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

Primary Purpose

Urinary Tract Infections

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Essential oils infused Perineal Hygiene wipe
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Tract Infections focused on measuring Perineal hygiene, Hygiene wipes, Hygiene Towels, Safety, Essential oils, Natural Health Product

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Essential oils infused Perineal Hygiene wipe

Outcomes

Primary Outcome Measures

Number of participants without any adverse events as a measure of safety
Number of participants without any adverse events

Secondary Outcome Measures

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
Self-reported comfort score on a scale of 1 to 10
Self-reported comfort score on a scale of 1 to 10

Full Information

First Posted
July 24, 2015
Last Updated
March 30, 2020
Sponsor
University of Alberta
Collaborators
Taiga BioActives Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02509403
Brief Title
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Acronym
WIPEAWAY
Official Title
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
The company responsible for funding has filed for bankruptcy
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Taiga BioActives Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Perineal hygiene, Hygiene wipes, Hygiene Towels, Safety, Essential oils, Natural Health Product

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Essential oils infused Perineal Hygiene wipe
Intervention Type
Drug
Intervention Name(s)
Essential oils infused Perineal Hygiene wipe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants without any adverse events as a measure of safety
Description
Number of participants without any adverse events
Time Frame
45 Days
Secondary Outcome Measure Information:
Title
Ease of use of the perineal hygiene wipe by the participants on a daily basis
Description
Ease of use of the perineal hygiene wipe by the participants on a daily basis
Time Frame
30 Days
Title
Self-reported comfort score on a scale of 1 to 10
Description
Self-reported comfort score on a scale of 1 to 10
Time Frame
30 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian S Wagg, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12113866
Citation
Foxman B. Epidemiology of urinary tract infections: incidence, morbidity, and economic costs. Am J Med. 2002 Jul 8;113 Suppl 1A:5S-13S. doi: 10.1016/s0002-9343(02)01054-9.
Results Reference
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PubMed Identifier
22031610
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. No abstract available.
Results Reference
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PubMed Identifier
17091423
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. doi: 10.1080/00016340600936977.
Results Reference
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PubMed Identifier
19469432
Citation
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.
Results Reference
background
PubMed Identifier
5085024
Citation
Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169. No abstract available.
Results Reference
background
PubMed Identifier
20139217
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.
Results Reference
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An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel

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