TX-004HR clinically improves symptoms of vulvar and vaginal atrophy in postmenopausal women.

Objective: This study aimed to evaluate improvement of dyspareunia and associated vaginal dryness with a 17ß-estradiol softgel vaginal insert (TX-004HR; TherapeuticsMD, Boca Raton, FL, USA) in women with postmenopausal vulvar and vaginal atrophy (VVA). Methods: Postmenopausal women with VVA and moderate to severe dyspareunia received TX-004HR (4, 10, or 25 µg) or placebo in the 12-week, randomized, double-blind, placebo-controlled, phase 3 REJOICE trial. Post hoc analyses examined improvement levels in dyspareunia and concurrent vaginal dryness with TX-004HR and assessed the effects of patient characteristics on vaginal dryness treatment. Results: Significantly more women treated with TX-004HR (all doses) than placebo had complete resolution or substantial improvement in dyspareunia or vaginal dryness (concurrent with dyspareunia) by 12 weeks, observed as early as week 2 with most doses. TX-004HR significantly improved both dyspareunia and vaginal dryness at least one level versus placebo by week 12 in women with both symptoms. Subgroup analyses showed TX-004HR improved vaginal dryness associated with dyspareunia regardless of age, body mass index, uterine status, prior pregnancy, and vaginal birth number. Conclusion: TX-004HR provided clinically meaningful improvements in dyspareunia and vaginal dryness associated with dyspareunia in postmenopausal women with VVA. Clinicians may be able to use this information when discussing patients' expectations regarding symptom improvement with the estradiol vaginal insert.

Complicated rectovaginal fistula secondary to Bartholin's cyst infection.

Rectovaginal fistula formation secondary to Bartholin's cyst is a very rare complication, and to date only three cases were reported in the literature. We report a case of a 32-year-old woman who suffered recurrent episodes of Bartholin's cyst infection with subsequent abscess formation that resulted in rectovaginal fistula formation. We treated her initially with transperineal repair; however, the fistulous tract recurred a month later. A laparoscopic colostomy and transperineal repair using biological graft was then performed, with excellent results. The patient underwent reversal of colostomy after 2 months, and remained asymptomatic upon follow-up 12 months later.

Early onset of action with a 17ß-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia.

OBJECTIVE: The softgel 17ß-estradiol (E2) vaginal inserts (4 and 10 µg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial. METHODS: Postmenopausal women received E2 vaginal inserts 4, 10, or 25 µg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population. RESULTS: The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2). CONCLUSIONS: A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.

Low-dose methotrexate-induced vulvar edema: A case report.

RATIONALE: Methotrexate (MTX) is an antimetabolite of folic acid, which is used for management of ectopic pregnancy. MTX-related toxicity may include cutaneous mucosal damage, bone marrow suppression, gastrointestinal disorders (gastritis, diarrhea, hematitis), liver and kidney function damage, pulmonary toxicity, cardiac toxicity, and nerve toxicity. However, it is not usual for vulvar edema induced by low-dose methotrexate. PATIENT CONCERNS: In this case report, we described a patient with severe vulvar edema and oral cavity ulceration and scalp ulceration induced by low-dose MTX treatment for ectopic pregnancy. Her presenting complaints were pain in the vulva, oral cavity, and scalp. DIAGNOSES: The patient was diagnosed based on clinical findings for MTX toxic reactions. INTERVENTIONS: Vulva was disinfectioned with iodide and Kangfuxin solution, her mouth was rinsed with mouthwash. Three compound glycyrrhizin tablets were orally administered (3 times/day). After 10 days, the broken skin and mucous membrane healed. OUTCOMES: The vulvar edema and oral cavity ulceration and scalp ulceration healed. LESSONS: Our study demonstrated that even low-dose MTX can be induced skin and mucosal injury, patients and doctors should timely detection of drug toxicity reactions, immediately rescue, prompt discontinuation of medication, and symptomatic treatment to avoid accidental occurrence.

Painful rash with hoarseness: an atypical presentation of syphilis.

