Vacuum Erection Device Research Articles

Intracavernosal mesenchymal stem cell therapy in ischaemic priapism: an experimental study.

The most common form of priapism is ischaemic and its prevalence in men has increased in recent years as a result of intracavernosal drug use. Currently, there is no approved specific treatment for ischaemic priapism other than cavernosal aspiration, which can only provide detumescence. This study aims to evaluate the efficacy of intracavernosal mesenchymal stem cell (MSC) therapy in an ischaemic priapism model. Thirty male Wistar albino rats were divided into three groups: sham (n = 6), priapism (n = 12) and priapism + MSC treatment (n = 12). The experimental groups were also divided into 1 and 12h subgroups of ischaemic priapism. The experimental model was created using a vacuum erection device and constrictive tape technique, and intracavernosal MSC were applied immediately after the tape was removed. After 4weeks, intracavernosal pressures (ICPs) and systemic mean arterial pressure (MAP) were measured. Penectomy was then performed to assess histopathological and molecular changes in the rats' penile tissues. In the ischaemic priapism model, MSC therapy showed significant improvements in peak and mean ICPs and mean ICP/MAP ratio. Histopathological analysis showed significant increases in smooth-muscle/collagen ratio and e-NOS and n-NOS expression. Although there was a decrease in fibrosis, it was not significant. At the molecular level, there were significant decreases in TGF-beta and VEGF mRNA expression, whilst NGF and BDNF mRNA-expression levels showed significant increases with MSC therapy. In terms of ICPs, the therapy showed more significant improvements in short-term priapism. However, when looking at histopathological and molecular parameters, the therapy had positive effects on a wider range of parameters in the long-term priapism. MSC treatment improved cavernosal physiology and had positive effects at the histopathological and molecular level in the ischaemic priapism model.

Assessing Attitudes and Confidence in Managing Erectile Dysfunction Among Urology, Internal Medicine, and Family Medicine Providers

ObjectiveTo assess and contrast attitudes and confidence regarding erectile dysfunction (ED) treatment among urologists (GU) and primary care providers (PCPs), identifying areas for collaboration, practice improvement, and additional training to enhance men's healthcare (MH) quality and access. MethodsAn anonymous survey with 25 questions on ED treatment, rated on a 5-point Likert scale, was conducted among our institution's providers in GU, internal medicine (IM), and family medicine (FM). Data were analyzed using descriptive statistics and Fisher’s exact test. Results138 providers responded, including 58 IM, 47 FM, and 33 GU. FM and IM responses generally overlapped with some differences. IM were more positive regarding vacuum erection device (VED) and inflatable penile prosthesis (IPP) satisfaction and risk.Comparing GU to FM + IM, GU displayed greater confidence and knowledge about ED. Notably, 63% of GU used the validated International Index of Erectile Function (IIEF) compared to 3% of FM + IM. Additionally, 100% of GU strongly/agreed that good options remained after pills failed vs 83% of FM + IM.Significant differences in GU vs FM + IM perspectives on IPP included patient willingness to undergo surgery for ED (67% vs. 12%), patient satisfaction (91% vs. 28%), partner satisfaction (79% vs. 26%) and willingness to recommend/repeat surgery (82% vs. 17%). Notably, 82% of GU vs 10% of FM + IM were aware that Medicare covered implants. ConclusionThis survey reveals significant knowledge gaps in ED treatment between GU and PCPs. Targeted provider education, particularly about penile prostheses, could optimize patient care.

Vacuum Erection Device Plus Once-Daily Tadalafil Improve Clinical Outcomes after Extracorporeal Shock Wave Therapy in Men Affected by Erectile Dysfunction Associated with Peyronie's Disease.

The purpose of this study is to examine the combination of the mechanical effects of penile therapy with vacuum erection devices (VEDs) plus PDE5i, which improve clinical outcomes after extracorporeal shockwave therapy (ESWT) in men affected by erectile dysfunction (ED) associated with Peyronie's disease (PD). A total of 153 medical records of patients affected by PD in stable stage with ED and treated with ESWT were divided into two groups. Group A (GA) included 72 men treated with ESWT, mechanical stretching with VEDs and PDE5ì (Tadalafil 5 mg), and Group B (GB) included 81 men who received only ESWT plus Tadalafil 5 mg with the same protocol of GA. The patients in both groups were assessed at baseline and follow-up for erectile function, painful erections, penile plaque size, and penile curvature. The results were evaluated at baseline and 3, 6, and 12 months after the treatments. Three months after the treatment, GA patients had a reduction in penile curvature degree from a mean ± SD of 33.91 ± 8.34° at baseline to a mean ± SD of 19.46 ± 7.15° after 12 months, whereas pain in an erection or during intercourse was resolved completely in 88.9% of the patients. The mean ± SD IIEF-15 score of patients affected by severe/moderate ED further improved significantly in the GA group (p < 0.001) after 3, 6, and 12 months of treatment. There were no permanent adverse sequelae after treatments. The regular use of a VED plus Tadalafil in patients who had undergone ESWT significantly provided more benefit in patients with PD in terms of penile deformity, pain, and erectile function.

