Phimosis is a condition where the foreskin cannot be fully drawn back (retracted) over the penis. Phimosis is normal at birth and often self-corrects without needing treatment during the first three to four years of life; only 10% of three year old boys have phimosis. This is known as congenital phimosis. Phimosis can also be caused by scarring of the skin protecting the head of the penis that is caused when the foreskin cannot be retracted. Phimosis caused by scarring is estimated to occur among 0.6% to 1.5% of boys less than 18 years of age, but this type of phimosis seldom occurs among boys under five years of age. Making a distinction between types of phimosis can sometimes be difficult.
Treatment for boys with phimosis has become controversial. Operations to remove or widen the foreskin (circumcision and prepuce plasty) have been widely used in the past to treat phimosis. More recently, creams and ointments containing corticosteroids (drugs that reduce inflammation limit or stop immune system activity) that are applied for four to eight weeks have shown promising results. The aim of topical corticosteroid treatment is to reduce skin tightening around the tip of the penis. This offers a much less invasive form of treatment and may limit the need for surgery among some boys.
We assessed the effects of topical corticosteroids to treat phimosis in boys aged up to 18 years compared with non-active treatment (placebo) or no treatment at all. We analysed 12 studies that included 1395 boys aged between 18 days and 17 years, and although we found that topical corticosteroids may increase the likelihood of full or partial resolution of phimosis without significant adverse effects, many studies did not report adverse events.
Topical corticosteroids may be a safe alternative to treat phimosis in boys before undergoing surgical treatment.
Topical corticosteroids offer an effective alternative for treating phimosis in boys. Although sub optimal reporting among the included studies meant that the size of the effect remains uncertain, corticosteroids appear to be a safe, less invasive first-line treatment option before undertaking surgery to correct phimosis in boys.
Until recently, phimosis has been treated surgically by circumcision or prepuceplasty; however, recent reports of non-invasive treatment using topical corticosteroids applied for four to eight weeks have been favourable. The efficacy and safety of topical corticosteroids for treating phimosis in boys has not been previously systematically reviewed.
We aimed to 1) compare the effectiveness of the use of topical corticosteroid ointment applied to the distal stenotic portion of the prepuce in the resolution of phimosis in boys compared with the use of placebo or no treatment, and 2) determine the rate of partial resolution (improvement) of phimosis, rate of re-stenosis after initial resolution or improvement of phimosis, and the rate of adverse events of topical corticosteroid treatment in boys with phimosis.
We searched the Cochrane Renal Group's Specialised Register through contact with the Trials' Search Co-ordinator using search terms relevant to this review. Date of last search: 16 June 2014.
We included all randomised controlled trials (RCTs) that compared use of any topical corticosteroid ointment with placebo ointment or no treatment for boys with phimosis.
Two authors independently assessed titles, abstracts and the full-text of eligible studies, extracted data relating to the review's primary and secondary outcomes, and assessed studies' risk of bias. Statistical analyses were performed using the random-effects model and results were expressed as risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). We contacted authors of primary articles asking for details of study design and specific outcome data.
We included 12 studies that enrolled 1395 boys in this review. We found that both types of corticosteroids investigated and treatment duration varied among studies.
Compared with placebo, corticosteroids significantly increased complete or partial clinical resolution of phimosis (12 studies, 1395 participants: RR 2.45, 95% CI 1.84 to 3.26). Our analysis of studies that compared different types of corticosteroids found that these therapies also significantly increased complete clinical resolution of phimosis (8 studies, 858 participants: RR 3.42, 95% CI 2.08 to 5.62). Although nine studies (978 participants) reported that assessment of adverse effects were planned in the study design, these outcomes were not reported.
Overall, we found that inadequate reporting made assessing risk of bias challenging in many of the included studies.Selection bias, performance and detection bias was unclear in the majority of the included studies: two studies had adequate sequence generation, none reported allocation concealment; two studies had adequate blinding of participants and personnel and one had high risk of bias; one study blinded outcome assessors. Attrition bias was low in 8/12 studies and reporting bias was unclear in 11 studies and high in one study.