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
Fernández-Pascual, E1; Turo, J1; Rodríguez-Monsalve, M1; Souto, A1; Martínez-Ballesteros, C1; Carballido, J1; Martínez-Salamanca, JI1
1: Hospital Universitario Puerta de Hierro Majadahonda, Spain
Objectives: The incision/partial excision and grafting techniques remain as the gold standard treatment for patients with severe PD (>60-70º) 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 PD grafting surgical techniques.
Materials and methods: From September 2016 to June 2017, a total of 35 patients were included, prospectively randomized to standard care (penile wrap) (16 pat.) or penile splint (19 pat.). All of them underwent plaque incision and grafting (Tachosil™) for PD curvature. Mean age was 51.7 (SD 9.1) years and mean curvature was 66.5º (SD 14.9). The 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™-Covidien™). After bending and fitted, it was fixed with two unabsorbable sutures to penile foreskin (at 3-o’clock and 9-o’clock) and kept there for 3-4 weeks (See pictures). Once the circumcision was healed, penile splint was replaced by a standard penile traction device. All patients provided informed consent and the protocol was approved by Institution Review Board.
Results: After a mean follow-up of 5.7 months, time to the first satisfactory sexual intercourse was shorter (3.5 months 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).
Conclusions: 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.
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