Multicenter prospective study of patients with Peyronie's disease (PD) who underwent incision or partial-plaque excision with collagen-fibrinogen-thrombin fleece grafting
Multiple surgical techniques have been proposed for patients with clinically significant PD. The technique of grafting with hemostatic self-adhesive fleece of collagen-fibrinogen-thrombin has been popularized in Europe (single surgeon, single institution) with potential advantages (shorter surgery duration, less technically demanding procedure and relatively cheaper than other graft materials). However, there is no prospective or multicenter evidence to evaluate the outcomes of this technique. Our aim is to evaluate the preliminary outcomes in patients who underwent this technique in 11 Spanish centers after 16 months of recruiting.
Between July 2016 and October 2017, 43 patients underwent surgery in 11 Spanish centers using the previously described technique. Preoperative, intraoperative and post-surgical data were collected prospectively and follow up at 3 and 6 months with questionnaires (PDQ, EHS, IIEF-5 and satisfaction) was performed. All patients provided consent and protocol was approved by IRB.
Mean age was 53.8 years (SD 5.9). Most patients had a single dorsal plaque, with an average size of 17.1 mm, and average curvature of 71.8° (SD 16.88). All patients underwent surgery after, at least, 3 months of stable phase disease, and 65.1% of them had tried other previous treatments. Mean surgery duration was 91.3 min, with a complete intraoperative resolution of the curvature in 93% of cases. Seven (16.3%) of the patients presented postoperative hematoma, managed conservatively. No vascular complications were observed. Mean follow-up time was 9.4 months (SD 4.6). Mean IIEF-5 and EHS scores remained stable at 6 months (6m) vs preoperative scores (PS) (19.5 VS 20.7 and 3.2 VS 3.5, respectively), while a statistically significant improvement was observed in PDQ and PDQ-bother scores at 6m vs PS (10.8 VS 31.1, p <0.001 and 3.9 VS 10.5, p <0.001, respectively). Thirty-six (83.7%) of the patients considered that their penis was totally or practically straight at 6m, 65.1% complained of shortening of between 1-3 cm and 55% of some glans hyposensitivity at 6m. 95.3% of the patients reported a clear improvement. Three patients were re-operated.</p>
The technique of incision of plaque plus collagen fleece grafting seems to be safe and effective with good aesthetic and functional results and should be considered as an option in the therapeutic arsenal of the management of PD. To extend this initial experience, the study will continue to collect data from more patients.