Introduction

Peyronie’s disease (PD) is a penile tunica albuginea connective tissue disorder characterized by plaque formation, penile deformity, and unsatisfactory sexual intercourse due to penile curvature [1]. Usually reported in late ages, recent data highlight a decreasing age of presentation with higher impact on overall men’s quality of life [2]. While epidemiological data on PD is limited, a prevalence of up to 20.3% has been reported [3].

Surgical treatment is recommended for patients with impaired quality of life, unsuccessful conservative therapies, medical devices or intraplaque injections, and stable disease [4,5,6,7] For patients with severe or complex curvatures and without erectile dysfunction (ED) or short penis, lengthening corporoplasty, with plaque incision or excision, and a grafting procedure is recommended [1, 4]. Several grafts are used for tunical lengthening (allografts, xenografts, or autografts), but none has shown clear superiority [8, 9].

Since Lahme et al. first reported using TachoComb collagen fleece grafts to treat PD in 2002 [10], this type of material has received increasing attention. While Horstam et al. first reported using TachoSil® (Baxter Healthcare Corporation, USA) to treat PD in 2011 [11], it has gained broader recognition when Hatzichristodoulou et al. popularized its use in 2013 [12]. TachoSil® is available since 2004 and has been increasingly used because of its theoretical advantages in hemostasis, suture-free closure, and reduced surgical time [13]. TachoSil® has been used either alone in grafting procedures or in conjunction with penile prosthesis implantation.

Given the limited evidence on the outcomes with this type of graft [14, 15], the current study aims at assessing clinical and sexual outcomes of lengthening corporoplasty with TachoSil® in patients with PD through a multicentric retrospective analysis.

Methods

This study was approved by the hospital’s ethics committee (protocol 22/90). It retrospectively analyzed all consecutive patients who underwent lengthening corporoplasty with TachoSil® between January 2016 and May 2024 at the Andrology units of four Portuguese hospitals.

All enrolled patients presented at the outpatient clinic because of severe penile curvature (>60°) which had been stable (for at least six months) and preserved erectile function (IIEF-5 > 21, without any therapy). Patients submitted to penile prothesis insertion or simultaneous plicature were excluded.

This study assessed demographic data; comorbidities; curvature angle; laterality (right, left, dorsal, or ventral); location (proximal, middle, or distal third); the presence of hourglass deformity; the interval between symptom onset, consultation, and surgery; the use of doppler ultrasound with intracavernosal alprostadil administration; and pre- and postoperative International Index of Erectile Function-5 (IIEF-5) scores [16, 17]. Penile curvature was assessed with standardized autophotography of fully erect phallus from craniocaudal, lateral, and frontal positions (Kelami method [18]) or during Doppler ultrasound.

All included patients undergone lengthening corporoplasty with TachoSil® used for tunical repair. Figure 1 provides a summary of the technique. This procedure involves penile degloving from skin and Buck fascia, exposure of tunica albuginea, and identification of the plaque. In the case of dorsal presentation of plaque and curvature, careful dissection of the dorsal neurovascular bundle from the corpora cavernosa is needed. After obtaining an artificial erection by injecting a saline solution into corpora cavernosa, the peak of curvature and the extension of the plaque are marked with a dermographic pen. This demarcation guides sequent plaque incision or excision. From surgical reports, we collected data on the type of incision (Y, H, or I) or excision of the plaque, and surgical duration timing (minutes). All patients underwent general anesthesia, and those without a penicillin allergy received cephazolin as an antibiotic for surgical prophylaxis. No suture and no hydraulic test were used after the application of Tachosil®. A compressive bandage was left in place for 2–7 days. The stretched penile length (SPL), measured dorsally from the pubis to the tip of the glans in a flaccid state, was assessed preoperative, immediately postoperative, at least 1 month postoperative. No postoperative antibiotics were prescribed. The patients were started on daily tadalafil 5 mg during 4 weeks and were instructed to perform penile massage (gentle penile stretching and contralateral bending for 30 min a day).

