Clinical trial NCT01956591: Long Term Results of the Use of Oxybutynin for the Treatment of Hyperhidrosis
Official title: Retrospective Evaluation of Long Term Use of Oxybutynin in the Pharmacological Treatment of Primary Hyperhidrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperhidrosis
Keywords: Treatment efficacy
Long-term effects
Tachyphylaxis
Undesirable effects
Side effects
Self-assessment
Hyperhidrosis
Quality of life
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Incomplete medical chart
* Patients with glaucoma

Primary outcomes:
measure: Quality of life
timeFrame: 1 day before treatment
measure: Quality of life
timeFrame: Forty-two days after treatment
Secondary outcomes:
measure: Perception of improvement in excessive sweating
timeFrame: After 42 days of treatment
measure: Perception of improvement in excessive sweating
timeFrame: 1 day (On the last medical visit)
Other outcomes:
measure: Side effects in the use of oxybutynin for hyperhidrosis
timeFrame: After 42 days of treatment
measure: Side effects in the use of oxybutynin for hyperhidrosis
timeFrame: 1 day )On the last medical visit)
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Nelson Wolosker, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Lefrandt JD, Maurer JM. Oxybutynin for hyperhidrosis. Neth J Med. 2007 Oct;65(9):356. No abstract available.
citation: 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.
citation: 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.
citation: 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.