A pilot study on the early use of the vacuum erection
device after radical retropubic prostatectomy

Tobias S. Köhler, Renato Pedro, Kari Hendlin, William Utz*, Roland Ugarte*,
Pratap Reddy*, Antoine Makhlouf, Igor Ryndin, Benjamin K. Canales, Derek Weiland,
Nissrine Nakib, Anup Ramani, J. Kyle Anderson and Manoj Monga
University of Minnesota, Minneapolis, and *Urology Associates, Edina, MN, USA
criterion for inclusion in the study. Only changes in penile flaccid length, prepubic fat patients in whom unilateral or bilateral nerves pad, or mid-shaft circumference in either were spared were subsequently randomized. OBJECTIVE
rehabilitation protocol consisting of 10 min/ 6 months, by ≈2 cm (P = 0.013) in group day using the VED with no constriction ring, 2. By contrast, stretched penile length was To evaluate the effect of the early use of the for 5 months. Patients were evaluated with the preserved in group 1 at all sample times. At vacuum erection device (VED) on erectile IIEF-5 questionnaire and measurements of the last follow-up, the proportion of men with dysfunction (ED) and penile shortening after penile flaccid length, stretched length, a mean loss of penile length of ≥2 cm was radical retropubic prostatectomy (RP), as prepubic fat pad, and midshaft circumference significantly lower in group 1 than group 2 before and at 1, 3, 6, 9 and 12 months after RP; (two/17, 12%, vs five/11, P = 0.044).
choosing among treatment alternatives for the mean (range) last follow-up visit was CONCLUSIONS
Initiating the use of a VED protocol at 1 month after RP improves early sexual The mean (SD) baseline IIEF scores were similar function and helps to preserve penile length.
randomized to early intervention (1 month in groups 1 and 2, at 21.1 (4.6) and 22.3 (3.3), after RP, group 1) or a control group (6 months respectively (P = 0.54). The IIEF scores were KEYWORDS
after RP, group 2) using a traditional VED significantly higher in group 1 than group 2 at protocol. An International Index of Erectile 3 months, at 11.5 (9.4) vs 1.8 (1.4) (P = 0.008) vacuum erection device, erectile dysfunction, Function (IIEF) score of >11 (no, mild or mild to and at 6 months, at 12.4 (8.7) vs 3.0 (1.9) penile rehabilitation, penile length, radical (P = 0.012) after RP. There were no significant INTRODUCTION
penile implants and vascular reconstruction. Another potential sequelae of RP is penile In a study of 30 patients, Montorsi et al. shortening. Apoptosis has been detected in [4] assessed early prophylactic vasoactive rats after penile denervation [6], and the prostatectomy (RP) for prostate cancer has resulting fibrotic changes in the corporeal decreased as a result of improvements in alprostadil after RP, and reported a 67% bodies after RP were recently evaluated and incidence of return to spontaneous erectile described, both of which could contribute to predictor of ED after RP is pre-existing shortening [7]. Many authors have reported erectile function and preservation of the circumference after RP. Fraiman et al. [8] improvements in technique, erectile function series, and the use of injectable agents is returns in only 9–40% of patients [1–3]. The values of flaccid length, erect length and practice of early penile rehabilitation after RP seeks to improve on these rates, but the inhibitors (PDE-5i) offer a less invasive optimal rehabilitation regimen is yet to be Munding et al. [9] showed that the stretched penile length decreased at 3 months after utility of PDE-5i might be limited by the RP in 71% of their patients. Savoie et al. [10], Options currently available for patients severity of cavernosal nerve injury after in a prospective study evaluating penile RP, which in turn inhibits initiation of the length 3 months after RP, found a significant intraurethral prostaglandin E1, injection required erectile cascade for PDE-5i to be therapy, vacuum erection devices (VEDs), circumferential measurements of the penis. J O U R N A L C O M P I L A T I O N 2 0 07 B J U I N T E R N A T I O N A L | 1 0 0 , 8 5 8 – 8 6 2 | doi:10.1111/j.1464-410X.2007.07161.x E A R L Y U S E O F T H E V A C U U M E R E C T I O N D E V I C E A F T E R R A D I C A L R E T R O P U B I C P R O S T A T E C T O M Y for intercourse was forbidden for the first Thereafter, the men were allowed to use the constriction band for intercourse if desired. By contrast, the group 2 were given instructions to use the VED after 6 months and to do so whenever they wished to attempt intercourse. The use of PDE-5i was not allowed in the first 6 months in either group, but after the first 6 months both groups were allowed to use erections for intercourse. Stretched penile length (an accepted surrogate for erect penile length [22]), penile flaccid length, prepubic fat pad, and mid-shaft circumference were also measured. Data were acquired before and at 1, 3, 6, 9 and 12 months after RP. The primary endpoint of the study was the proportion of Overall, 68% of patients had a decrease in PATIENTS AND METHODS
