Characterization of female intimate hygiene practices and vulvar health: A randomized double-blind controlled trial.

BACKGROUND: Inappropriate feminine hygiene practices are related to vulvar unpleasant symptoms (such as skin changes, lesions, burning, pruritus, fissures, and dyspareunia). AIMS: We assessed the daily use effects of intimate cleansers on vulvar skin by comparing two specific products for intimate care: Saugella Hydraserum (SIS), based on natural extracts, and a standard product based on lactic acid, such as Lactacyd Feminine Hygiene (LTC). Forty healthy women were enrolled in this double-blind controlled study. METHODS: After randomization, the cleansers were used twice daily for 30 days. The hydration level was determined using the Corneometer® CM 825, the pH using the Skin-pH-Meter PH 905® and the sebum level using the Sebumeter SM815® . Measurements were performed at baseline and on day 30 on the labia majora and labia minora. RESULTS: Both cleansers showed a reduction in the hydration level, but this was much less evident in the SIS group (-6.3% SIS vs -23,7% LTC). The pH values of the SIS group were lower than those of the LTC group, especially on the labia minora (5.27 ± 0.08 and 5.6 ± 0.1, respectively, P = .025). The sebum increased in both groups, but in the LTC group, it was higher on the labia majora (+96.2% vs +46.8%, respectively, P = .003), while on the labia minora, it was higher in the SIS group (+24.7% vs +17.1%, respectively P = NS). CONCLUSIONS: Both cleansers tested showed high performance for safety and tolerability on vulvar skin, but SIS showed better efficacy than LTC on some parameters.

Vaginal diazepam plus transcutaneous electrical nerve stimulation to treat vestibulodynia: A randomized controlled trial.

OBJECTIVE: To assess the effectiveness of vaginal diazepam in addition to transcutaneous electrical nerve stimulation (TENS) in the treatment of vestibulodynia (VBD). STUDY DESIGN: This study was a randomized, double-blind, placebo-controlled trial. Forty-two patients with VBD were randomized, 21 underwent diazepam and TENS (diazepam group) and 21 received placebo and TENS (placebo group). Vulvar pain was assessed on a on a 10-cm visual analogue scale (VAS) and dyspareunia according to the Marinoff dyspareunia scale. Vaginal surface electromyography (EMG) and vestibular current perception threshold (CPT) testing were performed at baseline and 60 days after treatment. The primary endpoints included the change in pain and dyspareunia from baseline to 60 days of pain and dyspareunia. The secondary endpoints was the variation in objectivity of pelvic floor muscle (PFM) function and vestibular nerve fiber current perception threshold (CPT). RESULTS: The VAS scores for pain from basal values of 7.5 and 7.2 for the diazepam and placebo, respectively, showed significant (p 0.01) decreases from 4.7 to 4.3, but this difference was not statistically significant. The Marinoff dyspareunia scores in the diazepam group showed a significant difference (p 0.05) from values measured in the placebo group. The ability to relax the PFM after contraction (difference between maximal contraction and rest tone) was significantly greater for the diazepam group versus the placebo group (3.8 µv and 2.4 µv, respectively, p 0.01). The CPT values for all of the nerve fibers increased after the treatment, but this increase was significant in the diazepam group only for the values at a 5-Hz stimulation (C fibers) with a change of 47.8% vs 26.9% (p < 0.05). Only two patients reported a mild drowsiness in the diazepam group. CONCLUSIONS: The present study provided indications that vaginal diazepam plus TENS is useful to improve pain and PFM instability in women with VBD.

Alpha Lipoic Acid Plus Omega-3 Fatty Acids for Vestibulodynia Associated With Painful Bladder Syndrome.

OBJECTIVE: This study assessed the effectiveness of alpha lipoic acid (ALA) plus omega-3 polyunsaturated fatty acids (n-3 PUFAs) in combination with amitriptyline therapy in patients with vestibulodynia/painful bladder syndrome (VBD/PBS). METHODS: Women with VBD/PBS were randomly assigned to receive amitriptyline or amitriptyline plus a commercially available preparation (ALAnerv Age; Alfa Wassermann, Bologna, Italy) containing, in 2 capsules, ALA 600 mg plus docosahexaenoic acid 250 mg and eicosapentaenoic acid 16.67 mg. Symptoms of burning and pain were assessed using a 10-cm visual analog scale and the short form of the McGill-Melzack Pain Questionnaire. RESULTS: Among 84 women who were randomized, the mean ± standard deviation dose of amitriptyline was 21.7 ± 6.6 mg/day, without statistical difference between the two groups. Pain, as assessed using both the pain rating index of the visual analog scale and the short-form McGill Pain Questionnaire, decreased significantly in both trial groups, with a greater effect seen with the addition of ALA and n-3 PUFAs. The addition of ALA/n-3 PUFAs to amitriptyline treatment was also associated with improvements in dyspareunia and pelvic floor muscle tone. The overall incidence of adverse events was low, and none led to treatment discontinuation. CONCLUSIONS: The addition of ALA/n-3 PUFAs to amitriptyline treatment in patients with VBD/PBS appears to improve outcomes and may allow for a lower dosage of amitriptyline, which may lead to fewer adverse effects.

