Is Restorex (penile traction device) a suitable treatment option for erectile dysfunction in a patient with a history of prostate cancer who has undergone radical prostatectomy?

Restorex for Erectile Dysfunction After Radical Prostatectomy

Restorex penile traction therapy is an effective treatment option for erectile dysfunction after radical prostatectomy, with randomized controlled trial evidence demonstrating significant improvements in both penile length preservation and erectile function compared to controls. 1

Evidence Supporting Restorex Use

The strongest evidence comes from a single-center randomized controlled trial specifically evaluating Restorex in post-prostatectomy patients. This 2021 study demonstrated that men using penile traction therapy for 6 months achieved:

• Greater penile length preservation (+1.6 cm vs +0.3 cm in controls, p <0.01) 1
• Better erectile function scores (IIEF-Erectile Function maintained at baseline vs -6.5 point decline in controls, p=0.03) 1
• Improved intercourse satisfaction (+1 vs -3.5 in controls, p <0.01) 1
• Enhanced overall sexual satisfaction (0 vs -3 in controls, p <0.01) 1

Importantly, men using Restorex required less aggressive erectogenic therapy, with significantly lower use of intracavernosal injections (19% vs 50%, p <0.05) compared to controls. 1

Positioning Within Treatment Algorithm

Start with PDE5 inhibitors as first-line therapy, then add Restorex as adjunctive or second-line treatment. The American Urological Association recommends all FDA-approved oral PDE5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) as safe and effective first-line treatments for post-prostatectomy erectile dysfunction. 2

However, post-prostatectomy patients respond less robustly to PDE5 inhibitors than the general ED population (54% success rate for tadalafil 20 mg vs 32% placebo). 2 This creates a clear role for Restorex as either:

• Adjunctive therapy alongside PDE5 inhibitors from the start
• Second-line therapy after inadequate response to PDE5 inhibitors (defined as failure after at least 5 attempts at maximum tolerated dose) 2

Critical Safety Screening Before Any ED Treatment

Before prescribing PDE5 inhibitors (which most post-prostatectomy patients will use alongside or before Restorex):

• Verify the patient is not taking nitrates in any form—this is an absolute contraindication due to risk of potentially fatal hypotension 2
• Assess cardiovascular fitness by determining if the patient can climb 2 flights of stairs in 20 seconds 2

Timing and Duration of Therapy

Begin penile rehabilitation as early as possible after surgery. Recovery of erectile function is gradual and often delayed, with maximal function sometimes not returning until 12-24 months after surgery. 3 Early treatment helps prevent corporal endothelial and smooth muscle damage from persistent hypoxia. 4

The Restorex trial protocol used 30-90 minutes of daily use for 6 months, which proved both effective and well-tolerated. 1 Adverse events were transient and mild, with 87% of men willing to repeat therapy and 93% willing to recommend it to others. 1

Factors Predicting Recovery Success

Recovery of erectile function depends on three critical factors that should guide patient counseling:

• Age at surgery: 76% of men younger than 60 years with full preoperative erections who had bilateral nerve-sparing surgery recovered full erections, compared to only 7.5% of men older than 65 years with diminished preoperative erections who had unilateral bundle resection 3
• Preoperative erectile function status 3
• Degree of cavernous nerve preservation during surgery 3

Common Pitfalls to Avoid

Inadequate sexual stimulation is a common cause of apparent PDE5 inhibitor treatment failure—these medications require arousal to work. 2 Counsel patients that PDE5 inhibitors are not automatic erection triggers.

Declaring treatment failure too early: An adequate trial of PDE5 inhibitors requires at least 5 separate attempts at maximum tolerated dose before moving to alternative therapies. 2

Delaying rehabilitation: Nerve grafts to replace resected nerves do not appear effective, highlighting that early intervention to prevent injury and hypoxic damage is more important than attempted repair. 3

Practical Implementation

For a typical post-prostatectomy patient with ED:

1. Initiate PDE5 inhibitor therapy early (tadalafil offers 36-hour duration allowing spontaneous activity) 2
2. Add Restorex penile traction therapy within the first few months post-surgery, using 30-90 minutes daily 1
3. Continue combined therapy for at least 6 months before assessing response 1
4. Reserve intracavernosal injections for non-responders to combined oral and traction therapy 2, 1
5. Consider penile implants only if patients do not respond to medical therapies 4