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RIGINAL ARTICLE

ntrascrotal injection of botulinum toxin A, male genital aesthetic demand: Techniquend limits

njection intra scrotale de toxine botulique A, une demande esthétiqueasculine: technique et limites

Eloi Ramelli a,b,∗, Nicolas Braulta, Chloe Tiernyc,Michael Atlana,d, Sarra Cristofari a,d

a Plastic surgery Department, Tenon Hospital, Assistance Publique-Hôpitaux de Paris, 4, ruede la Chine, 75020 Paris, Franceb Plastic surgery Department, Hautepierre Hospital, University Hospital of Strasbourg, 1,avenue Molière, 67000 Strasbourg, Francec Plastic Surgery and Burns Unit, University Hospital of Bordeaux, FX Michelet Center, placeAmelie Raba-Leon, 33076 Bordeaux, Franced Paris VI, Sorbonne University, Pierre et Marie Curie Campus, 4, place Jussieu, 75005 Paris,France

Received 23 February 2020; accepted 15 April 2020Available online 29 April 2020

KEYWORDSBotulinum toxin;Wrinkles;Genital;Scrotum;Testis;Scrotal rejuvenation

SummaryIntroduction. — Scrotal rejuvenation is a real male aesthetic demand. Scrotal injection ofbotulinum toxin makes the testicles smoother, less dangling and subjectively larger.Methods. — Intrascrotal botulinum toxin injections were performed to a 44-year-old patientfor aesthetic purposes. We used the intracremasteric injection protocol. Cremaster muscleinjections and dartos muscle injections were performed.Results. — The patient was satisfied. No adverse reaction to the intrascrotal botulinum toxininjection was observed. The patient wanted to repeat the procedure in the future.Conclusion. — At the moment, there is no recommendation about the aesthetic use of intrascro-tal injections of botulinum toxin A and the risks are unknown. The purpose of this article isto show the feasibility, context and technical modalities of intrascrotal injection. The risk ofinfertility is real, but marginal for men who no longer have progeny’s desire.Level of evidence.— Level 3.

© 2020 Elsevier Masson SAS. All rights reserved.

∗ Corresponding author at: Plastic surgery Department, Tenon Hospital, Assistance Publique-Hôpitaux de Paris, 4, rue de la Chine, 75020aris, France.

E-mail address: eloi.ramelli@gmail.com (E. Ramelli).

https://doi.org/10.1016/j.purol.2020.04.016166-7087/© 2020 Elsevier Masson SAS. All rights reserved.

Intrascrotal injection of botulinum toxin A: Technique and limits 313

MOTS CLÉSToxine botulique ;Rides ;Génital ;Scrotum ;Testicule ;Rajeunissementscrotal

RésuméIntroduction. — La demande esthétique concernant l’appareil génital masculin est réelle.L’injection intrascrotale de toxine botulique A est une méthode non chirurgicale permettantd’obtenir des testicules plus bas situées et subjectivement plus grosses.Matériels. — Des injections intrascrotales de toxine botulique A ont été réalisées chez un patientde 44 ans dans le cadre d’une demande esthétique. Nous avons utilisé le protocole d’injectionutilisé en thérapeutique pour les spasmes cremastériens. Nous avons réalisé des injectionsintramusculaires du muscle crémaster et du muscle dartos.Résultats. — Le patient était très satisfait. Nous n’avons pas observé d’effet indésirable. Lepatient souhaitait répéter la procédure.Conclusion. — Il n’existe pas de recommandations sur l’injection intrascrotale de toxinebotulique A et de ses risques. Au nom du principe de précaution, nous ne recommandons pas cetype d’injection. Le but de cet article est de rappeler la faisabilité, le contexte et les modalitéstechniques de ce type d’injection qui présentent un risque théorique d’infertilité.Niveau de preuve.— 3.© 2020 Elsevier Masson SAS. Tous droits reserves.

