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临床试验/NCT01956591
NCT01956591已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2007年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
1
主要终点
Quality of life

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Incomplete medical chart
  • Patients with glaucoma

研究组 & 干预措施

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.

干预措施: Oxybutynin (Drug)

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.

干预措施: Oxybutynin (Drug)

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.

干预措施: Oxybutynin (Drug)

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.

干预措施: Oxybutynin (Drug)

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.

干预措施: Oxybutynin (Drug)

结局指标

主要结局

Quality of life

时间窗: Forty-two days after treatment

Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) after 42 days of treatment

次要结局

  • Perception of improvement in excessive sweating(1 day (On the last medical visit))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelson Wolosker

PhD

Hospital Israelita Albert Einstein

研究点 (1)

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