Pediatrics, Volume 102, Issue 4. October 1998.
Department of Pediatrics, Marshfield Clinic — Lakeland Center, Minocqua, Wisconsin
Pediatrics, Volume 102, Issue 4. October 1998.
Department of Pediatrics, Marshfield Clinic — Lakeland Center, Minocqua, Wisconsin
Objective. To determine the most cost-effective treatment for phimosis.
Design. The costs of three treatment strategies for treating phimosis were evaluated using a decision-tree analysis. Three therapeutic approaches were considered: circumcision, preputial plasty (theuse of plastic surgical techniques to enlarge the preputial opening without removing tissue), and topical therapy with steroids and non-steroidal anti-inflammatories. Published failure and complication rates were used to calculate the cost per case.
Outcome Measures. Cost in dollars to treat each case of phimosis.
Results. Topical steroid therapy was the most cost-effective strategy, costing between $758 and $800 per case. Preputial plasty costbetween $2515 and $2580 per case. Circumcision cost between $3009 and $3241 per case.
Conclusions. The most cost-effective management for treating phimosis is to initiate topical therapy. Daily external application from thetip of the foreskin to the glandis corona with betamethasone 0.05% cream for 4 to 6 weeks has been demonstrated to be very effective,resulting in a 75% savings compared with circumcision. Surgical intervention should not be considered until topical therapy hasbeen given an adequate trial. When contemplating surgery, the lower morbidity, lower costs, and tissue preservation of preputialplasty may make it preferable.
Key words: phimosis, betamethasone, preputial plasty, circumcision.
It has recently been demonstrated that patients with true phimosis can be treated successfully with topical creams in 65%to 95% of cases.1-10 Also, a number of prepuce-sparing surgical treatments (preputialplasty) for phimosis have been developed.11-18 Two studies have compared the results of preputial plasty withconventional circumcision,19-20 finding thatthe plastic procedure lowered morbidity and recovery time as wellas the incidence of meatal stenosis after surgery.
With the advent of these newer, less invasive, less morbid alternatives, it is important to document the most cost-effectivemanner of treating phimosis.
A decision-tree analysis was performed for three initial treatment strategies: circumcision, preputial plasty, and topicalsteroids. The costs, complication rates, failure rates, and timemissed from work (parental or personal) are listed in Table 1.
|
TABLE 1 Assumptions Used to Calculate the Cost-efficiency of Treating Phimosis |
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| Circumcision | Preputial Plasty | Topical Steroids | Meatotomy | |
|---|---|---|---|---|
| Cost per procedure | $2000 | $2000 | $120 | $1000 |
| Failure rate | 4%19 | 18% | ||
| Overnight hospital stay | 6-20%19 | 2.4-8%19 | ||
| Reoperation rate | 3-6%19 | |||
| Meatal stenosis rate | 2.821-8%20 | |||
| Time lost from work (days) | 9.21519 | 3.8519 | 1 | 2 |
The failure rate for topical therapy was calculated by combining the results of the 10 studies published to date (Table 2).1-10 Time lost from work was based on the mean time it took after surgery for underpants to be worn comfortably.19 Income wasassumed to be $35 000 per annum.
|
TABLE 2 Studies Using Topical Creams to Treat Phimosis |
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| Author | Therapy Used | Number of Patients | Number Responding | % |
|---|---|---|---|---|
| Wright1 | Betamethasone 0.5% three times a day | 139 | 111 | 80 |
| Kikiros2 | Hydrocortisone 1% and 2%, betamethasone 0.05% twice a day four times a day |
63 | 51 | 81 |
| Jorgensen3 | Clobetasol 0.05% once daily | 54 | 38 | 70 |
| Lange4 | HCG injection, corticoid cream | 56 | 53 | 95 |
| Golubovic5 | Betamethasone 0.05% twice a day | 20 | 19 | 95 |
| Müller6 | Estrogen 0.1% twice a day | 30 | 27 | 90 |
| Linghagen7 | Clobetasol 0.05% once daily | 27 | 24 | 89 |
| Atilla8 | Diclofenac three times a day | 32 | 24 | 75 |
| Dewan9 | Hydrocortisone 1% three times a day* | 20 | 13 | 65 |
| Ruud10 | Potent steroid ointment† | 41 | 35 | 85 |
| Total | 482 | 395 | 82 | |
| * Those who did not respond to 1% hydrocortisone cream were subsequently successfully treated with 0.05% betamethasone cream. † Twelve of the patients who initially responded relapsed. |
||||
Although the British study by Cuckow et al19 documented a 20% overnight hospitalization rate after circumcision,the rate in the United States is unknown. Most of the overnighthospitalizations were secondary to anesthesia complications. Overnighthospitalization rates of 6% (the rate of reoperation for bleeding)and 20% were used for calculations. Hospitalization rates forpreputial plasty were 40% of those for circumcision.19The reported rates of meatal stenosis requiring meatotomy aftercircumcision range from 2.8%21 to 11.1%.22Calculations were made using meatotomy rates of 2.8% and 8%.20
