Early Use of Vacuum Therapy Has an Excellent Therapeutic Effect in Men undergoing Radical Prostatectomy

Introduction

Several studies have associated radical prostatectomy (RP) with high incidence of adverse events such as erectile dysfunction (ED) and penile shrinkage. Vacuum therapy is a good option in cases with contraindications or side effects associated with phosphodiesterase type 5 inhibitor (PDE-5i) treatment. Recent evidence suggests that early initiation of vacuum erection device (VED) after RP is an effective and safe method in penile rehabilitation. VED offers benefits such as increase in the amount of blood flowing into the penis, preservation of penile length and allows earlier return of spontaneous erection post RP. Although some randomized controlled trials demonstrate the efficacy of early VED, there is no formal meta-analysis done.

Aim

This is the first meta-analysis conducted to evaluate the safety and efficacy of vacuum therapy for early penile rehabilitation in post-RP men.

Method

Study Design

Meta-analysis using Review Manager (RevMan) version 5.3 software.

Inclusion Criteria

• Randomized, controlled clinical trial
• Study consisted of men who underwent RP as a treatment for prostate cancer
• Baseline assessments of sexual history, physical examination and laboratory testing
• The dosage of PDE-5i in the early VED group was equal to that in the control group, in case of a combination therapy of PDE-5i and VED
• Minimum follow up of 3 months

Search Strategy

• Databases of PUBMED, EMBASE, CNKI, Wanfang data, VIP information and Cochrane Library

Endpoint

• Erectile function according to 5-item International Index of Erectile Function (IIEF-5)
• Penile length
• Penile hardness

Results

• A total of 6 studies with 273 patients were included
• The IIEF-5 score of the early VED group was compared to controls in 5 trials of 228 patients
• A significant increase in the IIEF-5 score was reported in the early VED group; standardized mean difference (MD) of 4.76; p<0.00001.
• The erectile function was significantly better in the VED+ PDE-5i group than in only PDE-5i group (MD 3.84; p<0.00001)
• The early VED group had a significant improvement in the erectile function than the late VED group and no-treatment groups (MD 9.20; p<0.0001 and MD 4.83; p<0.00001 respectively)
• The number of men with reversed penile shrinkage was 5.44 times higher in the early VED group as compared to control group (odds ratio 5.44; p<0.00001), according to the pooled data from 3 trials
• Analysis of 2 trials revealed that early VED could increase the penile length in patients post-RP
• Pooled data from 2 trials demonstrated that early VED+PDE-5i group had a significantly longer penile length than the men treated with only PDE-5i group (MD 1.26; p<0.00001)
• A significant improvement in penile hardness was reported in VED+PDE-5i group as compared to only PDE-5i group (MD 0.85; p<0.00001)

• No serious adverse events were reported across the studies
• Side effects such as discomfort and cyanosis of the penis were reported

Conclusion

• Early use of vacuum therapy significantly improved the erectile dysfunction and penile shrinkage in men post radical prostatectomy (RP)
• Vacuum therapy enhanced the advantages of penile rehabilitation when used along with PDE-5i
• Overall, vacuum therapy resulted in an overall excellent therapeutic effect with no serious adverse events
• Larger trials are warranted to verify the therapeutic effect of vacuum therapy in penile rehabilitation

Am J Mens Health. 2018 Nov; 12(6): 2136–2143.