Review question
Are topical corticosteroids effective for the treatment of phimosis in boys?
What is phimosis?
Phimosis is a condition where the skin protecting the head of the penis (foreskin) cannot be fully drawn back (retracted). Phimosis is normal at birth and often self-corrects without treatment. This is known as congenital or physiological phimosis. Phimosis can also be caused by scarring of the foreskin, a condition called pathological phimosis. It can be difficult to distinguish between the two types. One in ten three-year-old boys and one in 100 16-year-old boys have phimosis.
How is phimosis treated?
Operations to remove or widen the foreskin (circumcision and prepuce plasty) have been widely used to treat phimosis. However, creams and ointments containing corticosteroids (medicines that reduce inflammation and limit or stop immune system activity) have shown promising results. This offers a less invasive form of treatment and may limit the need for surgery among some boys.
What did we want to find out?
We wanted to find out if corticosteroid creams or ointments (topical corticosteroids) were better than dummy treatment (placebo) or no treatment for improving the following outcomes.
• Complete retraction of the foreskin
• Partial retraction of the foreskin
• Change in retractability score
• Long-term complete resolution of phimosis
• Unwanted effects on the area treated or other parts of the body
What did we do?
We searched for studies that looked at topical corticosteroids compared with placebo or no treatment in boys (aged birth to 18 years) with phimosis. We only included randomized controlled trials, where boys were assigned to either corticosteroids or placebo/no treatment at random. We compared and summarized the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.
What did we find?
We found 14 randomized trials, including 1459 boys. The studies included boys of different ages (18 days to 17 years), with different types and degrees of phimosis. The studies used different types of corticosteroids, and treatment duration varied from four to eight weeks.
Main results
We found that topical corticosteroids compared to placebo or no treatment may increase the frequency of complete and partial retraction of the foreskin after four to eight weeks of treatment. Topical corticosteroids may also increase the probability of complete retraction of the foreskin measured six months after treatment. We are uncertain of the effect of corticosteroids on retractability of the foreskin compared to placebo. Only two studies reported unwanted effects at the site of treatment (out of 11 studies that measured unwanted effects). There may be little or no difference between corticosteroids and placebo or no treatment in the occurrence of unwanted effects.
What are the limitations of the evidence?
We have little or very little confidence in the evidence because most publications provided an inadequate description of the study methods; because there were important differences between the boys included in the studies (age, how severe the phimosis was) and between the treatments used (type of corticosteroids, duration of treatment); and because some of the results were very imprecise.
How up to date is this evidence?
This review updates our previous review (published in 2014). The evidence is up to date to October 2023.
Topical corticosteroids, compared to placebo or no treatment, may increase complete and partial resolution of phimosis when assessed after four to eight weeks of treatment, and may increase long-term complete resolution of phimosis assessed six or more months after treatment. Topical corticosteroids may have few or no adverse effects, and we are uncertain about their effect on retractability scores. The body of evidence is limited by poor reporting of methods in the studies, important clinical heterogeneity, and serious imprecision in the results. Future, higher-quality trials with long-term follow-up would likely improve our understanding of the effects of topical corticoids on phimosis in boys.
This is an updated version of a Cochrane Review first published in 2014. Phimosis is a condition in which the prepuce (foreskin) cannot be fully retracted past the head of the penis (glans). Phimosis is often treated surgically by circumcision or prepuce plasty; however, reports of non-invasive treatment using topical corticosteroids applied for four to eight weeks have suggested favorable outcomes.
To assess the effects of topical corticosteroids applied to the stenotic portion of the prepuce for the treatment of phimosis in boys compared with placebo or no treatment.
We searched CENTRAL, MEDLINE, Embase, LILACS, and ClinicalTrial.gov. We checked reference lists of included studies and relevant reviews for additional studies. There were no restrictions on the language of publication. The date of the last search was 4 October 2023.
We included all randomized controlled trials (RCTs) that compared the use of any topical corticosteroid with placebo or no treatment for boys with any type or degree of phimosis.
Two review authors independently selected studies, extracted data related to the review's primary and secondary outcomes, and assessed the studies' risk of bias. We used the random-effects model for statistical analyses and expressed dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We contacted the authors of the primary articles to request details of the study design and specific outcome data. We used GRADE to assess the certainty of evidence on a per-outcome basis.
In this update, we identified two new studies with 111 participants, bringing the total number of included studies to 14 (1459 randomized participants). We found that types of corticosteroids investigated, participant age, degree of phimosis, type of phimosis, and treatment duration varied considerably among studies.
Compared with placebo or no treatment, topical corticosteroids may increase the complete resolution of phimosis after four to eight weeks of treatment (RR 2.73, 95% CI 1.79 to 4.16; I² = 72%; 10 trials, 834 participants; low-certainty evidence). Based on 252 complete resolutions per 1000 boys in the control group, this corresponds to 436 more complete resolutions per 1000 boys (95% CI 199 more to 796 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.
Topical corticosteroids may also increase the partial resolution of phimosis at four to eight weeks of treatment compared with placebo or no treatment (RR 1.68, 95% CI 1.17 to 2.40; I² = 44%; 7 trials, 745 participants; low-certainty evidence). Based on 297 partial resolutions per 1000 boys in the control group, this corresponds to 202 more partial resolutions per 1000 boys (95% CI 50 more to 416 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.
We are uncertain of the effect of topical corticosteroids compared to placebo on change in retractability score (standardized mean difference [SMD] −1.48, 95% CI −2.93 to −0.03; I²91%; 2 trials, 177 participants; very low-certainty evidence). We downgraded the certainty of the evidence by one level for serious study limitations, one level for serious heterogeneity, and one level for serious imprecision.
Compared with placebo, topical corticosteroids may increase the long-term complete resolution of phimosis six or more months after treatment (RR 4.09, 95% CI 2.80 to 5.97; I² = 0%; 2 trials, 280 participants; low-certainty evidence). Based on 171 long-term complete resolutions per 1000 boys in the control group, this corresponds to 528 more complete resolutions per 1000 boys (95% CI 308 more to 850 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.
There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment (RR 0.28, 95% CI 0.03 to 2.62; I² = 22%; 11 trials, 1091 participants; low-certainty evidence). Only two of 11 studies that recorded adverse effects reported any adverse effects; one event occurred in the corticosteroid group and six in the control group. We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.