# Penile prosthesis for erectile dysfunction in France: A six-year nationwide database analysis

Omar Alkhandari, Clément Mazouin, Muaath Alshuaibi, Beverley Balkau, Deborah Koffi, Jean Luc Gaudry, Pascal Eschwege, Charles Mazeaud, Clément Larose

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## ► To cite this version:

Omar Alkhandari, Clément Mazouin, Muaath Alshuaibi, Beverley Balkau, Deborah Koffi, et al.. Penile prosthesis for erectile dysfunction in France: A six-year nationwide database analysis. The French Journal of Urology, 2024, 34 (9), pp.102669. 10.1016/j.fjurol.2024.102669. hal-04652801

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Original Article

# Penile prosthesis for erectile dysfunction in France: A six-year nationwide database analysis

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## Prothèse pénienne pour le traitement de la dysfonction érectile en France : analyse d'une base de données nationale de six ans

Omar Alkhandari<sup>a,*</sup>, Clement Mazouin<sup>b</sup>, Muaath Alshuaibi<sup>c,d</sup>, Beverley Balkau<sup>e</sup>, Deborah Koffi<sup>f</sup>, Jean Luc Gaudry<sup>f</sup>, Pascal Eschwege<sup>a,g</sup>, Charles Mazeaud<sup>a,h</sup>, Clement Larose<sup>a</sup>

ARTICLE INFO

Keywords:

Penile prosthesis
Erectile dysfunction
PMSI
France

ABSTRACT

**Introduction:** Urological consultations for erectile dysfunction (ED) are increasing worldwide. Penile prosthesis (PP) implantations are performed when other treatments are unsuccessful. However, there is no data regarding PP implantations in France beyond the year 2016.

**Objectives:** This study aimed to describe the changes in the number and type of PP implants used for the treatment of ED in France from 2016 to 2021 and the hospitalization rates following implantation using French national data from the Program for the Medicalization of Information Systems (PMSI).

**Materials and methods:** We analyzed data on PP implantations in all France hospitals. PPs were coded into three types according to the Common Classification of Medical Procedures (CCAM). The number of patients admitted to hospital with complications twelve months after implantation was also recorded.

**Results:** During the study period, 3675 men received 3868 PPs in France. A gradual increase in the total number of implanted PPs was observed, with an overall increase of 33.8%. In 2020, there was a sharp decline in the number of implanted PPs, primarily owing to the COVID-19 pandemic. The most commonly used implant was PPs with an extracavernous compartment, comprising 85% of all PPs. Twelve months after implantation, only 1-2% of the patients were rehospitalized.

**Conclusion:** PP implantation surgeries are highly reproducible and have a low incidence of complications, in terms of rehospitalization after one year of placement (1.8%). Moreover, there was an increase in the demand for penile prosthesis implantations in France between 2016 and 2021.

**Level of evidence:** 4: Descriptive epidemiological study.

© 2024 The Author(s). Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

<footnote><sup>a</sup> Department of Urology, University Hospital of Nancy, Vandœuvre-lès-Nancy, France</footnote>

<footnote><sup>b</sup> Department of Urology, Private Hospital of Lorraine - Nancy, Nancy, France</footnote>

<footnote><sup>c</sup> Department of Urology, Faculty of Medicine, University of Ha'il, 55476 Ha'il, Saudi Arabia</footnote>

<footnote><sup>d</sup> Department of Urology, Clinique Turin, Groupe Almaviva Santé, Paris, France</footnote>

<footnote><sup>e</sup> Centre for Research in Epidemiology and Population Health (CESP), Paris-Saclay University, Inserm U1018, Versailles Saint-Quentin University, Clinical Epidemiology Team, Villejuif, France</footnote>

<footnote><sup>f</sup> Tekkare Society, Healthcare Data service, Montrouge, Île-de France, France</footnote>

<footnote><sup>g</sup> Biopathology Laboratory, CNRS-CRAN UMR 7039, Nancy University, Vandœuvre-lès-Nancy, France</footnote>

<footnote><sup>h</sup> IADI-UL Laboratory, INSERM-U1254, Nancy University, Vandœuvre-lès-Nancy, France</footnote>

<footnote>* Auteur correspondant. Department of Urology, University Hospital of Nancy, rue du Morvan, Vandœuvre-les-Nancy, France.
E-mail address: omrkhaleel@gmail.com (O. Alkhandari).</footnote>
Mots clés:
Prothèse pénienne
Dysfonction érectile
PMSI
France

**Introduction** : Les consultations en urologie pour le traitement de la dysfonction érectile (DE) augmentent partout dans le monde. Les implants de prothèses pénielles (PP) sont réalisés si les autres traitements n'ont pas fonctionné. Pas de données concernant les implants de PP en France après 2016.

