Biopsy-proven Lichen Sclerosus Research Articles

(126) Development of a Patient Reported Outcome Measure for Lichen Sclerosus

Abstract Introduction Patient-reported outcome measures (PROMs) can provide information that complements the provider-assessed clinical outcome measures of gynecologic and dermatologic diseases. As part of a larger study on lichen sclerosus (LS), genetics and the microbiome, we noted discrepancy between clinical assessment of LS and participant symptoms. Without a PROM, it is impossible to compare our results to those in the literature. Lichen sclerosus is a chronic vulvar dermatosis that affects approximately 1 in 70 women and can cause scarring, sexual dysfunction and malignancy (Krapf, 2020). However, the severity of LS symptoms may not be representative of the current clinical appearance. For example, the patient may report extreme pruritus and general irritation, yet the vulva may not appear erythematous or even consistent with active disease. On the other hand, patients may incidentally be diagnosed w lichen sclerosus after the provider noted classic characteristics including white plaques, erythema, and architectural changes of the labia and clitoral hood and yet the patient may not realize they had a vulvar skin condition with a history of only minimal to no symptoms noted. Objective The aim of our study is to develop patient-reported outcome measures of lichen sclerosus to incorporate patient’s experiences of LS and be able to correlate them to clinical management. Methods Methods: We evaluated 25 initial participants with biopsy proven lichen sclerosus and collected incidence of patient reported outcome measures as the first step of developing a larger PROM based investigation. Results 25 participants enrolled in the study and completed questionnaires on symptoms. Many of these participants were not using topical steroid treatment for symptoms. Most commonly experienced symptoms were: prutitis (52%, n=13, burning (28%, n=7, general irritation (n=12, dryness (48%, n=8), dyspareunia (40% n=10). For many women, the symptoms radiated, woke them up from sleep and caused overall disruption of their quality of life. Conclusions The next step will be to create a prospective survey of women living with LS to collect the most important symptoms according to patients and not just frequency. We hope eventually therapeutic strategies can be targeted at treating these specific symptoms and managing the disease state. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Johnson and Johnson.

Comorbid Vulvar Lichen Sclerosus and High-Grade Squamous Intraepithelial Lesions: A Management Conundrum.

This study aimed to determine if treating lichen sclerosus (LS) with high-potency topical corticosteroids (TCS) increases the risk of high-grade squamous intraepithelial lesion (HSIL) recurrence in patients with comorbid vulvar LS and HSIL. This is a retrospective study of patients with comorbid vulvar LS and HSIL treated with TCS between 2015 and 2020. Patients with clinically diagnosed or biopsy-proven LS and biopsy-proven HSIL of the vulva were included. Clinical data included demographics, tobacco use, immune-modifying conditions, specimen pathology, treatment types, and HSIL recurrence. Bivariate analysis was performed to compare demographic and clinical characteristics between patients with and without HSIL recurrence. Twenty-six patients with comorbid LS and HSIL were identified. The median age was 66.0 years and median time in treatment for LS was 5.5 years. Thirteen (50%) had recurrence of HSIL and 13 (50%) did not have recurrence. Exposure to high-potency TCS was present in 20 (77%) patients, with 17 (65%) having use of more than 1-year duration and 9 (35%) having use at the time of HSIL diagnosis. When comparing the groups with and without HSIL recurrence, there was no significant difference in high-potency TCS exposure, duration of use, or use at time of HSIL diagnosis. High-potency TCS use for the treatment of LS did not seem to increase the risk of HSIL recurrence in patients with comorbid vulvar LS and HSIL. This suggests that high-potency TCS can be appropriately used for the treatment of LS even when HPV-associated disease is present.

Medical Management of Penile and Urethral Lichen Sclerosus with Topical Clobetasol Improves Long-Term Voiding Symptoms and Quality of Life.

We evaluated the success of minimally invasive management of lichen sclerosus with topical and intraurethral clobetasol, as defined by improvement in patient reported outcome measures and nonprogression to surgery. We conducted a review of our prospective ongoing quality improvement study to determine outcomes of our current standard practice for males with penile and urethral biopsy proven lichen sclerosus. Data were collected between 2011 and 2019, and included patient demographic information, medical and surgical histories, and location and extent of lichen sclerosus related pathology. The primary outcomes for this study were voiding function and voiding related quality of life, and were assessed using the AUASS (American Urological Association Symptom Score) and quality of life bother index, respectively. We identified 42 patients with biopsy proven lichen sclerosus related urethral stricture disease. Of these patients 85.7% were treated with intraurethral steroids alone and did not require surgical intervention. Median AUASS significantly improved from 12 to 8, and median quality of life bother index improved from 4 ("mostly dissatisfied") to 2 ("mostly satisfied"). Average stricture length of those with penile urethral disease and bulbar urethral disease was 4.8 cm (SD 3.0) and 16.2 cm (SD 6.5), respectively. Median followup was 8.4 months (IQR 2.6-26.4). Lichen sclerosus related urethral stricture disease can be effectively managed with intraurethral steroids. This minimally invasive management strategy improves patient reported voiding symptoms and voiding quality of life.