Syphilis is a sexually transmitted disease that can affect multiple organ systems, with central nervous system involvement at any stage. We present a 53-year-old woman with an unusual truncal rash with painful anogenital lesions, accompanied by patchy alopecia, oral lesions, photophobia and hoarseness. She was found to have positive serological tests for syphilis with cerebrospinal fluid findings suggestive of neurosyphilis. She underwent a 14-day course of intravenous penicillin G and exhibited successful resolution of painful anogenital lesions as well as marked improvement in dermatological, oropharyngeal, laryngeal, and neurological symptoms.

The vulvovaginal gingival syndrome: a severe subgroup of lichen planus with characteristic clinical features and a novel association with the class II HLA DQB1*0201 allele.

BACKGROUND: The vulvovaginal gingival syndrome is an uncommon and severe variant of lichen planus characterized by erosions or desquamation of vulval, vaginal, and gingival mucosae with a predilection for scarring and stricture formation. OBJECTIVE: We sought to define the clinical, immunopathologic, and human leukocyte antigen findings in a large cohort of patients. METHODS: The clinical presentation and outcome during long-term follow-up were documented in 40 patients. In addition, human leukocyte antigen typing for class II by polymerase chain reaction and sequence-specific primers was performed. RESULTS: During a mean follow-up period of 8.7 (SD +/- 6.8) years, long-term sequelae included strictures of the esophagus, lachrymal ducts, and external auditory canal; loss of vulval architecture; vaginal stenosis; and buccal mucosal fibrosis. The DQB1( *)0201 allele was present in 80% of patients versus 41.8% of control subjects (P

Mucous membrane pemphigoid of the vulva.

BACKGROUND: Mucous membrane pemphigoid is a rare autoimmune blistering disease primarily affecting mucosal surfaces. Blistering and scarring may occur in the eyes, mouth, esophagus, larynx, and on the vulva. Scarring can result in severe structural changes to the vulva that may mimic the findings of other inflammatory dermatologic disorders of the vulva, including lichen sclerosus and lichen planus. CASE: A 58-year-old woman presented with vulvar erosions, esophagitis, and laryngeal blisters. The clinical picture and the histopathology of a vulvar biopsy were suggestive of erosive lichen planus. Direct immunofluorescence, however, revealed findings diagnostic of mucous membrane pemphigoid. CONCLUSION: This case illustrates the importance of examining extragenital mucosal surfaces of any woman presenting with vulvar lesions. In addition, it demonstrates the importance of vulvar biopsy and the usefulness of direct immunofluorescence to differentiate between conditions with similar clinical and histopathologic changes.

Oro-vaginal-vulvar lichen planus: report of two new cases.

Atrophic-erosive lichen planus with oral and genital involvement is a rare condition and is often difficult to diagnose. Patients seldom report genital symptoms to the dentist and dentists do not generally investigate about genital lesions. Delays in diagnosis may cause complications and affect the quality of life. We report the clinical and histopathological features of two new cases of oro-vaginal-vulvar lichen planus and review current treatment options for this condition. Genital lichen planus should be suspected in case of atrophic-erosive oral lichen planus. A thorough multidisciplinary medical management and active early treatment are necessary to improve symptoms and prevent genital sequelae. This might also be a relevant prevention strategy for the risk of squamous cell carcinoma, although data to fully support this statement still need investigation.

Erosive lichen planus of the vulva and vagina.

BACKGROUND: Erosive lichen planus causes erosion of the vulva and vagina and characteristic oral lesions. Dyspareunia is usual, and vaginal stenosis may occur. This report highlights the clinical features and the response to medical therapy. CASES: We report the case histories of three women who presented to the Vulvovaginal Disorders Clinic of the University of Iowa with long histories of dyspareunia and advanced vaginal scarring. In each case, the clinical diagnosis of erosive lichen planus was obvious but had not been made previously. All three women have responded well to topical treatment with tacrolimus 0.1% ointment. CONCLUSION: Erosive lichen planus should be suspected in a case of vaginal erosion or narrowing. Surgical management is inappropriate when the mucosa is eroded. Inspection of the mouth may confirm the diagnosis.

Crohn's disease of the vulva.

