UROLOGY, Volume 56, Number 2: Pages 307-310,
Anna OrsolaaA, Jorge Caffarattia and Jose Maria Garata
a Department of Pediatric Urology,
A Reprint requests:
Anna Orsola, M.D.,
Department of Urology,
Harvard Medical School,
300 Longwood Avenue (HU-216),
Boston, MA 02115
Manuscript received 23 December 1999, Revised 9 March 2000, Accepted 9 March 2000;
Objectives. From 1997 through 1998, we conducted a prospective study to evaluate the long-term outcome of using topical steroids in the treatment of childhood phimosis.
Methods. Both the parents and their children were instructed to apply 0.05% betamethasone cream topically twice a day for 1 month and to retract the prepuce after the fifth day of treatment. Results were evaluated at the end of the treatment and 6 months later.
Results. One hundred thirty-seven boys were evaluated. The median age was 5.4 years. At initial presentation, 61 boys had a phimotic but retractable prepuce, 37 had a nonretractable phimotic ring, and 39 had a pinpoint opening. Patients with a history of previous forcible foreskin retractions were considered to have secondary phimosis. By 6 months following treatment, 90% (124 children) had an easily retractable prepuce without a phimotic ring. No differences were seen in the response rate between those with primary and secondary phimosis. In all cases, the treatment was well tolerated without local or systemic side effects. All the patients with persistent or recurrent phimosis were found to be noncompliant with the suggested daily foreskin care.
Conclusions. Topical steroid for the treatment of phimosis is a safe, simple, and inexpensive procedure that avoids surgery and its associated risks. It is effective both in primary and in secondary phimosis. We emphasize the importance of proper and regular foreskin care and hypothesize on the mechanism of action of the steroids.
The prepuce is a specialized, highly innervated, junctional mucocutaneous tissue that forms the anatomic covering of the glans penis.1 At birth, it is not retractable because the inner epithelial surface is fused to the glans; this normal anatomic condition in infants is often mistaken as phimosis. Within 2 to 3 years, the foreskin detaches from the glans following the formation of keratinized pearls.2 This, together with intermittent erections, allows the foreskin to separate, resulting in a physiologic retraction. In 80% to 90% of uncircumcised boys, the foreskin can be retracted over the glans by 3 years of age,3 although isolated adherent areas in the coronal margin may persist.
Circumcision is not only one of the oldest and more commonly performed surgical procedures, but it is also a source of dilemma and controversy.4 In countries such as the United States and Canada and in communities such as the Jewish community, it is frequently performed during the neonatal period for prophylactic or religious reasons.5 In contrast, about 80% of the world population does not practice routine neonatal circumcision, and the aesthetic of an uncircumcised phallus is accepted culturally.4
In uncircumcised males, adequate care and hygiene of the prepuce during childhood are of fundamental importance. In the absence of routine care and hygiene, a pathologic phimosis can result from a preputial ring becoming fibrotic, preventing the foreskin from fully retracting.6 [CIRP Note: The previous statement is a medical myth. There is no scientific evidence to support such an assertion. Proper care of the childhood prepuce is provided by the AAP pamphlet, Care of the Uncircumcised Penis (2000), which states "Caring for your son's uncircumcised penis requires no special action.".] In cases of pathologic phimosis, surgical correction is the standard treatment. However, in recent years, the topical application of steroids provides an alternative to the management of this disease.7 Herein, we present our results of the treatment of pathologic phimosis with topical steroids in a large group of patients, of diverse age, and with long follow-up. We hypothesize on the mechanism of action of topical steroids, focusing on the importance of developing routine foreskin hygiene for long-term satisfactory results.
From 1997 through 1998 all boys referred to our outpatient clinic for surgical treatment of phimosis and who were considered to have a phimotic foreskin were offered topical treatment with steroids. Phimosis was defined as the presence of a constrictive preputial ring that resulted in a cone-shaped foreskin.8 None of the patients had previously undergone a circumcision. Those boys with signs of balanitis or balanitis xerotica obliterans (BXO) were excluded. The types of phimosis were classified as (1) retractable when a tight and constricting phimotic ring existed, but it did not completely prevent the retraction of the foreskin; (2) nonretractable when the ring prevented the retraction of the foreskin, but the external urethral meatus was exposed; and (3) pinpoint when the foreskin was so constricted that the meatus could not be visualized. Preputial hygiene habits and previous history of forcible retractions were assessed; patients with a previous history of forcible foreskin retractions were considered to have secondary phimosis. [CIRP Comment: It is probable that the boys in this study did not have true phimosis because those boys with BXO and balanitis were excluded. The boys apparently had phony phimosis, which usually requires no treatment since it tends to resolve itself with increasing maturity.]
