<p>Clinicians may offer penile prosthesis surgery to patients with Peyronie's disease with erectile dysfunction (ED) and/or penile deformity sufficient to impair coitus despite pharmacotherapy and/or vacuum device therapy. <em>(Moderate Recommendation; Evidence Strength Grade C)</em></p>
Discussion
Discussion
<p>Forty-three observational studies reported on outcomes for 2,216 PD patients who had penile prosthesis surgery. <sup>9,</sup><sup>104,</sup><sup>110,</sup><sup>129,</sup><sup>135,</sup><sup>142,</sup><sup>183,</sup><sup>215,</sup><sup>217,</sup><sup>218,</sup><sup>221,</sup><sup>235,</sup><sup>240-270</sup> This literature is challenging to interpret because of: the observational designs; the small sample sizes (approximately half of the studies reported on < 25 patients); the diversity of surgical techniques and prostheses employed; the fact that approximately half of the studies do not specify a prosthesis type or note that various prostheses were used; the large range of follow-up durations from immediately post-surgery to four to six years post-surgery; and the provision of limited information regarding patient characteristics, outcomes, and follow-up procedures. In addition to prosthesis implantation, most studies used other surgical procedures, including modeling, plication, plaque incision or excision, tunica albuginea incision, and/or grafts of various materials.</p>
<p>The most commonly-reported outcome was the percent of patients who reported curvature improvement post-surgery. Twenty-six studies reported this information.<sup>9,</sup><sup>104,</sup><sup>110,</sup><sup>129,</sup><sup>142,</sup><sup>183,</sup><sup>221,</sup><sup>235,</sup><sup>241,</sup><sup>242,</sup><sup>245,</sup><sup>247,</sup><sup>249-255,</sup><sup>257,</sup><sup>262,</sup><sup>264-267,</sup><sup>270,</sup> All studies reported rates of >80% and twenty studies reported improvement rates of 100%. In addition, seven studies reported the percent of patients who experienced complete penile straightening with a range from 85 to 100%.<sup>242,</sup><sup>245,</sup><sup>249,</sup><sup>255,</sup><sup>259,</sup><sup>262,</sup><sup>266</sup></p>
<p>Other penile outcomes were reported by a small number of studies. Although several studies reported penile shortening information based on patient perception, only three studies actually measured SPL before and after surgery. Usta (2003) reported on two groups of patients. No shortening occurred among patients who had the AMS 700CX or Mentor Alpha I implanted in combination with modeling, plaque incision/excision, and pericardial graft. Among patients who had the AMS 700CX or Mentor Alpha I implanted with modeling only, 6.4% experienced shortening (Usta 2003). Zucchi (2013) noted no shortening among patients who had the Virilis I implanted with plaque incision and pericardial graft. Montorsi (1996) reported that 30% of patients experienced shortening with implant of the AMS 700CX with or without plaque incision/excision and lyodura graft. Six studies that measured SPL reported penile lengthening data. Length increases ranged from 1.3 to 3.6 cm. These studies used different surgical procedures (Egydio 2013 – various unspecified prosthesis with pericardium graft for lengthening; Djordjevic & Kojovic 2013 – malleable or inflatable prosthesis with TA incision; Montorsi 2001 – AMS 700CS inflatable with TA incision; Austoni 2005 – soft silicon prosthesis with plaque incision/excision and saphenous vein graft; Sansalone 2012 – various inflatable prostheses with circumferential lengthening graft; Zucchi 2013 – Virilis I axial with plaque incision and pericardial graft).</p>
<p>Fourteen studies reported percentages of patients that experienced persistent changes in penile sensation ranging from 0 to 50%; seven studies reported rates of 5% or less.<sup>215,</sup><sup>235,</sup><sup>240,</sup><sup>245,</sup><sup>246,</sup><sup>255,</sup><sup>269</sup> Three studies reported rates of 7%<sup>261</sup> or 8%.<sup>142,</sup><sup>259</sup> Two studies reported rates of 20% -- these studies used either circumferential lengthening procedures with graft (Sansalone 2012) or plaque incision with graft (Zucchi 2013). Marzi (1997) had a rate of 28.6% after using malleable prostheses with or without plaque excision. Montorsi (2001) reported a rate of 40% after implanting the AMS 700CX and using relaxing TA incisions.</p>
