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Efficacy of vacuum erectile devices (VEDs) after radical prostatectomy: the initial Irish experience of a dedicated VED clinic

Abstract

Controversy exists regarding optimal penile rehabilitation program following radical prostatectomy (RP). Vacuum erectile devices (VEDs) have become an important component of penile rehabilitation protocols. The aim of this study was to assess the efficacy and patient satisfaction of a dedicated VED clinic. A voluntary telephone questionnaire was performed of all patients who attended a VED clinic to date in two university teaching hospitals. Patient demographics, histopathological characteristics and functional status (International Index of Erectile Function (IIEF) scores) were obtained from a retrospective review of a prospectively maintained database. Sixty-five men attended the dedicated VED clinic in the two university teaching hospitals. Forty-men (76.3%) men purchased a VED following the dedicated clinic. There was significant differences noted between the mean preoperative and the 3-month postoperative IIEF scores (22.08±3.16 vs 11.3±3.08, P=0.0001) and between the 3-month postoperative IIEF score and the post-VED use IIEF score (11.3±3.08 vs 16.74±2.62, P=0.0001). Despite VED use, there was a significant reduction in erectile function from presurgery status (22.08±3.16 vs 16.74±2.62, P=0.0001). All patients reported that the dedicated VED was helpful and would recommend it to other patients. Our study demonstrates that, despite a reduction in erectile function after RP, successful erections are attainable with a VED. There is potential and need for the development of a standard penile rehabilitation program and treatment of ED after RP internationally.

Introduction

Radical prostatectomy (RP) is the gold standard therapeutic option for patients with clinically localized prostate cancer who have a life expectancy of >10 years who accept treatment-related complications.1 The incidence of ED after RP is reported to be between 14% and 89%.2 The return of potency after RP is dependent upon the patient’s age, preoperative erectile function, comorbidity status, the surgical modality used (robotic assisted, laparoscopic or open), the surgeon’s experience and the extent of nerve-sparing surgery performed.3 Despite attempts of nerve-sparing RP, most patients experience some degree of ED owing to damage to the cavernous nerves in the neurovascular bundles that skirt the prostate. Nerve damage occurs owing to stretching, cutting and thermal damage. There are a number of options available to manage ED after RP, including PDE5 inhibitors (PDE5is), intracorporeal injections, intraurethral alprostadil, vacuum erection devices (VEDs) and penile implants.

Despite a growing body of evidence supporting erectile function rehabilitation after RP, it is unknown what represents the optimal rehabilitation program with regard to strategies utilized, timing of intervention or duration of treatment.4 As a result, currently there is no standard after RP penile rehabilitation program in Ireland.

VED, because of their ability to draw blood into the penis regardless of nerve disturbance, have become an important component of penile rehabilitation protocols. The underlying hypothesis is that the artificial induction of erections shortly after surgery facilitates tissue oxygenation, reducing cavernosal fibrosis in the absence of nocturnal erections, potentially increasing the likelihood of preserving erectile function.5

The first Irish dedicated VED clinic was set up in Beaumont Hospital in December 2013. Similar clinics have since been established in other hospitals across Ireland. The aim of this study was to assess the efficacy and patient satisfaction of dedicated VED clinics.

Materials and methods

Following RP, all patients with ED not responding to medical treatment (PDE5is and intracavernosal injections) in our unit were invited to attend the clinic from 6 months after surgery. At the clinic, the patient has a one-to-one educational session regarding the use of a VED with a clinical nurse specialist. During this session, the patient is shown how to use the VED and given specific instructions regarding its use for penile rehabilitation as well as for sexual intercourse. Patients are advised to use the pump for 30 min per day without the constriction ring for penile rehabilitation and as required with the constriction ring for sexual activity. Following the advice at the clinic, the patient may purchase a VED if they wish at a cost of €199. Patients can attend the clinic on more than one occasion if they deem it necessary. At present, VEDs are not routinely prescribed as part of penile rehabilitation programs or treatment of ED in Ireland. Consultation for penile implants is also offered to patients with ED who fail medical treatments, but in our unit, it is standard that they attend the VED clinic beforehand.

The VED consists of a closed-ended clear plastic cylinder and a hand-held vacuum pump (Figure 1). Constriction rings may be used with the device to maintain an erection for penetration. The VED uses negative pressure in order to increase blood flow to the penis by distending the corporeal sinusoids. This negative pressure induces arterial inflow to the sinusoidal spaces, which aids oxygenation of the corpora. However, the constriction ring prevents venous outflow, which reduces the percentage of oxygenated blood and results in ischemia after 30 min. Therefore, the VED used without the constriction ring is a prime therapy for use in penile rehabilitation as it is able to stimulate oxygenation of the corpora without the need for an intact nerve supply; this increase in oxygenated blood flow may be able to reduce or even reverse some of the fibrotic changes occurring after RP.

Figure 1
figure1

Vacuum erectile device.

A voluntary telephone questionnaire was performed of all patients who have attended a VED clinic to date in two university teaching hospitals. The questionnaire assessed their use of the VED and their satisfaction with the VED clinic.

