Vacuum Erectile Device Research Articles

(222) Simultaneous Inflatable Penile Prosthesis and Adjustable Male Sling: A Step-by-Step Surgical Technique

Abstract Introduction Erectile dysfunction (ED) and urinary incontinence (UI) are common complications following radical prostatectomy (1). At twenty-four months post-surgery, approximately 43% of men experience some degree of ED, while UI affects around 15% of patients between twelve to twenty-four months (2, 3). Notably, nearly 20% of patients experience both ED and UI complications (4). Initial conservative management strategies include the use of PDE-5 inhibitors, intercavernosal injections, or a vacuum erectile device for ED and pelvic floor muscle training for UI (5). However, symptoms that persist or worsen beyond six months can be considered for surgical intervention (6). Surgical options include penile prosthesis implantation for ED and diverse techniques such as the Artificial Urinary Sphincter (AUS) or adjustable male urethral sling, depending on symptom severity, for UI management. Limited evidence suggests that a simultaneous surgical approach addressing both conditions can be a cost-effective and a safe alternative to separate surgeries (7, 8). Objective In this context, the objective of this video presentation is to illustrate a detailed, step-by-step technique for the simultaneous implantation of an inflatable penile prosthesis (IPP) and an adjustable male sling (AMS), while also discussing its feasibility, safety, and functional outcomes. Methods The combined IPP and AMS surgery is a safe, viable, and cost-effective option for patients who need to address both ED and UI. Rhee (2005) initially described the concurrent placement of a penile prosthesis (PP) and male sling (MS) in a series of four post-prostatectomy patients. Results The results demonstrated successful restoration of erections and complete continence in all patients, with no postoperative complications. Our previous systematic review, comparing the outcomes of simultaneous surgical placement of PP and MS versus PP and artificial urethral sphincter (AUS), found no clinically significant differences in outcomes between the two groups (Raheem 2021). Therefore, the simultaneous placement of IPP and AMS should be considered an option for patients, as it shows comparable effectiveness to other concurrent surgical interventions. Dual implantation of PP and male sling have also demonstrated cost savings of approximately $9,000 for patients, further enhancing its advantages in managing both ED and UI (Gorbatiy 2010). Ultimately, a collaborative discussion between patients and their urologist is crucial in determining the most suitable approach for patient individual needs. Conclusions The simultaneous surgical placement of an inflatable penile prosthesis (IPP) and adjustable male sling (AMS) presents a favorable and viable solution for managing erectile dysfunction (ED) and urinary incontinence (UI) in patients who exhibit an inadequate response to conservative management following prostatectomy. Disclosure No.

Potential primary prevention of Peyronie's disease post prostatectomy?-retrospective analysis of peri-operative multi-modal penile rehabilitation.

The surgical management of prostate cancer through radical prostatectomy has the potential to impact patients' sexual function, including erectile dysfunction and Peyronie's disease (PD). Historical data suggests the incidence of PD in post-prostatectomy patients is higher than in the general population at 15.9%. Our study objective was to measure the rate of the development of PD among patients that receive penile rehabilitation (PR) regimen prior to and immediately after radical prostatectomy. In this study, we retrospectively reviewed the charts of 581 patients who were diagnosed with prostate cancer, treated with radical prostatectomy, and engaged in a PR program. Patients with the diagnosis of PD prior to prostatectomy were excluded from this study. The PR program consists of daily tadalafil, L-citrulline, and weekly vacuum erectile device with the option of intracavernosal injections if patients fail to respond to the regular regimen. We found the incidence of PD to be 2.9%, suggesting that PR regimens programs may be associated with a reduced incidence of PD in post-prostatectomy patients. Ten (out of 17) patients were diagnosed with PD after 2 years of follow up. The return of erections was not statistically different among patients who developed PD and the rest of the patients. Prospective, multi-institutional trials will be required to elucidate whether PR can prevent the development of PD in this patient population.