**Objectifs** : Cette étude vise à observer l'évolution du nombre et du type d'implants PP utilisés en France entre 2016 et 2021 ainsi que les taux d'hospitalisation postimplantatoires selon les données du programme de médicalisation des systèmes d'information (PMSI).

**Matériels et méthodes** : Analyse des données sur les implants de PP dans tous les hôpitaux français. Les PP ont été codés en trois types selon la classification commune des procédures médicales (CCAM). Enregistrement du nombre de patients hospitalisés en raison de complications douze mois après l'implantation.

**Résultats** : Durant la période d'étude, 3675 hommes ont reçu 3868 PP en France. Une augmentation progressive du nombre total de PP implantés a été observée, avec une augmentation globale de 33,8 %. En 2020, le nombre de PP implantés a fortement diminué pendant la pandémie de COVID-19. L'implant le plus couramment utilisé était les PP avec un compartiment extra caverneux, représentant 85 % de tous les PP. 1 à 2 % des patients ont été réadmis à l'hôpital après douze mois de l'implantation.

**Conclusion** : Les implants PP sont hautement reproductibles et présentent un faible taux de complications, en termes de réhospitalisation après un an de placement (1,8 %). La demande d'implants prothétiques péniens a augmenté en France entre 2016 et 2021.

**Niveau de preuve** : 4 : étude épidémiologique descriptive.

© 2024 L'Auteur(s). Published by Elsevier Masson SAS. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

# 1. Introduction

Erectile dysfunction (ED) is characterized by a chronic inability to achieve and maintain sufficient erection for satisfactory sexual activity [1]. The overall management of ED is based on a psychological approach combined with drug therapies such as oral phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil, and avanafil) and prostaglandin E1 (alprostadil) administered via intraurethral or intracavernous injection [2]. It is also possible to combine these therapies with a mechanical treatment such as a vacuum [3].

Patients who do not respond well to these therapies or have a contraindication for drug therapy are offered surgical intervention [4]. Placement of a penile prosthesis (PP) or penile implant provides a sexual satisfaction rate of approximately 85% [5]. However, in a study in 2010 with a follow-up duration of 113 months, the incidence of mechanical failure was found to be 20.6% at the median of 82 months [6]. Nevertheless, the evolution of these devices and their improvement over the years decreased the mechanical failures to 10% occurring mostly late after 10 years of use [5]. Additionally, some perioperative measures have been evolved and led to decrease the infection rate of PP implantation up to 0.46% [7,8]. These measures include using antibiotic-covered implants, rigorous surgical site preparation and strict intraoperative antiseptic solutions and acquiring the ‘No Touch’ technique.

There are two types of penile implants: semi-rigid and hydraulic (inflatable) implants [9]. Hydraulic models (three parts) are most frequently used. They consist of two cylinders placed in the corpora cavernosa, a reservoir placed in the abdomen, and a pump placed over the scrotum [10]. The primary route is penoscrotal or suprapubic, but this depends on the practice of the surgeon and the institution [11]. Three manufacturers are currently marketing these implants: Boston Scientific, Coloplast, and Zephyr. Currently, three-compartment prostheses provide a more natural appearance, better stiffness, and flaccidity by filling the corpus cavernosum. A dual-compartment prosthesis is easier to implant and is indicated when it is not possible to position the balloon subperitoneally. Results are usually poor, with incomplete flaccidity [12]. Finally, semi-rigid prostheses offer constant rigidity and simple handling but at the cost of poor aesthetic and functional results [13]. They are reserved for older men or for rescue surgery to prevent fibrosis of the corpora cavernosa, either permanently or before reimplantation of a hydraulic PP.

In 2016, Lipsker et al. reported that the overall number of PPs implanted in France for ED between 2006 and 2013 doubled from 307 to 603 per year [14]. However, there are no available data on the number and type of PP implants in France beyond 2016.

