International Journal of Impotence Research (2006) 18, 77–81& 2006 Nature Publishing Group All rights reserved ORIGINAL ARTICLEEarly use of vacuum constriction device following radicalprostatectomy facilitates early sexual activity and potentiallyearlier return of erectile function R Raina1,2, A Agarwal1, S Ausmundson1, M Lakin1, KC Nandipati1, DK Montague1, D Mansour2 and CD Zippe1 1Center for Advanced Research in Human Reproduction, Infertility and Sexual Function, Glickman Urological Institute,The Cleveland Clinic Foundation, Cleveland, OH, USA; 2Department of Internal Medicine and Pediatrics, Case WesternReserve University (MHMC), Cleveland, OH, USA To assess the efficacy of vacuum constriction devices (VCD) following radical prostatectomy (RP)and determine whether early use of VCD facilitates early sexual activity and potentially earlierreturn of erectile function. This prospective study consisted of 109 patients who underwent nerve-sparing (NS) or non-nerve-sparing (NNS) RP between August 1999 and October 2001 and developederectile dysfunction following surgery. The patients were randomized to VCD use daily for 9 months(Group 1, N ¼ 74) or observation without any erectogenic treatment (Group 2, N ¼ 35). Treatmentefficacy was analyzed by responses to the Sexual Health Inventory of Men (SHIM) (abridged 5-itemInternational Index of Erectile Function (IIEF-5)), which were stratified by the NS status. Patientoutcome regarding compliance, change in penile length, return of natural erection, and ability forvaginal intercourse were also assessed. The mean patient age was 58.2 years, and the minimumfollow-up was 9 months. Use of VCD began at an average of 3.9 weeks after RP. In Group 1, 80% (60/74) successfully used their VCD with a constriction ring for vaginal intercourse at a frequency oftwice/week with an overall spousal satisfaction rate of 55% (33/60). In all, 19 of these 60 patients(32%) reported return of natural erections at 9 months, with 10/60 (17%) having erections sufficientfor vaginal intercourse. The abridged IIEF-5 score significantly increased after VCD use in both theNS and NNS groups. After a mean use of 3 months, 14/74 (18%) discontinued treatment. In Group 2,37% (13/35) of patients regained spontaneous erections at a minimum follow-up of 9 months aftersurgery. However, only four of these patients (29%) had erections sufficient for successful vaginalintercourse and rest of patients (71%) sought adjuvant treatment. Of the 60 successful users, 14(23%) reported a decrease in penile length and circumference at 9 months (range, 4–8 months)compared to 12/14 (85%) among the nonresponders. However, in control group 22/35 reporteddecrease in penile length and circumference. Early use of VCD following RP facilitates early sexualintercourse, early patient/spousal sexual satisfaction, and potentially an earlier return of naturalerections sufficient for vaginal penetration.
International Journal of Impotence Research (2006) 18, 77–81. doi:10.1038/sj.ijir.3901380;published online 18 August 2005 Keywords: erectile dysfunction; vacuum constriction device; early penile rehabilitation; radicalprostatectomy usually report the absence of spontaneous erection(both nocturnal and at awakening) during the early Patients who undergo nerve-sparing (NS) and non- postoperative period.1–4 The cause of this erectile nerve-sparing (NNS) radical prostatectomy (RP) dysfunction (ED) is mainly neurogenic – in the caseof NNS-RP, it stems from a failure to preserve thecavernous nerves, whereas in a NS procedure,the nerves are preserved but are sometimes Correspondence: Dr R Raina, Department of Urology/ physiologically injured despite the best efforts of Andrology, The Cleveland Clinic Foundation, 9500 Euclid the surgeon. The latter often results in a period Avenue, Desk A19.1, 9500, Euclid Avenue, Cleveland, OH A number of standard, nonoral treatments are E-mail: rraina@metrohealth.orgReceived 13 December 2004; revised 7 June 2005; accepted available for ED, but they produce erections via 7 June 2005; published online 18 August 2005 artificial means. Oral therapy can help salvage Early use of vacuum constriction device following radical prostatectomy erectile function but only in men who have under- after RP but before VCD therapy (postsurgery); this was carried ut as part of their routine care. To assess Fraiman et al.6 assessed penile morphometrics the efficacy of the treatment, data from the IIEF-15 following RP and found that denervation muscular questionnaire were condensed into the IIEF-5 ques- atrophy is most apparent between the first 4–8 tionnaire, which is an abridged 5-item