Pharmacological Treatments for Erectile Dysfunction in Diabetic Patients: Efficacy, Safety, and Emerging Therapies

Men with diabetes mellitus, particularly those with type 2 diabetes (T2DM), are known to experience erectile dysfunction (ED), a condition whose prevalence has risen to 75% in recent years. The pathophysiology of ED in diabetic patients involves vascular impairment, neuropathy, hormonal dysregulation, and chronic hyperglycemia, all of which contribute to endothelial dysfunction, reduced nitric oxide availability, and nerve damage. Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, tadalafil, and vardenafil, are the first-line pharmacological treatments for ED, though their efficacy is reduced in diabetic patients due to the extent of vascular and neurological damage. Other treatments, including testosterone replacement therapy (TRT), intracavernosal injections, and vacuum erection devices (VEDs), provide alternatives for patients unresponsive to PDE5 inhibitors. Emerging therapies such as low-intensity extracorporeal shockwave therapy (LI-ESWT) and regenerative medicine approaches, including stem cell and platelet-rich plasma (PRP) injections, show potential in improving erectile function in diabetic patients. Glycemic control plays a critical role in both preventing ED and enhancing the efficacy of treatments by improving vascular function and reversing nerve damage. This review was conducted through an extensive analysis of current literature on pharmacological and emerging treatments for ED in diabetic patients. In conclusion, integrating traditional pharmacotherapy with emerging treatments and emphasizing glycemic control holds promise for optimizing ED management in diabetic patients. Keywords: Erectile Dysfunction (ED), Diabetes Mellitus (T2DM), Phosphodiesterase Type 5 (PDE5) Inhibitors, Testosterone Replacement Therapy (TRT), Glycemic Control

Efficacy of a new vacuum erection device (Vigor 2020) for erectile dysfunction: A retrospective study in Japan.

The vacuum erection device (VED) is a second-line treatment tool recommended in erectile dysfunction (ED) guidelines but has long been unavailable in Japan. A new VED, Vigor 2020® (A & HB Company Limited, Tokyo, Japan), has now been manufactured and received medical approval from the Pharmaceuticals and Medical Devices Agency in Japan. We conducted a retrospective observational study of ED patients who used Vigor 2020 in clinical practice. We analyzed male ED patients aged ≥20 years treated with Vigor 2020 in our outpatient clinics. The primary endpoint was improvement of erection as evaluated by an Erection Hardness Score (EHS) of ≥1 point. Secondary endpoints were improvement of sexual function and adverse events as evaluated by the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD). Thirty-three patients (mean age, 57.21 [27-86] years) could be evaluated before and after using Vigor 2020. Among the 16 patients with baseline EHS ≤2, 14 (93.33%) improved by ≥1 point, and 10 of these 16 patients (62.50%) improved to EHS ≥3 and could insert vaginally. Significant improvement was observed for IIEF total score and for the MSHQ-EjD in patients with an EHS of ≥3 after use of Vigor 2020. No patient experienced significant adverse events. The Vigor 2020 may be an efficacious treatment tool for ED. Patients with significant ED experienced not only significant improvement of erection but also improvement of ejaculation with its use.

Efficiency of Early Penile Rehabilitation on Erectile Function Recovery after Open Radical Prostatectomy

Prostate cancer (PC) is one of the most commonly diagnosed malignancies worldwide and the second leading cause of mortality among men (1). Nowadays, radical prostatectomy is considered the primary therapeutic modality for treating patients with localized PC (stage pT2), providing a five-year survival rate of nearly 100% (2). Sexual dysfunction in men associated with PC treatment encompasses three distinct entities: erectile dysfunction (ED) and penile shortening; ejaculatory and orgasmic dysfunction; and psychosexual dysfunction, which pertains to sexual desire, intimacy, and mental health (3). Penile rehabilitation (PR) is defined as the use of any intervention or combination of procedures aimed not only at achieving an erection sufficient for satisfactory sexual intercourse but also at restoring erectile function to its preoperative level (4). Despite eff orts to preserve the neurovascular bundle during radical prostatectomy, ED remains a common outcome. Although prevalence rates of ED after the procedure vary widely, recent studies report rates as high as 85% (5). This is primarily due to the lack of control over factors that significantly influence the erection recovery, such as the patient’s age, preoperative erectile function, comorbidities, surgical approach (open, laparoscopic, or robot-assisted), surgical technique (non-, uni-, or bilateral nerve-sparing), and the surgeon’s skills and experience. The pathophysiology of postoperative ED is multifactorial. The primary mechanisms are believed to be damage to the cavernous nerves, whether through dis-section or neuropraxia, and vascular injury, which includes damage to the accessory pudendal arteries, hypoxia and fibrosis of the endothelium and smooth muscle, resulting in penile shortening (6-8). Although there is no consensus on the optimal approach to PR, accepted modalities include the use of phosphodiesterase type 5 inhibitors (PDE-5i; such as sildenafil, vardenafil, tadalafil) and vacuum erection de-vices (VED) or vacuum constriction devices (VCD) as first-line therapies. Second-line treatments involve prostaglandin E1 preparations for intracavernous, or intraurethral (MUSE – “Medicated Urethral System for Erection”) administration. The final therapeutic option is the implantation of penile prostheses (3-10).

