Background 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. Objectives 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. Search methods 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. Selection criteria 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. Data collection and analysis 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. Main results 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; I-2 = 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; I-2 = 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; I(2)91%; 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; I-2 = 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; I-2 = 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. Authors' conclusions 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.