09: A randomized controlled trial of clobetasol propionate versus fractionated CO2 laser for the treatment of lichen sclerosus (CURLS)

To compare six month safety and efficacy outcomes of fractionated CO2 laser (laser) to topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. Single-center randomized controlled non-inferiority trial comparing laser to steroid treatment for patients with biopsy proven lichen sclerosus. Randomization was stratified based on prior steroid use. Study included postmenopausal women with significant symptoms based on Skindex-29 scores >21 and excluded women with >Stage 2 prolapse, prior vaginal mesh or pelvic radiation, or active genital infection. The primary outcome was change in Skindex-29 score at six months. Secondary subjective outcomes included patient visual analog scale (subjective VAS) for bothersome vulvar symptoms, Vulvovaginal Symptom Questionnaire (VSQ), and a global impression of improvement (PGI-I) and satisfaction (PGI-S). Secondary objective outcomes were provider assessment of vulvar appearance (objective VAS) and Vaginal Health Index (VHI). An intention-to-treat and regression analysis based on prior steroid exposure were performed. From 2015 to 2018, 205 women were screened, 55 were randomized, and 51 completed six-month follow-up. No significant difference was found in baseline demographic data, symptoms, and provider assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6 months, 11-point effect size, p=0.007. The change in mean VSQ [-3.92 (SD 4.12) vs -0.58 (5.11), p = 0.014] and VHI [1.92 (SD 4.34) vs 0.43 (3.62), p = 0.046] scales were significantly better in the laser group at six months. Mean subjective and objective VAS were similar between groups. Overall, 89% of laser patients rated their symptoms as being “better or much better” on PGI-I compared to 62% of steroid patients, p = 0.07. Significantly more patients (81%) were “satisfied or very satisfied” on PGI-S with laser compared to steroid (41%), p = 0.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at laser site and activation of genital herpes one week after starting steroid. Fractionated CO2 laser treatment is non-inferior and showed statistically significant improvement in symptoms and objective outcomes compared to clobetasol propionate steroid cream with no serious safety or adverse events.

The Female Genital Self-image Scale in Adult Women With Vulvar Lichen Sclerosus.

There is no agreed upon standard way to measure vulvar lichen sclerosus disease severity. The Female Genital Self-Image Scale (FGSIS) is a validated survey tool assessing female genital self-image and is positively correlated with women's sexual function. A lower score represents a negative genital self-image. We evaluated the FGSIS in women with vulvar lichen sclerosus. Women with biopsy-proven lichen sclerosus and women presenting for routine gynecologic care without lichen sclerosus matched by age were surveyed with the 7-item FGSIS. National surveys of healthy women in the United States have shown the mean 7-item FGSIS score is 21. To detect one standard deviation (20% absolute difference) between groups with a power of 80% at p < .05, 15 women would are needed in each group. Sixteen women with lichen sclerosus and 16 matched controls were surveyed between February and July 2018. The mean ± SD age of women with lichen sclerosus was 56.8 ± 13.5 years, 94% were white, 69% married, 81% college educated, 69% postmenopausal, and 18% on hormone replacement therapy. None of these differences were statistically different from control women. Women with vulvar lichen sclerosus had a significantly lower median 7-item FGSIS when compared with control subjects, 18 (interquartile range = 16-21) versus 25 (interquartile range = 23-27), respectively, Mann-Whitney U test, p < .001. Women with vulvar lichen sclerosus have a lower score on the 7-item Female Genital Self-Image Scale compared with healthy controls.

025 Lysis of Vulvar Adhesions for Lichen Sclerosus: A Series of 5 Patients

Lichen sclerosus (LS) is a common but often underdiagnosed and undertreated disease affecting approximately 1 in 70 women. The chronic inflammatory character of the disease leads to the classic symptoms of pruritis and burning. In addition, progressive scarring of the vulvar skin causes fissuring, loss of vulvar architecture, and vulvar adhesions of the labia and clitoral prepuce. These architectural changes can interfere with basic functions such as micturition, clitoral stimulation, and vaginal penetration. Five patients were diagnosed with biopsy-proven LS and treated with topical clobetasol with or without topical or systemic hormone supplementation. Adhesions involved varying combinations of clitoral phimosis, labial adhesions, and narrowing of the anterior and posterior introitus. After all areas of lichen sclerosus were in remission, the patients were taken to the operating room for lysis of vulvar adhesions. Lysis was performed firstly by opening tissue planes with minimal sharp dissection, and subsequently with liberal blunt separation both manually and using a lacrimal probe along the natural planes of the adherent tissues. Patients used daily postoperative application of topical clobetasol and were instructed to aggressively separation and/or retraction of previously adherent tissues several time daily. Topical estradiol/testosterone was also frequently used an adjuvant therapy to help improve tissue health.

