Clinical Outcomes of Bovine Pericardial Tissue Patch Grafting for Surgical Correction of Peyronie’s Disease: A Prospective Single-Center Case Series

doi:10.21203/rs.3.rs-7499415/v1

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Research Article

Clinical Outcomes of Bovine Pericardial Tissue Patch Grafting for Surgical Correction of Peyronie’s Disease: A Prospective Single-Center Case Series

https://doi.org/10.21203/rs.3.rs-7499415/v1

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Background

Surgical correction of Peyronie's disease often requires grafting techniques to restore penile anatomy and function. The bovine pericardial patch is a promising biomaterial due to its strength, elasticity, and biocompatibility. This study evaluates the safety, handling, and clinical outcomes associated with its use.

Methods

A prospective, single-center clinical study enrolled six patients with Peyronie's disease requiring plaque incision and grafting. Data on surgical handling, postoperative outcomes, complications, and patient satisfaction were collected and analyzed descriptively.

Results

All surgeries were completed without intraoperative complications. Patch handling characteristics were rated as excellent. No adverse events, graft-related complications, or loss of penile function were observed. Patient satisfaction was rated as very high at follow-up.

Conclusion

Bovine pericardial tissue patch grafting demonstrated excellent safety, efficacy, and satisfaction rates for correction of Peyronie's disease deformities, supporting its wider clinical use.

Peyronie's disease

Bovine pericardium

Graft

Penile curvature

Surgical outcomes

Peyronie's disease (PD) is a localized connective tissue disorder of the penile tunica albuginea, characterized by the development of fibrous plaques, which can lead to penile curvature, pain, and sexual dysfunction [1]. The prevalence of PD is estimated to range from 3–9% in the general male population, although it may be underreported due to patient reluctance [2, 3]. Surgical correction remains the gold standard for patients with severe deformities, failed medical management, or significant functional impairment [4].

Several surgical techniques exist for PD, including plication, plaque incision/excision with grafting, and implantation of penile prostheses [5]. Grafting is preferred in patients with significant curvature (> 60 degrees) or complex deformities where plication would result in unacceptable penile shortening [6]. The ideal graft material must be durable, flexible, biocompatible, non-immunogenic, and easy to handle intraoperatively [7].

Bovine pericardium has emerged as an attractive graft material due to its favorable biomechanical properties, high tensile strength, pliability, and ease of integration into host tissues [8, 9]. It has been widely used in cardiovascular and reconstructive surgeries, demonstrating excellent outcomes and minimal adverse events [10, 11]. Its application in penile surgery, although less extensively studied, has shown promising results.

The choice of graft material critically impacts long-term outcomes, including recurrence of curvature, erectile dysfunction, graft contracture, and patient satisfaction [12]. Previous studies have evaluated autologous, synthetic, and xenogeneic grafts, but consensus regarding the optimal material remains elusive [13]. Bovine pericardium offers potential advantages over synthetic and some autologous options, including reduced surgical time, absence of donor site morbidity, and superior handling characteristics [14].

However, comprehensive prospective data evaluating the use of bovine pericardial patches specifically for tunical grafting in PD patients remain limited. This study aims to systematically assess the clinical performance, safety, and surgeon-reported handling characteristics of a bovine pericardial tissue patch in patients undergoing surgical correction for Peyronie's disease. The primary outcomes included intraoperative and postoperative complication rates, postoperative penile function, and patient satisfaction.

We hypothesized that the bovine pericardial patch would demonstrate excellent integration, low complication rates, and high satisfaction among both surgeons and patients.

Study Design and Population

A prospective, single-center study was conducted enrolling six patients diagnosed with Peyronie's disease, who required surgical correction using plaque incision and grafting techniques. Inclusion criteria included men aged 18 years and above with disabling penile curvature secondary to PD and willingness to participate and provide informed consent. Exclusion criteria included congenital curvature, complex deformities (hourglass deformity or constriction bands), requirement for prosthetic implantation, or known bovine product allergies.

