Urinary IncontinenceNCT01320046
Vulvar Contact Dermatitis Resulting From Urine Incontinence
An observational study of Urinary Incontinence and Vulvar Pruritus, run by Meir Medical Center at 1 site in Israel.
Trial summary
Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the general population is unknown. 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 Incontinence, Vulvar Pruritus, Vulvar Contact Dermatitis
- What is being tested?
- Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2011to Mar 2012
- Phase
- Observational
- 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
Study population: The prevalence of UI induced VCD will be evaluated in 3 groups: 1. Patients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD 2. Patients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI. 3. Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients). These patients will be evaluated for symptoms of UI and VCD
Who may be able to join
- Patients with a diagnosis of vulvar contact dermatitis, with or without urinary incontinence; OR
- Patients with a diagnosis of urinary incontinence, with or without VCD; OR
- Patients without either UI or VCD, age-matched
Who cannot join
- Diagnosis of other dermatoses
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ramat Eshkol Women health center, Clalit health Services
Jerusalem
About this study
Official title: Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors
Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the general population is unknown.
Contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic, resulting from prolonged exposure to weak irritating substances.
Read more
The most common form of VCD is irritant contact dermatitis, and it usually presents as vulvar itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin to irritants compared to other body parts, decrease in the skin barrier function due to exposure to sweat, urine and vaginal discharge and constant friction of the vulvar area. In menopausal women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the effect of irritants on the vulvar skin.
One of the most common irritating substances that cause VCD is urine. The phenomenon of urine-induced VCD is known as" diaper rash" in babies, and it was also described in bedridden patients using diapers constantly. Women with urine incontinence (UI), a problem that its prevalence in women increases with aging, may use constantly panty liners or pads to prevent urine leakage. The urine is being absorbed in the pad, and the vulvar skin is continually exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of this phenomenon in the general population is unknown.
The patients complain of itch, burning or irritation of the vulvar skin, and on exam erythema, edema and irritated skin are found. As most patients do not connect between UI to their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the vulvar complaints is not recognized, patients do not receive proper treatment that requires primary management of UI.
The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize risk factors for UI induced VCD.
- Being tested
- Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage
- Keywords
- Urinary Incontinence, Vulvar pruritus, Vulvar contact dermatitis
- Medical subject headings
- Urinary Incontinence, Pruritus Vulvae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakageOther
Patients will undergo the following evaluation:
- Questionnaires- age, medical background, BMI, UI characteristics , usage of pads, other hygiene practices,hormonal therapy, presence of allergic tendency and history etc.
- Medical history.
- Gynecological exam including bladder/rectum/uterine prolapse, vaginal atrophy, discharge, findings of VCD (as part of the usual evaluation in the clinic).
- Vaginal smear: this will be used for vaginal pH measurement and for wet mount, which will assess estrogen deficiency, yeast infection and other inflammatory conditions. Vaginal smears are done as part of the usual evaluation in the clinic.
- Evaluation of the severity of urinary incontinence will be done by collection and weighting of pads during 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Patients with urinary incontinence | Patients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD Receives: Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage | |
| Patients with vulvar contact dermatitis | Patients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI. Receives: Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage | |
| Age matched control group | Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients). These patients will be evaluated for symptoms of UI and VCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vulvar contact dermatitis among patients with urinary incontinence
Measured: one year
Secondary outcomes (1)
Risk factors for urinary incontinence induced vulvar contact dermatitis
Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320046
- Sponsor's protocol ID
- MMC11029-2011kCTIL
- Status last verified
- Apr 2012
- First submitted
- 20 Mar 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Margesson LJ. Contact dermatitis of the vulva. Dermatol Ther. 2004;17(1):20-7. doi: 10.1111/j.1396-0296.2004.04003.x.
PubMed 14756887Farage MA, Miller KW, Berardesca E, Maibach HI. Incontinence in the aged: contact dermatitis and other cutaneous consequences. Contact Dermatitis. 2007 Oct;57(4):211-7. doi: 10.1111/j.1600-0536.2007.01199.x.
PubMed 17868212Crone AM, Stewart EJ, Wojnarowska F, Powell SM. Aetiological factors in vulvar dermatitis. J Eur Acad Dermatol Venereol. 2000 May;14(3):181-6. doi: 10.1046/j.1468-3083.2000.00080.x.
PubMed 11032061
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors
- ClinicalTrials.gov ID
- NCT01320046
- Acronym / sponsor ID
- MMC11029-2011kCTIL
- Keywords
- Urinary Incontinence, Vulvar pruritus, Vulvar contact dermatitis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Mar 2011 (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.