HCG supplement did not accelerate tunica albuginea remodeling to facilitate penile growth

Penile size is closely concerned and short penis contributes serious sexual dysfunction and tremendous psychological problems to couples. Androgen is essential for penile development and testosterone replacement is recommended to patients with micropenis. We previously proved that inhibiting activity of lysyl oxidase (Anti-lysyl oxidase, Anti-LOX) combined with vacuum erectile device (VED) lengthened penis by remodeling tunica albuginea. We thus explored whether HCG supplement could accelerate tunica albuginea remodeling (induced by Anti-LOX + VED) to promote penile growth. Forty-two SD male rats (4 weeks old) were purchased and divided into 7 groups: control, Anti-LOX, HCG, VED (with a negative aspirated pressure of − 300 mmHg), Anti-LOX + VED, HCG + VED, and Anti-LOX + HCG + VED. After an intervention for 4 weeks, all rats’ penile length, exposed penile length, and erectile function were measured. Serum samples were collected to detect hormone levels and penile corpus cavernosum were harvested for histo-pathological analysis. All intervention groups showed significantly longer penis than controlled rats. Anti-LOX sharply increased penile length and exposed length by 15% and 9% respectively, this lengthening effect was more obvious in Anti-LOX + VED group (26% and 19%, respectively). Although HCG promoted penile length by 8%, this effect was slight for exposed length (3%). Moreover, Anti-LOX + HCG + VED dramatically increased penile length and exposed length by 22% and 18%, respectively, which was similar with that in Anti-LOX + VED (26% and 19%, respectively). HCG dramatically stimulated testosterone and dihydrotestosterone secretions than control group, whether with or without Anti-LOX and VED; while it induced more AR expression than other groups. Finally, all procedures did not improve or deteriorate normal erectile function. Although we verified that Anti-LOX + VED lengthened penis by inducing tunica albuginea remodeling, however, HCG supplement did not synergize with Anti-LOX + VED to accelerate albuginea remodeling to facilitate penile growth.

(382) Trimodal Therapy for Erectile Dysfunction: Combination of Low-intensity Shock Waves, Platelet Rich Plasma (PRP) Injections and Vacuum Erectile Device Physiotherapy

Abstract Introduction Nowadays it is proved that low intensity shockwave therapy (LISW) have a positive effect in men with erectile dysfunction (ED). Platelet rich plasma (PRP) as well is used to treat ED. PRP contains many growth factors, such as IGF-1, BDNF and VEGF play a significant role in neural regeneration and up-regulation nNOS, as well as in the recovery of erectile function. Vacuum erectile device is used as physiotherapy to treat many penile disease. Objective The goal of our study is to investigate the efficacy of this trimodal treatment (Rigenerection ®) to treat ED Methods This prospective, randomized, controlled, interventional study enrolled 150 pts and randomly divided in two groups: Group A receiving LISW alone (1 weekly sessions) for 6 weeks and Group B receiving LISW + PRP (1 shot a week per 6 weeks) + Vacuum erectile device physiotherapy (15 minutes/daily per 3 months). Main outcome measures were: erectile function (evaluated through the IIEF5 questionnaire) and the peak systolic velocity (PSV) of the cavernosal artery (evaluated through color Doppler ultrasonography). Follow-up was at 3 months. The Mann-Whitney and Wilcoxon tests with a p<0.05 where used to analize the data. Results In both groups, at 3 months follow-up, mean IIEF score and mean PSV ameliorated significantly. Intergroup analysis revealed a statistically significant higher mean IIEF score and PSV increase in patients receiving the trimodal treatment (p<0.03; p<0.001 respectively). Group A: IIEF score from a baseline of 14.2 to 17.9 at 3 months. PSV from 24.4 +/− 12.4 at baseline to 33.8 +/− 8.2 at 3 months. Group B: IIEF score from a baseline of 13.8 to 21.4 at 3 months. PSV from 27.3 +/− 42.6 +/− 7.3 at 3 months. Conclusions The trimodal therapy proved to be a valid tool in the treatment od ED. The combination of these procedures leads to better outcomes compared with the only therapy with LISW. Disclosure No

(538) Penile Enlargement for Patient with Buried Penis: Pubic Dermolipectomy, Scrotoplasty and Mons Pubis Reconstruction