We aimed to study the evolution of the implantation of PPs and their types for ED in France from 2016 to 2021 using the French Hospital Discharge Database (Programme de Médicalisation des Systèmes d'information [PMSI]), which collects data from each patient's stay in healthcare facilities on both the medical and administrative sides to distribute financial resources. Declarations in this database are necessary for all medical care and surgical procedures in every French hospital, whether public or private. Hospitalization costs are categorized based on these medical details to enable the reimbursement of care providers in the French social security system. The database is accessible for free to promote health research. However, there are limitations as it includes raw data that require refinement before analysis. All surgical procedures were coded using the Commune des Actes Médicaux (CCAM). Three types of PPs were extracted using their respective codes from the aggregated CCAM (JHLA 002/JHLA 003/JHLA 004).

# 2. Materials and methods

## 2.1. Data collection

In this study, we included all men who underwent PP implantation for ED in France (including both public and private sectors) from January 1st, 2016, and December 31st, 2021.

We used the national database of the PMSI, and the data were verified to avoid duplication.

The CCAM codes we used to identify this type of surgery (penile prosthesis implantation) from the database were:

* JHLA002: placement of a hydraulic penile prosthesis without extracavernous component;

* JHLA003: rigid or semi-rigid penile prosthesis;

* JHLA004: hydraulic penile prosthesis with extracavernous component.

## 2.2. Measures

The first measure we reported is the number of PP procedures in France, in both public and private hospitals, using the three codes above, from 2016 to 2021. The second measure we reported is the number of rehospitalizations for any cause in the 12 months after implantation; only the first implants were included, although some patients had more than one implant in the same year. The data on the causes of rehospitalization were obtained from the PMSI.
## 2.3. Data analysis

Qualitative variables are described as percentages (%) for the entire French population. Statistical tests were not applicable in our study as there were no variations. The data were analyzed using Microsoft Excel software® (version 16.73).

# 3. Results

## 3.1. Total number of penile prosthesis procedures in France

Between January 1, 2016, and December 31, 2021, 3868 PPs were implanted in 3675 patients. The number of PP procedures performed in France was higher in 2019 than in 2016 (respectively *n* = 745 versus *n* = 559), with an overall increase of 33.2%. This increase was gradual over the following three years (16.8% in 2017, 1.3% in 2018, and 12.5% in 2019). However, in 2020, there was a sharp decline in the number of PP procedures (*n* = 534) compared with the previous year (*n* = 745), with an overall decrease of 28.4%. This decrease was primarily because of the peak of the COVID-19 pandemic. Nevertheless, an increase in activity was observed again in 2021 (*n* = 715) compared to the previous year (*n* = 534), with an overall increase of 33.8%. These numbers are shown in detail in Fig. 1.

## 3.2. Different types of penile prosthesis implants in France

Three types of PPs were used as implants during the studied period (6 years). The most commonly used implant was PP with an extracavernous component (*n* = 3338), followed by semi-rigid PP (*n* = 457), and PP without an extracavernous component (*n* = 125). No obvious difference was found between the number of semi-rigid PPs and PPs without extracavernous compartments during the study period. However, the number of PPs in the extracavernous compartment was the largest (85%) compared with the other two types of PPs implanted each year. These numbers are shown in detail in Fig. 2.

## 3.3. Number of implantations of penile prostheses with an extracavernous compartment in both public and private hospitals in France

Of the 3338 PPs with an extracavernous compartment implanted in France during the study period, 1967 (58.9%) were implanted in public hospitals and 1371 (41.1%) in private hospitals. No significant difference was found between public and private hospitals in terms of the number of PP implantations with an extracavernous compartment during the study period. Fig. 3 shows the evolution of the number of PP implantations with

<figure><img src="image_4.png" /><figcaption>**Fig. 1.** Total number of penile prosthesis implants in France between 2016 and 2021.</figcaption></figure>

<figure><img src="image_5.png" /><figcaption>**Fig. 2.** Number of different types of penile prosthesis implanted in France between 2016 and 2021.</figcaption></figure>

<figure><img src="image_6.png" /><figcaption>**Fig. 3.** Number of penile prosthesis implants with extracavernous compartment in both public and private hospitals between 2016 and 2021. PP: penile prosthesis; EC: extracavernous compartment.</figcaption></figure>

an extracavernous component between 2016 and 2021 in the public and private hospitals in France.