<p>Adverse events were sparsely reported in this literature. Only half of the studies reported data on post-operative infection rates. Five studies reported rates of 0%,<sup>241,</sup><sup>245,</sup><sup>250,</sup><sup>257,</sup><sup>258</sup> seven studies reported rates of < 3%<sup>218,</sup><sup>246,</sup><sup>249,</sup><sup>251,</sup><sup>254,</sup><sup>255,</sup><sup>269</sup> and eleven studies reported rates ranging from 3.5 to 12.0%.<sup>135,240,242,244,249,252,253,258,261,262,267</sup> One study (Rigaud & Berger 1995) reported a rate of 60%. This study had only 5 patients and used an unspecified inflatable prosthesis with circumferential lengthening GoreTex graft. Twenty-seven studies reported rates of infection that required surgical revision or prosthesis explant. Fifteen studies reported rates of 0 to 3%.<sup>129,218,240,241,245,246,248-252,254,255,263,26</sup>9 Eleven studies reported rates between 3.4% and 16.7%.<sup>104,135,183,242,244,249,253,262,265,267,268</sup> Rigaud & Berger (1995) reported a rate of 40%.</p>
<p>Revision rates for mechanical failure were reported by nineteen studies. Eleven studies reported rates of < 5%.<sup>129,</sup><sup>135,</sup><sup>241,</sup><sup>245,</sup><sup>249,</sup><sup>250,</sup><sup>251,</sup><sup>252,</sup><sup>254,</sup><sup>261,</sup><sup>263</sup> The remaining studies reported rates ranging from 6.0% to 33.3%.<sup>110,</sup><sup>243,</sup><sup>244,</sup><sup>246,</sup><sup>253,</sup><sup>268,</sup><sup>269</sup> The studies with the highest rates used either modeling or complex surgical procedures in addition to prosthesis implantation, however, other studies with equally complex procedures had revision rates < 5%. Surgical complexity, therefore, is not a strong predictor of high revision rates. Revision rates for patient dissatisfaction or discomfort were reported by twelve studies. Seven studies reported rates of 5% or less.<sup>249,</sup><sup>250,</sup><sup>251,</sup><sup>253,</sup><sup>255,</sup><sup>267,</sup><sup>268</sup> The remaining studies reported rates ranging from 5.8% to 17%.<sup>245,</sup><sup>246,</sup><sup>249,</sup><sup>259,</sup><sup>260</sup> The highest rates were reported in Montorsi (1993) and Montorsi (1995). In both studies the Finney semi-rigid prosthesis was used and patients who had revision for dissatisfaction had replacement with AMX Ultrex models. Other adverse events associated with surgery, such as urethral laceration, urethral erosion, or hematoma, were addressed by five or fewer of the prosthetic surgery studies.</p>
<p>Twenty-four studies reported patient satisfaction rates.<sup>110,</sup><sup>129,</sup><sup>217,</sup><sup>221,</sup><sup>235,</sup><sup>240,</sup><sup>242,</sup><sup>243,</sup><sup>245,</sup><sup>246,</sup><sup>248,</sup><sup>249,</sup><sup>250,</sup><sup>251,</sup><sup>255,</sup><sup>257,</sup><sup>259</sup><sup>260,</sup><sup>261,</sup><sup>262,</sup><sup>266,</sup><sup>267,</sup><sup>268</sup> All rates were above 70% except for Montorsi (1993) and Montorsi (1995) which had rates of 48% and 51% respectively. These study arms used the Finney semi-rigid prosthesis and had large numbers of patients who requested revision because of dissatisfaction with the device. Only six studies reported partner satisfaction rates.<sup>235,</sup><sup>240,</sup><sup>257,</sup><sup>259-261</sup> Rates ranged from 75 to 90% satisfied with the exception of rates from Montorsi (1993) and (1995) which used the Finney semi-rigid prosthesis. In these two study arms rates were 40% and 41% respectively – likely because a large number of patients had revisions for patient dissatisfaction.</p>
<p>The Panel interpreted these data to indicate that for the majority of patients penile prosthesis implant results in curvature correction and restoration of satisfactory sexual function in the context of surgical adverse event rates that are relatively low in most studies. Body of evidence strength is Grade C based on the observational designs. The Recommendation is Moderate given the clear benefits of surgery to ameliorate symptoms of PD with the relatively low risk in most studies of serious adverse events such as infection or the need for revision.</p>