Abstract Introduction Acquired buried penis is a common condition in obese patients. Abnormal excess fat accumulation under the pubic skin leads to the partially or completely disappearance of the penis. This condition is related to voiding difficulties and sexual dysfunction. The goal of surgical treatment is to expose full penile lengthy by excising the adipose pubic tissue and part of excess pubic skin. Objective The aim of this kind of surgery is to make possible to have a normal sexual life to obese patients with buried penis. Methods We performed this technique for buried penis in 25 patients aged from 18 to 72 y (mean 48). Preoperatively, the patient is marked for the procedure in the standing position. Two transversal incisions are made on the pubis and joined laterally on both sides towards anterior iliac spines with the care taken to avoid the formation of "dog ears". The suprapubic fat is removed. Following the inner surface of the Scarpas fascia, the fat is also removed from the penoscrotal angle and from the scrotum as much as possible leaving exposed funiculus and testis on both sides. Suspensory ligament of the penis was incised. Penile skin redistribution leads to a better organ exposure. Postoperative vacuum erectile device was used in order to prevent penile retraction. Results Follow up was at 6 months. Early postoperative complications were hematoma (7pts), penile skin edema (5pts), seroma (5pts), wound infection (5pts), penile shaft retraction (3pts). Majority of pts (22pts) were satisfied good aesthetical and functional outcome. Conclusions Pubic dermolipectomy is a safe procedure with satisfactory results to treat men with buried penis. Surgical exposition of the penile shaft was accomplished in all patients. Disclosure No

Regenerative therapies for erectile dysfunction: the influence of direct-to-consumer marketing on patient interest.

Despite a lack of evidence, a number of "regenerative" therapies have become popularized treatments for erectile dysfunction (ED). Platelet-rich plasma (PRP) injections and shockwave therapy have received significant attention through direct-to-consumer marketing and are advertised as viable alternatives to guideline-backed therapies. Additionally, focused low-intensity shock wave therapy (LiSWT) has become conflated with acoustic or radial wave therapy (rWT), although their mechanism of wave generation and tissue penetration is distinct. GAINSWave, a marketing platform for acoustic wave therapy, has also pervaded the marketplace. We aim to evaluate the relative impact of direct-to-consumer marketing of shockwave therapy and PRP by analyzing the quantity of Google internet search queries for selected regenerative and guideline-backed non-regenerative therapies for ED. National Google Search trends in the United States (www.google.com/trends) were analyzed to characterize interest in different forms of therapy for ED. Search trends for PRP, LiSWT (and various iterations), intracavernosal injections (ICI), intraurethral injections (IU), vacuum erectile device (VED), and GAINSWave were analyzed. Monthly search data were compiled over multiple years, ending at 2/28/2020, just before the COVID-19 pandemic and state of emergency in the United States. Macro-level changes in public interest were quantified using yearly averages. Patterns in Google Search interest in PRP and LiSWT increased respectively by 3-fold and 275-fold over the decade, representing a larger share of Google Searches by 2020. Trends in Google Search interest in selected types of shockwave therapy for ED also show that queries for GAINSWave commanded public interest, increasing by 219-fold from 2016 to 2020. Regenerative therapies for ED have produced interest surpassing other adjunct guideline-backed therapies, despite receiving the designation of "experimental" or "investigational" therapies. The establishment of GAINSWave also constitutes an inflection point for the whole shockwave market: searches for shockwave therapy increased by 782% between 2016 and 2020. Direct-to-consumer marketing of PRP and shockwave therapy has upturned the customary role of physicians in counseling patients about evidence-based therapies for ED. This increase in public interest in GAINSWave emphasizes its success as a marketing platform. The urological community should consider strategies to address misinformation, such as search-engine optimization, social media, and educational outreach.

Penile Rehabilitation after Prostate Cancer Treatment: Which Is the Right Program?

The management of sexual complications after treatment of localized prostate cancer, such as erectile dysfunction, changes in the length of the penis, pain during sexual intercourse, and lack of orgasm, is still an unsolved problem with an important impact on patients’ quality of life. In this review, we summarize the current scientific literature about the rehabilitation of erectile dysfunction after prostate cancer treatment. The therapy for penile rehabilitation includes different types of treatments: the combination of phosphodiesterase type 5 inhibitors (PDE5-I) and the vacuum erectile device (VED) are considered first-line treatment options. When therapy begins, the duration of treatment, the dosage and the drug used all play very important roles in the treatment outcome. Intracavernous injection (ICI) therapy represents the second-line option for patients ineligible for PDE5-I therapy. Technological development has led to the emergence of devices for the stimulation of the penis without the use of drugs, such as penile vibratory stimulation (PVS) for stimulation of ejaculation in spinal cord injury and low-intensity extracorporeal shockwave therapy (LIESWT). The rapid diffusion of the latter, thanks to its easy use, attains good results without side effects. The panorama of penile rehabilitation after PC treatments is vast and many studies are needed, especially on new technologies, to find the best therapeutic regimen possible, personalized to the patient’s characteristics and the type of treatment for PC.