Fig. 1: Summary of lengthening corporoplasty with TachoSil®.
Fig. 1: Summary of lengthening corporoplasty with TachoSil®.
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A After degloving, an artificial saline erection is induced, and the axis of penile curvature is noted. B Following mobilization of the dorsal neurovascular bundle and identification of the plaque, an incision/excision is made. C The collagen fleece is cut to the appropriate size. D The collagen fleece is then applied over the defect (fleece must overlaps the defect) in the plaque area with help of a wet moist. E The technique’s final image is shown.

In September 2024, all patients were assessed and data on postoperative complications were evaluated, including registers of penile hematoma, surgical site infection, suture dehiscence, glans hypoesthesia and necrosis, and surgical reintervention need. Patients were evaluated for ED with the IIEF-5 and scores below 22 points were considered as postoperative ED. A questionnaire was used to record patient-reported outcomes such as the presence of penile pain, residual curvature, glans hypoesthesia, penile nodule sensation, penile shortening. The need for further treatment was noted. Residual curvature and penile shortening were confirmed through objective measurements. Regarding ED treatment, the last one used was noted.

Statistical analysis

Data were collected and analyzed with the Statistical Package for the Social Sciences (version 27; IBM, USA). The Shapiro–Wilk test was used to assess the normality of the parameter distribution. Normally distributed continuous variables are expressed as the mean ± standard deviation, and non-normally distributed variables are expressed as the median (25th–75th percentile). The association of variables with postoperative ED was tested using chi-square test. A significance level of p < 0.05 was considered indicative of statistically significant differences.

Results

The sample comprised 88 patients with a preoperative median age of 59.0 (56.0–63.0), an IIEF-5 score of 22.5 (22.0–23.0) and postoperative follow-up time was 31.0 (13.0–52.8) months. Dyslipidemia, hypertension, and diabetes mellitus were the most common comorbidities—40.9% (n = 36), 37.5% (n = 33), and 22.7% (n = 20), respectively. The median time between symptom onset and presentation was 12.0 (6.0–18.0) months, between consultation and surgery was 8.0 (4.8–14.0) months, and between symptom onset and surgery was 21.0 (15.0–28.0) months.

The median preoperative SPL was 13.0 (12.0–14.0) cm, with a median curvature angle of 80.0 (78.8–90.0)°. To evaluate erectile function and curvature degrees, Doppler ultrasound with intracavernous injection of alprostadil was used in 71.6% patients (n = 63). Most curvatures were dorsal (65.9%, n = 58), with hourglass deformity presented by 33.0% (n = 29) of patients. The most common type of plaque incision was H-fashion (44.3%, n = 39) and surgical timing was 92.5 (80.0–106.3) min (Table 1).

Table 1 Pre-operative demographic and clinical characteristics of all the 88 patients undergone penile lengthening procedure with TachoSil® between 2016 and 2024 at four Portuguese hospitals.
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Regarding postoperative complications, 8.0% (n = 7) of patients had local penile hematoma, 2.3% (n = 2) had surgical site infection and 1.1% (n = 1) had glans necrosis and none required surgical reintervention. At follow-up, patients reported andrological complications such as ED in 38.6% (n = 34), residual curvature in 19.3% (n = 17), subjective reduced penile length in 9.1% (n = 7), penile pain in 8.0% (n = 7), and glans hypoesthesia in 5.7% (n = 5).

Regarding SPL, we recorded a median (IQR) of 13.5 (12.5–14.5) cm immediately after surgery and 14.0 (12.8–15.0) cm at 1-month postoperative assessment. All but one patient had penile lengthening after objective measurement. We did not find any associations between pre- and intra-operative findings and the onset of postoperative ED (Table 2). For its management, 34.1% (n = 30) of patients required oral therapy with phosphodiesterase type 5 inhibitors (PDE5is), 1.1% (n = 1) required intracavernous alprostadil, and 3.4% (n = 3) were indicated to penile prosthesis implantantion.