Intraurethral Steroids are a Safe and Effective Treatment for Stricture Disease in Patients with Biopsy Proven Lichen Sclerosus

We investigated outcomes of the contemporary practice of administering intraurethral steroids to treat stricture disease in patients with biopsy proven lichen sclerosus. We performed an institutional review board approved review of the records of patients with biopsy proven lichen sclerosus stricture disease from October 2010 to September 2015. Study inclusion criteria were age 18 years or greater and male gender. Extracted data included patient demographics, comorbidities, location of lichen sclerosus, previous therapies and need for further interventions. Management was considered successful when there was no need for subsequent escalation of therapy. The intraurethral steroid regimen consisted of applying clobetasol cream to the affected urethra to lubricate a calibration device such as a urinary catheter or meatal dilator. The initial phase of therapy included twice daily application for 2 to 3 months, at which point the frequency was decreased by the clinician, enabling the patient to titrate medication use as needed. We identified 40 patients with biopsy proven lichen sclerosus who had urethral stricture as part of the disease state. Of these patients 28 received the intraurethral steroid regimen and success was achieved in 25 (89%). Mean followup was 24.8 months. No patient who was started on the intraurethral steroid regimen proceeded to urethroplasty. Based on our outcomes we have developed a stepwise treatment algorithm for patients with biopsy proven lichen sclerosus stricture disease that uses intraurethral steroids before initiating plans for invasive surgery.

849 ROLE OF TESTOSTERONE IN THE PATHOGENESIS AND TREATMENT OF LICHEN SCLEROSUS

You have accessJournal of UrologyPenis/Testis/Urethra: Benign & Malignant Disease III1 Apr 2010849 ROLE OF TESTOSTERONE IN THE PATHOGENESIS AND TREATMENT OF LICHEN SCLEROSUS Joshua Meeks, Tao Qi, John Cashy, Ximing Yang, and Chris Gonzalez Joshua MeeksJoshua Meeks More articles by this author , Tao QiTao Qi More articles by this author , John CashyJohn Cashy More articles by this author , Ximing YangXiming Yang More articles by this author , and Chris GonzalezChris Gonzalez More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.2351AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lichen sclerosus (LS) is an inflammatory disorder that affects the urethra of men and genital skin of both men and women. Testosterone cream has been used to treat vulvar lichen sclerosus but the role of hormonal deficiency and testosterone application in the treatment of LS remains undescribed. The goal of our study was to determine the frequency of hypogonadism in men with LS and quantify the expression of the androgen receptor in tissue from men with LS. METHODS From the Northwestern University Enterprise Data Warehouse, a database of over 2 million patients cared for at Northwestern University from 1986 to 2009, men with pathologically identified LS were identified. As a control population, a cohort of control men matched 5:1 by both age and race were identified from the men who presented to our urology department for any treatment. A diagnosis of hypogonadism was identified by ICD9 code and medications used to treat hypogonadism were selected from a list of medications prescribed by physicians. Immunohistochemistical analysis was performed on formalin-fixed and paraffin embedded tissue sections of men with LS using standard protocols and immunoreactivity for the androgen receptor (AR) was determined by a urological pathologist. RESULTS A total of 97 men were identified to have biopsy proven LS and this cohort was compared to 485 men without LS as a control population. Of men with LS 3(3%) had a diagnosis of hypogonadism as compared to 62 men (12.8%) in the control population (p=0.006). There were no men with LS receiving testosterone supplementation for hypogonadism as compared to 12 men (2.5%) of the control population (p=0.11). Immunohistochemical analysis of 31 specimens for AR expression was performed to determine if tissues affected by LS could benefit from treatment with testosterone application. Weak (focal) or cytoplasmic expression of the AR was found in 9 (29%) men, while strong nuclear positive expression was identified in only 7 (22%). CONCLUSIONS Men with LS rarely have an associated diagnosis of hypogonadism and none have undergone testosterone supplementation at our institution. Importantly, immunohistochemical analysis of LS affected tissue did not demonstrate androgen receptor expression in the majority of specimens from men with LS. This suggests that local testosterone application would have benefit in only a subset of LS patients. Chicago, IL© 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e331 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.MetricsAuthor Information Joshua Meeks More articles by this author Tao Qi More articles by this author John Cashy More articles by this author Ximing Yang More articles by this author Chris Gonzalez More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Anogenital lichen sclerosus in women.

A study of 350 women with lichen sclerosus, originally made to elucidate the relationship between lichen sclerosus and autoimmunity, led to the amassing of a considerable amount of clinical material. Our review is confined to those with anogenital lesions (342), supplemented by some new cases (15), giving a total of 357 women with biopsy proven lichen sclerosus. It demonstrates the wide age range of the condition, the association with morphoea and lichen planus and the occurrence of squamous cell carcinoma in some cases. It also shows that inappropriate surgery has continued to be carried out for benign disease.