version of the months after RP. This research has encouraged IIEF-15 questionnaire referred to as the Sexual clinicians’ to use ‘early penile rehabilitation’ to Health Inventory of Men (SHIM).13,14 The SHIM is maintain the vascular and cellular integrity of the a validated, multidimensional, self-administered penis after RP. With this approach, the integrity of questionnaire that is a sensitive indicator of changes the cavernous tissues may be maintained, which can in erectile function. It is scored from 1 to 5: potentially prevent cavernous tissue fibrosis from 1 ¼ never/occasionally; 2 ¼ less than half of the time; precluding the return of spontaneous erections or 3 ¼ sometimes/half of the time; 4 ¼ more than half decreasing the response to erectile aids.7–9 of the time; and 5 ¼ almost always. The total IIEF-5 Vacuum constriction devices (VCD) have been score was calculated by totaling the response to all successfully used in a variety of patients with organic ED.10 Its use included those patients treated A second questionnaire developed at our institute for prostate carcinoma with either RP or radiation (Post Prostatectomy Questionnaire (PPQ)) was used therapy.7,8,10,11 Colombo et al.12 found that their to determine the sexual satisfaction of the patients’ patients who practiced early application of VCD spouses/partners. The spouses/partners were speci- without the constrictive band to produce ‘stretching’ fically asked how often they were satisfied with for the smooth muscle fibers showed significant intercourse and how often the patient was able to improvement of spontaneous erectile ability.
achieve and maintain an erection. This question- In an attempt to encourage early sexual activity naire was scored from 1 to 5: 1 ¼ never/occasionally; and prevention of post-RP veno-occlusive dysfunc- 2 ¼ less than half of the time; 3 ¼ sometimes/half tion, we prospectively studied the effect of early of the time; 4 ¼ more than half of the time; and intervention clinical protocols using VCD in men 5 ¼ almost always. Total spousal satisfaction was who underwent NS and NNS RP at our institution.
calculated from these questions and expressed as a We specifically set out to determine whether early use of VCD facilitates early sexual activity and Both surveys were also mailed to all patients in potentially earlier return of erectile function.
the VCD group and their spouses/partners 9 monthsafter VCD therapy was started. We also mailed theother 35 patients (Group 2) the IIEF-15 and spousalquestionnaires 9 months after RP to assess prospec- tively long-term potency and attrition in sexualfunction. Data from the IIEF-15 at 9 months was also condensed into the IIEF-5 (SHIM). At this time, we The Cleveland Clinic Institutional Review Board also performed a chart review to collect data on approved this study, and all patients granted their mean duration of intercourse, number of patient written informed consent. The study consisted of all attempts at intercourse, number of successful consecutive patients who underwent NS (unilateral attempts (vaginal penetration), change in VCD or bilateral) or NNS RP as a treatment for prostate efficacy and frequency of use, compliance, return cancer between August 1999 and October 2001. To of natural erections, and new side effects. All be eligible, patients must have been sexually active patients were followed at 2- to 3-month intervals before surgery and free of any comorbid conditions.
for 9 months. We also assessed the penile length Patients were excluded if they received preoperative or postoperative hormonal therapy or monotherapy.
All eligible patients were initially evaluated with a comprehensive sexual history, physical examination, and pertinent laboratory testing. They were then The baseline scores of SHIM were compared before randomized to the VCD group (Group 1) or to no and after treatment with VCD to determine the change erectogenic treatment (Group 2). Patients in Group 1 in response using Wilcoxon’s signed-rank tests. The were instructed to begin using the VCD daily after use of VCD for vaginal intercourse, return of natural catheter removal (2 weeks after surgery). An experi- erections, and return of erection sufficient for vaginal enced nurse practitioner (AS) conducted a training intercourse, quality of erections, and reason for session to teach the patients how to select and use a discontinuation were also assessed. The responses VCD. Patients were instructed to apply the constric- were stratified by type of surgery (NS or NNS) and tion ring only when attempting sexual intercourse.
were compared with Wilcoxon’s rank-sum tests.