Prevalence and Interventions for Behavioral Pathology in Spinal Cord Injury

AbstractSpinal cord injury (SCI) represents a significant life event for an individual, encompassing physiological, psychological, and social changes. The potentially traumatic or distressing nature of acquiring an SCI and the associated life changes that ensue following an injury can increase the risk of mental health concerns. This review aimed at identifying prevalence of behavioral pathologies and interventions following SCI across the world. To identify the articles of interest for this review, the search was narrowed by using the combination of search terms as follows: “Spinal Cord Injury”, “Depression,” “Anxiety,” “Psychological Impact,” “Quality of life,” and “Sexual dysfunction.” Prevalence of depression and anxiety was noted to be in the range of 7 to 47.7%. SCI patients were also commonly seen to be associated with sexual dysfunction. The pharmacological interventions included drugs such as phosphodiesterase inhibitors like sildenafil and tadalafil, whereas certain studies also mentioned a few devices like the penile vibratory stimulation and electroejaculation and vacuum erection devices. Apart from empowering and educating healthcare providers, neuromodulation has been shown to be an efficient treatment. Patients with SCIs have a suicide rate that is two to six times greater than that of general population. Effects of mindfulness on functional limitation and quality of life were promising. Guided Internet-delivered cognitive behavioral therapy showed improvement in depression and anxiety symptoms with appreciable adherence to therapy programs. Hyperbaric oxygen therapy showed improvement in depressed SCI patients.

Patient out-of-pocket costs for guideline-recommended treatments for erectile dysfunction: a medicare cost modeling analysis.

Patient out-of-pocket (OOP) cost represents an access barrier to erectile dysfunction (ED) treatment. We determined OOP cost for men with ED covered by Fee-for-Service Medicare. Coverage policies were obtained from the Medicare Coverage Database for treatments recommended by the 2018 American Urological Association (AUA) guidelines. OOP cost was retrieved from the 2023 Centers for Medicare & Medicaid Services Final Rule. OOP cost for treatments without Medicare coverage were extracted from GoodRx® or literature and inflated to 2022 dollars. Annual prescription costs were calculated using the published estimate of 52.2 yearly instances of sexual intercourse. Medicare has coverage for inflatable penile prostheses (IPP; strong recommendation), non-coverage for vacuum erection devices (VED; moderate recommendation) and phosphodiesterase type-5 inhibitors (PDE5i; strong recommendation), and no policies for intracavernosal injections (ICI; moderate recommendation), intraurethral alprostadil (IA; conditional recommendation), or low-intensity extracorporeal shock wave therapy (ESWT; conditional recommendation). Annual IA prescription is most costly ($4022), followed by ICI prescription ($3947), one ESWT course ($3445), IPP ($1600), PDE5i prescription ($696), and one VED ($213). PDE5i and IPP, both strongly recommended by AUA guidelines, are associated with lower OOP cost. Better understanding of patient financial burden may inform healthcare decision-making.

Multimodal treatments based on Tadalafil during acute phase of Peyronie's disease: experience at two referral academic centers.

The purpose of this study is to identify the clinical outcomes of patients during acute phase of Peyronie's disease (PD) treated with daily Tadalafil 5mg associated with non-surgical treatments such as intra-plaque verapamil injections (IVI), vacuum erection devices (VED) or extra corporeal shockwave therapy (ESWT). 445 patients with PD in acute stage were treated as it follows: Group 1(G1) 117 men with only Tadalafil 5mg once a day for 3months; Group 2(G2) 106 men with IVI plus Tadalafil 5mg for a period of 12weeks; Group 3(G3) 124 men that received ESWT for 6weeks plus Tadalafil with the same protocol of G1; Group 4(G4) 98 men with VED plus Tadalafil 5mg for 3months. There were assessed at baseline and follow-up: Erectile dysfunction (ED), presence and severity of painful erections, penile plaque size and penile curvature degree. The results were evaluated at baseline and 3,6,12months. Not statistically significant differences emerged between the two groups at baseline, except for higher presence of patients with ED in in G3(7.4%) vs other groups(p < 0.001). Three months after the treatment in G3 men had a significant reduction of penile curvature degrees after 1year by treatments, whereas pain in an erection or during intercourse was resolved completely in 75% of the patients. Our study highlights that multimodal therapy has beneficial long-term effects not only in the decrease of ED symptoms, but also in the relief of the penile curvature and the quality of life.