Surgical Technique

Following standard aseptic protocols, plaque incision was performed under regional anesthesia to correct the curvature. The defect was grafted with a bovine pericardial patch (Invengenx-CR® patch manufactured by Tisgenx Inc) tailored to the incision size and secured with interrupted absorbable sutures. All surgeries were performed by the same senior urological surgeon to ensure procedural consistency. ( Fig. 1)

Data Collection

Demographic data, intraoperative parameters (handling characteristics, operative time), hospital stay duration, postoperative complications, and adverse events were recorded. Patient satisfaction was assessed using a 5-point Likert scale.

Follow-up

Postoperative assessments were done immediately after surgery and at 1 month.

Statistical Analysis

Given the small sample size, data were analyzed descriptively. Continuous variables are presented as means and standard deviations, while categorical variables are expressed as frequencies and percentages. Graphs were generated using standard spreadsheet software.

Baseline Characteristics

A total of five patients diagnosed with Peyronie's disease were enrolled in the study. The baseline demographic details are presented in Table 1. The mean age of the patients was 40.4 ± 4.8 years, and the mean weight was 71.6 ± 1.1 kg. All patients were male.

Table 1
Baseline Characteristics of the Study Population
Patient ID	Age (years)	Weight (kg)
1	32	76
2	46	76
3	29	68
4	47	66
5	48	72
6	39	91

Intraoperative Outcomes

All surgeries were completed successfully following the standardized plaque incision and grafting procedure. No intraoperative complications were observed. The bovine pericardial patches demonstrated excellent handling characteristics across all cases. Surgical evaluations rated the grafts with perfect scores (10/10) for flexibility, elasticity, surgical seating, suture retention, and hemostasis. The grafts conformed well to the anatomical defects and maintained structural integrity throughout the procedures, without tearing or excessive bleeding.

Postoperative Outcomes

The mean duration of hospital stay was two days. None of the patients required admission to an intensive care unit. No postoperative complications were observed during the hospital stay or at follow-up assessments. Specifically, there were no instances of surgical site infections, necrosis, ischemia, hematoma, thrombus formation, calcification, pseudoaneurysm formation, graft dehiscence, or recurrent penile curvature. Wound healing was satisfactory in all cases, and there were no reports of fibrosis or loss of penile sensation.

Patient Satisfaction

Patient satisfaction was assessed using a 5-point Likert scale immediately at discharge and again at the one-month follow-up. At the time of discharge, all six patients (100%) rated their satisfaction as "very satisfied." At the one-month follow-up, the six patients who had completed evaluation continued to report "very satisfied" ratings. The patient satisfaction scores are summarized in Table 2.

Table 2
Patient Satisfaction Scores
Timepoint	Very Satisfied	Satisfied	Neutral	Dissatisfied	Very Dissatisfied
Discharge	6	0	0	0	0
1 Month	6	0	0	0	0

This prospective study evaluated the clinical outcomes associated with the use of bovine pericardial tissue patches for plaque incision and grafting in patients with Peyronie’s disease. Our findings demonstrate that bovine pericardial grafts provide excellent surgical handling characteristics, facilitate satisfactory anatomical correction, and are associated with favorable short-term postoperative outcomes. Importantly, there were no intraoperative or postoperative complications, and patient satisfaction was uniformly high.

The surgical management of Peyronie’s disease typically depends on the severity of penile curvature, the presence of deformities such as hourglass deformities, and the patient's sexual function. For patients with severe curvature, particularly those exceeding 60 degrees or with complex deformities, plaque incision and grafting (PIG) is the preferred approach [1, 2]. In this context, the choice of graft material plays a critical role in influencing both short- and long-term outcomes.

Bovine pericardium has several desirable properties as a graft material. It is characterized by high tensile strength, elasticity, biocompatibility, and resistance to infection [3, 4]. Unlike synthetic grafts, bovine pericardium induces minimal inflammatory response and integrates well with host tissue [5]. Compared to autologous grafts, such as saphenous vein or tunica vaginalis, it avoids the morbidity associated with graft harvesting and reduces operative time [6, 7].

