Table 2.
Referenced Studies of Regenerative Technologies Restoring Erectile Function
| Regenerative technology | Study | Year | Patients, n | Interventions | Study duration | Study design | Summarized outcomes |
|---|---|---|---|---|---|---|---|
| Immunomodulator (tacrolimus) | Mulhall et al | 2018 | 124 | Tacrolimus 2–3 mg daily vs placebo post-RP | 27 wk | RCT | No significant difference |
| Stem cell therapy | Yiou et al | 2016 | 12 | Intracavernous injection of bone marrow-mononuclear cells post-RP | 12 mo | Phase I clinical trial | Significant dose dependent improvements in intercourse satisfaction, IIEF, and EHS; no significant side effects |
| Stem cell therapy | Haahr et al | 2018 | 15 | Intracavernous injection of adipose-derived regenerative cells post-RP after failed conservative therapy | 12 mo | Phase I clinical trial | Intracavernous injection of adipose-derived regenerative cells is safe with efficacy starting at 6 mo and sustained at 12 mo |
| Gene therapy | Melman et al | 2006 | 11 | A single-dose intracavernous injection of hMaxi-K, a “naked” DNA plasmid carrying the human cDNA encoding human slow-poke (hSlo) at doses ranging from 500 - 7500 ug | 24 wk | Phase I clinical trial | Clinically significant sustained IIEF improvements over 24 wk at the two highest doses of hMaxi-K (5000 and 7500 ug) |
| Low intensity extracorporeal shockwave therapy | Frey et al | 2016 | 16 | Six treatments with a Duolith® SD1 T-Top machine over 6 wk | 12 mo | Case-control | Significant improvement in IIEF scores from baseline (+3.5 and + 1) at 1 mo and 12 mo, respectively. No severe side-effects were reported |
| Low-intensity extracorporeal shockwave therapy | Baccaglini et al | 2020 | 77 | Both arms started tadalafil 5 mg/day post-RP: the experimental group received 2,400 shocks/session-week on 4 different penile regions for a total of 19,200 impulses across 8 weeks | 12 mo | RCT | No clinically significant difference in erectile function using shockwave therapy |
| Low-intensity pulsed ultrasound (LIPUS) | Cui et al | 2019 | 104 | LIPUS or sham treatment was applied to bilateral corpora and crus for 5 min, twice a week for four weeks | 12 wk | RCT | Significant improvement in IIEF and SEP3 without adverse effects |
IIEF: International Index of Erectile Function; EHS: Erection Hardness Scale; SEP3: Sexual Encounter Profile; RP: radical prostatectomy; RCT: randomized control trial.