Over the past 10 years, it has been well established that Crohn's disease may involve any segment of the gastrointestinal tract from the mouth to the anus and may also cause destructive extraintestinal lesions. Extensive cutaneous ulceration has recently been recognized as one of the rare extraintestinal complications. A case of chronic vulvar ulceration due to Crohn's disease is reported. The clinical manifestations and management of such a lesion are discussed.

Adverse effects of pregnancy on multifocal eosinophilic granuloma.

An unusual case of a patient diagnosed as having the histiocytic proliferative disorder characterized by the lesion eosinophilic granuloma (histiocytosis X) is presented. Fifteen-year follow-up revealed a progression from a solitary eosinophilic granuloma of the bone to multifocal involvement of many body structures including the vulva, vagina, and cervix. This progression occurred after nine asymptomatic years and was temporally related to the patient's first pregnancy. After successful treatment and remission, rapid appearance and growth of observable genital lesions were noted during a second pregnancy. Pregnancy termination in the first trimester was advised due to signs of dissemination and local symptoms.

The vulvovaginal-gingival syndrome of lichen planus. The clinical characteristics of 22 patients.

BACKGROUND AND DESIGN: The vulvovaginal-gingival syndrome is a variant of mucosal lichen planus characterized by erosions and desquamation of the vulva, vagina, and gingiva. The clinical features of patients initially evaluated for vulvitis who exhibited the additional features of this syndrome have been described in one previous study. In the current study, 22 women with biopsy-proved oral lichen planus and clinical evidence of vulvovaginal lichen planus were examined and treated. This group of patients represents the largest reported series demonstrating the vulvovaginal-gingival syndrome. RESULTS: Gingival lichen planus, present in all patients, was characterized by erosions and erythema in 16 subjects and by white, reticulated lesions in six others. Vulvovaginal lichen planus also displayed erosions in the majority of patients. The response to a wide variety of therapeutic agents was satisfactory in most patients. However, concomitant use of several drugs was usually required to achieve beneficial results. CONCLUSIONS: Patients with oral lichen planus should be routinely examined for the presence of disease on other mucosal surfaces. The recognition of this syndrome, which is undoubtedly more common than previously reported, will avoid unnecessary delay in the treatment of these patients.

Burning mouth syndrome and vulvodynia coexisting in the same patient: a case report.

The 'dynias' are a group of chronic focal pain syndromes with a predilection for the orocervical and urogenital regions. This is a case report of stomatodynia (burning mouth syndrome) and vulvodynia coexisting in a middle-aged woman. The dynias are an enigma in terms of aetiology, which is multifactorial, making clinical investigations difficult and often requiring liaison with other specialties.

Late-onset allergic reaction to povidone-iodine resulting in vulvar edema and urinary retention.

BACKGROUND: Povidone-iodine, a surgical antiseptic, is associated with adverse side effects ranging from minor skin irritation to anaphylaxis, with symptoms occurring within minutes and up to 8 hours after contact. CASE: We report a case of a patient, with no history of allergy to povidone-iodine, who developed an allergic reaction 24 hours after intraoperative exposure to povidone-iodine, presenting with acute urinary retention secondary to extensive vulvar edema, which resolved after administration of antihistamines. CONCLUSION: Allergic reactions to povidone-iodine can be late in onset and, in vaginal surgeries, may present with atypical symptoms such as acute urinary retention secondary to vulvar edema. Prompt diagnosis and effective treatment requires strong clinical suspicion in patients presenting postoperatively with a known history of exposure.

Nail dystrophy due to lichen sclerosus?

Lichen sclerosus (LS) affects anogenital skin alone in 80% of cases. When extragenital disease occurs, it usually affects the trunk, neck, axillae and wrist flexures. Nail involvement with LS is rare. In contrast, lichen planus (LP) commonly affects extragenital skin. Mucosal lesions occur in 50% of cases, affecting the mouth and genitalia. Nail disease in LP is common, and, if severe, can lead to destruction of the nail bed. LS and LP can coexist. We report two cases of LS with nail involvement. In the Case 1 disease was confined to the nail, and nail biopsy confirmed LS. In the Case 2, the nail changes formed part of the widespread genital and extragenital LS, confirmed histologically. We review existing literature on nail disease in LS and discuss the possible aetiology of the nail changes.