Intrascrotal injection of botulinum toxin A, a male genital aesthetic demand: Technique and limits

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ORIGINAL ARTICLE

Intrascrotal injection of botulinum toxin A, a male genital aesthetic demand: Technique and limits

Injection intra scrotale de toxine botulique A, une demande esthétique masculine: technique et limites

Eloi Ramelli

^a^,^b^,∗

, Nicolas Brault

^a

, Chloe Tierny

^c

, Michael Atlan

^a^,^d

, Sarra Cristofari

^a^,^d

aPlasticsurgeryDepartment,TenonHospital,AssistancePublique-HôpitauxdeParis,4,rue delaChine,75020Paris,France

bPlasticsurgeryDepartment,HautepierreHospital,UniversityHospitalofStrasbourg,1, avenueMolière,67000Strasbourg,France

cPlasticSurgeryandBurnsUnit,UniversityHospitalofBordeaux,FXMicheletCenter,place AmelieRaba-Leon,33076Bordeaux,France

dParisVI,SorbonneUniversity,PierreetMarieCurieCampus,4,placeJussieu,75005Paris, France

Received23February2020;accepted15April2020 Availableonline29April2020

KEYWORDS Botulinumtoxin;

Wrinkles;

Genital;

Scrotum;

Testis;

Scrotalrejuvenation

Summary

Introduction.—Scrotal rejuvenation is a real male aesthetic demand. Scrotal injection of botulinumtoxinmakesthetesticlessmoother,lessdanglingandsubjectivelylarger.

Methods.—Intrascrotalbotulinumtoxininjections wereperformed toa44-year-oldpatient for aestheticpurposes.We used theintracremastericinjection protocol. Cremastermuscle injectionsanddartosmuscleinjectionswereperformed.

Results.—Thepatientwassatisﬁed.Noadversereactiontotheintrascrotalbotulinumtoxin injectionwasobserved.Thepatientwantedtorepeattheprocedureinthefuture.

Conclusion.—Atthemoment,thereisnorecommendationabouttheaestheticuseofintrascro- talinjectionsofbotulinumtoxinAandtherisksareunknown.Thepurposeofthisarticleis toshowthefeasibility,contextandtechnicalmodalitiesofintrascrotalinjection.Theriskof infertilityisreal,butmarginalformenwhonolongerhaveprogeny’sdesire.

Levelofevidence.— Level3.

∗Correspondingauthorat:PlasticsurgeryDepartment,TenonHospital,AssistancePublique-HôpitauxdeParis,4,ruedelaChine,75020 Paris,France.

E-mailaddress:[email protected](E.Ramelli).

https://doi.org/10.1016/j.purol.2020.04.016

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MOTSCLÉS Toxinebotulique; Rides;

Génital; Scrotum; Testicule; Rajeunissement scrotal

Résumé

Introduction.—La demande esthétique concernant l’appareil génital masculin est réelle.

L’injectionintrascrotaledetoxinebotuliqueAestuneméthodenonchirurgicalepermettant d’obtenirdestesticulesplusbassituéesetsubjectivementplusgrosses.

Matériels.—DesinjectionsintrascrotalesdetoxinebotuliqueAontétéréaliséeschezunpatient de44ansdanslecadred’unedemandeesthétique.Nousavonsutiliséleprotocoled’injection utilisé enthérapeutique pour lesspasmes cremastériens.Nous avonsréalisé des injections intramusculairesdumusclecrémasteretdumuscledartos.

Résultats.—Lepatientétait trèssatisfait.Nousn’avons pasobservéd’effetindésirable. Le patientsouhaitaitrépéterlaprocédure.

Conclusion.—Il n’existe pas de recommandations sur l’injection intrascrotale de toxine botuliqueAetdesesrisques.Aunomduprincipedeprécaution,nousnerecommandonspasce typed’injection.Lebutdecetarticleestderappelerlafaisabilité,lecontexteetlesmodalités techniquesdecetyped’injectionquiprésententunrisquethéoriqued’infertilité.

Niveaudepreuve.— 3.

Introduction

Botulinum toxin is produced by the anaerobic bacteria Clostridiumbotulinum.Thisneurotoxinpreventstherelease ofacetylcholinecontainedinthepresynapticneurons’vesi- clesof thestriatedmuscles’neuromuscularjunction.This inhibition leads to muscle relaxation. The subtype A was ﬁrstusedinOphthalmologytotreatmusclehyperfunction.In Urology,intramuscularcremastericinjectionsareperformed indiseases suchascremasterspams[1,2]or chronicscro- talpain[3].Itsutilizationwasthenextendedtoaesthetic purposesmakingbotuliniumtoxinfacialinjectionsthemost common nonsurgical aesthetic procedure [4,5]. Recently, botulinium toxin has gained new uses and is now used intesticularrejuvenation[6—8].Intracremastericinjection inhibits thecremastermuscle contraction[9],making the scrotum smoother, rounder,lower andmore relaxed.Dar- tosmuscleinjectionscanbeperformedatthesametimeto reducescrotalwrinkles.Thisnewscrotumappearancehas generatedincreasinginterestamongmen,exacerbatedby themedia[10,11].

