Male Lichen Sclerosus - Risk Factors, Treatment, and Impact on Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Circumcision.
- Who it may be relevant to
- Registry conditions: Lichen Sclerosus. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Procedure Circumcision
Circumcision performed as part of standard clinical care in patients with phimosis, which may be caused by lichen sclerosus. The procedure is not assigned by the study but observed as part of routine treatment
Primary outcome measures
- Long-term clinical outcome of treatment for lichen sclerosus [Time frame: baseline, 1 year, 3 years, 5 years, 10 years]
Secondary outcome measures (4)
- Detection of epithelial atypia or dysplasia [Time frame: At time of surgery and at follow-up (up to 10 years)]
- Quality of life assessed by Dermatology Life Quality Index (DLQI) [Time frame: Baseline, 1 year, 3 years, 5 years, 10 years. Controls assessed at baseline only]
- Exploratory analysis of microbiome composition [Time frame: Baseline only]
- Exploratory analysis of metabolomic profiles [Time frame: Baseline only]
Eligibility criteria
Inclusion Criteria 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.
Exclusion Criteria for all groups:
- Age under 18 years old
- Not able to read and write in Swedish.
- Unable to leave an informed consent to participate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Umeå University Hospital — Umeå
Identifiers
NCT: NCT06984263 · 2024-03331-01