NCT02509403

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
4.4 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

Same day

First QC Date

July 24, 2015

Last Update Submit

March 30, 2020

Conditions

Urinary Tract Infections

Keywords

Perineal hygieneHygiene wipesHygiene TowelsSafetyEssential oilsNatural Health Product

Outcome Measures

Primary Outcomes (1)

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

    Number of participants without any adverse events

    45 Days

Secondary Outcomes (2)

  • Ease of use of the perineal hygiene wipe by the participants on a daily basis

    30 Days

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

    30 Days

Study Arms (1)

Intervention

EXPERIMENTAL

Essential oils infused Perineal Hygiene wipe

Drug: Essential oils infused Perineal Hygiene wipe

Interventions

Essential oils infused Perineal Hygiene wipeDRUG

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy or within 12 months post-partum
  • Current vulvo-vaginitis
  • Known allergies to tea-tree oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Edmonton, Alberta, T6G 2P4, Canada

Location

Related Publications (6)

  • 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.

    PMID: 12113866BACKGROUND

  • 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.

    PMID: 22031610BACKGROUND

  • 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.

    PMID: 17091423BACKGROUND

  • 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.

    PMID: 19469432BACKGROUND

  • Temple JG. Perineal hygiene in the prevention of recurring cystitis in women. Proc R Soc Med. 1972 Feb;65(2):169. doi: 10.1177/003591577206500222. No abstract available.

    PMID: 5085024BACKGROUND

  • 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.

    PMID: 20139217BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Adrian S Wagg, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

January 1, 2020

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 1, 2020

Record last verified: 2020-03

Locations

CA(1)