Both the parents and the patients (when they were old enough to understand) were instructed to apply a thin layer of 0.05% betamethasone cream on the prepuce twice a day (in the morning and evening) for 4 weeks. After the fifth day of treatment, they were asked to gently retract the foreskin several times after applying the cream. They were also encouraged to retract the foreskin when they voided and during their daily bath. The importance of complying with these care measures was strongly emphasized. Patients were evaluated after 5 weeks and at 6 months. The outcome was defined as (1) a success if the prepuce was retractable and was without a ring; (2) a partial response when both the physician and the parents noted that there was a subjective improvement but not a complete disappearance of the ring; and (3) a failure if a constrictive ring persisted. Boys who had a partial response or a failure underwent a second course of topical treatment after discontinuing its usage for 1 month. Results for primary and secondary phimosis and in different age groups or type of phimosis at presentation were analyzed with the use of the chi-square test.
One hundred fifty-one boys entered the study and 137 were available for follow-up. During the same period, 11 circumcisions were performed in patients that did not enter the study for several reasons (including rejection of topical treatment, suspicion of BXO, other associated surgeries, or inability to perform the treatment). The ages of the patients ranged between 13 months and 14 years, with a median age of 5.4 years. At initial presentation, 61 patients had a retractable but phimotic prepuce, 37 had a nonretractable prepuce, and 39 had a pinpoint prepuce. None of the patients practiced daily retraction of their foreskin prior to entering the study, and 71% (98 of 137) were considered to have secondary phimosis.
Five weeks after enrolment, 82% (112 patients) had a successful result, 12% (17 patients) had a partial response, and 6% (8 patients) were considered failures; the latter 25 patients underwent a second course of treatment. At 6 months of follow-up, 90% (124 patients) had a retractable prepuce without recurrence of phimosis: 110 after one course of treatment and 14 after two courses. In the remaining 13 patients (3 of them after an initial success, 4 after initial partial response, and 6 after initial failure), phimosis recurred or persisted. On careful evaluation, all of these patients were found to be noncompliant with the suggested daily foreskin care. They subsequently underwent circumcision. The histopathologic study of the prepuce showed nonspecific dermal fibrosis.
Success rate was similar for patients with primary or secondary phimosis and for the different age groups (Table I). No differences in outcome were found related to the appearance of the prepuce at initial evaluation (retractable, nonretractable, or pinpoint prepuce) (Table II). In all cases, the procedure was well tolerated without evidence of atrophic skin changes as well as systemic or local side effects because of steroid absorption. In general, boys older than 6 years performed the retraction by themselves, and, in younger boys, the retraction was done by the parent.
TABLE I. Results at final follow-up (6 months) between primary and secondary (history of previous forcible foreskin retractions) phimosis and grouped by age legend
Init. Presentation(No. of Cases) Age(No. of Cases) Successful Result(%) Unsuccessful Result(%) Statistical Significance Primary (39) 5 yr (22) 21 (95.4) 1 (4.7) NS (P >0.05) >5 yr (17) 14 (82.3) 3 (17.6) Secondary (98) 5 yr (30) 26 (86.6) 4 (13) NS (P >0.05) >5 yr (68) 63 (92.6) 5 (7.3) Total (137) 124 (90.5) 13 (9.5)
Key: NS = not significant.
Successful result was considered as a retractable prepuce without a ring. Unsuccessful result includes both partial result and failure (see text). No statistically significant difference in outcome was seen when evaluating separately boys older or younger than 5 years.
TABLE II. Results at final follow-up (6 months) according to the appearance of prepuce at initial evaluation legend
Type of Phimosis (No. of Cases) Good Result (%) Unsuccessful Result (%) Retractable (61) 55 (90.1) 6 (9.8) Nonretractable (37) 33 (89) 4 (10.8) Pinpoint (39) 36 (92.3) 3 (7.7) Total (137) 124 13
We could not show significant differences in the results depending on the type of phimosis at the beginning of the study (P >0.05).
Pathologic phimosis is a common problem throughout the world. In Europe, Asia, South America, and Central America neonatal circumcision is not routinely performed, thus childhood phimosis is not rare. In addition, in the United States and Canada the rates of neonatal circumcision, estimated to be 60% to 90%,5 are declining.9 Thus, even in the United States and Canada, phimosis is a commonly faced problem. Obviously, one of the difficulties that arises when studying phimosis is the lack of a clear definition and differentiation between a pathologic phimosis and a physiologic nonretractile foreskin.10 In our study, nonretractable and pinpoint prepuces correspond to type II and type I of the classification by Kayaba et al.11 The cases classified as ''retractable'' phimosis might not be considered pathologic by others because of a potential for spontaneous resolution with increasing age. However, all patients included in our study were originally referred for circumcision, they all had a constrictive ring for which they had sought medical attention, and they would have been considered candidates for circumcision if topical therapy had not been offered. [CIRP note: These doctors show the common inability to distinguish between normal in childhood developmentally narrow foreskin and a pathological condition called phimosis.]
