6):771-4.
- Wolosker N, Yazbek G, de Campos JR, Munia MA, Kauffman P, Jatene FB, Puech-Leao P. Quality of life before surgery is a predictive factor for satisfaction among patients undergoing sympathectomy to treat hyperhidrosis. J Vasc Surg. 2010 May;51(5):1190-4. doi: 10.1016/j.jvs.2009.11.078. Epub 2010 Mar 29.
- Wolosker N, Yazbek G, Ishy A, de Campos JR, Kauffman P, Puech-Leão P. Is sympathectomy at T4 level better than at T3 level for treating palmar hyperhidrosis? J Laparoendosc Adv Surg Tech A. 2008 Feb;18(1):102-6. doi: 10.1089/lap.2007.0030.
- Yazbek G, Wolosker N, Kauffman P, Campos JR, Puech-Leão P, Jatene FB. Twenty months of evolution following sympathectomy on patients with palmar hyperhidrosis: sympathectomy at the T3 level is better than at the T2 level. Clinics (Sao Paulo). 2009;64(8):743-9. doi: 10.1590/S1807-59322009000800006.
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