Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Long-term clinical outcome of treatment for lichen sclerosus
研究概览
简要总结
This observational study aims to evaluate routine treatment outcomes in men with lichen sclerosus (LS), including a long-term follow-up to assess disease progression and histopathological changes. The study also investigates potential risk factors for LS and the disease's impact on quality of life and sexual health.
详细描述
Lichen sclerosus (LS) is a chronic inflammatory and scarring dermatosis with a predilection for the anogenital area. While both sexes can be affected, this study focuses on men, in whom LS can cause phimosis and may require circumcision. Topical corticosteroids are first-line treatment, but there is a lack of long-term studies evaluating the efficacy of circumcision in male LS. In addition, risk factors and the impact of LS on quality of life and sexual health are insufficiently studied.
This observational cohort study aims to follow male patients with LS over time to assess treatment outcomes, disease progression, and the potential development of epithelial atypia. Patients aged 18 years or older, Swedish-speaking, and diagnosed with LS will be recruited from both the urology and dermatology departments in Västerbotten County, Sweden. At the urology department, patients undergoing circumcision for phimosis will be included; at the dermatology department, all men diagnosed with LS will be invited to participate. All participants will provide written informed consent and will receive treatment according to standard clinical routines and national or international guidelines.
Participants will complete a standardized questionnaire regarding symptoms, quality of life, and sexual health. A control group of age-matched, Swedish-speaking men without genital symptoms will also complete the same questionnaire once but will not be followed longitudinally. For exploratory analyses, patients recruited from the urology department will also provide biological samples (e.g. foreskin, urine, feces) at baseline to facilitate future investigations of microbiome composition and metabolic profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •for patients with LS (LS Urology and LS dermatology):
- •Biologically male
- •≥18 years old
- •Referred to the dermatology department or the urology department in Västerbotten and diagnosed with LS.
- •Must be able to read and write Swedish to fill in questionnaire and informed consent.
- •Inclusion criteria for control group "Controls - Urology":
- •Biologically male
- •≥18 years old
- •Phimosis without LS, treated with circumcision at the urology department in Västerbotten
- •Must be able to read and write Swedish to fill in questionnaire and informed consent.
- •Inclusion criteria for control group "Controls - General Population":
- •Biologically male with male genitalia
- •≥18 years old
- •No genital symptoms
- •Must be able to read and write Swedish to fill in questionnaire and informed consent.
排除标准
- •for all groups:
- •Age under 18 years old
- •Not able to read and write in Swedish.
- •Unable to leave an informed consent to participate.
研究组 & 干预措施
LS Urology
Male patients (≥18 years), undergoing circumcision due to phimosis at the Department of Urology. Diagnosis of lichen sclerosus (LS) confirmed by histopathological examination of the foreskin. Participants will complete questionnaires and provide biological samples (e.g., skin, urine, and fecal samples) for exploratory analyses. Follow-up will be conducted to assess long-term treatment outcomes.
干预措施: Circumcision (Procedure)
LS dermatology
Male patients (≥18 years), diagnosed with LS in outpatient care at the Department of Dermatology. Participants will complete questionnaires and be followed over time to evaluate treatment and quality of life.
Controls - Urology
Male patients (≥18 years), undergoing circumcision at the Department of Urology, with no histopathological evidence of LS. These participants will provide biological samples at baseline and serve as urology-based controls for comparison with LS patients.
干预措施: Circumcision (Procedure)
Controls - General Population
Male participants (≥18 years) without any known genital symptoms or history of LS, recruited from the general population. They will complete the same questionnaire as other study groups but will not be sampled or followed longitudinally.
结局指标
主要结局
Long-term clinical outcome of treatment for lichen sclerosus
时间窗: baseline, 1 year, 3 years, 5 years, 10 years
Assessment of symptom resolution, recurrence, and need for additional treatment over a follow-up period of up to 10 years, based on clinical assessment and patient-reported outcomes. The severity of the disease will be graded on a four point scale 0-3 (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms)
次要结局
- Detection of epithelial atypia or dysplasia(At time of surgery and at follow-up (up to 10 years))
- Quality of life assessed by Dermatology Life Quality Index (DLQI)(Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only)
- Exploratory analysis of microbiome composition(Baseline only)
- Exploratory analysis of metabolomic profiles(Baseline only)