Coital pain in the elderly: could a low dose estriol gel thrill the vulvar vestibule?

OBJECTIVE: The aim of this study was to evaluate the effectiveness of the application of 0.005% estriol gel to the vulvar vestibule in the management of postmenopausal dyspareunia. STUDY DESIGN: Postmenopausal women with dyspareunia were enrolled in this study. Patients were instructed to use a fingertip to apply 0.25g of vaginal gel containing 25µg of estriol to the vulvar vestibule daily for three weeks and then twice weekly for up to 12 weeks. RESULTS: Assessment of symptoms (dyspareunia and cotton swab test) and signs of vestibular atrophy were performed, and changes between baseline and weeks 3 and 12 were assessed. Adverse events were recorded. A total of 63 women were included. Of the 63, 59 (93.6%) completed the 12-week treatment period, and four dropped out for vestibular burning. Dyspareunia improved or was cured (score ≤1) by week 12 in 81.4% of patients. The patients also showed a statistically significant reduction in vestibular atrophy and cotton swab test at the end of treatment. CONCLUSIONS: Application of 0.005% estriol gel to the vulvar vestibule is effective in correcting menopausal coital pain. This suggests that reduction in sensory vestibular innervation sensitivity is likely to play a pivotal role in the relief of dyspareunia. One limitation of this study is the limited follow-up, but the therapy may be continued for as long as the patients are distressed by their symptoms without estrogen intervention.

Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study.

INTRODUCTION: Chronic vulvar pain and burning remains one of the most perplexing problems faced by practicing gynecologists. AIM: To evaluate the effectiveness and safety of the application of micro-ablative fractional CO2 laser to the vulvar vestibule in the management of patients with vulvar pain from vestibulodynia or genitourinary syndrome of menopause. METHODS: Patients (N = 70) underwent fractional micro-ablative CO2 laser treatment for vestibular pain plus vestibulodynia (n = 37) or genitourinary syndrome of menopause (n = 33). Inclusion criteria were the existence of vestibular atrophic changes and the absence of moderate or severe pelvic floor hypertonic dysfunction. MAIN OUTCOME MEASURES: A visual analog scale of pain and the Marinoff score of dyspareunia were chosen to evaluate improvement. Grading of vestibular health also was quantified using a four-point scoring system (0 = no atrophy, 3 = severe atrophy). Data were collected at baseline, at weeks 4, 8, and 12, and 4 months after the final treatment. RESULTS: For visual analog scale and dyspareunia scoring and for the overall vestibular health index scoring, statistically significant improvement was noted after three sessions of vestibular fractional CO2 laser treatment. Improvement gradually increased throughout the study period and was maintained through the 4-month follow-up visit. There was no statistically significant difference in outcomes between the two study groups. No adverse events from fractional CO2 laser treatment were noted. Overall, 67.6% of patients stated significant improvement from the laser procedure. CONCLUSION: This preliminary case series showed encouraging results using fractional CO2 laser treatment of the vestibule in women with vestibulodynia and genitourinary syndrome of menopause.

Vulvar lichen sclerosus: a comparison of the short-term topical application of clobetasol dipropionate 0.05% versus mometasone furoate 0.1%.

OBJECTIVE: To compare the efficacy of the short-term application of clobetasol propionate 0.05% (CLB) and mometasone furoate 0.05% (MMF) in the treatment of vulvar lichen sclerosus (VLS). STUDY DESIGN: This study was a retrospective review of 96 women who were diagnosed with lichen sclerosus with a follow-up of at least 1 year. Of these 96 women, 47 were treated with the topical application of CLB and 49 were treated with the topical application of MMF. All patients received treatment for 8 weeks. The drug was administered once daily for 4 weeks and then twice weekly for another 4 weeks in combination with a moisturizing cream that was continued as maintenance therapy. Subsequently, a topical steroid was applied on an as-needed basis if symptoms recurred. Follow-up visits were scheduled at 3, 6, and 12 months. The primary endpoint was the clinical response of the patients. RESULTS: A mean of 77.3% of the patients were defined as responders at the 12-month observation, without any significant difference between the 2 treatment groups (CLB mean 73% vs MMF mean 81.6%, p = .2). A pronounced improvement in itching was observed after 3 months of treatment in the MMF group (p = .04), whereas the other symptoms were not significantly different between the 2 groups. CONCLUSIONS: This study indicates that CLB 0.05% and MMF 0.1% in a short protocol regimen are effective, safe, and reliable treatments for VLS, with no significant difference between the 2 steroids in their efficacy. However, a moisturizing cream should be an integral part of the treatment.

