An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel

Urinary Tract Infections Clinical Trial

— WIPEAWAY  

Official title:

An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02509403
• Other study ID #: TAI-WA-0707
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2020
• Est. completion date: January 2020

Study information

• Verified date: March 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety (absence of skin irritation) of a feminine hygiene product for perineal hygiene prior to undertaking a clinical effectiveness trial. The feminine hygiene towel or wipe is an anti-bacterial Natural Health Product solution.

Description:

The design of the trial will be open-label and uncontrolled.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women aged =18 years willing to use the perineal towels for an entire month

Exclusion Criteria:

• Pregnancy or within 12 months post-partum

• Current vulvo-vaginitis

• Known allergies to tea-tree oil

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Drug:
• Essential oils infused Perineal Hygiene wipe
Each participant will be asked to complete a treatment period of one month's duration. At the start of the study, the participants will be asked to fill-out a baseline questionnaire and will be given a month's supply of the perineal hygiene towel with instructions about its use. At day 15, 30 and 45 follow-ups will be conducted.

Locations

Country	Name	City	State
Canada	Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Taiga BioActives Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (6)

Amiri FN, Rooshan MH, Ahmady MH, Soliamani MJ. Hygiene practices and sexual activity associated with urinary tract infection in pregnant women. East Mediterr Health J. 2009 Jan-Feb;15(1):104-10. — View Citation

Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis and management of recurrent urinary tract infection in women. Can Urol Assoc J. 2011 Oct;5(5):316-22. doi: 10.5489/cuaj.11214. — View Citation

Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. Review. — View Citation

Leydon GM, Turner S, Smith H, Little P; UTIS team. Women's views about management and cause of urinary tract infection: qualitative interview study. BMJ. 2010 Feb 5;340:c279. doi: 10.1136/bmj.c279. — View Citation

Persad S, Watermeyer S, Griffiths A, Cherian B, Evans J. Association between urinary tract infection and postmicturition wiping habit. Acta Obstet Gynecol Scand. 2006;85(11):1395-6. — View Citation

Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants without any adverse events as a measure of safety	Number of participants without any adverse events	45 Days
Secondary	Ease of use of the perineal hygiene wipe by the participants on a daily basis	Ease of use of the perineal hygiene wipe by the participants on a daily basis	30 Days
Secondary	Self-reported comfort score on a scale of 1 to 10	Self-reported comfort score on a scale of 1 to 10	30 Days