Vulvar contact dermatitis (VCD) is a common problem presenting as vulvar pruritus, burning or irritation. Its estimated prevalence is 20-30% in vulvar clinics, but the prevalence in the general population is unknown.
Contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen. The skin reaction may be acute, subacute or chronic, resulting from prolonged exposure to weak irritating substances.
The most common form of VCD is irritant contact dermatitis, and it usually presents as vulvar itch. The causes that contribute to VCD are increased sensitivity of the vulvar skin to irritants compared to other body parts, decrease in the skin barrier function due to exposure to sweat, urine and vaginal discharge and constant friction of the vulvar area. In menopausal women, lack of estrogen contributes to tissue atrophy and thinning, and may increase the effect of irritants on the vulvar skin.
One of the most common irritating substances that cause VCD is urine. The phenomenon of urine-induced VCD is known as" diaper rash" in babies, and it was also described in bedridden patients using diapers constantly. Women with urine incontinence (UI), a problem that its prevalence in women increases with aging, may use constantly panty liners or pads to prevent urine leakage. The urine is being absorbed in the pad, and the vulvar skin is continually exposed to urine. This can cause VCD, similar to diaper rash. The prevalence of this phenomenon in the general population is unknown.
The patients complain of itch, burning or irritation of the vulvar skin, and on exam erythema, edema and irritated skin are found. As most patients do not connect between UI to their vulvar disorder, and as most care-givers do not ask routinely about UI, the vulvar symptoms are mistakenly attributed to yeast infection or other factors. As the cause to the vulvar complaints is not recognized, patients do not receive proper treatment that requires primary management of UI.
The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize risk factors for UI induced VCD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with urinary incontinence | – | Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakagePatients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD |
| Patients with vulvar contact dermatitis | – | Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakagePatients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI. |
| Age matched control group | – | –Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients). These patients will be evaluated for symptoms of UI and VCD |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The prevalence of UI induced VCD will be evaluated in 3 groups: 1. Patients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD 2. Patients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI. 3. Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients). These patients will be evaluated for symptoms of UI and VCD
Key inclusion criteria (3 listed)
- Patients with a diagnosis of vulvar contact dermatitis, with or without urinary incontinence; OR
- Patients with a diagnosis of urinary incontinence, with or without VCD; OR
- Patients without either UI or VCD, age-matched
Key exclusion criteria (1 listed)
- Diagnosis of other dermatoses
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 |
|---|---|---|
| Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakagePatients will undergo the following evaluation: 1. Questionnaires- age, medical background, BMI, UI characteristics , usage of pads, other hygiene practices,hormonal therapy, presence of allergic tendency and history etc. 2. Medical history. 3. Gynecological exam including bladder/rectum/uterine prolapse, vaginal atrophy, discharge, findings of VCD (as part of the usual evaluation in the clinic). 4. Vaginal smear: this will be used for vaginal pH measurement and for wet mount, which will assess estrogen deficiency, yeast infection and other inflammatory conditions. Vaginal smears are done as part of the usual evaluation in the clinic. 5. Evaluation of the severity of urinary incontinence will be done by collection and weighting of pads during 24 hours. | Other | Patients with urinary incontinence, Patients with vulvar contact dermatitis |
Primary outcome
Prevalence of vulvar contact dermatitis among patients with urinary incontinence
Time frame: one year
1 secondary outcome
Risk factors for urinary incontinence induced vulvar contact dermatitis
Time frame: one year
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 8 Apr 2015.
- Background: PubMed 14756887Margesson LJ. Contact dermatitis of the vulva. Dermatol Ther. 2004;17(1):20-7. doi: 10.1111/j.1396-0296.2004.04003.x.
- Background: PubMed 17868212Farage MA, Miller KW, Berardesca E, Maibach HI. Incontinence in the aged: contact dermatitis and other cutaneous consequences. Contact Dermatitis. 2007 Oct;57(4):211-7. doi: 10.1111/j.1600-0536.2007.01199.x.
- Background: PubMed 11032061Crone AM, Stewart EJ, Wojnarowska F, Powell SM. Aetiological factors in vulvar dermatitis. J Eur Acad Dermatol Venereol. 2000 May;14(3):181-6. doi: 10.1046/j.1468-3083.2000.00080.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Vulvar Pruritus, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 1 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 8 Apr 2015. 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 Israel. 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.
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?
Prevalence of vulvar contact dermatitis among patients with urinary incontinence (time frame: one year). 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 NCT01320046, which also lists 3 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 8 Apr 2015.