In the treatment of childhood phimosis, surgical correction has been for many years the standard. In this age group, circumcision requires general anesthesia. Although circumcision is associated with a low complication rate, potential problems, such as bleeding, unaesthetic scar, or meatitis with meatal stenosis, do occur.6 Surgical alternatives to circumcision, such as preputial plasty, also require anesthesia and have up to 4% recurrence rate.12 In recent years, topical application of steroids has provided an effective nonsurgical treatment for phimosis,7 and this treatment is, at present, the recommended management of phimosis by the Australasian Association of Paediatric Surgeons.13 When evaluating costs, steroid creams are also the most cost-effective treatment; $758 to $800 per treatment compared with $2512 to $3241 for surgery (either conventional circumcision or preputial plasty).14
Previous series using topical steroids for phimosis have demonstrated a high success rate, ranging from 67% to 95%.7, 8, 9, 10, 11 Our result of 90% success rate is similar; however, to our knowledge, our report has longer follow-up, allowing for assessment of long-term outcome. Of importance, we did not find statistically significant differences in the response rate when stratifying the patients on the basis of age or type of phimosis at presentation. Moreover, we showed for the first time that the treatment is equally beneficial when a previous history of forcible foreskin retractions (secondary phimosis) is present. Of interest, we observed that in most cases the response to topical steroid treatment was durable at the 6-month follow-up. We believe that both failure and recurrence rate are clearly related to the discontinuation of regular foreskin retraction and hygiene. This belief was evident in cases in which the child had a successful initial response but phimosis recurred when daily retraction of the foreskin was discontinued. Furthermore, in a study in which the parents were instructed not to make any specific attempt at foreskin retraction, the success rate was lower, and, because there was no follow-up after the first month, the possible recurrence of phimosis was not evaluated.19 These observations suggest that topical steroids act temporarily in treating phimosis, and it is the change of habits in the local handling of the foreskin that is key to long-term success.
In our study, the use of topical steroids in children was safe, and signs of skin atrophy or systemic absorption were not seen. None of the cases of poor compliance were related to pain or irritation secondary to the application of the steroid cream. Although, theoretically, there might be a risk of systemic effects, such as suppression of the hypothalamic-pituitary-adrenal axis, this risk is low because the quantity of cream applied and the skin surface to which it is applied are very small. To avoid increased absorption, it was emphasized in all cases to use small amounts of cream only in the constrictive ring and not to use occlusive dressings. Golubovic et al.18 demonstrated that topical steroid treatment for phimosis did not significantly change morning cortisol levels. In our series, 4 boys younger than 2 years of age were treated with betamethasone cream without any local or systemic side effects. For these patients, the families were strongly advised of the potential risks and to carefully monitor for signs of toxicity (eg, headaches, vomiting). Other studies similarly showed no side effects in treating children younger than 4 years of age with topical steroids.18,19 The number of children in this age group treated in these studies, however, is limited.
The main effect of betamethasone cream is likely to be in its local anti-inflammatory activity. Although not proven, we speculate that the mechanism of action of topical steroids on the phimotic ring is similar to that in the treatment of BXO (also known as lichen sclerous et atrophicus or LSA).20, 21, 22 Even though the pathogenesis of BXO/LSA and phimosis are probably different, they both have mucocutaneous thinning and dermal fibrosis on histology. With the use of clobetasol dipropionate for treating LSA, Dahlman-Ghozlan et al.22 recently showed that its effect is most likely exerted through restoring the balance of collagen synthesis by the fibroblasts and thus improving the preexisting epidermal atrophy. We suggest that in phimosis, topical steroid treatment similarly improves the elasticity of the foreskin. This improved elasticity together with the moisturizing effect of the cream allows the child to easily retract the prepuce and perform daily hygiene. [CIRP note: Daily retraction is not necessary according to the AAP.] These routine care measures will help to prevent the recurrence of phimosis.
Parents' preference should play a role and when, for whatever reason, they decide not to circumcise a child in the newborn period, it remains the physician's duty to educate them and provide them with guidelines for foreskin care. In a child younger than 1 year of age, it is adequate just to see the meatus. [CIRP Note: There is no medical or scientific basis for the previous statement.] Between the ages of 2 and 5 years, local care should consist of careful retraction and cleaning during bathing with progressive exposure of the glans.3 [CIRP Note: The foreskin of a small child should never be retracted in the bathwater because the bathwater is likely to contain fecal matter carrying E. coli, the cause of most UTI.] Forcible retraction should be avoided because it causes pain and bleeding, contributing to future adhesions and cicatrix formation that might lead to phimosis.6 In our experience, noncompliance to these measures is due to lack of knowledge regarding the proper care of the foreskin.23 By complying with these care measures, it is estimated that less than 1% of the infants will have a foreskin problem later in life6 (with an incidence of phimosis as low as 0.4 cases/1000 boys per year and, cumulatively, 0.6% of boys affected by their 15th birthday 24). We encourage fathers, whether or not they are circumcised, to play a role in the daily care of their child's foreskin. We suggest that the success of the nonsurgical management of phimosis be initially due to the effect of the steroids on the narrowed prepuce. Its success, however, will eventually depend on acquiring the habit of gently retracting the foreskin when voiding and during bathing.
In summary, topical treatment of phimosis with corticosteroids is a simple, safe, and economical procedure. It obtains excellent results in diverse age groups and is well accepted by parents despite the fact that they have to play a more active role in the care of the foreskin.
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