Pilot study to assess feasibility, safety and efficacy of penile splint device in the immediate postoperative management of grafting technique in Peyronie's Disease (PD) surgery: Prospective randomized study
The incision/partial excision and grafting techniques remain as the gold standard treatment for patients with severe PD (>60-70°) and good erectile function. Several grafting materials have been used over time, and none of them showed to be perfect. Thus, the ideal grafting material remains questionable. We hypothesized that keeping the penis straight during the early healing process would be useful to minimize retraction/contraction and early traction therapy could lead to achieve optimal outcomes. The aim of this study is to evaluate the feasibility, safety and efficacy of the use of penile splint device, as immediate traction therapy, in the postoperative management after grafting techniques.
From September 2016 to June 2017, a total of 35 patients with complex PD were included, prospectively randomized to standard care (penile wrap) (16 pat.) or penile splint (19 pat.). All of them underwent plaque incision and grafting (TachosilTM). Mean age was 51.7y (SD 9.1) and mean curvature was 66.5° (SD 14.9). Penile splint was self-adapted by the surgeon to every single patient, based on penile size and girth, using two 10CH intubating stylet (Shiley/Mallinckrodt-CovidienTM). After bending and fitting, it was fixed with two unabsorbable sutures to penile foreskin (at 3 and 9-o'clock) and kept there for 3-4 weeks (See pictures). Once the circumcision was healed, penile splint was replaced by standard penile traction device. All patients provided consent and protocol was approved by IRB.
After a mean follow-up of 5.7 months, time to the first satisfactory sexual intercourse was shorter (3.5 VS 1.5 months, p<0,001), loss of penile length was alleviated (-3 cm VS + 0.5cm, p<0,001) and postoperative hematoma was reduced (40% VS 14.3%, p = 0.02). No significant differences were found in other parameters analyzed (residual curvature, hospital discharge time).</p>
Early traction therapy using this inexpensive, fully available, and self-adapted penile splint device followed by standard traction therapy seems to be feasible, safe and effective. However, larger, multinstitutional series, and longer follow-up are needed to confirm these preliminary results.