Preliminary outcomes of Collagenase Clostridium Histolyticum (CCH) using a modified technique “Percutaneous Needling Tunneling (PNT)” in the treatment of Peyronie's Disease (PD): Prospective randomized study
INTRODUCTION
In the absence of effective non-surgical treatments for PD, CCH is an alternative in patients who are not willing a surgery. The use of CCH as a non-invasive treatment of PD has a level of evidence 1B according to the 2017 EAU Male Sexual Dysfunction guidelines. Percutaneous Needle Fasciotomy is a minimally invasive technique used in the treatment of Dupuytren disease with good results and few complications. Leriche technique, described for PD, consists of creating holes inside the plaque percutaneously. We hypothesized that a combination of techniques could improve current CCH outcomes. Our aim is to evaluate our early experience with a combined treatment of CCH injection previous multiple percutaneous needling plaque tunneling (PNT).
METHODS
From February to June 2017, we evaluated a total of 33 patients, randomized to receive one cycle (2 doses) of standard CCH injection (Group A: 17 pat.) vs. PNT followed by CCH injection (Group B: 16 pat.). Mean age was 52.4 (SD 8.7) years. Baseline mean curvature was 45.5° (SD 13.8) in Group A and 47.8° (SD 11.9) in Group B. Patients provided informed consent explaining both procedures. After local anesthesia, multiple incisions were percutaneously performed with a 21G needle in the palpable plaque. After this, the intralesional injection of the CCH was performed, according to usual dose and technique, trying to cover the whole surface of the lesion. The sensation perceived during the injection of the plaque was better after PNT, regarding to our previous experience. We used a treatment protocol (LYX protocol) consisting of a weekly injection for two weeks followed by modeling the week after the 2nd injection. Subsequently, patients receive triple therapy for two months (traction therapy, daily tadalafil and pentoxifylline).
RESULTS
All patients completed a full treatment cycle (two injections (standard CCH / PNT+CCH; and modeling), with a mean follow-up time of 4.8months. Mean reduction on Group A was 13° (SD 4.7) vs. Group B 21° (SD 4.3); p=0.03. Significant hematoma was present in 3 pat. (Group A) vs. 2 pat. (Group B), p>0.05; all managed conservatively, with no delays of the second injection or the modeling due to penile swelling or hematoma in any patient.
CONCLUSION
Despite being a very preliminary experience, we consider that this modified CCH protocol could improve outcomes with same safety profile. To gather more evidence, more patients need to be included in future studies.
Funding: None