Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis
Study Details
Study Description
Brief Summary
Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
This retrospective study aims to evaluate the medical charts of patients who were treated with oxybutynin for at least six months for primary hyperhidrosis. The investigators variables of interest are: (1) quality of life before pharmacological therapy and after six weeks, (2)self-perception of improvement in hyperhidrosis after six weeks of treatment and on last visit (whenever this occur, as long as this happens after six months), (3) side effects related to drug use.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Axillary hyperhidrosis Patients whose major complaint is excessive sweating in the axillary region (i.e, sweating in the armpit). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., palmar hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Drug: Oxybutynin
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
|
| Palmar hyperhidrosis Patients whose major complaint is excessive sweating in the palmar region (i.e, sweating in the hands). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Drug: Oxybutynin
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
|
| Plantar hyperhidrosis Patients whose major complaint is excessive sweating in the plantar region (i.e, sweating in the feet). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Drug: Oxybutynin
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
|
| Cranio-facial hyperhidrosis Patients whose major complaint is excessive sweating in the cranio-facial region (i.e, sweating in the face). Patients that also have hyperhidrosis - but that are less bothersome on other sites (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Drug: Oxybutynin
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
|
| Other sites hyperhidrosis Patients whose major complaint is excessive sweating in other sites of the body (e.g., on the chest, on the abdomen). Patients that also have hyperhidrosis - but that are less bothersome on other sites previously grouped (e.g., axillary hyperhidrosis) are not excluded, but are accounted for accordingly to their main complaint. |
Drug: Oxybutynin
All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
|
Outcome Measures
Primary Outcome Measures
- Quality of life [1 day before treatment]
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment
- Quality of life [Forty-two days after treatment]
Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment
Secondary Outcome Measures
- Perception of improvement in excessive sweating [After 42 days of treatment]
We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating after forty-two days of treatment
- Perception of improvement in excessive sweating [1 day (On the last medical visit)]
We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating on the last medical visit (whenever this happens).
Other Outcome Measures
- Side effects in the use of oxybutynin for hyperhidrosis [After 42 days of treatment]
Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported
- Side effects in the use of oxybutynin for hyperhidrosis [1 day )On the last medical visit)]
Assess the side effects that have been reported on patient's charts, such as: dry mouth, constipation, headache, glaucoma, bowel obstruction and any other side effect reported on the last medical return of the patient
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Primary hyperhidrosis
-
At least 180 days of treatment with oxybutynin
Exclusion Criteria:
-
Incomplete medical chart
-
Patients with glaucoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Israelita Albert Einstein | São Paulo | Brazil | 05652000 |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
Investigators
- Principal Investigator: Nelson Wolosker, PhD, MD, Hospital Israelita Albert Einstein
Study Documents (Full-Text)
None provided.More Information
Publications
- Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356.
- Maillard H, Fenot M, Bara C, Célérier P. [Therapeutic value of moderate-dose oxybutynin in extensive hyperhidrosis]. Ann Dermatol Venereol. 2011 Oct;138(10):652-6. doi: 10.1016/j.annder.2011.07.002. Epub 2011 Aug 17. French.
- Mijnhout GS, Kloosterman H, Simsek S, Strack van Schijndel RJ, Netelenbos JC. Oxybutynin: dry days for patients with hyperhidrosis. Neth J Med. 2006 Oct;64(9):326-8. Review.
- Schollhammer M, Misery L. Treatment of hyperhidrosis with oxybutynin. Arch Dermatol. 2007 Apr;143(4):544-5.
- Try C, Messikh R, Elkhyat A, Aubin F, Humbert RP. [Use of oral oxybutynin at 7.5 mg per day in primary hyperhidrosis]. Rev Med Liege. 2012 Oct;67(10):520-6. French.
- Tupker RA, Harmsze AM, Deneer VH. Oxybutynin therapy for generalized hyperhidrosis. Arch Dermatol. 2006 Aug;142(8):1065-6.
- Wolosker N, Campos JR, Kauffman P, Munia MA, Neves S, Jatene FB, Puech-Leão P. The use of oxybutynin for treating facial hyperhidrosis. An Bras Dermatol. 2011 May-Jun;86(3):451-6.
- Wolosker N, de Campos JR, Kauffman P, Neves S, Munia MA, BiscegliJatene F, Puech-Leão P. The use of oxybutynin for treating axillary hyperhidrosis. Ann Vasc Surg. 2011 Nov;25(8):1057-62. doi: 10.1016/j.avsg.2011.06.007.
- Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, Puech-Leão P. An alternative to treat palmar hyperhidrosis: use of oxybutynin. Clin Auton Res. 2011 Dec;21(6):389-93. doi: 10.1007/s10286-011-0128-4. Epub 2011 Jun 19.
- Wolosker N, de Campos JR, Kauffman P, Puech-Leão P. A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. J Vasc Surg. 2012 Jun;55(6):1696-700. doi: 10.1016/j.jvs.2011.12.039. Epub 2012 Feb 16.
- Wolosker N, de Campos JR, Kauffman P, Yazbek G, Neves S, Puech-Leao P. Use of oxybutynin for treating plantar hyperhidrosis. Int J Dermatol. 2013 May;52(5):620-3. doi: 10.1111/j.1365-4632.2012.05746.x.
- Wolosker N, Krutman M, Campdell TP, Kauffman P, Campos JR, Puech-Leão P. Oxybutynin treatment for hyperhidrosis: a comparative analysis between genders. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):405-8. English, Portuguese.
- Wolosker N, Schvartsman C, Krutman M, Campbell TP, Kauffman P, de Campos JR, Puech-Leão P. Efficacy and quality of life outcomes of oxybutynin for treating palmar hyperhidrosis in children younger than 14 years old. Pediatr Dermatol. 2014 Jan-Feb;31(1):48-53. doi: 10.1111/pde.12142. Epub 2013 Apr 29.
- HIsraelitaAE