The Efficacy of Li-ESWT Combined With VED in Diabetic ED Patients Unresponsive to PDE5is: A Single-Center, Randomized Clinical Trial.

IntroductionPhosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. We performed a perspective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients who were unresponsive to PDE5is.MethodsOne hundred and five eligible patients were randomly divided into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID), which was considered as the main index of efficacy.ResultsThe MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A at the follow up on 4 weeks, 8 weeks and 12 weeks, respectively (36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C). There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P<0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).ConclusionOur findings indicated the combined therapy Li-ESWT and VED was more beneficial to shift turn PDE5is non-responders to responders for moderate patients with DMED than VED or Li-ESWT monotherapy. Moreover, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives.

Assessment of combination therapies versus phosphodiesterase type 5 inhibitor monotherapy for erectile dysfunction: A systematic review and meta-analysis

ABSTRACT Introduction Combining two first-line treatments for erectile dysfunction (ED) or initiating other effective modalities on top of phosphodiesterase type 5 inhibitors (PDE5i) may produce beneficial outcomes. Objective To assess the efficacy and safety of different combination therapies with PDE5i compared to PDE5i monotherapy in various subgroups of patients with ED through a systematic review and meta-analysis. Methods We considered randomized trials on males with ED that assessed the effect of combination therapy versus PDE5i monotherapy with validated questionnaires. Studies were identified by searching Medline, Cochrane Library and Scopus databases We undertook a meta-analysis for the mean international index of erectile function (IIEF) change, and for the number of adverse events (AEs) based on different treatment modalities and subgroups of patients. Results We included 3,853 individuals (44 trials). Combination therapy with PDE5i, compared to PDE5i monotherapy, was associated with a mean IIEF improvement of 1.92 points (95% CI: 1.41 to 2.44, I2=82%). Adding to PDE5i: daily tadalafil, low-intensity shockwave therapy, vacuum erectile device or antioxidants resulted in a significant IIEF improvement. The latter was not observed with a-blockers. Compared to monotherapy, combination treatment improved IIEF in patients with hypogonadism, monotherapy-resistant or prostatectomy-induced ED. The treatment-related AEs did not differ between combination treatment with PDE5i and PDE5i monotherapy (OR:1.10, 95% CI: 0.66 to 1.85, I2=78%). Still, despite multiple subgroup and sensitivity analyses, the levels of heterogeneity for all outcomes remained high. Conclusions Combination therapy with PDE5i and antioxidants improves ED without increasing the AEs, while treatment with PDE5i and daily tadalafil, shockwaves or vacuum device seems effective, but data are scarce. Combination treatment should be initially preferred in patients with hypogonadism or prostatectomy-induced ED. Conversely, the addition of a-blockers to PDE5i does not provide additional efficacy in patients with urinary symptoms. Overall, combination therapy with PDE5i is safe and effective and should be considered as first-line treatment for refractory or difficult-to-treat cases of ED. Disclosure Work supported by industry: no.

A prospective randomized controlled study on scheduled PDE5i and vacuum erectile devices in the treatment of erectile dysfunction after nerve sparing prostatectomy.

Cavernous nerve injury is an important cause of erectile dysfunction (ED). Although protective nerve technology has been widely used in nerve-sparing radical prostatectomy (nsRP), the incidence of ED is still very high after surgery. The purpose of our study was to evaluate erectile function (EF) and penile length in the non-erectile state (PLNES) following scheduled phosphodiesterase 5 inhibitor (PDE5i), vacuum erectile device (VED) treatment, and combination therapy after nsRP. One hundred patients with localized prostate cancer and normal EF were randomized to scheduled PDE5i group, VED treatment group, a combined treatment group, and the control group without any intervention. The International Index of Erectile Function-5 (IIEF-5) scores and PLNES were evaluated after 6 months and 12 months of treatment. Sexual Encounter Profile (SEP-Question 2 and SEP-Question 3) were evaluated after 12 months of treatment. Ninety-one of the 100 randomized patients completed the study. We found that the 5 mg tadalafil once a day (OaD) combined with VED can help improve IIEF-5 scores in nsRP patients after both 6 months and 12 months. VED alone or combined with tadalafil OaD can help patients maintain PLNES. VED combined with tadalafil OaD can improve the rate of successful penetration (SEP-Question 2) after 12 months. There were no significant differences in the return to target EF after 12 months among the groups. No significant correlation was noted between the variables and return to target EF (IIEF ≥ 17), and between the variables and effective shortening of the patient's penis (shortening ≥ 1 cm) after 12 months of intervention.