Patients were asked to complete the International An algorithm for determining potency was de- Index of Erectile Function-15 (IIEF-15) question- vised such that the patients’ pretreatment status was naire13 before undergoing RP (presurgery) and then assessed. Then, for each patient, the last potency International Journal of Impotence Research
Early use of vacuum constriction device following radical prostatectomyR Raina et al status was recorded based upon the time that follow- began an average 3.9 weeks after surgery (range, 2–8 up visit. The data are presented as means and weeks). All of the 74 patients who initiated early percentages as summary statistics. The methods VCD for treatment of ED following RP had attempted consist of comparison of scores of the patients to use their VCD, and 60 (80%) successfully used before and after VCD treatment using mean values.
VCD with a constriction ring for vaginal intercourse The number of patients discontinuing treatment for (50 had used manual devices, six had used battery- multiple reasons was calculated as a percentage operated devices, and four had tried both). These 60 of the total. In addition to the Wilcoxon tests, w2 tests patients used their VCD for sexual intercourse on an average of twice a week, and their spousal satisfac- Statistical significance was assessed with two- tion rate was 55% (33/60) (Table 1).
tailed test at Po0.05. Computations utilized SAS Patients reported an improved erectile function version 8.1 software (SAS Institute Inc., Cary, NC, after using VCD (Table 2) with significant improve- USA). Summary statistics for the continuous ments in the mean IIEF-5 score to 1677.33 from a variables are expressed as mean7s.d.
baseline pretreatment score of 4.873.62 (Pp0.05).
There was no statistical difference in the total IIEF-5 score or response to individual questions betweenthe NS and NNS groups (PX0.05). Of the 60 men, 19 During the study, 450 patients underwent RP at our (32%) who successfully used a VCD for sexual institution. Of those patients, 109 (31.7%) were intercourse reported a return of natural erections at eligible (PSAo10, G’s p6, stage T1–T2, and base- mean interval of 9 months; for 10 of these 19 line total IIEF-5 X16); 74 were randomized into patients (52%), erections were sufficient for vaginal Group 1 and 35 were randomized into Group 2.
intercourse. Overall in the early VCD group, 17% All 109 patients completed the IIEF-15 question- (10/60) had return of natural erections sufficient for naire at all three designated times (presurgery, postsurgery, and 9 months post-therapy), and all Of the 14 patients who discontinued treatment spouses/partners responded to the PPQ question- (18%), 55% did so because of discomfort, 8% were naire. The minimum follow-up for all 109 patients unable to get an airtight seal, 17% reported that was 9 months. The average age of the men at follow- VCD use was socially inconvenient, and 20% quit up was 58.6 years (range, 50–71 years).
because of penile bruising. The mean time intervalat which the patients discontinued VCD was 2.5months after starting the therapy. The patients who Group 1 (VCD): efficacy of early VCD use and tried both battery and manual VCD did not seem to An NS RP was carried out in 53 patients and an NNS When patients were asked about the length of the RP was carried out in 21 patients. Use of the VCD penis while using VCD, 65% (39/60) were satisfied Table 1 Comparison between patients with NS and NNS prostatectomies in response to early use of VCD Return of natural erection with VCD at 9 months Natural, erection sufficient, for intercourse at 9 months P-value is not significant between the three group.
Table 2 Response to abridged 5-item version of IIEF questionnaire following early use of VCD Values are represented in mean7s.d.
*Po0.05, considered statistically significant between baseline and after the use of VCD.