patients with moderate to severe ED (IIEF ≤11) The study was initiated after consent was Secondary endpoints included penile size, Zippe et al. [11] reported a study in which including significant penile shortening, for patients successfully used a VED after RP boards of the participating institutions. and confirmed its safety and tolerability. Twenty-eight patients having a unilateral progression of IIEF scores over time, and Numerous published studies report successful or bilateral nerve-sparing retropubic RP occurrence of spontaneous erections in the erections being attainable with the VED in gave consent and were randomized to early early period after RP. Questionnaires were 84–95% of patients [12–15]. Most patients intervention (1 month after RP, group 1) and a report an improved sex life [13], seen by an control group (6 months after RP, group 2). visits and given to the study co-ordinator. increase in both the quality and frequency of Baseline information was obtained from all After completing the paperwork, the penile patients, including age, sexual activity, penile improvement in marital relationships and characteristics, IIEF scores, PSA level before physicians who were unaware of the patient self-esteem as a result [13,16–18]. Columbo et al. [19] reported a series of 52 patients cores positive, marital status, hypertension, diabetes, history of back surgery, depression, All results were analysed statistically using constriction ring, unrelated to intercourse, led tobacco use, number of nerves spared, and Student’s t-tests and paired sample t-tests, to an improvement in spontaneous erections penile curvature; the patients’ baseline with significance indicated at P < 0.05.
characteristics are summarized in Table 1.
Raina et al. [20] showed that the use of a VED To be deemed eligible for the study patients after RP (with and with no nerve preservation) had to be able to attain a partial or full improved the International Index of Erectile erection before RP and have only mild to Compliance with the protocol was excellent, Function (IIEF) scores, patient reported moderate ED (IIEF score of ≥12). Excluded with no patients in either group reporting preservation of penile length, and aided in were patients on anticoagulation therapy or difficulties with the rehabilitation protocol. the early return of spontaneous erections. those with bleeding diatheses, insufficient There was no early cessation of therapy due to In a separate small series of patients, use of manual dexterity of the patient or spouse to VED-related side-effects in either group; no a VED had some benefit in correcting penile use the VED, an IIEF score at baseline of <12, patients withdrew in the first 6 months of the shortening in men with Peyronie’s disease or those who did not have a nerve-sparing RP.
study. The mean (range) follow-up was 9.5 (6– after tunical incisions and grafting [21].
12) months; after 6 months, four patients in Men in the group 1 were instructed to use the group 1 and one in group 2 withdrew because Thus the objective of the present study was to VED daily starting 1 month after RP; all used they lived too far from the study centre or assess, in the first randomized prospective started radiation therapy for increasing PSA clinical trial addressing this issue, the Prairie, MN). The men were instructed to levels. Only one patient in each group had a effectiveness of the VED in assisting with inflate the device for two consecutive 5-min unilateral nerve-sparing RP. Before RP, both periods after a brief release of suction in groups had similar mean (SD) IIEF scores; in between inflations. The use of a tension band group 1 it was 21.1 (4.6), and of these men, 2 0 07 T H E A U T H O R SJ O U R N A L C O M P I L A T I O N 2 0 07 B J U I N T E R N A T I O N A L 53% had no ED (score 22–25), 29% had mild flaccid penile length, or suprapubic fat pad FIG. 1. The change with time in: a, percentage of ED (17–21) and 18% had mild to moderate ED dimensions. When using a threshold of 2 cm men with an IIEF score of >11; b, the IIEF scores; and (12–16). Group 2 had a mean IIEF score of for penile shortening at the last follow-up, c, the change in stretched penile length. 22.3 (3.3) and of these 11 men, five had no five of 11 patients in group 2 had penile ED, five had mild ED, and one had mild to shortening, vs two of 17, 12%, in group 1 There were significant differences between the groups in the primary endpoint of the DISCUSSION