Current treatment options for erectile dysfunction in kidney transplant recipients.

Erectile dysfunction (ED) and kidney dysfunction share common risk factors linked to conditions involving endothelial impairment, such as coronary artery disease, dyslipidemia, diabetes mellitus, hypertension, smoking, and obesity. Men with chronic kidney disease experience a high incidence and prevalence of ED. While a functional renal graft can alleviate the issue for some patients, a significant portion of recipients still experience ED (20%-50%). This narrative review describes the variety of current treatments modalities on ED in kidney transplant recipients (KTRs) and their clinical outcomes. MEDLINE, Web of Science, PubMed, and Google Scholar were used to find eligible articles pertaining to the treatment options of ED in KTRs. A total of 64 articles were evaluated. In KTRs, ED stems from a multifaceted etiology: anxiety, drug side effects, interference with penile vascularity, or the response of cavernosal muscle to neurotransmitters, along with changes in the endocrine milieu. A diverse range of treatments to restore erectile function has proven to be safe and effective for KTRs. Options include drug therapy, surgical interventions, intracavernosal injection therapies, vacuum erection devices, and extracorporeal shockwave therapy. The initial treatment approach may involve the use of a phosphodiesterase type 5 inhibitors at a low dosage, especially if testosterone-circulating levels align with the diagnosis of hypogonadism. The consideration of a combination therapy involving testosterone and phosphodiesterase type 5 inhibitors should be contemplated due to the associated beneficial effects. Extracorporeal shockwave therapy has shown positive short-term clinical and physiological effects on erectile function in patients who did not respond to first-line treatments, resulting in spontaneous erections sufficient for sexual penetration in 50% of cases. Penile implants should be considered as third-line options based on specific patient needs and compliance with clinical conditions.

A contemporary systematic review of penile lengthening procedures with penile prosthesis.

Penile prosthetic devices are the standard treatment for erectile dysfunction (ED) after failure of maximum medical therapy and conservative options. Several penile lengthening procedures (PLPs) can be performed concurrently with penile prosthesis (PP) insertion in patients with severe ED, penile shortening, and/or Peyronie's disease to help combat negative emotional and psychological concerns from penile length loss with penile prosthetic device placement. An extensive, systematic literature review of the various pre-, intra-, and post-operative techniques that can be applied to preserve, restore or enhance penile length at the time of penile prosthetic implantation. Numerous pre-operative and post-operative inflation protocols exists with vacuum erection devices and penile traction therapy. Intraoperative surgical techniques include cavernosal sparing and channeling without dilatation, subcoronal incision with circumferential penile degloving and grafting, the sliding technique, the modified sliding technique, the multiple-slit technique, the tunical expansion procedure (TEP), modified TEP, and the auxetic expansion procedure. These approaches can be meaningful to restore and/or preserve length for patients undergoing PP insertion. PLPs can be performed by surgeons who have extensive penile reconstruction experience and have been trained to do these procedures, as there is significant risk to the patient and limitations to what can be expected. Each patient must be counseled in detail about the risks and benefits of these procedures and have their expectations managed as the average postoperative penile length recovery is around 3 cm and can range from 0-4.0 cm. Future research is needed to identify the appropriate candidate for each approach, and how much length gain the patient can expect.

Cosmetic penile enhancement procedures: an SMSNA position statement.

Penile cosmetic enhancement procedures have been performed for many years with varying success. However, they have historically been relegated to niche areas of sexual medicine, with limited data, and have not achieved mainstream adoption. More recently, the topic has been increasingly discussed within academic congresses due to availability of novel techniques, therapies, and procedures. Given their distinctive nature, the Sexual Medicine Society of North America (SMSNA) felt that it was pertinent to develop formal position statements to help guide both patients and sexual medicine providers on the current state of the scientific literature and to give recommendations for future research. The study sought to provide an evidence-based set of recommendations for injection and surgical procedures designed to lengthen, augment, or otherwise cosmetically enhance the penis. A review was performed of all scientific literature listed in PubMed from inception through December 2023 relating to penile cosmetic enhancement procedures. Only invasive (injection/surgery) therapies were included due to their distinct risk-benefit profile compared with more conservative treatments (eg, vacuum erection devices, penile traction devices). Similar therapies were categorized, with pertinent data summarized and used to help create relevant position statements. All statements were expert opinion only and were based on analyses of the potential risks and benefits of the specific therapies. A total of 6 position statements were issued relating to 5 distinct sexual medicine cosmetic enhancement procedures. A consensus opinion was reached by SMSNA leadership on the state of injection/surgical penile cosmetic enhancement procedures as of 2024. Key topic areas addressed included injectable soft tissue fillers, suspensory ligament division, graft-and-flap procedures, silicone sleeve implants, and sliding/slicing techniques. Distinct recommendations were tailored to each therapy and were based solely on the current state of the literature. It is anticipated that future studies will further inform position statements and will lead to ongoing modifications. The current position statements provide both patients and clinicians evidence-based, expert recommendations on best practices relating to penile cosmetic enhancement procedures. Strengths include the use of an expert panel of sexual medicine clinicians, consensus design, and summary of existing literature. Limitations include expert opinion and limited research on the topic. The current SMSNA position statements provide evidence-based, consensus opinions on the appropriate role for penile augmentation and cosmetic procedures in 2024.

