Successful Management of Post Prostatectomy Erectile Dysfunction with the Use of a Novel Penile Constriction Ring (MaxErect®)

ABSTRACT. The effect of a novel penile constriction ring on erectile dysfunction

in a cohort of post-radical prostatectomy patients was measured utilizing the International Index of Erectile Function (IIEF) before and after the constriction ring was introduced. This group consisted of patients who had failed on a variety of commonly used interventions including most of the pharmacopeia for erectile dysfunction. The ring itself is engineered to maintain a relatively constant resistance across a wide circumference range representing a "constant resistance ring" (CRR) thereby averting the property of current penile constriction rings to tighten exponentially as erection occurs. CONCLUSION: A penile constriction ring with stable resistance across a broad range of circumferences shows promise as a significant improvement in current technology as a safe and inexpensive intervention in conjunction with known pharmaceutical interventions in this difficult group of patients with erectile dysfunction. Application in other groups of this technology requires additional study, but indications are that this might allow reduction in use and dosage of drugs used for erectile dysfunction. This would confer benefits for function, safety, and costs.

INTRODUCTION. Prostate cancer is the most common cancer among men.1 The highest incidence (27.3%) occurs between the ages of 55 and 64 years of age.2 Radical prostatectomy (RP) has long been established as the standard of care for early stage disease. Improvements in surgical technique, most notably nerve sparing radical prostatectomy (NSRP), have improved the rate of complications. However, the most common complications continue to be erectile dysfunction (ED) and urinary incontinence.3 Considering that age and a previous history of erectile dysfunction are major factors in post operative recovery,4 it is not surprising that the overall 5 year rate of return to normal erectile function is still estimated to be ~ 28% with 55% of these patients suffering from complete erectile dysfunction.5 Veno-occlusive disease/syndrome is a common consequence of post-radical prostatectomy with an incidence between 45 and 80%.6,7 Patients who undergo NSRP suffer from ED due to physiologic injury of the cavernous nerves resulting in a period of neuropraxia.2 Fabrizio et al, demonstrated that progressive fibrosis in the corpora cavernosa after radical prostatectomy resulted in a loss of elasticity and function of the erectile tissue.8 The progression of cavernosal fibrosis is believed to negatively impact the veno-occlusive mechanism for erection. Treatment for the recovery of erectile function following RP, commonly referred to as penile rehabilitation, is implemented to help prevent or decrease the amount of corporal fibrosis and aid in the recovery of satisfactory erectile function.

Increasingly, concern for the risk of failure to achieve satisfactory erectile function after prostate surgery may compel many men to consider postponing potentially curative surgery. This concern has led to the exploration of newer treatments that would better ensure the preservation of post-operative erectile function. Today, many institutions utilize currently available therapies such as phosphodiesterase 5 inhibitors (PDE5i), intraurethral suppositories, intracavernosal injections, or vacuum erection devices (VEDs) in various fashions to facilitate increased arterial perfusion to the cavernosal tissue. Failure to successfully help NSRP patients return to baseline function often results in the surgical placement of an internal penile pump (IPP). VEDs have been utilized for nearly four decades and have proven to be a safe and effective method of treating erectile dysfunction of various etiologies.10 Use of VEDs with a constriction band has expanded due to improvements in both the design of the devices themselves and the constriction bands. Furthermore, usage of VEDs following radical prostatectomy has been reported to aid in the rehabilitation of penile tissue. Raina, et al., reported their experience with early use of VEDs following radical prostatectomy. Their study showed a significant improvement in response to therapy and restoration of erectile function following early usage of VEDs.11 Koehler et al have shown that VEDs are suitable and successful at "reconditioning" erectile function in patients undergoing post radical prostatectomy who have erectile dysfunction, particularly if their use is begun early in the post operative period.9

These devices by necessity utilize penile constriction rings that invariably are unforgiving and which are likely responsible for the attrition most practitioners experience with respect to their long term use. Very little has been published to document the sustainability of using VEDs despite their successful application early in the post operative period. Even if patients can withstand the discomfort associated with these rings, many may not achieve satisfactory sexual function as a result of the discomfort associated with the constriction ring itself -- oftentimes regardless of the level of erectile function achieved. However, reasons for discontinuation of therapy remained historically consistent in that many patients complain of penile bruising or discomfort with the use of constriction bands.

Despite the efforts of clinicians to provide early penile rehabilitation, many patients will have persistent veno-occlusive disease following RP. Although VEDs invariably employ some form of penile venous constriction (PVC) in order to override "venous leak", very little data is available that objectively characterizes their safety or efficacy. It has been the impression of these clinicians that the penile constriction rings themselves more often create enough discomfort and impairment such that they discourage the use of the VED itself. We report here on the use of a uniquely engineered penile constriction ring utilizing the principle of constant circumferential resistance (Figure 1) or "constant resistance ring" (CRR). This represents a potentially significant advancement in achieving the goal of restored function in the subset of patients with variable levels of post radical prostatectomy erectile dysfunction (PRPED).

METHODOLOGY. Forty-six men who had undergone a bilateral or unilateral nerve sparing radical retropubic prostatectomy (BNSRRP or UNSRRP) were randomly selected from the patient population at Metro Urology in St. Paul, MN. All forty-six men were being treated for PRPED, but were having a suboptimal response from their treatments. Treatment failures included oral PDE5 inhibitors, intra-urethral Alprostadil, commonly used injectable erectogenic agents, VEDs with a standard supplied constriction ring, or combination therapy. Each man was asked to fill out the International Index of Erectile Function (IIEF) Questionnaire, a validated, multi dimensional scale for measuring erectile function. The men filled out the questionnaire routinely throughout their treatment for PRPED thus providing the most current level of erectile function prior to the addition of the CRR (MaxErect, Doctors Naturals Corp.*). Please note that Question 9 of the IIEF evaluating ejaculation was omitted as not being relevant to the test. Each patient was then evaluated and given a CRR of the correct size and firmness with instructions for proper usage to be utilized in combination with their current therapy. The patients were then seen for follow-up after three months and asked to answer the same IIEF questionnaire.

RESULTS. Cumulative scores of the IIEF were gathered but statistical analysis was performed by examining the cumulative scores of the abridged 5 version of the International Index of Erectile Function (IIEF-5). Baseline IIEF-5 scores were compared to IIEF-5 scores following the addition of the CRR. The mean baseline score for the erectile function (EF) domain was (3.62) prior to the addition of the CRR ring. The mean IIEF EF domain score following the addition of the CRR was (20.81). p

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