International Journal of Impotence Research
Early use of vacuum constriction device following radical prostatectomy (NS; 75% (33/44) vs NNS; 37% (6/16)). Concerning 83% in the other patient groups. They reported long- the circumference of the penis with VCD use, 85% term efficacy and patient satisfaction rates of more (51/60) of the patients were satisfied (NS; 92% (41/ than 80% with statistically significant increase in the 44) vs NNS; 62% (10/16)). Of the 60 successful frequency of successful intercourse attempts in 79% users, 14 (23%) reported a decrease in penile length of the patients using the device for 1 year, which were and circumference at 6 months (range, 4–8 months) maintained in 77% beyond the first year.
compared to 12/14 (85%) among the nonresponders.
Parallel to these findings, Derouet et al.16 reported that VCD was most preferred by their patients withradical pelvic surgery. However, despite this ex-cellent satisfaction in this subset of patients, various Group 2 (observation): long-term sexual potency authors reported overall dropout rate was 30– and attrition in sexual function after RP 70%.16,17 The primary reasons for discontinuation Of total 35 patients, 29 underwent NS RP and six were bruising and petechiae (5%), pivoting at the NNS RP. Although 37% (13/35) of patients in this base of the penis (6%), coldness and numbness group regained spontaneous erections at a minimum around the penis (5%) and pain related to VCD or follow-up of 9 months from surgery, in 71% (9/13) of the constriction band (10%), and decreased ability these patients penile erections were not sufficient to achieve orgasm with device (10%). Sidi et al.18 for successful vaginal intercourse and sought adju- reported similar high degree of satisfaction.
vant treatment. In these 13 patients, the total mean To date, most urologists performing NS RP have IIEF-5 score was 15.7671.13, with a spousal suggested that patient should wait until completion satisfaction rate of 54%. Overall, these 35 patients of postoperative year 1 before evaluating the actual had a total mean IIEF-5 score of 11.1771.76; this is recovery of spontaneous erectile function. We significantly lower than early VCD group (Po0.05).
Overall, 11% (4/35) had return of natural erections with VCD may restore nocturnal erections (both frequency and duration), may facilitate vascular When asked about the penile length and circum- perfusion of the corpus cavernosum, and can ference, 22/35 reported a decrease in the parameters.
subsequently inhibit corporeal hypoxia and fibrosis.
Initial data with intracavernous (IC) agents havebeen very encouraging and lend support to this hypothesis.15 However, alternative mechanisms ofaction cannot be excluded, such as a direct effect on ED commonly occurs after NS and NNS RP. Most collagen synthesis. Numerous physiological insults standard treatments make erectile function possible lead to the production of TGF-beta and subsequent through artificial means, or they work only in men tissue fibrosis. It is possible that erectogenic agents who have undergone an NS procedure. Early penile like VCD, IC injections, or transurethral alprostadil rehabilitation using erectile aids have been pro- (MUSE) may modulate the expression of TGF-beta, posed to enhance recovery of natural, spontaneous or other factors, independently of tissue oxygena- erections earlier than what are normally anti- tion. Moreover, Althof19 stated that one of the most cipated.15 Moreover, it can be used after NS and important causes of failure of therapy of ED and the high dropout rates is the long asexual period of time In the current study, our patients were asked to the couple spends before the onset of therapy.
use a VCD as part of an early penile rehabilitation Besides VCD, other nonsurgical ED treatments program. Our results suggest that early use of VCD are available, including IC pharmacotherapy and resulted in a normal erection recovery rate (erections MUSE.7,8,10 In our early penile rehabilitation pro- sufficient for vaginal intercourse) that was higher gram, the VCD was the preferred erectile aid. The than the rate among nontreated controls (17 vs advantage of VCD is that the erections produced are 11%). No significant difference was present in the independent of endogenous vasoactive substance response rate in patients undergoing NS or NNS RP.
such as nitric oxide (NO) production, which is When patients were asked about the length of the impaired by nerve damage. However, the degree of penis while using VCD, 65% were satisfied. Con- smooth muscle relaxation may be more complete cerning the circumference of the penis with VCD with pharmacologically induced erections so that use, 85% (51/60) of the patients were satisfied. In patient with a mild venous leak still may veno- all, 14 of 60 (23%) responders reported decrease occlude to the point of functional erection.
