PD11-09 PROSPECTIVE RANDOMIZED TREATMENT OF ERECTILE DYSFUNCTION AFTER RADICAL PROSTATECTOMY WITH AUTOLOGOUS ADIPOSE-DERIVED REGENERATIVE CELLS

Abstract

You have accessJournal of UrologyCME1 Apr 2023PD11-09 PROSPECTIVE RANDOMIZED TREATMENT OF ERECTILE DYSFUNCTION AFTER RADICAL PROSTATECTOMY WITH AUTOLOGOUS ADIPOSE-DERIVED REGENERATIVE CELLS Sabrina Toft Hansen, Sabrina Hansen, Charlotte Harken Jensen, Ditte Caroline Andersen, Per Damkier, Jens Ahm Sørensen, and Lars Lund Sabrina Toft HansenSabrina Toft Hansen More articles by this author , Sabrina HansenSabrina Hansen More articles by this author , Charlotte Harken JensenCharlotte Harken Jensen More articles by this author , Ditte Caroline AndersenDitte Caroline Andersen More articles by this author , Per DamkierPer Damkier More articles by this author , Jens Ahm SørensenJens Ahm Sørensen More articles by this author , and Lars LundLars Lund More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003251.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We have previously reported safety and preliminary efficacy outcomes from a phase 1 clinical trial using autologous adipose-derived regenerative cells (ADRCs) to treat erectile dysfunction (ED) in 21 men after radical prostatectomy (RP). To further evaluate the effectiveness of the stem cell intervention, we here performed a randomized double-blind placebo-controlled phase 2 trial. METHODS: The trial was approved by The Danish National Committee on Health Research Ethics (60915) and included 70 men (58-67 years) with normal erectile function (EF) before robotic-assisted RP, and undetectable PSA levels at inclusion. Patients were randomized (35:35) to placebo or ADRC treatment using REDCap. The trial's primary endpoint was changes in EF using the International Index of Erectile Function 5 (IIEF-5) and Erection Hardness Score (EHS) questionnaires as an online survey at baseline, 1, 3, 6, and 12 months after treatment. The secondary endpoint was an objective measure of nocturnal erection at baseline and 6 months after treatment using RigiScan® that besides the frequency-, registers tumescence- (TAU) and rigidity (RAU) of erections at the base and tip of the penis during sleep. As a normal reference, RigiScan® -values from men of similar age and no ED were used. All 70 participants underwent liposuction of 200-360 ml from the abdominal subcutis and ADRCs were isolated using a Cytori Celution® System. Immediately after isolation, the patient received an injection into each corpus cavernosum of 2 ml with either Ringer`s lactate or ADRCs. RESULTS: The two groups were similar regarding age and comorbidity. Patient-reported outcome measures showed no statistical difference between groups in either the IIEF-5 or EHS scores at baseline, 1, 3, 6, or 12 months. RigiScan® evaluation following method validation and reference setting, showed that for each of the four RAU/TAU parameters, more patients in the treatment group had a response beneficial effect compared to the placebo group with tip TAU being significantly higher (46% vs 11%; p=0.0097). We observed that the probability for improvement in EF remained higher in the treatment group independent of the time between surgery and treatment. No severe adverse events related to the treatment were reported during the follow-up period. CONCLUSIONS: In conclusion, ADRCs had no measurable effect on IIEF-5 and EHS scores in this study. ADRCs injected into the corpora cavernosum had some effect as evaluated by Rigiscan®, which suggest a potential for ADRC in subgroups of patients despite negative clinical findings in this study. Source of Funding: Innovation Found Denmark © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e335 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sabrina Toft Hansen More articles by this author Sabrina Hansen More articles by this author Charlotte Harken Jensen More articles by this author Ditte Caroline Andersen More articles by this author Per Damkier More articles by this author Jens Ahm Sørensen More articles by this author Lars Lund More articles by this author Expand All Advertisement PDF downloadLoading ...