Legally,intheUnitedStates,theuseofbotulinumtoxin for cosmetic purposes was authorized by the Food and Drug Administration (FDA) in 2004. In France, botulinum toxin has received a legal authorization from the health authorities for its cosmetic use. The administration of botulinum toxin must be performed by qualiﬁed doctors.

Only physicians specializing in plastic, reconstructive and cosmetic surgery, dermatology, neurology, face and neck surgery, maxillofacialsurgery, urology and ophthalmology areallowedtouseit.Initsaestheticapplications,different typesofbotulinumtoxinAproductshaveobtainedtheMar- ketingAuthorizationforacorrectionofglabellarwrinkles, periorbital wrinkles and frontal ones (Vistabel^® (Allergan France, Courbevoie FR), Azzalure^® (Galderma, Lausanne CH),Bocouture^® (MerzPharmaFrance,CourbevoieFR)and Xeomin^® (Merz PharmaFrance,CourbevoieFR)).Thepres- criptionanduseofbotulinumtoxinAforaestheticpurposes inscrotumisanunusualactgovernedbyArticleL5121-12- 1of thePublicHealthCode.It givesrisetoadistribution

ofresponsibilitiesbetweenhealthprofessionals:prescribing doctor,operatingdoctoranddispensingpharmacist.

Anatomically,scrotum istheskin envelopeof bothtes- ticles,itsexternalaestheticaspectislinkedtotheaction of twomuscles. The cremaster muscle is a striated mus- clemade upof 2 muscular bundles. The external bundle startsfromthe inguinalligamentand theinternaloblique muscle,andtheinternal bundlestartsfromthepubisand theinguinalaponeuroticfalx.Cremasterﬁbresareoriented downwardsuntilthevaginaltunicofthetesticle.Cremaster musclehastwomainphysiologicalfunctionsinhumans.The mainone, inassociation withthermoregulation byscrotal sweating,istokeepthetesticlesatatemperatureof35^◦C neededfor spermatogenesis,toensure reproductivefunc- tions.Thesecondroleofcremastermuscleistoprotectthe testicleswiththecremastericreﬂex.Duringphysicalactiv- itiesor stress, the cremastermuscle contracts leading to testiclesretractionandprotection[12].

Dartosmuscleisascrotalcutaneousmuscle,coveringthe externaltestisfascia. Itprovidesthe testicles’superﬁcial thermalregulation,andcausesscrotumskinwrinkling.

Themainobjectiveofthiscasereportwastoexposethe outcomeoftheseinjectionsandtoassesstheinjectiontech- niqueused.Aliteraturereviewwasconductontherisksand adverseeffectsofthistypeofinjections.

Material and methods Case report

A 44-year-old man presented a buried penis associated with a retracted and high positioned testicular appearance.Hedidnothaveanymedicalorsurgicalhistory.Any contraindicationwaseliminated:pathologiesconferringan innate or acquired haemorrhagic tendency (anticoagulant andplateletaggregationtreatments),allergytobotulinum toxin,infectionorscarringofthescrotalarea.Thepatient already had 2 children and did not want to have more.

The patient found his testicles toosmall and motionless.

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Table1 IMGIscore[8].

Extremely dissatisﬁed

Ihavenofeelingone wayortheother

Extremely satisﬁed

Lengthoferectpenis 1 2 3 4 5 6 7

Girthoferectpenis 1 2 3 4 5 6 7

Sizeofﬂaccidpenis 1 2 3 4 5 6 7

Colorofgenitals 1 2 3 4 5 6 7

Shapeofglans 1 2 3 4 5 6 7

Locationofurethra 1 2 3 4 5 6 7

Textureofskin 1 2 3 4 5 6 7

Curvatureofpenis 1 2 3 4 5 6 7

Circomcisionstatus 1 2 3 4 5 6 7

Sizeoftesticules 1 2 3 4 5 6 7

Genitalveins 1 2 3 4 5 6 7

Amountofpubichair 1 2 3 4 5 6 7

Amountofsemen 1 2 3 4 5 6 7

Scentofgenitals 1 2 3 4 5 6 7

FromDavisSN,BinikYM,AmselR,CarrierS.Theindexofmalegenitalimage:anewscaletoassessmalegenitalsatisfaction.JUrol.