Patient demographics and histopathological characteristics from their RP were obtained from a retrospective chart review. All patients undergoing a RP fill out International Index of Erectile Function (IIEF-5) scores prospectively as part of the rapid access prostate clinic (Table 1).

Table 1 International Index of Erectile Function (IIEF-5) ED is graded as severe (5–7), moderate (8–11), mild to moderate (12–16), mild (17–21) and no ED (22–25)

The prostatectomies were performed by three established fellowship trained consultant urologists—open (RP and GD), laparoscopic (GS and GD) and robotic (RP).

This study was approved by the institutional review board.

Statistical analysis was performed using Student's T-test on SPSS version 21 (Armonk, NY, USA). A P-value of <0.05 was deemed statistically significant.

Results

To date, 65 men have attended the dedicated VED clinic in the two university teaching hospitals. Histopathological details are listed in Table 2.

Table 2 Histopathological demographics and IIEF scores preoperatively and at 3 months

Nineteen (29.3%) men underwent an open RP, 18 (27.7%) a laparoscopic RP and 28 (43.1%) a robotic-assisted RP. Forty-two (64.6%) had a nerve-sparing procedure.

There were significant differences noted between the nerve-sparing (n=42) and non-nerve-sparing (n=23) preoperative (24.1±0.2 vs 20.6±2.1, P=0.013) and 3-month postoperative (15.4±3.1 vs 9.6±2.7, P=0.004) IIEF scores. Overall, there was significant differences noted between the mean preoperative and 3-month postoperative IIEF scores (22.08±3.16 vs 11.3±3.08, P=0.0001) and between the 3-month postoperative IIEF score and the post-VED use IIEF score (11.3±3.08 vs 16.74±2.62, P=0.0001). Despite VED use, there was a significant reduction in erectile function from presurgery status (22.08±3.16 vs 16.74±2.62, P=0.0001), Figure 2.

Figure 2
figure2

Dot plots of preoperative (a), 3-month postoperative (b) and post-vacuum erectile device (VED) use (c) International index of erectile function (IIEF) scores. *31 patients are using the VED regularly.

Fifty-nine (90.7%) men responded to our telephone survey. Of these, 45 (76.3%) men purchased a VED following the dedicated clinic. Patients commenced using a VED at a median of 8.7 months (range 3–24 months) following RP. All patients had a trial of a PDE5i initially prior to using the VED—none of these had achieved satisfactory erections for intercourse. Twenty-eight (62.2%) are using oral agents in combination with the VED. Fifty (84.7%) men had a trial of intracavernosal injections following failed PDE5i treatment. Of these, 7 (14%) achieved erections sufficient for intercourse and did not purchase a VED and continue to use injections. No patients are using injections in combination with the VED. Thirty-one (68.9%) of those who own a VED are currently sexually active, 22 (70.1%) with a partner (all had a female partner) and 9 (29.9%) for masturbation only. Of those who are engaged in sexual intercourse, 18 (81.8%) report their erection with the VED to be sufficient for penetration. Of those who own a VED who are not currently sexually active, five report a complete loss of libido while eight report partner-related issues and one has abstained owing to cardiac comorbidities. Four (6.1%) patients who attended the clinic also attended a urologist with regard to a penile implant; however, none proceeded with surgery.

Only two patients reported complications associated with the VED, one with penile bruising and one with penile pain. All patients reported that the dedicated VED was helpful and would recommend to other patients. Eight patients requested a return appointment to the clinic owing to initial difficulty using the VED. Of the 45 men who own a VED, 35 (77.8%) would recommend purchasing a VED.

Discussion

Our study demonstrates the efficacy and patient satisfaction associated with using the VED for ED following RP. Erectile function had deteriorated in our cohort at 3 months despite a 65% undergoing a nerve-sparing procedure. Contrary to many published series, our patients reported high satisfaction and few complications using the VED following a dedicated session in the VED clinic, perhaps owing to appropriate one-to-one education regarding safe technique. Although erectile function decreased following RP, a significant improvement in erections was noted in patients who used the VED after RP.

Numerous studies report that successful erections are attainable with the VED in 84–95% following RP,6, 7, 8 similar to our findings. Zippe et al.9 confirmed its safety and tolerability after RP. Furthermore, most patients report an improved sex life,7 reported as an increase in both the frequency and quality of intercourse and orgasm. There was also an improvement in martial relationships and self-esteem as a result.7, 10, 11 Patient and partner satisfaction rates with these devices are in the range of 85%12—this compares well to all patients in our cohort. The nature of our clinic—one-to-one patient education and instruction with a VED nurse—is likely the reason we experience such high success and compliance with the VED. The patient can also attend the clinic with their partner if they so wish—they are shown educational videos and given practical instructions. We feel this dedicated instruction is a key factor in our success as in other series many men discontinued VED use owing to difficulties with technique.