The Role of Long Term Label-Retaining Cells in the Treatment of Erectile Dysfunction by Vacuum Erectile Device.

IntroductionVacuum erectile device (VED) therapy is commonly used for penile rehabilitation after radical prostatectomy, however, the underlying mechanism of this effect is not fully understood.AimTo evaluate the presence of label-retaining cells (LRCs), cells with long-term retention of 5-ethynyl-2-deoxyuridine (EdU) labeling and recognized as adult stem cells or progenitor-like cells, in cavernous tissue after VED treatment using a BCNC rat model.MethodsPostnatal pups (1 day old) of Sprague Dawley (SD) rats were intraperitoneally injected with EdU (50 ug/g, BID for 3 days) and BCNC surgery was conducted at 6 weeks old (designated as natal-labeled rats). Adult SD rats underwent BCNC surgery and EdU injection (50 ug/g, once) after surgery (designated as adult-labeled rats). One week after surgery, both natal- and adult-labeled rats received daily VED treatment for 4 weeks. Intracavernous pressure (ICP) and mean arterial pressure (MAP) were measured for all rats and then the penile tissue was harvested. The ratio of ICP/MAP was calculated to represent erectile function. Penile tissue was examined by immunofluorescence staining to detect EdU positive cells.Main Outcome MeasuresThe ratio of Intracavernous pressure (ICP) /MAP and the percentage of EdU positive cells were measured.ResultsThe erectile function was impaired after BCNC and partially restored after VED treatment in both natal- and adult-labeled rats (P < .05). There was no difference in the percentage of EdU positive cells in natal-labeled rat cavernous tissue in BCNC group compared with VED group. Among the adult-labeled rats, the percentage of EdU positive cells increased in BCNC group (P < .05) but didn't change significantly after VED treatment (P = .35).ConclusionLRCs may play a limited role in the restoration of erectile dysfunction through VED treatment after BCNC.Yang B, Luse D, Cao Y, et al. The Role of Long Term Label-Retaining Cells in the Treatment of Erectile Dysfunction by Vacuum Erectile Device. Sex Med 2021;9:100442.

Sexual rehabilitation recommendations for prostate cancer survivors and their partners from a biopsychosocial Prostate Cancer Supportive Care Program.

This study aimed to highlight the biopsychosocial recommendations provided to prostate cancer survivors and their partners during sexual rehabilitation. Retrospective analysis of a prospectively maintained patient database was conducted for visits between 2013 and 2019. The sexual health rehabilitation action plan (SHRAP) is a standardized 29-item list of biopsychosocial recommendations. The frequency of biopsychosocial recommendations provided to patients via their SHRAPs was assessed. Among 913 patients, across 2671 appointments, nearly 74% of patients underwent radical prostatectomy. Other treatments included combination therapy (surgery, radiation, and/or androgen deprivation therapy (ADT)) (13%), radiation (external beam radiation or brachytherapy) (5%), and active surveillance (2%). Each patient had a median of 2 (SD 2.06) appointments and received a mean of 10.0 (SD 3.9) recommendations at each visit. Educational recommendations (penile rehabilitation, orgasmic guidelines, and climacturia management) were provided in 84% of visits followed by psychosexual recommendations (pleasure-focused, dedicated time, simmering, sexual aids, and sensate focus) in 71% of all appointments. The top recommendations (total n, frequency of recommendation) were penile rehabilitation (2253, 84%), pleasure-focus (1887, 71%), phosphodiesterase inhibitors (1655, 62%), clinical counselor (1603, 60%), vacuum erectile device (1418, 53%) and intracavernosal injections (1383, 52%). Biopsychosocial programs are evolving to be a key part of prostate cancer survivorship. This study's insight suggests that prostate cancer survivors require education around their sexual consequences and psychosexual counseling alongside proven biomedical strategies for erectile dysfunction. Cancer survivorship programs should integrate educational and psychosocial strategies alongside biological strategies for prostate cancer survivors and their partners.