For the preputial plasty group, failures were treated with circumcision. For the topical therapy, failures were treated withcircumcision under the assumption that those who failed topicaltherapy did not respond because the underlying pathology was balanitisxerotica obliterans (BXO) based on the determination that thefailure rate of topical therapy was nearly the same as the incidenceof BXO in circumcision specimens (Table 3).23-29
|
TABLE 3 Incidence of Balanitis Xerotica Obliterans in Circumcision Specimens |
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| Study | Number of Specimens | Number With Balanitis Xerotica Obliterans | % | |
|---|---|---|---|---|
| Clemmensen23 | 78 | 15 | 19.2 | |
| Meuli24 | 100 | 10 | 10.0 | |
| Kristiansen25 | 59 | 9 | 15.3 | |
| Bale26 | 232 | 44 | 19.0 | |
| Flentje27 | 140 | 6 | 4.3 | |
| Chalmers28 | 100 | 14 | 14.0 | |
| Liatsikos29 | 75 | 8 | 10.7 | |
| Total | 709 | 98 | 13.8 | |
For each case of phimosis it costs between $3009 and $3241 to use circumcision as the primary treatment modality. Preputialplasty costs between $2515 and $2579 per case. Using topical therapyas the initial therapy costs between $758 and $800, a 75% savingscompared with circumcision.
Topical therapy would need to exhibit a 93% failure rate to be as costly as initially relying on circumcision. A failure rateof 20% to 24% for preputial plasty would make that option as costlyas circumcision. In those treated initially with topical therapy,treatment failure accounted for more of the costs than their initialtherapy (Fig 1).
These calculations demonstrate that topical therapy is the most cost-efficient initial therapy for phimosis.
The definition of phimosis has never been precise and has been applied to foreskins which do not retract,30 haveadhesions to the glans,31 have a tightness,
32are elongated,18 are redundant,
33 are thickened,34are inflamed,35 have a fibrous ring,15 or have a narrow orifice.36 In the United States physiciansare encouraged to list redundant prepuce and phimosis
as theindication for elective circumcisions on normal foreskins to receivethird-party payment.37 Unfortunately, the term phimosisis often incorrectly applied to any foreskin that cannot be retracted,38which includes 96% of newborns, 85% of 3 month olds, 50% of 1year olds,39 and 1% of 17 year olds.40
The reported incidence of phimosis varies. In a population of military dependents receiving postneonatal circumcisions, theincidence of true phimosis was between 0.2 and 0.3%.41Krueger and Osborn42 found phimosis in 3 of 28 boys(10.7%) more than the age of 4, Herzog and Alvarez43saw symptomatic phimosis in 8 of 272 intact boys (2.94%) theystudied, and following a cohort of 1265 children in Christchurch,New Zealand, Fergusson et al44 found that 16% of noncircumcisedboys aged 0 to 8 had phimosis. Whether these authors could distinguishbetween pathologic and physiologic phimosis through retrospectivechart reconstructions is debatable. How many of these boys requiredintervention is likewise unknown.
Prospective studies have demonstrated phimosis to be a rare finding. Smith et al45 found 1 case of phimosis in 1000boys. In 213 Japanese boys under age 2 years, only 4 (1.88%) had a pinhole prepuce.
46 In France the rate is 2.6%,47whereas in England, the incidence of true pathologic phimosis was calculated to be 0.9%.48
Øster,40 who examined nearly 2000 schoolchildren between the ages of 6 and 17, found that 91% of the 6- to 7-year-old age group had retractile prepuces and the incidence of spontaneouslyretractile foreskins increased yearly until age 17 years whenonly 1% of the foreskins remained nonretractile. The incidenceof a completely retractile prepuce in a study of 603 Japaneseboys showed a gradual increase from 0% at age 6 months to 62.9%by 11 to 15 years, while the incidence of a tight preputial ringdecreased with age from 84.3% to 8.6%.46 One large studyfailed to find a case of pathologic phimosis in a boy under 5years of age.49
Without clear diagnostic criteria, confusion exists about what constitutes pathologic phimosis as distinct from a physiologic non-retractile foreskin.38 The majority of referrals to pediatric urologists for circumcision constitute developmentally non-retractile foreskin rather than true phimosis.49-51
When applying gentle retraction to the normal but nonretractable infant foreskin the distal part of the foreskin puckers and the narrow portion is proximal to the preputial tip. When the same gentle retraction is applied to the foreskin with true phimosis it results in a cone-shaped foreskin with a fibrotic, circular band forming the most distal and narrowest part of the prepuce.9
Topical therapy has resulted in consistently favorable results (Table 2), a finding that has prompted the Australasian Association of Paediatric Surgeons52 to recommend circumcision only for BXO, recurrent balanoposthitis, and phimosis resistant to topical steroid cream. All three placebo-controlled studies have demonstrated topical therapy's superiority (Table 4).5,7,8 The antiinflammatory and immunosuppressive effects as well asthe skin thinning effects of the topical steroids may explain their effectiveness.9 Betamethasone has been the most studied cream, with external application giving similar results to mucosal application.