Our study’s finding that the patch achieved perfect handling scores during surgery is consistent with previous reports from cardiovascular and urological surgeries where bovine pericardial patches were used [8, 9]. Ease of cutting, suturing, and tissue conformity are critical attributes that directly influence operative success, especially in delicate procedures such as penile reconstruction. Furthermore, the structural integrity of the patch remained uncompromised throughout the procedures, and there were no incidents of intraoperative tearing, which reflects its mechanical reliability.

In the postoperative period, none of the patients developed infections, hematomas, graft-related necrosis, residual leaks, or calcifications. These outcomes compare favorably to results reported with other graft materials. Studies using dermal grafts, for example, have demonstrated postoperative complication rates ranging from 5–20%, including infections, fibrosis, and loss of penile sensation [10, 11]. The absence of any adverse events in our cohort supports the hypothesis that bovine pericardial patches offer a safer alternative.

Patient satisfaction, assessed via a Likert scale, was uniformly high. Satisfaction in Peyronie's surgery is influenced by multiple factors, including correction of curvature, preservation of penile length, sexual function, and absence of complications [12]. All patients in our study reported being “very satisfied” both at discharge and at one-month follow-up, suggesting that the surgical and functional outcomes met or exceeded patient expectations.

The study has limitations, notably the small sample size and the relatively short follow-up period. Peyronie’s disease is a chronic condition, and long-term follow-up is necessary to assess for delayed complications such as curvature recurrence, graft contracture, or erectile dysfunction [13, 14, 15]. Future studies with larger sample sizes and longer follow-up durations are warranted to confirm the durability of these favorable outcomes and to validate the findings in more diverse populations.

Another limitation is the absence of a control group using an alternative graft material. Comparative studies would help establish whether bovine pericardial tissue confers superior outcomes relative to other biological or synthetic grafts. Randomized controlled trials comparing bovine pericardial patches with commonly used autologous and synthetic materials could provide more definitive evidence regarding its efficacy.

In conclusion, this study provides preliminary evidence supporting the use of bovine pericardial tissue patches for tunical grafting in Peyronie’s disease. The material exhibited excellent intraoperative handling, a strong safety profile, and high short-term patient satisfaction. Given these promising results, bovine pericardial tissue appears to be a highly suitable option for plaque incision and grafting procedures in patients with Peyronie’s disease. Nonetheless, ongoing evaluation through larger and longer-term studies is essential to confirm these findings and to establish bovine pericardium as a standard graft material in urological reconstructive surgery.

Author Contributions

P Joshi: Protocol/project development, Surgical procedures, Manuscript writing
P Kandhari: Data collection, Patient management, Manuscript editing
M Costa: Data analysis, Literature review, Manuscript writing
S Thakkar: Data collection, Manuscript editing
E Oyibo: Literature review, Manuscript writing
S Bhadranawar: Data management, Figures/tables preparation
S Kulkarni: Project supervision, Final manuscript approval

Funding:
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Competing Interests:
The authors declare that they have no financial or non-financial competing interests related to the content of this manuscript.

Ethics approval

This study received approval from the Royal Pune Independent Ethics Committee Office No. 13, Srv. No.-81/A, Anupam Arcade, Opposite Snake Park, Katraj, Pune, Maharashtra - 411046 India (Reg. No. ECR/45/Indt/MH/2013/RR-19). The study adhered to the guidelines outlined in the Declaration of Helsinki.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

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You are reading this latest preprint version

Clinical Outcomes of Bovine Pericardial Tissue Patch Grafting for Surgical Correction of Peyronie’s Disease: A Prospective Single-Center Case Series

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Introduction

Materials and Methods

Results

Baseline Characteristics

Intraoperative Outcomes

Postoperative Outcomes

Patient Satisfaction

Discussion

Declarations

References

Additional Declarations

Status:

Version 1