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Introduction

Botulinum toxin is produced by the anaerobic bacteriaClostridium botulinum. This neurotoxin prevents the releaseof acetylcholine contained in the presynaptic neurons’ vesi-cles of the striated muscles’ neuromuscular junction. Thisinhibition leads to muscle relaxation. The subtype A wasfirst used in Ophthalmology to treat muscle hyperfunction. InUrology, intramuscular cremasteric injections are performedin diseases such as cremaster spams [1,2] or chronic scro-tal pain [3]. Its utilization was then extended to aestheticpurposes making botulinium toxin facial injections the mostcommon nonsurgical aesthetic procedure [4,5]. Recently,botulinium toxin has gained new uses and is now usedin testicular rejuvenation [6—8]. Intracremasteric injectioninhibits the cremaster muscle contraction [9], making thescrotum smoother, rounder, lower and more relaxed. Dar-tos muscle injections can be performed at the same time toreduce scrotal wrinkles. This new scrotum appearance hasgenerated increasing interest among men, exacerbated bythe media [10,11].

Legally, in the United States, the use of botulinum toxinfor cosmetic purposes was authorized by the Food andDrug Administration (FDA) in 2004. In France, botulinumtoxin has received a legal authorization from the healthauthorities for its cosmetic use. The administration ofbotulinum toxin must be performed by qualified doctors.Only physicians specializing in plastic, reconstructive andcosmetic surgery, dermatology, neurology, face and necksurgery, maxillofacial surgery, urology and ophthalmologyare allowed to use it. In its aesthetic applications, differenttypes of botulinum toxin A products have obtained the Mar-keting Authorization for a correction of glabellar wrinkles,periorbital wrinkles and frontal ones (Vistabel® (AllerganFrance, Courbevoie FR), Azzalure® (Galderma, LausanneCH), Bocouture® (Merz Pharma France, Courbevoie FR) and

Xeomin® (Merz Pharma France, Courbevoie FR)). The pres-cription and use of botulinum toxin A for aesthetic purposesin scrotum is an unusual act governed by Article L5121-12-1 of the Public Health Code. It gives rise to a distribution

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f responsibilities between health professionals: prescribingoctor, operating doctor and dispensing pharmacist.

Anatomically, scrotum is the skin envelope of both tes-icles, its external aesthetic aspect is linked to the actionf two muscles. The cremaster muscle is a striated mus-le made up of 2 muscular bundles. The external bundletarts from the inguinal ligament and the internal obliqueuscle, and the internal bundle starts from the pubis and

he inguinal aponeurotic falx. Cremaster fibres are orientedownwards until the vaginal tunic of the testicle. Cremasteruscle has two main physiological functions in humans. Theain one, in association with thermoregulation by scrotal

weating, is to keep the testicles at a temperature of 35 ◦Ceeded for spermatogenesis, to ensure reproductive func-ions. The second role of cremaster muscle is to protect theesticles with the cremasteric reflex. During physical activ-ties or stress, the cremaster muscle contracts leading toesticles retraction and protection [12].

Dartos muscle is a scrotal cutaneous muscle, covering thexternal testis fascia. It provides the testicles’ superficialhermal regulation, and causes scrotum skin wrinkling.

The main objective of this case report was to expose theutcome of these injections and to assess the injection tech-ique used. A literature review was conduct on the risks anddverse effects of this type of injections.

aterial and methods

ase report

44-year-old man presented a buried penis associatedith a retracted and high positioned testicular appear-nce. He did not have any medical or surgical history. Anyontraindication was eliminated: pathologies conferring annnate or acquired haemorrhagic tendency (anticoagulant

nd platelet aggregation treatments), allergy to botulinumoxin, infection or scarring of the scrotal area. The patientlready had 2 children and did not want to have more.he patient found his testicles too small and motionless.

314 E. Ramelli et al.

Table 1 IMGI score [8].

Extremelydissatisfied

I have no feeling oneway or the other

Extremelysatisfied

Length of erect penis 1 2 3 4 5 6 7Girth of erect penis 1 2 3 4 5 6 7Size of flaccid penis 1 2 3 4 5 6 7Color of genitals 1 2 3 4 5 6 7Shape of glans 1 2 3 4 5 6 7Location of urethra 1 2 3 4 5 6 7Texture of skin 1 2 3 4 5 6 7Curvature of penis 1 2 3 4 5 6 7Circomcision status 1 2 3 4 5 6 7Size of testicules 1 2 3 4 5 6 7Genital veins 1 2 3 4 5 6 7Amount of pubic hair 1 2 3 4 5 6 7Amount of semen 1 2 3 4 5 6 7Scent of genitals 1 2 3 4 5 6 7

From Davis SN, Binik YM, Amsel R, Carrier S. The index of male genital image: a new scale to assess male genital satisfaction. J Urol.2013 Oct;190(4):1335-9.