(PM-04) EFFECTS OF VIBRATORY STIMULATION AND VACUUM ERECTION DEVICE IN THE TREATMENT OF MALE SEXUAL DYSFUNCTIONS: A LITERATURE REVIEW

Abstract Introduction Erectile dysfunction, premature ejaculation, retrograde ejaculation, delayed ejaculation, anejaculation, painful ejaculation, anorgasmia, hematospermia and low sexual desire are the main male sexual dysfunctions. The 2022 European Association of Urology recommends the use of vibratory stimulation and vacuum erection devices in the treatment of male sexual dysfunctions (mainly anejaculation and erectile dysfunction), both as adjuvant therapy and as combination therapy with other interventions. The objective of the study was to verify if there is scientific evidence for the use of vibrating stimulation and the vacuum erection device in male sexual dysfunctions that allow clinical indication in an effective and safe manner. Methods Literature review by searching for scientific articles in the Pubmed database of the National Library of Medicine published in the last 10 years, including randomized clinical trials, meta-analysis studies, pilot studies, systematic literature reviews and guidelines. Results As a result 1,230 articles on male sexual dysfunction. After screening, 16 studies were selected that are part of this research, seven articles on vibratory stimulation and nine on vacuum erection devices. Conclusion This review suggests that vacuum erection and vibratory stimulation devices, as they offer low risk, minimal side effects, are accessible and cost-effective compared to other approaches, are promising devices for the non-invasive treatment of male dysfunctions. sex. Other studies with greater methodological rigor are needed. Descriptors Vibratory stimulation; sexual dysfunction; penis vibrator; male sexual dysfunction; vacuum erectile; vacuum erection; Peyronie's disease Financing No conflict.

(139) Efficacy of a New Vacuum Erection Device (Vigor 2020) for Erectile Dysfunction in a Retrospective Study in Japan

Abstract Introduction Phosphodiesterase 5 inhibitors (PDE5i) are the first-line treatment for erectile dysfunction (ED), but there is in approximately 30% of ineffective patients or contraindicated in patients taking nitrate medications. Although vacuum erection device (VED) is the second line in ED guidelines, they have long been unavailable in Japan, due to the withdrawal of their manufacturers. Objective A new VED, Vigor 2020, has now been manufactured and received medical approval by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It is very important to be able to sexual intercourse with VED, recommended in the ED guidelines. We conducted a retrospective observational study of patients with Vigor 2020 in clinical practice. Methods We analyzed male patients aged 20 years or older who presented to an outpatient clinic with ED and were treated with Vigor 2020 as a second-line treatment, because PDE5i was ineffective or contraindicated. Sexual and ejaculatory function were assessed using questionnaires [Erection Hardness Score (EHS), International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD), the numerical rating scale (NRS)]. Results There were 34 participants who could be evaluated before and after the use of Vigor 2020, with a mean age of 57.85 (27–86) years. Significant improvement in EHS and IIEF total score were observed with the use of Vigor 2020 in all participants. There was a significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 3 or higher after the use of Vigor 2020. But no significant improvement in MSHQ-EjD and NRS for participants who had an EHS of 2 or lower after the use of Vigor 2020. The participants experienced no significant adverse events. Conclusions Vigor 2020 may be one treatment tool for ED, as defined in the ED guidelines. There is not only significant improvement of erection with Vigor 2020 but also improvement of ejaculation in cases of significant erectile efficacy. Disclosure No.