Table 2 Patients’ pre- and intra-operative clinical characteristics as stratified according to the diagnosis of postoperative erectile dysfunction.
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Discussion

TachoSil® is a xenograft derived from a human fibrinogen and human thrombin coated onto an equine collagen sponge that when activated forms clots that have hemostatic and sealing abilities. It distinguishes itself from other collagen fleeces by lacking aprotinin, a protease inhibitor present in earlier formulations [19]. Animal studies have indicated that TachoSil® establishes an anti-inflammatory barrier, safeguarding the underlying corpus cavernous, without evidence of tunica albuginea regeneration or neovascularity but with excellent safety [20, 21].

In our sample, the clinical diagnosis of penile curvature was supported by penile Doppler ultrasound in almost three-quarters of our patients, allowing also for penile hemodynamic assessment in cases of dubious erectile function [22]. Consistent with the literature, dorsal penile curvature was the most common and was found in nearly 70% of our patients [23]. The choice of plaque incision type was based on the surgeon’s preference. Notably, no specific technique has demonstrated clear superiority in other studies [9]. As a multicentric study, with surgeries conducted by different surgeons, slight differences in surgical techniques were to be expected.

Our data can be compared to a review article on using this collagen fleece to treat PD published in 2021 that included five studies involving patients with a mean age between 56.4 and 57.2 years, mean curvature angle between 66.9° and 98.3°, and mean postoperative follow-up period until 59 months [15]. Another comparable study is a multicentric Spanish study published in 2021 involving patients with a mean age of 54.5 years and postoperative follow-up of 5.2 months [14].

Regarding postoperative complications, 8.0% had hematoma, consistent with the 7.0%–13.9% observed in other studies [14, 15]. Surgical site infection was present in 2.2%, comparable to the 2.3–3.8% observed in other studies [14, 15], all treated with oral antibiotics. TachoSil® lacks immunogenic epitopes, meaning that immune reactions and infections are reduced compared to Dacron and Gore-Tex grafts [19]. Despite cardiovascular risk factors, such as diabetes or hypertension, being common in our patients, glans necrosis was observed in only 1.1%, compared with the 2.4% reported in another study with other grafts [24]. Considering these complications, none of the patients required surgical reintervention.

ED is common in patients with PD, affecting up to 57%, and can affect up to 68% after grafting procedures [12, 25]. We only included patients without previous ED as assessed by preoperative IIEF-5 and/or penile Doppler ultrasound. Nevertheless, postoperative ED was the most common complication reported by 38.6% of patients and a median decrease of 5.5 was observed in IIEF-5 scores when comparing before and after surgery. This rate is comparable to the 4.7–48.8% reported in other studies using Tachosil® grafting [15]. ED is the most common andrological complication and may arise from cavernosal tissue exposure, leading to potential disruption of the veno-occlusive mechanism [26, 27]. However, it can also arise from neurovascular bundle mobilization or a psychogenic etiology [28]. There is a lack of published information regarding the treatment of ED after lengthening corporoplasty with TachoSil®. Only one study reported that 14.3% of participants initiated medical therapy for ED [14], but it did not state whether this included only PDE5i or also included intracavernous injections. Despite the high rate of postoperative ED, most were mild to moderate or mild in IIEF-5 score, with good response to PDE5i. While studies have demonstrated the concomitant use of TachoSil® and penile prosthesis implantation for patients with pre-existing ED and PD, there is a lack of knowledge on penile prosthesis use in treating ED after lengthening corporoplasty with TachoSil®. A second-stage penile prosthesis was required by 3.4% of our patients. None of the examined variables were significantly associated with postoperative ED. Furthermore, specific analyses were not conducted due to missing data, such as the association between the tunical defect area and postoperative ED, despite previous studies suggesting its relevance [29, 30]. Given the significant rate of postoperative ED, even when performed by experts, many surgeons now opt for the simultaneous implantation of penile prosthesis, even in patients without preoperative ED [31].