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Figure 1. Pré opérative spermatic cord block.

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e mainly had an aesthetic demand and wanted lower andore mobile testicles. He did not have any request about

he aesthetic aspect of his penis. Clinically, the patient hadainless testicles very close to the penis. He did not haveenital symptoms such as orchitis or urethral discharge.here was no testicular mass on palpation. The preoper-tive patient’s IMGI score (Index of Male Genital Image)as 67/98 [13] (Table 1). His scrotal raphe measured 10 cm.he patient was informed of the non-specific risks of intra-uscular botulinum toxin injection procedures: hematoma,

dema, erythema at the injection site, non-specific inflam-ation. The patient signed an informed consent form before

he injection procedure. There was no recommendation onilution nor on intrascrotal injection technique of botulinumoxin. As a result, we chose an intracremasteric injectionrotocol based on the one used in therapeutic indicationsith an effect on cremasteric relaxation.

echnique

he patient was placed in supine position. The treated areaas disinfected. Bilateral local anaesthesia by spermaticord block [14] was performed to ensure a painless andore comfortable procedure (Fig. 1) with a pure lidocaine

njection (10 ml/1%). We used a 5 ml syringe and injectedidocaine with a 4 cm 25G needle at 1 cm below and insidehe pubic spine. In contact with the pubic bone, the needleas slightly removed and lidocaine injected after an aspira-

ion test. Complete anaesthesia was obtained by injectingoluses of 3 to 4 mL in various orientations around the sper-atic cord. The procedure was repeated on the other side.

0 to 15 mL each side were needed to obtain a completenaesthesia.

A dilution of 100 Allergan International Unit (AIU) of

otulinum toxin in 10 ml of injectable saline solution [1]as made. We performed an intramuscular injection at theroximal third of the cremaster muscle where it is super-cial and palpable. Two to three 3 mL intra-cremasteric

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igure 2. 30 UI injection of botulinium toxin in the left cremasteruscle.

njections (30 AIU) were carried out in the proximal thirdf the muscle in different axes to obtain a complete mus-ular fibres relaxation (Fig. 2). Punctual injections of 1 mL10 AIU) or less were made into the dartos muscle [7] in the

Intrascrotal injection of botulinum toxin A: Technique and limits

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Figure 3. 10 UI injection of botulinium toxin in the dartos muscle.

most pronounced scrotal furrows (Fig. 3). The procedure wasrepeated contralaterally. Overall, 75 to 200 AIU of botulinumtoxin were required to achieve complete relaxation of thecremaster and dartos muscles [1] (Fig. 4).

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Figure 4. Injection procedure schema.

315

esults

he result of botulinum toxin injection is generally observedn 3 to 15 days [1]. We saw the patient 10 days after the pro-edure. The cremaster muscle was relaxed and the scrotumad deployed. The patient described a softer and smoothercrotum (Fig. 5). The testicles seemed larger. The patientas very satisfied with the aesthetic result. The postopera-

ive IMGI score was 75/98. In detail, the criterion ‘‘size ofhe testicles’’ went from 1 (extremely dissatisfied) beforehe procedure to 5 (satisfied) after the procedure. No imme-iate complication secondary to intramuscular injectionas observed, such as hematoma or bleeding. The scro-

al median raphe measured 15 cm in the same consultationonditions (heat, schedule, stress). As intrascrotal injec-ions have an inhibitory effect on the inguinal sweat glands,he reduction of perspiration had a comfortable effect onatients’ quality of life. The duration of action of intrascro-al botulinum toxin injections is usually from 3 to 6 months.

lasting effect requires repetition of injections. The patienteclared that he was ready to undergo a new injection ses-ion when the effect would wear off. At 3 months follow-up,he effects were still observed. The same procedure was

316 E. Ramelli et al.

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igure 5. Patient before (top row) and 15 days after scrotal inesticles.

