Erectile dysfunction (ED) following radical prostatectomy (RP) has a negative impact on quality of life. Herein, the aim was to assess the effectiveness of autologous adipose-derived regenerative cells (ADRCs) for treating ED after RP.
This was a randomized, double-blinded, placebo-controlled study. A total of 70 men with ED were enrolled at Odense University Hospital, Denmark. Patients received one intracavernous bolus of ADRCs (n = 35) or placebo (n = 35). The primary endpoint was a change in the International Index of Erectile Function 5 (IIEF-5) at 12 mo after intervention versus baseline. The secondary endpoints were changes in Erectile Hardness Scale (EHS) and RigiScan values at 6 mo versus baseline.
There was no significant difference between the two groups in IIEF-5 (p > 0.99) and EHS (p = 0.85) scores. RigiScan values showed no overall effect of ADRCs versus placebo (tumescence activity units at the tip of the penis p = 0.19 and the base of the penis p = 0.60, and rigidity activity units at the tip of the penis p = 0.97 and the base of the penis p = 1). No severe adverse events were observed, and none had prostate-specific antigen relapse. Study limitations include the use of online surveys for patient registration of IIEF-5 and EHS scores.
Intracavernous injections of ADRCs appear safe, but had no measurable effect on ED after RP and thus cannot be recommended in its current form.
European urology focus. 2026 Feb 26 [Epub ahead of print]
Sabrina Toft Hansen, Ditte Caroline Andersen, Charlotte Harken Jensen, Per Damkier, Jens Ahm Sørensen, Lars Lund
Department of Urology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Center for Vascular Regeneration, Odense University Hospital, Odense, Denmark., Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Center for Vascular Regeneration, Odense University Hospital, Odense, Denmark; Andersen Group, University of Southern Denmark, Odense, Denmark., Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark., Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Center for Vascular Regeneration, Odense University Hospital, Odense, Denmark; Research Unit for Plastic Surgery, Odense University Hospital, Odense, Denmark., Department of Urology, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Center for Vascular Regeneration, Odense University Hospital, Odense, Denmark. Electronic address: .