Penile shortening complaints in males with erectile dysfunction: a narrative review on penile lengthening procedures during penile prosthesis surgery.

Patients complaining of short penile length pose a challenge in urology practice. Those men who present seeking penile lengthening surgery usually overestimate 'normal' penile length, and may in often cases relate their penile length with the degree of masculinity and self-esteem. Penile prosthetic devices are the gold standard treatment of erectile dysfunction (ED) after failure of conservative options. Penile shortening is the most prevalent long-term complaint after successful inflatable penile prosthesis (IPP) placement. This has a significant impact on patient’s overall satisfaction and quality of life. Using PubMed, we performed a thorough literature review of the current procedures of preservation or enhancement of penile length as well as reported perioperative protocols in patients undergoing penile prosthesis (PP) insertion. Keywords used were “penile lengthening”, “penile enhancement”, “penile girth”, “inflatable penile prosthesis” and “glans augmentation”. Several surgical techniques can be offered in the setting of penile shortening concurrently with PP insertion, e.g., sub-coronal approach of PP placement, sliding technique, modified sliding technique (MoST), multiple-slide technique (MuST), and tunica mesh expansion procedure (TMEP). Adjuvant techniques can also improve subjective penile length include, ventral phalloplasty, suprapubic lipectomy, suspensory ligament release and use of expanding penile implants. Preoperative protocols including use of a vacuum erectile device, traction therapy also seem to improve postoperative outcomes, minimizing postoperative pain, and encouraging the early device use. Currently, there is no consensus among experts on a particular lengthening procedure or when they can be performed to optimize outcomes. Furthermore, it is imperative to set proper expectations before surgery, with extensive patient and partner counseling. When used in the properly selected patient, penile lengthening procedures show promising results with minimal complication rates.

Assessment of Combination Therapies vs Monotherapy for Erectile Dysfunction

Combining 2 first-line treatments for erectile dysfunction (ED) or initiating other modalities in addition to a first-line therapy may produce beneficial outcomes. To assess whether different ED combination therapies were associated with improved outcomes compared with first-line ED monotherapy in various subgroups of patients with ED. Studies were identified through a systematic search in MEDLINE, Cochrane Library, and Scopus from inception of these databases to October 10, 2020. Randomized clinical trials or prospective interventional studies of the outcomes of combination therapy vs recommended monotherapy in men with ED were identified. Only comparative human studies, which evaluated the change from baseline of self-reported erectile function using validated questionnaires, that were published in any language were included. Data extraction and synthesis were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. A meta-analysis was conducted that included randomized clinical trials that compared outcomes of combination therapy with phosphodiesterase type 5 (PDE5) inhibitors plus another agent vs PDE5 inhibitor monotherapy. Separate analyses were performed for the mean International Index of Erectile Function (IIEF) score change from baseline and the number of adverse events (AEs) by different treatment modalities and subgroups of patients. A total of 44 studies included 3853 men with a mean (SD) age of 55.8 (11.9) years. Combination therapy compared with monotherapy was associated with a mean IIEF score improvement of 1.76 points (95% CI, 1.27-2.24; I2 = 77%; 95% PI, -0.56 to 4.08). Adding daily tadalafil, low-intensity shockwave therapy, vacuum erectile device, folic acid, metformin hydrochloride, or angiotensin-converting enzyme inhibitors was associated with a significant IIEF score improvement, but each measure was based on only 1 study. Specifically, the weighted mean difference (WMD) in IIEF score was 1.70 (95% CI, 0.79-2.61) for the addition of daily tadalafil, 3.50 (95% CI, 0.22-6.78) for the addition of low-intensity shockwave therapy, 8.40 (95% CI, 4.90-11.90) for the addition of a vacuum erectile device, 3.46 (95% CI, 2.16-4.76) for the addition of folic acid, 4.90 (95% CI, 2.82-6.98) for the addition of metformin hydrochloride and 2.07 (95% CI, 1.37-2.77) for the addition of angiotensin-converting enzyme inhibitors. The addition of α-blockers to PDE5 inhibitors was not associated with improvement in IIEF score (WMD, 0.80; 95% CI, -0.06 to 1.65; I2 = 72%). Compared with monotherapy, combination therapy was associated with improved IIEF score in patients with hypogonadism (WMD, 1.61; 95% CI, 0.99-2.23; I2 = 0%), monotherapy-resistant ED (WMD, 4.38; 95% CI, 2.37-6.40; I2 = 52%), or prostatectomy-induced ED (WMD, 5.47; 95% CI, 3.11-7.83; I2 = 53%). The treatment-related AEs did not differ between combination therapy and monotherapy (odds ratio, 1.10; 95% CI, 0.66-1.85; I2 = 78%). Despite multiple subgroup and sensitivity analyses, the levels of heterogeneity remained high. This study found that combination therapy of PDE5 inhibitors and antioxidants was associated with improved ED without increasing the AEs. Treatment with PDE5 inhibitors and daily tadalafil, shockwaves, or a vacuum device was associated with additional improvement, but this result was based on limited data. These findings suggest that combination therapy is safe, associated with improved outcomes, and should be considered as a first-line therapy for refractory, complex, or difficult-to-treat cases of ED.