epeated 6 months later, after the decline of the botulinumoxin’s effect. The scrotal median raphe measurement washen 11 cm.

iscussion

nterest for male genital aesthetics is on the rise [10,11],ith the onset of augmentation phalloplasty and penilenlargement surgery [15—17]. Genital rejuvenation hasecome a real part of aesthetic medicine and surgery foromen and most recently for men. Nowadays, men areore and more concerned about age-related physiological

hanges or pathological changes. Various physiological orathological symptoms can be observed, regarding hairi-ess (alopecia and hypertrichosis), appearance (laxity andrinkles), morphology (testicular atrophy) or vasculariza-

ion (angiokeratoma) of the scrotum. All these elements canow be treated after an analysis of the patient’s requestombined with a general and targeted clinical examination18—20].

Intrascrotal injection of botulinum toxin A paves the wayo a new demand in genital aesthetics. The aim of the proce-ure is to obtain lower and apparently larger testicles. To ournowledge, there is no other medical or surgical techniqueo get such a result. In the literature, only functional stud-es can be found, where the toxin is used for cremastericpasms’ treatment [1,2]. The functional results of thesetudies are safe and satisfying, that’s why we used the sameechnique and dilution of botulinum toxin for aesthetic pur-oses.

In the literature, no study assesses the associated-risks

f intrascrotal injection of botulinum toxin in humans. How-ver, rat studies show a decrease in sperm production and anlteration of the histological structure of the seminiferousubules [21,22]. Suppression of the physiological function of

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on (lower row). We notice lower hanging and subjectively larger

he cremaster and dartos muscles in thermoregulation maye responsible for spermatogenesis’ alteration. This conceptust be known by the practitioner who must inform hisatient before any intrascrotal injection of botulinum toxin

for aesthetic purposes.Our patient was very satisfied with the aesthetic result

nd he declared himself ready to repeat the injection ses-ion. It should be noted that the characteristics of the IMGIcore mainly concern the overall appearance of the maleenitals. Only 2 questions out of 14 (genitals’ color and tes-icles’ size) deal with testicular aspect. These two questionsed to an improvement in the post-procedure score in thease of our patient. IMGI score is a measure of male genitalmage and it has demonstrated good psychometric abilities.ts weakness is the lack of a demonstrated threshold beyondhich the patient’s quality of life is better, by improvingis own vision of his genitals. The MGIS (Male Genital Imagecale) score is another validated score in the male geni-al aesthetic evaluation [23,24]. It was initially developedo assess the genital image of men undergoing hypospadiasurgery. This score includes 31 items. As only 3 items out of1 deal with the testicular aspect, it is less appropriate thanhe IMGI score in the testicular aesthetic evaluation.

Objectively, the distance from the apex to the base of thecrotal median raphe was increased. Although this measure-ent depends on environmental variations, we have tried to

imit the confounding factors: same consultation time, sameontext and same temperature in the consultation room.

It is important for our team to highlight the risk-benefitatio of the intrascrotal botulinum toxin injection proce-ure. Indeed, the long-term side effects are not known.n the name of the precautionary principle, especially con-

erning the potential adverse effect on fertility and theisk of infertility, we do not recommend this type of aes-hetic procedure for men of reproductive age. In all cases,he performance of the intrascrotal botulinum toxin A

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[24] Weber DM, Schönbucher VB, Landolt MA, Gobet R. The Pediatric

Intrascrotal injection of botulinum toxin A: Technique and li

injection procedure requires informed consent, particularlyon the potential risks for fertility.

Conclusion

The injection of intrascrotal botulinum toxin for aestheticpurposes is not approved by health authorities and it is car-ried out under the physician’s responsibility. Its use in thisindication requires more documentation on potential sideeffects, including infertility. Botulinum toxin A injectionswere effective and very satisfying in this case. However, asit stands, we cannot recommend its use in men of repro-ductive age, because of the lack of hindsight. This articleexposes the injection technique in selected and informedpatients.

Ethical approval

This article respects ethical approval with human partici-pants.

Informed consent

For this type of study, informed consent was required andapplied.

Funding

The authors declare that they have no competing financialinterests and no funding associated with this publication.

Disclosure of interest

The authors declare that they have no competing interest.

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