(023) Mechanical Therapy After Inflatable Penile Prosthesis: A Scoping Review

Abstract Introduction While inflatable penile prosthesis (IPP) allows reliable axial rigidity, common complaints perceived are shorter penis and reduced glans engorgement. Pre-operative factors, such as vasculogenic erectile dysfunction (ED) or corporoglandular morphology, provide a convenient explanation. However, post-operative factors are more recently being interrogated. Post-IPP mechanical therapy protocols, like vacuum erection devices (VED), are being instituted to ameliorate these complaints. The physiological rationale is to improve perfusion of residual erectile tissues and limit cavernous fibrosis/pseudo-capsule formation. This has been hypothetically explained by upregulating endothelial nitrous oxide synthase release, decreasing hypoxia inducible factor and tissue growth factor 1. Post-IPP maximal inflation protocols similarly resulted in a more capacious and compliant tunica albuginea and capsule. Objective To assess the utility of post-IPP mechanical therapy in addressing common post-operative complaints and enhance prosthetic erection. Methods Intervention: Post-op mechanical therapy Population: Men with IPP for ED, with/without Peyronie’s disease (PD) Inclusion Criteria: Articles published in English with full-text available Search Strategy: Literature search was performed in June 2023 using Medline, PubMed, Embase and Scopus. PubMed search included “Mesh” protocols and “free text” to correctly capture study population. Articles relating to the intervention were identified with free text search searches (“VED,” “vacuum erection device,” “vacuum constriction device,” “penis pump,” “mechanical therapy,” or “rehabilitation”). Review Type &amp; Analysis: While a systematic model was initially adopted, a scoping model was ultimately chosen given the limited available literature &amp; variable outcome measures. In this way, we sought to identify knowledge gaps and scope of current literature to guide further studies in this field. Higher-powered analyses were not possible due to inter-study outcome measure variability. Results Initial search strategy retrieved 81 non-duplicate studies with 30 selected for initial screening after search limitations. Ultimately, 5 satisfied inclusion criteria after full-text review and were divided into 3 categories according to post-IPP protocol employed: Early activation (1), Maximal inflation (2,3) and VED (4,5) (Table 1). A common theme encountered was that mechanical therapy improved post-IPP penile length and girth, compared to immediate post-operative measurements. Only one study used a control group who had their device activated for the first time after 4 weeks. The intervention employed in this study was device activation immediately after surgery, left 80% inflated and deflated at 3 weeks, then full erection at night for 3 further weeks. Compared to the control, at maximum inflation, penile length mean was 3.28cm longer and circumference was 1cm greater. In each of these studies, the differences reported were statistically significant. This was also associated with an increased number of pumps required to achieve full inflation over time, irrespective of mechanical protocol used. Articles that reported IIEF-5 and EDITS scores demonstrated a statistically significant improvement over time with post-op intervention. Conclusions Within limits of the included studies, post-implantation mechanical therapy appears to be useful in improving penile dimensions and patient satisfaction over time. The correlation with increasing number of pumps implies that compliance of the tunica albuginea and residual cavernous tissue may play a role in the pathogenesis of shorter penis post-IPP. Further high-powered studies in this area are warranted. Disclosure No.

(025) Laparoscopic Assisted Reservoir Removal of an Infected Inflatable Penile Prosthesis in a Patient with Ipsilateral Inguinal Hernia Mesh Implant

Abstract Introduction Infection is a devastating complication of penile prosthesis implantation ranging from 0.33 to 11.4%. 1 Although a salvage procedure is an option in case of infection, the rule of thumb is to remove all device components. 2 Special considerations and pre-operative planning are essential for better outcome in the management of such condition. We are presenting a video case presentation demonstrating the use of laparoscopic assisted approach to aid in the extraction of the reservoir of an infected penile prosthesis from a patient who had ipsilateral inguinal hernia mesh implant Objective To demonstrate the feasibility and efficacy laparoscopic assisted approach in the removal of difficult to extract inflatable penile prosthesis (IPP) reservoir. Methods A 72-year-old gentleman with past medical history of Diabetes and hypertension presented to our clinic 3 weeks after an IPP insertion that was done in another center. He was complaining of right inguinal bulge and scrotal pain. The bulge developed suddenly without any preceding event. Examination confirmed a prosthesis reservoir herniation in to the right groin. Plan CT abdomen&amp; pelvis confirmed the diagnosis. In three days, the herniated reservoir was managed by inguinal exploration, repositioning of the same reservoir in the right Retzius space and posterior inguinal canal wall repair using a mesh. The patient was discharged on post-operative day 1 in a stable condition, but unfortunately, he developed persistent scrotal pain that progressed into an overt scrotal infection over the early follow up period. During the examination, a scrotal collection was observed, swap was taken from the draining pus and results showed moderate growth of pseudomonas aeruginosa. On the other hand, the inguinal scar showed good healing with no tenderness, indicating the presence of an intact and non-infected inguinal mesh. Therefore, the decision was made to remove all components of the prosthesis without removing the mesh. Considering the anticipated challenges associated with removing the reservoir of the IPP through a scrotal approach, a decision was made to incorporate an additional laparoscopic-assisted abdominal approach for reservoir removal. Results Removal of the IPP cylinders and pump was performed through a scrotal incision, then a laparoscopic assisted abdominal approach was used successfully to remove the reservoir. After the IPP explant procedure, patient had an uneventful smooth recovery at the two and four weeks follow up visits, he was advised to use Vacuum erection device (VED) to alleviate possible penile fibrosis/shortening. A penile prosthesis reimplantation procedure was planned in a 6 months period Conclusions Laparoscopic assisted approach for penile prosthesis reservoir extraction is a feasible and safe technique that can be used in anticipated cases of difficult reservoir extraction. Pre-operative assessment, planning and counselling are crucial in obtaining a favorable outcome in such complex cases. Disclosure No.