Early Penile Rehabilitation with a Vacuum Erectile Device in Patients Undergoing Robotic-Assisted Radical Prostatectomy

Purpose: This aim was to study the efficacy of a vacuum erectile device (VED) in rehabilitating the erectile function of patients undergoing nerve-sparing robotic-assisted radical prostatectomy. Materials and Methods: This prospective randomized study enrolled 35 prostate cancer patients from Thailand who had intact baseline erectile function and underwent nerve-sparing robotic-assisted radical prostatectomy. These patients were randomly assigned into either a study group which applied the VED for 10 min daily for 6 months or a control group which received no additional interventions. A 5-item version of the International Index of Erectile Function (IIEF-5) score, stretched penile length, and midshaft circumference were measured at 1, 3, and 7 months after surgery, respectively. Results: The mean patient age was 65.6 years, and the mean baseline IIEF-5 score was 22.91, which were comparable between the two groups. Three patients in the study group did not follow the VED protocol due to postoperative urinary incontinence. A per-protocol analysis revealed that the mean IIEF-5 score at 7 months was significantly higher in the study group compared to the control group (11.29 ± 7.47 vs. 6.61 ± 5.33, P = 0.047). The mean midshaft circumference was also higher in the study group (9.24 ± 1.43 cm vs. 7.91 ± 0.37 cm, P = 0.002). No statistically significant difference in the mean stretched penile length between the two groups was found. Conclusion: Early VED usage for penile rehabilitation following radical prostatectomy significantly improves IIEF-5 score and better preserves penile circumference but not penile length. A larger-scale multi-institutional study is required to validate these findings.

HP-3-3 Early Penile Rehabilitation With Vacuum Erectile Device in Patients Undergoing Robotic-Assisted Radical Prostatectomy

HP-3-3 Early Penile Rehabilitation With Vacuum Erectile Device in Patients Undergoing Robotic-Assisted Radical Prostatectomy

MP84-14 VACUUM ERECTILE DEVICE TREATMENT FOR ERECTILE DYSFUNCTION AFTER CAVERNOUS NERVE INJURY: NOVEL MECHANISM

INTRODUCTION AND OBJECTIVE:Vacuum Erectile Device (VED) therapy is a common method used in penile rehabilitation (PR) for improving spontaneous erectile function and penile size after radical prost...