## 3.4. Rate of rehospitalization within 12 months of the PP implantation

There was a very low rate of rehospitalization within 12 months for any cause after any type of PP implantation. Over the study period, only 65 of the 3675 patients were rehospitalized, which is a relatively low number (1.8%). These rates are listed in Table 1. It should be noted that the rate of 1–2% was constant over the years. There were several primary diagnoses related to these rehospitalizations, which are detailed in Table 2. The causes for rehospitalization were distributed as follows: organic impotence, which is a generalist term for dysfunction of the prosthesis without a cause mentioned in the PMSI, 27 patients; adjusting and maintaining a genital prosthesis, 14; inflammatory disorders of the penis, scrotum or due to a prosthesis, 11; and mechanical complications, six. There were 74 primary diagnoses in 65 patients, as some patients had multiple rehospitalizations within 12 months post-implantation.

# 4. Discussion

This national retrospective study investigated the use of PPs in France from 2016 to 2021. The total number of PP procedures during the period of study was 3868 implants in 3675 patients. Of the total number of patients, only 65 were rehospitalized for causes listed in Table 2 within
<table><caption>**Table 1**
Number (%) of men with at least one rehospitalization in the year after penile prosthesis implantation in France.</caption><thead><tr><th></th><th>2016</th><th>2017</th><th>2018</th><th>2019</th><th>2020</th><th>2021</th><th>Total<br>2016-2021</th></tr></thead><tbody><tr><td>Patients with PP</td><td>559</td><td>653</td><td>662</td><td>745</td><td>534</td><td>715</td><td>3675</td></tr><tr><td>At least one rehospitalization within 12 months</td><td>8 (1.4%)</td><td>11 (1.7%)</td><td>9 (1.3%)</td><td>14 (1.9%)</td><td>11 (2%)</td><td>14 (1.9%)</td><td>65 (1.8%)</td></tr></tbody></table>

<table><caption>**Table 2**
Primary causes of rehospitalization associated with penile prosthesis implantation and their frequencies from 2016 to 2021 in France.</caption><thead><tr><th>Primary diagnoses</th><th>Number</th></tr></thead><tbody><tr><td>Organic impotence</td><td>27</td></tr><tr><td>Adjustment and maintenance of a genital internal prosthesis</td><td>14</td></tr><tr><td>Mechanical complication of other prostheses, implants, and grafts of the genital system</td><td>6</td></tr><tr><td>Other inflammatory conditions of the penis</td><td>5</td></tr><tr><td>Inflammatory conditions of the scrotum</td><td>3</td></tr><tr><td>Infection and inflammatory reaction due to a prosthesis, an implant, or a genital system graft</td><td>3</td></tr><tr><td>Priapism</td><td>2</td></tr><tr><td>Contusion of the external genital organs</td><td>2</td></tr><tr><td>Transsexualism</td><td>1</td></tr><tr><td>Other specified conditions of the bladder</td><td>1</td></tr><tr><td>Plastic induration of cavernous body</td><td>1</td></tr><tr><td>Other specified conditions of the penis</td><td>1</td></tr><tr><td>Other conditions of the genito-urinary system after a diagnostic and therapeutic procedure</td><td>1</td></tr><tr><td>Mechanical complication of other prostheses and urinary implants</td><td>1</td></tr><tr><td>Inflammatory reaction and infection due to a prosthesis, implant, and graft of the urinary tract</td><td>1</td></tr><tr><td>Examination and observation for preoperative assessment</td><td>1</td></tr><tr><td>Monitoring examination after other treatments for other conditions</td><td>1</td></tr><tr><td>Surveillance of sutures and surgical dressings</td><td>1</td></tr><tr><td>Hyperbaric oxygen therapy session</td><td>1</td></tr><tr><td>Implant not performed for other reasons</td><td>1</td></tr><tr><td>Total</td><td>74</td></tr></tbody></table>

the first-year of follow-up. Whether those 65 patients underwent reimplantation surgery or other patients within the next 5 years is unknown. This could explain the difference between the total number of implanted PPs and enrolled patients in the study. However, the national PMSI, an extremely rich and free-access database, allowed for the extraction of the data on all PP implantations in France during the study period. The major finding of this study was the increased demand for PP procedures, as evidenced by the steady increase in the number of implanted PPs compared to previous years. Moreover, this study revealed that PP implantation has a very low rehospitalization rate, indicating that it is a safe practice.