in penile length and circumference at 6 months IC pharmacotherapy has high efficacy (up to (average 4–8 months) compared to 12/14 (85%) 80%), and it produces natural erections of good rigidity. However, it has many side effects, including A study by Cookson and Nadig10 reported long- painful erections, penile fibrotic changes, and term results of post-RP patients who used a VCD.
priapism. These side effects together with later loss They found that the their subgroup of impotent of effectiveness may explain the high incidence of patients had a 100% satisfaction rate compared with dropout among its users.20–23 MUSE has the dis- International Journal of Impotence Research
Early use of vacuum constriction device following radical prostatectomyR Raina et al advantages of penile and urethral pain and the most Presentation at 95th Annual Meeting of AUA, Atlanta, GA, Although sildenafil has a high success rate in RP 6 Fraiman MC, Lepor H, McCullough AR. Changes in penile morphometrics in men with erectile dysfunction after nerve- patients, it early use in patients who undergo NNS is sparing radical prostatectomy. Mol Urol 1999; 3: 109–115.
theoretically ineffective. However, some authors 7 Zippe CD, Raina R, Thukral M, Lakin MM, Klein EA, Agarwal found it justifiable to use sildenafil in such patients A. Management of erectile dysfunction following radical depending on its effect mediated through non- prostatectomy. Cur Urol Rep 2001; 2: 495–503.
neuronal-NO pathway to produce tumescence 8 Zippe CD, Jhaveri FM, Klein EA, Kedia S, Pasqualotto FF, Kedia A et al. Role of viagra after radical prostatectomy.
enough to maintain integrity of cavernous tissue, encourage patients of early regaining sexual interest, 9 Padma-Nathan H, McCullough AR, Giuliano F, Bicetre LK, and activity thus enhancing chances of spontaneous Toler SM, Wohlhuter C et al. Postoperative nightly adminis- recovery of erections and/or successful long-term tration of sildenafil citrate significantly improves the return ofnormal spontaneous erectile function after bilateral nerve therapy. Recently, Padma-Nathan et al.9 reported sparing radical prsotatectomy. J Urol 2003; 169: 375 (abstract that early daily sildenafil following RP appears to increase the recovery of spontaneous erections by 10 Cookson MS, Nadig PW. Long term results with vacuum seven time compare to the placebo (no treatment).
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Mc Auley et al.23 demonstrated experimentally that 11 Dutta TC, Eid JF. Vacuum constriction devices for erectile dysfunction: a long-term, prospective study of patients with IC sildenafil has an erectogenic effect independent mild, moderate, and severe dysfunction. Urology 1999; 54(5): of the classical NO/cGMP pathway. Furthermore, Medina et al.24 found that the relaxant effect of 12 Colombo F, Cogni M, Deiana G, Mastromarino G, Vecchio D, sildenafil on penile vessels involves in addition to Patelli E et al. Vacuum therapy. Arch Ital Urol Nephrol Androl1992; 64: 267–269.
the NO-mediated relaxation an inhibitory effect on 13 Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J. The the noradrenergic contractions and on the smooth international index of erectile function (IIEF): a multidimen- sional scale for assessment of erectile function. Urology 1997; Although our study was based on a limited number of the patients assessed at a short-term 14 Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM.
Development and evaluation of an Abridged 5-Item version of follow-up. We still believe early intervention with the International Index of Erectile Function (IIEF-5) as a VCD after RP may be able to restore nocturnal diagnostic tool for erectile dysfunction. Int J Impot Res 1999; erection (both frequency and duration) and can 15 Montorsi F, Guazzoni G, Strambi LF, Da Pozzo LF, Nava L, Barbieri L et al. Recovery of spontaneous erectile function Early use of VCD following RP facilitates early after nerve-sparing radical retropubic prostatectomy with and sexual intercourse, early patient/spousal sexual without early intracavernous injections of alprostadil: results satisfaction, and maintenance of penile length/girth of a prospective, randomized trial. J Urol 1997; 158: and, potentially, an earlier return of natural erec- tions. Sexual activity that occurs during the first 16 Derouet H, Caspari D, Rohde V, Rommel G, Ziegler M.
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