(312) Manhandling: Post-IPP Mechanical Therapy – A Scoping Review

Abstract Introduction While inflatable penile prosthesis (IPP) allows reliable axial rigidity, common complaints are perceived shorter penis and reduced glans engorgement. Pre-operative factors, such as vasculogenic erectile dysfunction (ED) or corporoglandular morphology, provide a convenient explanation. However, post-operative factors are more recently being interrogated. Post-IPP mechanical therapy protocols, like vacuum erection devices (VED), are being instituted to ameliorate these complaints. The physiological rationale is to improve perfusion of the residual erectile tissues and limit cavernous fibrosis or pseudo-capsule formation. This has been hypothetically explained by upregulating release of endothelial nitrous oxide synthase, decreasing hypoxia inducible factor  and tissue growth factor □1. Post-IPP maximal inflation protocols may similarly result in a more capacious and compliant tunica albuginea and capsule. Objective To assess the utility of post-IPP mechanical therapy in addressing common post-operative complaints and enhance prosthetic erection. Methods Intervention: Post-op mechanical therapy Population: Men with IPP for ED, with/without Peyronie’s disease (PD) Inclusion Criteria: Articles published in English with full-text available Search Strategy: Literature search was performed in June 2023 using Medline, PubMed, Embase and Scopus. PubMed search included both “Mesh” protocols and “free text” to capture the correct study population. Articles relating to the intervention were identified with free text search searches (“VED,” “vacuum erection device,” “vacuum constriction device,” “vacuum,” “penis pump,” “mechanical therapy,” or “rehabilitation”). Review Type &amp; Analysis: While a systematic model was initially adopted, a scoping model was ultimately chosen given the limited available literature and variable outcome measures. In this way, we sought to identify knowledge gaps and the scope of current literature to guide further studies in this field. Higher-powered analyses were not possible due to inter-study outcome measure variability. Results Initial search strategy retrieved 81 non-duplicate studies with 30 selected for initial screening after search limitations. Ultimately, 5 satisfied inclusion criteria after full-text review and were divided into 3 categories relating to the post-IPP protocol employed: Early activation (1), Maximal inflation (2,3) and VED (4,5) (Table 1). A common theme encountered was that mechanical therapy improved post-IPP penile length and girth, compared to immediate post-operative measurements. Only one study used a control group who had their device activated for the first time after 4 weeks. The intervention employed in this study was device activation immediately after surgery, left 80% inflated and deflated at 2-3 weeks, then full erection at night for 3-4 further weeks. Compared to the control, at maximum inflation, penile length mean was 3.28 cm longer and circumference was 1 cm greater. In each of these studies, the differences reported were statistically significant. This was also associated with an increased number of pumps required to achieve full inflation over time, irrespective of mechanical protocol used. Articles that reported IIEF-5 and EDITS scores also demonstrated a statistically significant improvement over time with post-op intervention. Conclusions Within limits of the included studies, post-implantation mechanical therapy appears to be useful in improving penile dimensions and patient satisfaction over time. The correlation with increasing number of pumps implies that compliance of the tunica albuginea and residual cavernous tissue may play a role in the pathogenesis of shorter penis post-IPP. Further high-powered studies in this area are warranted. Disclosure No.

(288) Trends in Penile Prosthesis Placement in Men with Erectile Dysfunction

Abstract Introduction Erectile Dysfunction (ED) is a common problem impacting 20% of all men. Current treatment options include oral medications, vacuum erection devices, intraurethral suppositories, intracavernosal injections, and penile prosthesis placement (PPP). A shared decision-making framework is increasingly utilized for treatment decisions where an appropriate treatment is selected from all options based on the values and priorities of the patient and their partner. Objective Our objective is to identify trends in PPP, including the proportion of patients who pursue PPP as an initial treatment as well as the time from ED diagnosis to PPP. Methods We retrospectively reviewed all men with an ED diagnosis based on ICD9/ICD10 codes using the IBM MarketScan insurance claims database. The initial treatment option processed through an insurance claim following an ED diagnosis was identified and categorized using ICD, HCPCS, NDC, J, and CPT codes. Time from ED diagnosis to PPP was also recorded. Only patients with at least one year of enrollment pre-ED diagnosis and with at least one year of follow-up were included. Linear regressions were performed to investigate the trends of each year based on the time of initial ED diagnosis. Results We identified a total of 670,096 patients diagnosed with ED between 2012-2019. The mean age was 56 years (47-62). Of those patients, 11% were smokers, 29% had diabetes, 24% had cardiovascular disease, 65% had hypertension, and 29% were obese. Among those who received treatment, the most common initial treatment was oral medications in 26% of patients. PPP was an initial treatment in &amp;lt;1% of patients. The proportion of patients who underwent this surgical intervention as an initial treatment significantly decreased from 2012-2019 (P&amp;lt;0.001) as patients utilized other initial treatment modalities more commonly. Over the same period, the time from ED diagnosis to PPP significantly decreased from approximately 500 days in 2012 to &amp;lt;200 days in 2019 (P=0.001). Conclusions Although the proportion of patients who utilize other ED treatment options prior to PPP is higher, patients diagnosed with ED more recently undergo PPP in a significantly shorter timeframe. Utilization of other treatment modalities as an initial treatment option may stem from changes in insurance coverage. Patients moving more quickly from an ED diagnosis to PPP is likely due to several factors, including improvements in the device leading to less mechanical and infectious complications, familiarity with the device due to marketing, and an earlier discussion with the physician about the device based on a shared decision-making model. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Inherent bio, Paterna bio, Firmtech, Turtle health, Maximus, Carrot.

