Through a series of research studies and clinical experience with hundreds of men over the past 15 years, Duke urologists have found that intraurethral application of clobetasol propionate 0.05% cream with a lubricated delivery vehicle is a safe and effective treatment for urethral stricture disease caused by biopsy-proven lichen sclerosus (LS). The findings have changed the treatment dogma for this uncommon but vexing condition.
“LS-induced urethral stricture disease is uncommon, but it’s one of the most difficult challenges in the field of reconstructive urology,” says Andrew C. Peterson, MD, MPH, a Duke reconstructive urologic surgeon. “Most of these patients are angry and distraught because it’s a debilitating disease process involving lesions on the genitalia, voiding dysfunction, and painful erections. This has a huge effect on quality of life, particularly because the condition often occurs in men who are only in their 50s and 60s.”
Complex surgery with poor outcomes
Historically, the gold standard treatment for significant stricture disease caused by LS was substitution urethroplasty with replacement of the entire involved area using extragenital skin grafts from areas thought to be resistant to LS. “To get rid of LS lesions, we had to remove the skin from the penis and graft it with skin from the mouth or bladder. The surgery required prolonged convalescence and time off work. And, most men needed a second surgery 6 to 12 months later,” says Peterson.
Peterson, who served on active duty in the U.S. Army until 2010, says that he and his colleagues realized years ago that surgical outcomes were very poor in this patient population and set out to find a better solution. “The dogma was always, ‘Just take the bad stuff off and do the skin graft,’” he says.
New, nonsurgical treatment
Peterson reports that since the early 2000s, his groups work, research studies, published journal articles, and clinical experience have demonstrated that because LS is an autoimmune disorder with inflammatory properties, intraurethral high-dose topical steroids result in excellent outcomes.
“For external LS patches, we would simply have men apply clobetasol propionate cream topically to the genitalia, and that would make the patches go away,” says Peterson. “When we started telling men with LS-induced stricture disease to slide the cream inside with a catheter, it took some convincing, but mostly they were glad to do it because the condition is so distressing, and many had been through years of pain.”
Peterson explains that the intraurethral steroid protocol is insertion of clobetasol propionate 0.05% cream with a straight catheter or meatal dilator once daily for one week, gradually reducing the dosage over the next few weeks, then using it as needed for voiding symptoms. The protocol does not exclude the possibility of future surgical interventions in the event of refractory disease or patient dissatisfaction.
“We’ve completely changed the perceived dogma of this disease process—moving away from morbid surgery with often poor outcomes to aggressive use of topical steroids,” says Peterson. “Patients are uniformly very pleased with the outcomes, as it helps them get back to normal and get on with life.”
Studies demonstrate improved outcomes
In two Duke studies published in The Journal of Urology, one in 2016 and one in 2020, Peterson and colleagues demonstrated that LS-related urethral stricture can be effectively managed with intraurethral steroids.
In the latest article from July 2020, Duke medical student Joshua Hayden worked with Peterson to show this treatment also improves patient-reported voiding symptoms and quality of life. “This is the type of collaboration that makes working at Duke special—the ability to work in interdisciplinary teams with experienced researchers and learners such as medical students, residents, and fellows,” says Peterson.
As part of the 2020 study, the team developed an algorithm to guide clinicians in evaluating the condition and beginning the treatment regimen; they concluded the regimen should be considered first-line therapy to help avoid surgery.
With Duke’s high volume of patients who have the condition to provide more clinical experience, and upcoming multicenter studies and collaborations to deepen their knowledge, Peterson says Duke urologists have the tools and the power needed to study large cohorts and continue to refine treatments for urethral stricture disease and other urologic conditions.