### 4.1. Penile prosthesis implantation is a safe procedure

There were 74 primary diagnoses regarding the complications in 65 patients because some patients had multiple rehospitalizations within 12 months post-implantation during the study period. A rehospitalization rate of 1–2% was constant over the study period.

PP implantation is a well-codified and reproducible technique with excellent results when indications are followed and the patient is motivated [15]. Tri-compartmentalized PPs, or PPs with extracavernous components, clearly remain the most frequent implants, and their use is increasing. However, the other two types of PPs appeared to plateau during the study period. This can be explained by the comfort (flaccidity/ rigidity) and reliability provided by this type of PP [16,17].

Surgical specialties are becoming hyperspecialized, and some urological surgeons specialize in andrological surgeries. Their institutions become centers of excellence or reference centers where most PP procedures are performed in either the public or the private sector.

Several studies have suggested that the volume of penile prosthesis implants provided by a surgeon can influence the quality of results [18]. In France, there is a university diploma (diplôme inter-universitaire [DIU]) in penile surgery. It provides theoretical and practical training during two years [14]. Nowadays, more urologists in France are enrolling in the DIU to obtain this diploma.

Although a diploma is not mandatory for penile implant surgeons, it is strongly recommended. Indeed, a positive association between the number of procedures performed by a surgeon, the quality of the results, and patient satisfaction has been clearly demonstrated in this type of surgery [19–21]. Henry et al. compared the results of one surgeon at a referral center (57 implants), compared with 57 implants performed by standard surgeons. The specialist surgeon had better results: shorter operating time, fewer complications, and a better aesthetic appearance while preserving the length of the penis [22]. In France, only a small number of urologists perform these procedures.

### 4.2. The increasing number of penile prosthesis implantations in France

From 2006 to 2013, an increase of approximately 106% in the number of PP implantations was observed in France [14]. In 2006, 34% of PP implantations were performed in the public sector, compared to 66% in the private sector. In 2013, these rates were 59% and 41%, respectively [14]. In contrast to the last decade, when there was a significant decline in private sector activity, the distribution of activity in the public versus private sectors currently tends to stabilize at 55–60% versus 40–45%, respectively.

During the study period (2016 to 2021), there was also a steady increase in the number of PPs implanted (33.8% increase). The number of PPs in the extracavernous compartment was the largest (85%) compared with the two other types of PP, with no significant difference noted between public (58.9%) and private hospitals (41.1%). This increase is evidence that penile implants are increasingly becoming part of the therapeutic arsenal of urological surgeons and that patients are increasingly demanding satisfactory sexual activity [23]. However, a decline in the number of implantations (28.4% decrease) occurred in 2020, most probably due to it being the peak of the COVID-19 pandemic. As a result of hospital strain on both reception capacity and human resources, many surgeries were cancelled, postponed, or put on hold. However, the French Committee for Andrology and Sexual Medicine published recommendations for the management of patients with PPs with levels of urgency for reprogramming, particularly during the COVID-19 pandemic [24].

### 4.3. The low rehospitalization rate after penile prosthesis implantations

There was a very low rate of rehospitalization over the study period. Only 65 of the 3675 patients were rehospitalized (1.8%) within 12 months for any cause after any type of PP implantation. The rates of complications and rehospitalization remain extremely low [25,26]. As can be seen for the primary causes of rehospitalizations within twelve months (Table 2), some diagnoses are completely inappropriate or correspond to the primary etiology that motivated the initial surgery (e.g., organic impotence). One of challenging limitation of our study was obtaining the number of repeated operations during the twelve months follow up, and this was due to deficient in the documentations in the database. Therefore, this could be a source of bias, and the data accuracy
depends on how the stay was coded by the Department of Medical Information upon discharge from the hospital. The reliability of the PMSI as a medicoeconomic database depends on the accuracy of the data entered in medical institutions, predisposing to documentation errors.

## 5. Conclusion

Despite the decline in elective surgeries during the COVID-19 pandemic, the number of PP implantations in France continued to grow from 2016 to 2021. This indicates an increased demand for PPs. PPs with an extracavernous component were the most commonly used in both the public and private sectors, followed by semi-rigid PPs and PPs without extracavernous components. With a very low rehospitalization rate (1.8% within 12 months follow up), PP implantation can be considered a safe procedure. Nevertheless, the procedure is challenging and requires a specialized skilled urologist to anticipate any related consequences.

## Disclosure of interest

The authors declare that they have no competing interest.

## Acknowledgments

Not applicable.

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