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

Study Overview
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Brief Summary
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Evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.

Detailed Description
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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.

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

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Drug: Oxybutynin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hyperhidrosis At least 180 days of treatment with oxybutynin Exclusion Criteria: Incomplete medical chart Patients with glaucoma

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axillary hyperhidrosis<br>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<br>* 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.<br>|
| Palmar hyperhidrosis<br>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<br>* 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.<br>|
| Plantar hyperhidrosis<br>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<br>* 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.<br>|
| Cranio-facial hyperhidrosis<br>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<br>* 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.<br>|
| Other sites hyperhidrosis<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment efficacy, Long-term effects, Tachyphylaxis, Undesirable effects, Side effects, Self-assessment, Hyperhidrosis, Quality of life