Multicenter Prospective Study of Grafting with Collagen Fleece TachoSil in Patients with Peyronie's Disease

Abstract

Background A xenograft consisting of equine collagen coated with human fibrinogen and thrombin (TachoSil; Baxter, CA) has recently been introduced in grafting procedures for Peyronie’s disease (PD). Aim To describe the results of a multicenter prospective registry on patients with PD undergoing plaque incision or and grafting (PIG) or plaque excision and grafting (PEG) with collagen fleece TachoSil, to evaluate the efficacy and safety of this procedure. Methods A prospective non-controlled multicenter study of patients with PD was performed between May 2016 and March 2018. Patients from 10 centers with stable PD for at least 3 months, difficulties in sexual intercourse, normal erectile function with or without pharmacological treatment, curvature >45°, and/or penile shortening and/or complex deformities were included. All patients underwent PIG/PEG with collagen fleece TachoSil. Outcomes The main outcome measure of this study were penile curvature correction (intraoperative), penile shortening (intraoperative), erectile function with the 5-item version of the International Index of Erectile Function (IIEF-5) and the Erection Hardness Score, subjective patient outcomes with non-validated questionnaires, and complications. Results A total of 52 patients were enrolled in the study. The mean (SD) preoperative penile curvature was 72.8° (17.0). PIG was the preferred technique (80.8%). Intraoperatively, complete curvature correction was achieved in 92.3%, and no significant penile shortening was recorded in 80.8% of subjects. Subjective penile shortening was reported in 83.3% of patients at 6 months. No objective measurement of penile curvature and length was recorded during follow-up. No statistically significant difference from the baseline was found in IIEF-5 and Erection Hardness Score at 3 or at 6 months, although 16.7% of men experienced a worsening of IIEF-5 scores and 14.3% required de novo phosphodiesterase type 5 inhibitor use. 6 months after surgery, 78.5% of men were satisfied with intervention. Swelling and ecchymosis/hematoma were the most common perioperative complications (40.4%). 2 cases (3.8%) of wound infection were recorded. At 6 months, 35.7% of patients reported mild penile hypesthesia. Clinical implications Our results confirm the high success rate of grafting with TachoSil, and the surgeon perceived low percentage of penile shortening. Strength & Limitations This is the first multicentre study on patients with PD undergoing grafting with TachoSil without concomitant placement of penile prosthesis. The main limitations are the short follow-up and the relatively small sample size. Conclusion Grafting with TachoSil after PIG/PEG in patients with PD is an effective and safe procedure. Among the main advantages of this technique, there are ease of use of the graft and reduced operative time.

A study of the histopathology of collagen fleece (TachoSil) patching of tunica albuginea in the rat penis and a literature review of penile graft materials in experimental animals

“…Multiple literature reviews reported that these grafts are comparable regarding clinical outcomes; however, the heterogeneity of the series published makes it difficult to conclude ( 1 - 3 , 41 - 43 ). Nevertheless, TachoSil stands out as an operative time saver compared to others ( 3 , 36 , 37 , 44 , 45 ). Due to its ready availability, sutureless application, and hemostatic effect, TachoSil gained popularity in PD surgery.…”

Impact of extracorporeal shockwave therapy for erectile dysfunction and Peyronie's disease on reproductive and hormonal testicular function

“…[17][18][19][20] Non-steroidal anti-inflammatory drugs (NSAIDs), penile traction therapy (PTT), collagenases, and shortening or lengthening surgical procedures are some treatment options for PD. [21][22][23][24] In recent years, ESWT has proven to be an effective treatment in selected patients with ED and PD, to improve erectile function and relieve penile pain, respectively. [4][5][6] ESWT is generally described as a safe andrological procedure characterized by mild and transient side effects.…”

“…Oral PDE5Is, intracavernous or topical alprostadil, vacuum devices, and penile prostheses are some therapeutic options for ED 17–20 . Non‐steroidal anti‐inflammatory drugs (NSAIDs), penile traction therapy (PTT), collagenases, and shortening or lengthening surgical procedures are some treatment options for PD 21–24 . In recent years, ESWT has proven to be an effective treatment in selected patients with ED and PD, to improve erectile function and relieve penile pain, respectively 4–6 …”

Suture-Free Sealing of Tunical Defect with Collagen Fleece after Partial Plaque Excision in 319 Consecutive Patients with Peyronie's Disease: The Sealing Technique

“…16 Moreover, TachoSil displays additional hemostatic effects that minimize the risk of hematoma and, subsequently, protect against infections or other perioperative complications. 17 Of note, the collagen fleece has a minimal risk of contraction and, thus, leads to preservation or even increase in penile length compared to the preoperative status. 18 Another important advantage of TachoSil is its low cost.…”