proportion of men classified with no, mild or mild to moderate ED (IIEF ≥ 12) after RP at As shown in previous studies, the present both 3 and 6 months. Both groups had similar study showed a statistically significant benefit values before RP and after 1 month, with all with the early use of a VED after RP, and men having an IIEF of ≥12 before RP, and established the safety of early initiation of or better, respectively, at 1 month. The improved at 3 and 6 months for group 1. After proportion with mild to moderate ED or better (IIEF ≥ 12) in group 1 remained relatively they desired, after 6 months, the IIEF scores constant, with values of 31%, 38% and 38% at 3 and 6 months and the last follow-up, respectively. However, all men in group 2 classified themselves as having worse than difference between the groups. Importantly, mild to moderate ED at 3 or 6 months. After in the period after group 2 were allowed to 6 months group 2 was allowed to use a VED use the VED, the mean IIEF score increased by and thereafter the prevalence of mild to >4 points (indicating a noticeable increase in moderate ED, at three of 11, approached that of group 1 at the last follow-up (Fig. 1a). The studies). The most plausible explanation for this is that group 2 started using their VEDs significantly different at 3 (P = 0.005) and and this affected the IIEF scores, but this 6 months (P = 0.033). At the last follow-up increase might also represent the expected there was no significant difference between return of erectile function at 6–12 months [23]. Physiologically, VED tumescence occurs the groups (P = 0.75). The mean IIEF scores at after RP. If this were the case, a parallel from passive engorgement, with constriction the various sample times are shown Fig. 1b. increase in the scores in group 1 might be rings preventing venous return of blood [24]. A study by Bosshardt et al. [25] confirmed intercourse were reported at the last follow- that there is a passive congestion of mixed up for any patient in either group. Partial commented on how they felt empowered and arterial and venous blood, with extra-tunical erections were reported for two patients in were pleased to be taking an active role in tissue making up a large component of the the group 1 vs none in group 2. PDE-5i use their penile rehabilitation. PDE-5i use is increased diameter. Some authors speculated was similar in both groups, with 47% (eight/ another factor that could influence IIEF that the use of the VED helps to inhibit 17) of group 1 beginning use at a mean date scores; as the percentage of PDE-5i use was abnormal collagen or scar formation in the of 10 months after RP, vs six of 11 of group 2 similar in both groups (eight/17, 47%, in hypoxic penile conditions after RP, perhaps beginning use at a mean of 6 months after RP.
group 1; and six of 11 in group 2) it probably had similar effects on both groups. However, Analysis of secondary endpoints showed a oxygenation [20]. This, in turn, could promote significant loss of stretched penile length in tended to initiate its use 4 months earlier the earlier return of erectile function and/or group 1 than in group 2 (Fig. 1c). In group 2, (6 months in group 2 vs 10 months in group the mean (95% CI) loss in penile length was 1) which might confound the IIEF scores after incomplete understanding of ED after RP a 1.87 (−3.26 to 0.48) cm at 3 months (P = 0.013) and 1.82 (−3.2 to 0.47) at 6 months success of penile rehabilitation and the use of (P = 0.013). At the last follow up (up to 1 year Despite the long-standing experience of ED in half the sample), the mean loss in penile induced by RP, penile shortening after RP has length was 1 (−2.8 to 0.8) cm but was not become clinically recognized only recently [8– The present study showed preserved penile statistically significant (P = 0.242). By 10]. There is an overlap between the causes of length in group 1, vs a statistically significant ED after RP and penile shortening. Current loss in group 2 at 3 and 6 months. At the last significant decrease in stretched penile length theories to explain this include cavernosal follow-up t-tests showed no significant at any time; the mean change in penile length nerve injury and its associated structural difference in length in group 2, even though at 3 and 6 months was −0.24 (−1.04 to 1.05; alterations in the penis, cavernosal hypoxia P = 0.7) and 0.6 (−2.53 to 1.29; P = 0.5). There and its induction of structural changes in the significance at the last follow-up is probably were no significant differences in penile girth, penis, and sympathetic hyper-innervation multifactorial. Penile shortening might have J O U R N A L C O M P I L A T I O N 2 0 07 B J U I N T E R N A T I O N A L E A R L Y U S E O F T H E V A C U U M E R E C T I O N D E V I C E A F T E R R A D I C A L R E T R O P U B I C P R O S T A T E C T O M Y helped to preserve penile length. Urologists sparing radical retropubic prostatectomy. 6 months in group 2, as well as differences in should consider adding a VED to the penile Mol Urol 1999; 3: 109–15
the time of starting PDE-5i. Alternatively, rehabilitation regimen after RP. By contrast Munding M, Wessells H, Dalkin B. Pilot
6 months might not be the optimum duration of penile rehabilitation; it is possible that an rehabilitation, the VED might be more cost- length 3 months after radical retropubic extended period of up to 1 year might have effective, with low risks of systemic side- prostatectomy. Urology 2001; 58: 567–9
further benefit. Finally, patient withdrawal effects, and present the added benefit of 10 Savoie M, Sandy K, Soloway M. A
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Newsletter 051127b

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