What clinical studies support vacuum erection device use for penile rehabilitation after radical prostatectomy?

1. Randomized clinical trials that form the backbone of the evidence

Key randomized studies include early trials such as the Montorsi et al. randomized trial and the 1997 randomized clinical work cited repeatedly in reviews, plus a 2007 pilot randomized study by Köhler et al. and other small randomized trials that tested early versus delayed or versus no VED use; these trials are the primary controlled data showing mixed effects on erectile function but more consistent benefit for penile size preservation ^{[4] [5] [6]}.

2. What systematic reviews and meta-analyses conclude

Multiple systematic reviews and a 2018 meta-analysis and scoping review (search to October 2022) pooled randomized and observational studies and concluded that early VED therapy is safe, tolerable and can improve some measures of erectile function and penile dimensions, while noting heterogeneity in protocols, endpoints and follow-up durations; the 2022 systematic scoping review identified 16 papers including seven randomized trials, underscoring limited but growing trial evidence ^{[3] [4] [7]}.

3. Prospective and observational studies that add clinical texture

Prospective cohorts and institutional series—examples include Cleveland Clinic reports, the Irish dedicated VED clinic experience, and a 2015–2021 set of prospective studies such as a randomized Thai trial of daily 10‑minute VED use—report improved patient satisfaction, preserved stretched penile length and sometimes better IIEF scores in VED users versus controls, but these are often non-blinded and vary in patient selection and nerve-sparing status ^{[8] [9] [6] [10]}.

4. Mechanistic and combined-therapy evidence supporting VED use

Basic science and translational reports argue a plausible mechanism—VED increases arterial inflow, reduces hypoxia, and may exert anti-apoptotic and anti-fibrotic effects on corporal tissue—which supports using VED early to prevent structural changes; clinically, several studies and reviews report that VEDs work particularly well in combination with PDE5 inhibitors to “synergize” recovery and to combat postoperative changes ^{[2] [1] [7]}.

5. Limitations, controversies and alternative interpretations

Despite consistent signals for penile length preservation and tissue benefits, the literature is heterogeneous: some randomized trials found no significant improvement in spontaneous erectile function with early VED versus delayed use, and reviewers emphasize uneven study quality, variable schedules (daily versus intermittent use), small sample sizes and short follow-up in many trials—limitations that temper claims that VEDs reliably restore natural erections for all patients ^{[5] [3] [4]}. Additionally, agendas exist in surgical and device communities to promote rehabilitation protocols despite imperfect trial designs, and some reviews explicitly call for larger, standardized randomized trials to clarify VED’s role ^{[8] [3]}.

6. Bottom line for clinicians and patients from the clinical literature

Clinical studies—randomized trials, prospective cohorts and multiple systematic reviews—support early VED therapy as safe and beneficial for preserving penile length and possibly aiding erectile function recovery in subsets of men after RP, especially when combined with PDE5 inhibitors, but evidence for consistent restoration of spontaneous erections is mixed and further high-quality randomized trials with standardized protocols are needed to define which patients benefit most and the optimal schedule ^{[1] [3] [4] [2]}.