2013Oct;190(4):1335-9.

Hemainlyhadanaestheticdemandandwantedlowerand moremobiletesticles.Hedidnothave anyrequest about theaestheticaspectofhispenis.Clinically,thepatienthad painlesstesticlesveryclosetothepenis. Hedidnothave genital symptoms such as orchitis or urethral discharge.

There wasno testicular mass on palpation.The preoper- ative patient’s IMGI score (Index of Male Genital Image) was67/98[13](Table1).Hisscrotalraphemeasured10cm.

Thepatientwasinformedofthenon-specificrisksofintra- muscularbotulinumtoxininjectionprocedures:hematoma, edema,erythemaattheinjectionsite,non-specificinflam- mation.Thepatientsignedaninformedconsentformbefore theinjectionprocedure.Therewasnorecommendationon dilutionnoronintrascrotalinjectiontechniqueofbotulinum toxin.As a result,we chosean intracremastericinjection protocolbasedonthe oneusedintherapeutic indications withaneffectoncremastericrelaxation.

Technique

Thepatientwasplacedinsupineposition.Thetreatedarea was disinfected. Bilateral local anaesthesia by spermatic cord block [14] was performed to ensure a painless and morecomfortableprocedure(Fig.1)withapure lidocaine injection(10ml/1%). We useda5mlsyringe andinjected lidocainewitha4cm25Gneedleat1cmbelowandinside thepubicspine.Incontactwiththepubicbone,theneedle wasslightlyremovedandlidocaineinjectedafteranaspira- tiontest. Completeanaesthesiawasobtainedbyinjecting bolusesof3to4mLinvariousorientationsaroundthesper- maticcord.Theprocedurewasrepeatedontheotherside.

10to 15mL each sidewere needed toobtain a complete anaesthesia.

A dilution of 100 Allergan International Unit (AIU) of botulinum toxin in 10ml of injectable saline solution [1]

wasmade.Weperformedanintramuscularinjectionatthe proximalthirdof thecremastermuscle whereit issuper- ﬁcial and palpable. Two to three 3mL intra-cremasteric

Figure1. Préopérativespermaticcordblock.

Figure2. 30UIinjectionofbotuliniumtoxinintheleftcremaster muscle.

injections (30AIU) were carriedoutin theproximal third ofthemuscleindifferentaxestoobtainacomplete mus- cularﬁbresrelaxation(Fig.2).Punctualinjectionsof1mL (10AIU)orlessweremadeintothedartosmuscle[7]inthe

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Figure3. 10UIinjectionofbotuliniumtoxininthedartosmuscle.

mostpronouncedscrotalfurrows(Fig.3).Theprocedurewas repeatedcontralaterally.Overall,75to200AIUofbotulinum toxinwererequiredtoachievecomplete relaxationofthe cremasteranddartosmuscles[1](Fig.4).

Results

Theresultofbotulinumtoxininjectionisgenerallyobserved in3to15days[1].Wesawthepatient10daysafterthepro- cedure.Thecremastermusclewasrelaxedandthescrotum haddeployed.Thepatientdescribedasofterandsmoother scrotum(Fig.5).The testiclesseemedlarger.Thepatient wasverysatisfiedwiththeaestheticresult.Thepostopera- tiveIMGIscorewas75/98.Indetail,thecriterion‘‘sizeof thetesticles’’wentfrom1(extremelydissatisfied) before theprocedureto5(satisfied)aftertheprocedure.Noimme- diate complication secondary to intramuscular injection was observed, such as hematoma or bleeding. The scro- talmedianraphemeasured15cminthesameconsultation conditions (heat, schedule, stress). As intrascrotal injec- tionshaveaninhibitoryeffectontheinguinalsweatglands, thereductionofperspirationhad acomfortableeffecton patients’qualityoflife.Thedurationofactionofintrascro- talbotulinumtoxininjectionsisusuallyfrom3to6months.

Alastingeffectrequiresrepetitionofinjections.Thepatient declaredthathewasreadytoundergoanewinjectionses- sionwhentheeffectwouldwearoff.At3monthsfollow-up, theeffects were still observed. The same procedure was

Figure4. Injectionprocedureschema.

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Figure5. Patientbefore(toprow) and15daysafterscrotalinjection(lowerrow).Wenoticelowerhangingandsubjectivelylarger testicles.

repeated6monthslater,afterthedeclineofthebotulinum toxin’seffect.Thescrotalmedianraphemeasurementwas then11cm.

