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The company responsible for funding has filed for bankruptcy
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| Name | Class |
|---|---|
| Taiga BioActives Inc. | INDUSTRY |
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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.
The design of the trial will be open-label and uncontrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Essential oils infused Perineal Hygiene wipe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential oils infused Perineal Hygiene wipe | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants without any adverse events as a measure of safety | Number of participants without any adverse events | 45 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Self-reported comfort score on a scale of 1 to 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian S Wagg, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp | Edmonton | Alberta | T6G 2P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12113866 | Background | 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. | |
| 22031610 | Background | 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. |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
Self-reported comfort score on a scale of 1 to 10
| 30 Days |
| 17091423 | Background | 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. |
| 19469432 | Background | 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. |
| 5085024 | Background | 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. |
| 20139217 | Background | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |