{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T06:25:10Z","timestamp":1791440710572,"version":"4.3.3"},"reference-count":41,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2025,9,16]],"date-time":"2025-09-16T00:00:00Z","timestamp":1757980800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100002738","name":"Assistance Publique\u2013H\u00f4pitaux de Paris","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002738","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Programme Hospitalier de Recherche Clinique\u2013PHRC 2020"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Studies suggest intracavernosal botulinum toxin A (BTX\/A) could improve difficult-to-treat erectile dysfunction (ED) ie with an insufficient response to phosphodiesterase type 5 inhibitors (PDE5-Is).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To investigate efficacy and safety of intracavernosal injection (ICI) of BTX\/A combined with sildenafil 100\u00a0mg on demand in patients with ED and insufficient response to PDE5-Is.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Double-blind, placebo-controlled, multicenter, randomized phase 2 trial to investigate the efficacy and safety of bilateral 0.5\u00a0ml ICIs of incobotulinumtoxinA 50\u00a0U or placebo, both combined with sildenafil 100\u00a0mg on demand in men with ED and insufficient response to sildenafil 100\u00a0mg on demand. The inclusion criteria were International Index of Erectile Function-Erectile Function (IIEF-EF) domain score\u2009&amp;lt;\u200917 and\u2009&amp;gt;50% of attempts at sexual intercourse unsuccessful during a 4-week open-label run-in phase with sildenafil 100\u00a0mg on demand.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>Mean change in IIEF-EF score and the proportion of \u201cYes\u201d responses to Sexual Encounter Profile (SEP)-Q2 (ability to penetrate) and SEP-Q3 (ability to maintain an erection for successful intercourse) at 3\u00a0months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 226 patients screened, 165 patients were randomized (mean age: 60.1\u00a0years, mean IIEF-EF on sildenafil 100\u00a0mg: 11.1). Intention-to-treat (ITT) analysis showed no significant improvement in IIEF-EF score with incobotulinumtoxinA 100\u00a0U combined with sildenafil 100\u00a0mg at 3\u00a0months. IncobotulinumtoxinA 100\u00a0U improved penetration (SEP-Q2) and erection maintenance (SEP-Q3), but not significantly. These results were confirmed by the complete-case and per-protocol analyses. Adjusted analysis for 100% adherence to sildenafil 100\u00a0mg showed a significant interaction effect (P\u00a0=\u2009.032), suggesting greater IIEF-EF improvement in fully compliant patients. The safety profile was positive.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Implications<\/jats:title>\n                    <jats:p>IncobotulinumtoxinA 100\u00a0U combined with sildenafil 100\u00a0mg on demand is safe; however, there is yet no robust evidence to support its use to treat ED.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Strengths and Limitations<\/jats:title>\n                    <jats:p>Main strengths include the double-blind, placebo-controlled design, which was preceded by an open-label run-in phase, a 3-month follow-up, the use of ITT analysis and meaningful outcome measures. Limitations include no adherence to sildenafil (28%), inconsistent clamping at the penile crus post-incobotulinumtoxinA injection, and an underpowered sample size due to an overestimated treatment effect.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Despite negative ITT effectiveness results, this study demonstrated the safety of intracavernosal BTX\/A. The results raise hypotheses regarding its potential role in combination with PDE5-Is, warranting further investigation. Future trials should refine patient selection and injection technique, assess dose-response effects, and improve protocol adherence to yield more reliable results for ED resistant to PDE5-Is.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jsxmed\/qdaf225","type":"journal-article","created":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T11:35:46Z","timestamp":1755948946000},"page":"1994-2001","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy and safety of intracavernosal incobotulinumtoxinA (Xeomin) as add-on therapy to sildenafil for the treatment of erectile dysfunction insufficiently responsive to phosphodiesterase type 5 inhibitors"],"prefix":"10.1093","volume":"22","author":[{"given":"Francois","family":"Giuliano","sequence":"first","affiliation":[{"name":"Neuro-Uro-Andrology Department, R. 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