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

Completed

• Conditions: Hyperhidrosis
• Interventions: Drug: Oxybutynin

• Registration Number: NCT01956591
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2013-08-16
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

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

Exclusion Criteria

• Incomplete medical chart
• Patients with glaucoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axillary hyperhidrosis	Oxybutynin	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.
Other sites hyperhidrosis	Oxybutynin	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.
Palmar hyperhidrosis	Oxybutynin	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.
Plantar hyperhidrosis	Oxybutynin	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.
Cranio-facial hyperhidrosis	Oxybutynin	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil