Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis

Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis

Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: Oxybutynin

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 Type: Observational
• Enrollment (Actual): 1100

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05652000
    • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Out-patients on two tertiary hospitals (Hospital Israelita Albert Einstein and Hospital das Clínicas - HCFMUSP) who seeked medical attention because of hyperhidrosis.

Description

Inclusion Criteria:

• Primary hyperhidrosis
• At least 180 days of treatment with oxybutynin

Exclusion Criteria:

• Incomplete medical chart
• Patients with glaucoma

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment	1 day before treatment
Quality of life	Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment	Forty-two days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of improvement in excessive sweating	We want to analyze the patient's self perception (grades 0 to 10) of amelioration in sweating after forty-two days of treatment	After 42 days of treatment
Perception of improvement in excessive sweating	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).	1 day (On the last medical visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects in the use of oxybutynin for hyperhidrosis	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	After 42 days of treatment
Side effects in the use of oxybutynin for hyperhidrosis	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	1 day )On the last medical visit)

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Nelson Wolosker, PhD, MD, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• Wolosker N, Schvartsman C, Krutman M, Campbell TP, Kauffman P, de Campos JR, Puech-Leao 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.
• 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-Leao P. Oxybutynin treatment for hyperhidrosis: a comparative analysis between genders. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):405-8. doi: 10.1590/s1679-45082012000400002. English, Portuguese.
• Wolosker N, de Campos JR, Kauffman P, Puech-Leao 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, Neves S, Munia MA, BiscegliJatene F, Puech-Leao 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, Campos JR, Kauffman P, Munia MA, Neves S, Jatene FB, Puech-Leao P. The use of oxybutynin for treating facial hyperhidrosis. An Bras Dermatol. 2011 May-Jun;86(3):451-6. doi: 10.1590/s0365-05962011000300005.
• Wolosker N, de Campos JR, Kauffman P, Neves S, Yazbek G, Jatene FB, Puech-Leao 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.
• 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.
• Maillard H, Fenot M, Bara C, Celerier 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.
• Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. No abstract available.
• Schollhammer M, Misery L. Treatment of hyperhidrosis with oxybutynin. Arch Dermatol. 2007 Apr;143(4):544-5. doi: 10.1001/archderm.143.4.544. No abstract available.
• 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.
• Tupker RA, Harmsze AM, Deneer VH. Oxybutynin therapy for generalized hyperhidrosis. Arch Dermatol. 2006 Aug;142(8):1065-6. doi: 10.1001/archderm.142.8.1065. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): October 8, 2013
• Last Update Submitted That Met QC Criteria: October 7, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Quality of life; Treatment efficacy; Long-term effects; Tachyphylaxis; Undesirable effects; Side effects; Self-assessment; Hyperhidrosis
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Oxybutynin
• Other Study ID Numbers: HIsraelitaAE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No