Post-steroid management of chronic vulvar itching with a topical formula containing natural anti-itching and anti-inflammatory actives.

AIM: To determine whether use of a topical, nonsteroidal, anti-inflammatory, and anti-itching formula was able to preserve the absence of symptoms, mainly itching and burning, induced by an earlier and relatively short treatment with topical steroids in women diagnosed with vulvar dermatitis or lichen simplex. METHODS: Ninety-six subjects (36 with contact dermatitis, 29 with allergic dermatitis, 31 with lichen simplex) were enrolled in the study. All participants were first treated with topical mometasone furoate (MF) 0.1%. When the symptoms disappeared, they were treated either with Zantogin(®), a multicomponent topical formula containing anti-inflammatory and anti-itching natural actives, or a control cream for 60 days. RESULTS: The study demonstrated that, in about 85% of the participants treated with Zantogin(®), symptoms disappeared completely, and only 15% had to resort to MF as needed, with an average use of about three applications per subject (in total). In the placebo group, approximately 90% of participants had to resort to MF as needed, with an average use per person of more than 16 applications in 60 days. CONCLUSION: Our study demonstrates that, following use of a topical steroid, symptoms such as burning and itching can be validly controlled with subsequent and longer therapy with a herbal topical formula, Zantogin(®), which is able to properly counteract itching and inflammation, prevent symptom relapse, and avoid the typical side effects associated with prolonged use of topical steroids.

Vestibulodynia: synergy between palmitoylethanolamide + transpolydatin and transcutaneous electrical nerve stimulation.

OBJECTIVE: The study aimed to assess the effect of palmitoylethanolamide + transpolydatin combination in patients with vestibulodynia undergoing transcutaneous electrical nerve stimulation (TENS) therapy and to confirm the effectiveness of TENS also in a domiciliary protocol. The study is based on the premise that palmitoylethanolamide + transpolydatin combination may contribute to a down-regulation of mast cell hyperactivity, which is believed to be responsible for the proliferation and sprouting of vestibular pain fibers and the associated hyperalgesia and allodynia. MATERIALS AND METHODS: Twenty women with vestibulodynia were randomly assigned to receive oral palmitoylethanolamide (PEA) 400 mg and transpolydatin 40 mg or placebo, twice daily for 60 days. All patients underwent TENS therapy in a self-administered home protocol. Visual analogue scale (VAS), Marinoff score for dyspareunia, and current perception threshold obtained from the vulvar vestibule were assessed at baseline and at the end of treatment. RESULTS: The patients received a mean of 26.7 TENS sessions. All scores in the 2 groups improved significantly, although the level of improvement was similar between the groups (VAS, p < .57; dyspareunia, p < .38). Nevertheless, the analysis of regression of symptoms related to the duration of disease revealed the therapy to be more effective when PEA + transpolydatin is included in cases with more recent disease onset, as compared with the placebo group (PEA: VAS, p < .01; dyspareunia, p < .01) (placebo: VAS, p = nonsignificant; dyspareunia, p = nonsignificant). CONCLUSIONS: This study confirms that TENS is of significant benefit in the management of vestibulodynia, also in a home environment. PEA + transpolydatin can be a value-added treatment adjunct when the onset of vestibulodynia is more recent or when the disease relapses.

Electrodiagnostic functional sensory evaluation of patients with generalized vulvodynia: a pilot study.

OBJECTIVE: To objectively evaluate vulvodynia by the current perception threshold (CPT) neurometer. METHODS: Neuroselective CPT measures of the pudendal nerve were obtained at the perineum by a neurometer (Neurotron, Inc, Baltimore, MD), using constant alternating sinusoid waveform electrical stimulus at 2,000-, 250-, and 5-Hz frequencies, in 20 healthy volunteers and 38 women with vulvodynia. The mean +/- SD CPT values in vulvodynia and healthy (control) women were analyzed with the Student t test. RESULTS: Women with vulvodynia showed lower mean CPT values (p <.01). CONCLUSIONS: Results of this study support a neuroselective sensory dysfunction in generalized vulvodynia. The field is opened for CPT measures in vulvodynia in selecting therapy strategy, monitoring response to treatment, and assessing vestibulodynia. Assessment of threshold values in a greater number of controls is needed to set a cutoff in CPT values for diagnosis and to grade the severity of the diseases.