|
TABLE 4 Placebo-controlled Studies of Topical Therapy for Phimosis Response to Therapy |
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| ??? | ??? | ??? | ??? | |
|---|---|---|---|---|
Although the studies using topical creams have produced dramatic results, the boys studied were often younger than 5 yearsold. How many of these boys merely had a normal, nonretractileprepuce is unknown. Topical therapy may have only acceleratedthe normal developmental process in these boys. Still, these boyswould have been considered candidates for circumcision if topicaltherapy had not been offered. Lindhagen7 noted that placeboresponders were 2.4 years older than placebo nonresponders, reinforcing the opinion that this is a physiological process with increasingpotential for spontaneous resolution with increasing age.
The failure rate of topical creams (19%) is nearly identical with the rate of BXO (14%) found on histologic examination ofprepuces excised from patients with phimosis.23-29 Of the boys who failed after a complete course of topical therapy,14 had a histologic examination performed. BXO was diagnosed in12 (86%) of them.1,3,7 Although topicalsteroids are recommended for early BXO,53 their usemay act as a screening tool to identify those with more advancedBXO. With the development of effective topical therapy and preputialplasty, the indication for circumcision in the treatment of phimosishas been reduced to the rare cases of BXO.
Meatal stenosis requiring meatotomy after circumcision is seen in 2.8%21 to 11.1%22 of patients. Persadet al20 found that after 88 circumcisions for phimosis,7 (8%) boys developed meatal stenosis, whereas none of the 91boys who underwent preputial plasty did (P < .01). Traumatic meatitisof the unprotected postcircumcision urethral meatus and/or meatalischemia after damage to the frenular artery at circumcision havebeen cited as possible etiologic factors.
Of two similar groups of 50 boys, one underwent circumcision and the other underwent preputial plasty in a recent Britishstudy.19 Of the boys who underwent circumcision, 20%required an overnight stay, 14% had anesthetic complications,and 6% required reoperation because of bleeding. Only 8% of patientshad an overnight stay after preputial plasty. None of these patientsrequired reoperation and no bleeding problems were noted. Parentalassessment of both operations showed that morbidity was significantlyless and of shorter duration for the preputial plasty group. Twopatients in the preputial plasty group (4%) had recurrent narrowingof the foreskin caused by scarring and contraction of the incision.The acceptance of preputial plasty as an alternative to circumcisionmay not occur immediately, despite reductions in cost, morbidity,and the amount of tissue excised, because most surgeon will needto be convinced of the need for change.54
Several noneconomic factors deserve consideration. The ridged band at the tip of the prepuce may be the most neurologicallycomplex portion of the penis.55 Topical therapy andpreputial plasty both spare this highly erogenous tissue. Likewise,severe emotional problems have been documented after circumcisionin young boys.56 The vast majority of males with a prepuceare not eager to part with it, and these newly developed therapiesprovide reasonable alternatives.
Lindhagen7 states, contrary to epidemiological data that showed spontaneous resolution of most cases of phimosis,circumcision has become the first line of treatment for thesepatients. The argument that circumcision is a minor surgical procedurewithout complications is not only erroneous, but also irrelevant.It is ethically as well as economically questionable to operateon a child to treat a physiological process.
Received for publication Sep 9, 1997; accepted May 18, 1998.
Reprint requests to (R.S.V.H.) Marshfield Clinic, Lakeland Center, 9601 Townline Rd, PO Box 1390, Minocqua, WI 54548.
I thank Christopher J. Cold, MD, for his invaluable assistance in explaining the pathology of BXO.
BXO, balanitis xerotica obliterans.
Triple incision plasty. A convenient procedure for preputial relief. Scand J Urol Nephrol 1992; 26:107-110 [Medline]
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