036 A Trial of Low-Intensity Shockwave Therapy for Penile Rehabilitation After Radical Prostatectomy

Erectile dysfunction (ED) is a common complication of radical prostatectomy, usually due to nerve damage. Low-intensity shockwave therapy (LISWT) is an encouraging new treatment for men with vasculogenic ED, but the role of LISWT in the post-prostatectomy setting is unknown, as existing LISWT trials excluded men who underwent prostatectomy. Interestingly, rat models of cavernosal nerve injury suggest LISWT may restore penile blood flow via revascularization and neuronal regeneration. We hypothesize that LISWT-based penile rehabilitation will accelerate recovery of erectile function following nerve-sparing radical prostatectomy. To evaluate the hypothesis that PDE5i therapy combined with LISWT, delivered early in the post-prostatectomy period, will lead to more rapid recovery of erectile function compared to men treated with PDE5i alone. This is an interim analysis of an IRB approved, non-randomized trial of LISWT for penile rehabilitation. Patients were identified for inclusion if their pre-operative sexual health inventory for men (SHIM) score was ≥ 17 and they underwent a bilateral nerve-sparing prostatectomy at our academic referral hospital. Exclusion criteria included: concurrent use of intracavernosal injections or vacuum erectile device; or Gleason Grade Group ≥ 4 disease. Men were enrolled in either the LISWT arm (intervention) or the PDE5i only arm (control) at their own discretion. Beginning two weeks post-operatively, intervention patients received six consecutive LISWT sessions delivered once weekly using the Zimmer enPuls 2.0 device. During each session, settings were 90 mJ and 15 Hz to deliver a total of 10,000 “shocks” distributed to the corpora and cavernosal neurovascular bundles bilaterally. SHIM and erection hardness score (EHS) surveys were mailed to both cohorts at 6, 12, and 24-weeks post-operatively. All patients were prescribed a PDE5i at the discretion of their treating surgeon.

Efficacy of a preprostatectomy multi-modal penile rehabilitation regimen on recovery of postoperative erectile function.

To evaluate the efficacy of a novel, multi-modal, preoperative approach to postprostatectomy penile rehabilitation (PR), we performed a retrospective review of patients who underwent nerve-sparing robotic-assisted laparoscopic prostatectomy (NS-RALP). All patients were evaluated at a comprehensive, academic sexual medicine clinic between 2016 and 2017. The "prehabilitation" PR group (n = 106) consisted of men who were seen in the pre-op period and began tadalafil and L-citrulline 2 weeks prior to surgery. Vacuum erectile device (VED) therapy was started at 1-month post-op. These interventions were continued throughout the 12-month follow-up period. Individuals refractory to these therapies could start treatment with intracavernosal injections. The postprostatectomy PR group (n = 25) consisted of men who were not seen in the pre-op period and started the above therapies immediately following their first visit. A higher percentage of men in the prehabilitation group reported return of erectile function within 12 months (56% vs. 24%, P = 0.007). The prehabilitation group also showed better compliance with PR (PDE5i [96% vs. 64%, P < 0.001], L-citrulline [93% vs. 49%, P < 0.001], and VED [55% vs. 20%, P < 0.001]). Seventy-eight percent of men who attended 4-5 follow-up visits reported return of erectile function. Our results suggest that men undergoing a preoperative protocol show superior recovery of erectile function following NS-RALP. Further studies with prospective designs are warranted.

Vacuum therapy prevents corporeal veno-occlusive dysfunction and penile shrinkage in a cavernosal nerve injured rat model.

Erectile dysfunction and penile shrinkage are the common complications after radical prostatectomy. Penile rehabilitation is widely applied after the surgery. Vacuum therapy is one of the three penile rehabilitation methods used in the clinical setting, but its mechanism is not well known. This study was designed to investigate whether vacuum erectile device (VED) can prevent corporeal veno-occlusive dysfunction and penile shrinkage in the bilateral cavernous nerve crush (BCNC) rat model. Adult male Sprague–Dawley rats were randomly assigned into three groups: sham group, BCNC group, and BCNC + VED group. After 4 weeks, penile length and intracavernosal pressure (ICP) were measured, and then the middle part of the penis was harvested after dynamic infusion cavernosometry to complete the following items: smooth muscle/collagen ratios and collagen I/III ratios; ultramicrostructure of the tunica albuginea, endothelial cell, and smooth muscle cell; and the expression of calponin-1 and osteopontin. The penile shortening, peak ICP and ICP drop rate after alprostadil injection were significantly improved with vacuum therapy after 4-week treatment. Compared with BCNC group, VED significantly increased smooth muscle/collagen ratios, decreased collagen I/III ratios, and preserved the ultramicrostructure of the tunica albuginea, endothelial cell, and smooth muscle cell. The data also showed that animals exposed to VED could partially reverse the expression of calponin-1 and osteopontin induced by BCNC. In conclusion, vacuum therapy is effective to prevent penile shrinkage and veno-occlusive dysfunction in penile rehabilitation, which may be associated with well-preserved structure and function of the tunica albuginea, endothelial cell, and smooth muscle cell.