Raina et al.,13 in a nonrandomized study of 109 patients at the Cleveland Clinic, evaluated the use of early VED after RP. Group 1 (74 patients) used the VED at least twice weekly with the constrictor ring starting 1 month after RP for a total of 9 months. Group 2 (35 patients) was the control group and did not receive any erectogenic treatment. The study group obtained significantly more erections sufficient for sexual intercourse. Kohler et al.14 demonstrated that early use (1 month after RP) of the VED improves early sexual function and helps to preserve penile length. Patients who initiated VED therapy early (1 month postoperation) reported significantly improved IIEF scores (IIEF>12) at 3 and 6 months compared with patients who delayed VED therapy (6 months). However, at final follow-up (9.5 months) there was no difference between the groups.14 In our study, the median time to commencing using a VED was over 8 months—earlier initiation of treatment could improve results further as has been shown by Kohler et al.14 To facilitate penile rehabilitation, we aim to commence VED earlier (before 6 months) as the clinic becomes more established. Canguven et al.15 demonstrated significant improvements in functional outcomes following the combined use oral PDE5is and VED in whom PDE5i alone failed.

RP can be performed as a nerve-sparing or as a non-nerve-sparing procedure. Despite which procedure is performed, there is an element of nerve damage owing to the proximity of nerves to the prostate. Factors such as thermal damage, ischemic injury, mechanically induced nerve stretching and the local inflammatory effects of surgical trauma may impair the cavernous nerves following RP. The resultant neuropraxia can affect erectile function. Although nerve regeneration occurs postoperatively, these nerves are slow to recover and can take up to 3 years to return to baseline function, which can result in either an absence or decrease in erectile function.16 In addition, there appears to be reduced arterial supply to the corpora as a result of injury to the accessory pudendal arteries.16 This reduction in arterial inflow to the penis causes hypoxia and subsequently increased production of transforming growth factor-β, apoptosis and collagen deposition, culminating in corporeal fibrosis.16, 17 The concept of penile rehabilitation is the prevention or reversal of these changes. Regular oxygenated blood flow to the corpora is required for smooth muscle maintenance, which has been found to atrophy 4–8 months after RP.18 Penile rehabilitation was first examined by Montorsi et al.19 in 1997—the clinical strategy of postoperative penile rehabilitation after RP arose from the idea that induced early sexual stimulation and augmented blood flow to the penis would facilitate the return of natural erections and the resumption of medically unassisted sexual activity. They showed that the early use of intracavernosal alprostadil injections improved the recovery of spontaneous erections compared with the untreated group.19 Current strategies included PDE5i, intraurethral suppositories, intracavernosal injections and VED or a combination. There is no consensus about when to initiate penile rehabilitation after surgery, treatment duration or treatment regimen and practice varies widely.4, 20 However, Mulhall et al.21 advocate that penile rehabilitation should become the norm after prostatectomy.

At present in Ireland, patients have to purchase the VED themselves at a cost of €199. Given that there is no limitation to usage of the VED, it is by far the cheapest long-term option among all ED treatments in the market today. Equally, the cost of PDE5i is comparably low—sildenafil costs approximately €20 per tablet, with the recommendation that PDE5i be used at least once weekly. Even in combination, PDE5i and VEDs cost considerably less than intracorporeal injections alone; injectable alprostadil costs approximately €10 per single low-dose injection. When combined with the high compliance rates that have been demonstrated with VED use (as high as 80%), compared with only 40% compliance for intracorporeal injections,22 dual therapy with PDE5i and VEDs is economically a far more cost-effective choice.

When first-line medications (PDE5is) fail, intracavernosal injections and VEDs are the next options considered. Medical therapy can help in improving quality of life and erectile function, but unfortunately the literature describes a drop-out rate of up to 80%.23 Surgical treatment (penile implants) is usually offered after the failure of medical therapy. Penile implants have high levels of satisfaction despite the risks of surgery. Penile prostheses are associated with better sexual function, perception and with patient's and partner's high satisfaction.24 Penile implants are available in our unit—four patients in this cohort attended for consultation regarding the implant and none proceeded to surgery.

This retrospective study has a number of limitations. We report the initial experience with the VED as only a fraction of patients have attended these dedicated clinics to date. The subjective nature of this survey reports patients who are using the VED and may demonstrate a bias toward the clinic as a result. The authors found that the benefit of the clinic was that patients who bought the pump were adequately trained in the appropriate technique and more likely to use it as a result. Penile length was not assessed as part of this study although VEDs can be used to encourage penile length after RP.

There is scope for the development of a standardized penile rehabilitation program and treatment of ED after RP. All men after RP could be given a VED and attend one of the dedicated VED clinics. Men could be encouraged to use the VED early (within 6 months) for penile rehabilitation in an effort to encourage spontaneous erections and return to potency.

Conclusion

The introduction of a dedicated VED clinic is a useful adjunct for the treatment of ED after RP. Our study demonstrates successful erections are attainable after RP with a VED. There is potential and need for the development of a standard penile rehabilitation program after RP internationally.

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Correspondence to G J Nason.

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Nason, G., McNamara, F., Twyford, M. et al. Efficacy of vacuum erectile devices (VEDs) after radical prostatectomy: the initial Irish experience of a dedicated VED clinic. Int J Impot Res 28, 205–208 (2016). https://doi.org/10.1038/ijir.2016.23

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