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

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ClinicalTrials.gov Identifier: NCT01956591
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Nelson Wolosker, Hospital Israelita Albert Einstein

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

Condition or disease Intervention/treatment
Hyperhidrosis 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.

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Study Type : Observational
Actual Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis
Study Start Date : September 2007
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Quality of life [ Time Frame: 1 day before treatment ]
    Evaluate the Quality of life (using a standardized questionnaire for hyperhidrotic patients) before pharmacological treatment

  2. Quality of life [ Time Frame: 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 :
  1. Perception of improvement in excessive sweating [ Time Frame: 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

  2. Perception of improvement in excessive sweating [ Time Frame: 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:
  1. Side effects in the use of oxybutynin for hyperhidrosis [ Time Frame: 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

  2. Side effects in the use of oxybutynin for hyperhidrosis [ Time Frame: 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



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Incomplete medical chart
  • Patients with glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956591


Locations
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Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652000
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Nelson Wolosker, PhD, MD Hospital Israelita Albert Einstein

Publications:

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Responsible Party: Nelson Wolosker, PhD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01956591     History of Changes
Other Study ID Numbers: HIsraelitaAE
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013
Keywords provided by Nelson Wolosker, Hospital Israelita Albert Einstein:
Treatment efficacy
Long-term effects
Tachyphylaxis
Undesirable effects
Side effects
Self-assessment
Hyperhidrosis
Quality of life
Additional relevant MeSH terms:
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Sweat Gland Diseases
Hyperhidrosis
Skin Diseases
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents