Vestibulitis, Vestibulodynia, Vulvar Diseases, Vulvar Pain, Vulvodynia
Conditions
Keywords
Nifedipine treatment, Vestibulitis, Placebo
Brief summary
To evaluate the use of topical application of Nifedipine cream for the treatment of Provoked localized Vulvodynia (vestibulitis, vestibulodynia).
Detailed description
30 women aged 18-45 diagnosed with Provoked localized Vulvodynia will be included. 10 women will use topical Nifedipine cream 0.2% 4 times a day for 6 weeks (except for menstrual period). 10 other women will use topical Nifedipine cream 0.4% 4 times a day for 6 weeks (except for menstrual period). 10 women will be a control group and will use a placebo cream. The study will be randomized and double blind. Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment. A special detailed questionnaire has been prepared in three languages and will be used to compare dyspareunia and associate variables between the groups. The Q-tip tests will be performed and findings will be drawn in each examination. Differences between the groups will be examined, and uni- and multi-variate analysis will be performed.
Interventions
DRUGNifedipine cream topical application
Sponsors
Western Galilee Hospital-Nahariya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women diagnosed with vestibulitis according to Friedrich's criteria: * Severe pain with vestibular touch or attempted vaginal entry. * A positive Q-tip test: pain produced by touching the vestibule with a cotton tipped applicator. * Physical findings limited to varying degree of vestibular erythema. 2. Non-pregnant women aged 18-45. 3. Women use effective contraception and are not interested in becoming pregnant during the study period. 4. No known Nifedipine allergy. 5. No medical diseases.
Exclusion criteria
1. Women who have undergone vestibulectomy. 2. Active vaginal or pelvic infection. 3. A medical disease uch as Diabetes, immune suppression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete resolution of vestibulitis. | Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire and the Q-tip applicator for detection of vestibular sensitivity. |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the Nifedipine treatment. | Participants will be examined before starting the treatment, at the end of the treatment and 3 months after completion the treatment, using the questionnaire. |
Countries
Israel
Outcome results
None listed