Discussion

Interestfor malegenitalaestheticsis ontherise[10,11], with the onset of augmentation phalloplasty and penile enlargement surgery [15—17]. Genital rejuvenation has becomea realpart ofaestheticmedicine andsurgery for women and most recently for men. Nowadays, men are moreandmoreconcernedabout age-relatedphysiological changes or pathological changes. Various physiological or pathological symptoms can be observed, regarding hairi- ness(alopeciaandhypertrichosis),appearance (laxityand wrinkles), morphology (testicular atrophy) or vasculariza- tion(angiokeratoma)ofthescrotum.Alltheseelementscan nowbe treatedafter an analysis of the patient’s request combinedwithageneralandtargetedclinicalexamination [18—20].

IntrascrotalinjectionofbotulinumtoxinApavestheway toanewdemandingenitalaesthetics.Theaimoftheproce- dureistoobtainlowerandapparentlylargertesticles.Toour knowledge,thereisnoothermedicalorsurgicaltechnique togetsucharesult.Intheliterature,onlyfunctionalstud- iescanbefound, wherethe toxin isusedfor cremasteric spasms’ treatment [1,2]. The functional results of these studiesaresafeandsatisfying,that’swhyweusedthesame techniqueanddilutionofbotulinumtoxinforaestheticpur- poses.

Intheliterature,nostudyassesses theassociated-risks ofintrascrotalinjectionofbotulinumtoxininhumans.How- ever,ratstudiesshowadecreaseinspermproductionandan alterationofthehistologicalstructureoftheseminiferous tubules[21,22].Suppressionofthephysiologicalfunctionof

thecremasteranddartosmusclesinthermoregulationmay beresponsibleforspermatogenesis’alteration.Thisconcept must be known by the practitioner who must inform his patientbeforeanyintrascrotalinjectionofbotulinumtoxin Aforaestheticpurposes.

Ourpatientwasverysatisﬁedwiththeaestheticresult andhedeclaredhimselfreadytorepeattheinjectionses- sion.ItshouldbenotedthatthecharacteristicsoftheIMGI score mainlyconcern the overall appearance of themale genitals.Only2questionsoutof14(genitals’colorandtes- ticles’size)dealwithtesticularaspect.Thesetwoquestions ledtoan improvementinthepost-procedurescorein the caseofourpatient.IMGIscoreisameasureofmalegenital imageandithasdemonstratedgoodpsychometricabilities.

Itsweaknessisthelackofademonstratedthresholdbeyond which the patient’s qualityof life is better,by improving hisownvisionofhisgenitals.TheMGIS(MaleGenitalImage Scale) score is another validated score in the male genital aestheticevaluation [23,24].Itwasinitiallydeveloped toassessthegenitalimageofmenundergoinghypospadias surgery.Thisscoreincludes31items.Asonly3itemsoutof 31dealwiththetesticularaspect,itislessappropriatethan theIMGIscoreinthetesticularaestheticevaluation.

Objectively,thedistancefromtheapextothebaseofthe scrotalmedianraphewasincreased.Althoughthismeasure- mentdependsonenvironmentalvariations,wehavetriedto limittheconfoundingfactors:sameconsultationtime,same contextandsametemperatureintheconsultationroom.

Itisimportantforourteamtohighlighttherisk-beneﬁt ratio of the intrascrotal botulinum toxin injection procedure. Indeed, the long-term side effects are not known.

Inthenameoftheprecautionaryprinciple,especiallycon- cerning the potential adverse effect on fertility and the risk of infertility,we donot recommendthis typeof aes- theticprocedureformenofreproductiveage.Inallcases, the performance of the intrascrotal botulinum toxin A

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injectionprocedurerequiresinformedconsent,particularly onthepotentialrisksforfertility.

Conclusion

The injectionofintrascrotalbotulinumtoxinfor aesthetic purposesisnotapprovedbyhealthauthoritiesanditiscar- riedoutunderthephysician’sresponsibility.Itsuseinthis indication requires moredocumentation onpotential side effects, including infertility. Botulinum toxin A injections wereeffectiveandverysatisfyinginthiscase.However,as it stands,we cannot recommendits usein menof repro- ductiveage,becauseofthe lackof hindsight.Thisarticle exposes theinjection techniquein selected andinformed patients.

Ethical approval

This article respects ethicalapproval withhuman partici- pants.

Informed consent

Forthistypeof study,informedconsentwasrequired and applied.

Funding

Theauthorsdeclarethattheyhavenocompetingﬁnancial interestsandnofundingassociatedwiththispublication.

Disclosure of interest

Theauthorsdeclarethattheyhavenocompetinginterest.

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