Residual curvature was reported by 19.3% of our patients, higher than the 7.0–17.0% reported in previous studies [14, 15]. However, due to the low grades of residual curvature (all lower than 30° in objective measurements), none of our patients required additional surgery to correct it. A matched-control comparative study comparing grafting procedures with porcine small intestinal submucosa (SurgiSIS® by Cook Medical, United States of America) vs. TachoSil® found higher rates of curvature recurrence and penile shortening with SurgiSIS® than with TachoSil® [13]. One possible explanation can be found in TachoSil®’s non-immunogenic properties contributing to reduced tissue contraction and fibrosis, potentially minimizing curvature recurrence, while other on methodological limitations as patients were only matched for curvature severity and it was the comparison of two case series by different surgeons.

Penile pain was present in 8.0%, higher than the 2.4% reported in a previous Spanish study [14] but all patients were controlled with non-opioid analgesics. Glans hypoesthesia was identified in 5.7% of our patients, inferior to the 7.0–35.7% reported in other studies [14, 15] and up to 39% when considering all types of grafts [1]. The main factor contributing to this complication is believed to be neurovascular bundle mobilization, and, even if it can be a source of stress, the condition is generally transient [32, 33].

None of our patients reported palpable sutures or graft material, which can occur in up to 50% of cases with other types of grafts [1]. Eliminating the need for graft sutures reduced operative times and the sensation of suture nodules.

There was a uniform increase in SPL, from a median of 13.0 cm preoperative to 14.0 cm at one month postoperative with a median increase of 1.0 (0.8–2.0) cm. Our patients’ perceptions of postoperative penile shortening were disparate, with 9.1% reporting subjective shortening, contrasting with the objective measurements only documented in one patient (1.1%), which is lower than the 4.7% reported by previous studies [13, 15]. When informing patients about the nature of the lengthening procedure, it is crucial to be careful and not to create inaccurate expectations. While external penile traction and vacuum erection devices are suggested by some authors to prevent postoperative penile shortening, both access to these devices and patient adherence is low in Portugal [32, 34].

Closure of the tunical defect after plaque incision or excision in patients with PD can be achieved using different grafts. Each available graft has its advantages and disadvantages, and none fulfills all the criteria of an ideal graft [8]. Furthermore, none have shown definitive superiority over the others [35]. As shown by results from our study, TachoSil® is a tool for surgical correction of penile curvature with some benefits: acceptable operative times, low to no sensation of suture nodules, very low postoperative hematoma risk, low curvature recurrence, and low penile shortening risk.

It is important to recognized that due to the retrospective design of our study, it has several methodological limitations. Although an a priori protocol was present in each center, there were some disparities and heterogeneity in protocols and, thus, some missing data precluded a broader analysis of certain variables, such as the impact of the tunical defect area on postoperative ED. While the definition of severe curvature is >60°, no studies have validated this threshold [4]. Erectile function was evaluated using validated instruments, including the IIEF-5, although it has not been validated in patients with PD. Notably, this study did not include a control group, and different four principal surgeons were involved, and minor differences in surgical technique and/or postoperative rehabilitation might have impacted our results. Complications were not assessed with validated questionnaires. The Peyronie’s Disease Questionnaire scale [36] was not used. While this study’s sample may be considered medium-sized, to our knowledge, it represents the largest sample of patients with PD undergoing lengthening corporoplasty with TachoSil without concomitant penile prosthesis implantion after the original Hatzichristodoulou report [12]. The ED assessment exclusively used an objective and validated tool for evaluating ED. While objective clinical surgical outcomes are integral in determining treatment success, patient-reported outcomes hold greater significance, particularly in therapies primary focusing on enhancing their quality of life, such as those for PD. Another significant limitation of the article is its limited external validity, given that the findings reflect outcomes achieved by experts.

Conclusion

This study has provided a national multicentric experience on lengthening corporoplasty with TachoSil® for patients with severe or complex PD. Despite the high effectiveness in correcting penile curvature, we recorded high rates of postoperative ED with frequent need of PED5i for its management. Rarely, a penile prothesis insertion was needed. Thus, patients undergoing this procedure should be counseled on the potential need for additional treatment to address erectile function. Additional comparative, prospective, and multicentric studies are needed.