Urinary Tract InfectionsPhase 1WIPEAWAYNCT02509403
An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
A Phase 1 study testing Essential oils infused Perineal Hygiene wipe in people with Urinary Tract Infections, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Essential oils infused Perineal Hygiene wipe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2020to Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged ≥18 years willing to use the perineal towels for an entire month
Who cannot join
- Pregnancy or within 12 months post-partum
- Current vulvo-vaginitis
- Known allergies to tea-tree oil
Trial locations and contacts
1 site in 1 country.
Canada1 site
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, T6G 2P4
About this study
Official title: An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
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.
Read the detailed description
The design of the trial will be open-label and uncontrolled.
- Conditions
- Urinary Tract Infections
- Being tested
- Essential oils infused Perineal Hygiene wipe
- Keywords
- Perineal hygiene, Hygiene wipes, Hygiene Towels, Safety, Essential oils, Natural Health Product
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Essential oils infused Perineal Hygiene wipe Receives: Drug: Essential oils infused Perineal Hygiene wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without any adverse events as a measure of safety
Number of participants without any adverse events
Measured: 45 Days
Secondary outcomes (2)
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
Measured: 30 Days
Self-reported comfort score on a scale of 1 to 10
Self-reported comfort score on a scale of 1 to 10
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: The company responsible for funding has filed for bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Taiga BioActives Inc.
- Responsible party
- Sponsor
- Investigators
- Adrian S Wagg, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509403
- Sponsor's protocol ID
- TAI-WA-0707
- Acronym
- WIPEAWAY
- Status last verified
- Mar 2020
- First submitted
- 24 Jul 2015
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12113866Dason 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.
PubMed 22031610Persad 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.
PubMed 17091423Amiri 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.
PubMed 19469432Temple 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.
PubMed 5085024Leydon 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.
PubMed 20139217
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
- ClinicalTrials.gov ID
- NCT02509403
- Acronym / sponsor ID
- WIPEAWAY / TAI-WA-0707
- Conditions
- Urinary Tract Infections
- Keywords
- Perineal hygiene, Hygiene wipes, Hygiene Towels, Safety, Essential oils, Natural Health Product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The company responsible for funding has filed for bankruptcy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Taiga BioActives Inc.
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Essential oils infused Perineal Hygiene wipeEssential oils infused Perineal Hygiene wipe |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged ≥18 years willing to use the perineal towels for an entire month
Key exclusion criteria (3 listed)
- Pregnancy or within 12 months post-partum
- Current vulvo-vaginitis
- Known allergies to tea-tree oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential oils infused Perineal Hygiene wipeEach 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. | Drug | Intervention |
Primary outcome
Number of participants without any adverse events as a measure of safety
Time frame: 45 Days
Number of participants without any adverse events
2 secondary outcomes
Ease of use of the perineal hygiene wipe by the participants on a daily basis
Time frame: 30 Days
Self-reported comfort score on a scale of 1 to 10
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Background: PubMed 12113866Foxman 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.
- Background: PubMed 22031610Dason 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.
- Background: PubMed 17091423Persad 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.
- Background: PubMed 19469432Amiri 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.
- Background: PubMed 5085024Temple 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.
- Background: PubMed 20139217Leydon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian S Wagg, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Essential oils infused Perineal Hygiene wipe in people with Urinary Tract Infections, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants without any adverse events as a measure of safety (time frame: 45 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02509403, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.