(013) How do Sexual Medicine Specialists Handle Patient Counseling and Penile Rehabilitation in Patients Undergoing Robotic Assisted Radical Prostatectomy (ralp): Trends in Pre Op and Post Operative Management

Abstract Introduction Guidelines for Sexual Health Care for Prostate Cancer Patients: Recommendations of an International Panel has been published in Journal of Sexual Medicine in late 2022. However, evaluation and treatment in this subset of patients appears to be variable and not evidence driven. Objective The objective of our study was to poll sexual medicine specialists regarding their current evaluation and treatment of sexual dysfunction before and after RALP. Methods 22 sexual medicine specialists took a questionnaire at the time of the SMSNA/ISSM meeting in the fall of 2022. Queries were made regarding the demographics of the specialists, their pre operative evaluation, guidance and treatments, and the nature of their referral base. Information was also collected regarding pre operative questions about multiple sexual parameters such as ejaculation, penile curvature, erectile function, climacturia and any initiation of pre op therapies. Post operative questionnaire data included timing of initial evaluation, therapeutic recommendations and likelihood and timing of post operative recovery of function. Results 23 responses were collected. 100% of respondents were SMSNA members, 8 (34.8%) were ISSM members. 22 (95.7%) had a subspecialty practice in sexual medicine. 100% were located in North America. A majority of respondents (19/23, 82.6%) had between 2-10 prostate surgeons in their practice. 9 (39.1%) reported that those surgeons routinely sent patients for preoperative optimization; 4 (17.4%) reported that none did so. 7 (31.8%) regularly counseled patients preoperatively about the risk of ejaculatory pain, 11 (47.8%) about the risk of climacturia, 16 (69.6%) about the risk of penile length loss, 17 (73.9%) about the risk of significant erectile dysfunction, and 7 (30.4%) about the risk of penile curvature. 22 (95.7%) cautioned patients that they would most likely need medication to assist with erectile function postoperatively. For preoperative optimization, 12 (54.5%) respondents regularly recommend preoperative PDE5is, 7 (30.4%) regularly recommend a vacuum erection device, and 3 (13%) recommend pelvic floor rehabilitation. Postoperatively, 13 (56.5%) recommend a vacuum device postoperatively, another 3 (13%) sometimes do so, and 19 (82.6%) encouraged patients to start PDE5is immediately postoperatively. 19 (82.6%) continued PDE5is after 3 months without spontaneous erections. 17 (73.9%) recommended Tadalafil 5mg daily, others used Sildenafil at varying doses. 15 (65.2%) respondents believed that penile rehabilitation made a difference in outcomes at 2 years. Another 5 (21.7%) were unsure, but had enough data to continue with their protocol. Conclusions Despite new guidelines for evaluation and treatment of patients undergoing RALP, there appears to be diverse counseling, recommendations and treatment both preoperatively and postoperatively. Evidence based and expert opinion guidelines may alter pre operative counseling and treatment in the future. Disclosure No.

(229) A Pilot Study of a Novel PRP Protocol to Increase Penile Length, Girth, and Function

Abstract Introduction A study of a novel PRP protocol to increase penile length, girth, and function Intro: Various solutions have been utilized to increase penis size, including fillers, fat transfers, traction devices, suspensory ligament ligation, and silicon augmentation. None of these improve length, girth, function and are completely safe. PRP is an autologous source of growth factors. The RestoreX is a well-studied traction device. Vacuum erection devices provide a stimulus for circumferential penile growth. Nitric Oxide boosters improve blood flow and nighttime erections. Objective The P-Long Study aims to find a safe and reproducible way to increase the length, girth, and function of a normal male penis. Methods The study is IRB approved and patient consented. Inclusion criteria: healthy men aged 20 to 55 with normal erectile function (SHIM greater than 22) and no Peyronie’s Disease, previous penile interventions, or congenital penile issues. Measurement of penile length and girth were performed by the patient on an erect penis during self-stimulation at full tumescence with standard protocol and measuring instruments (transparent rigid ruler and flexible tape measure) and documented with digital images. No PDE-5 inhibitors or Trimix were used. Measurements were taken at baseline and once a month for six months. PRP was administered in the right and left corpora under ultrasound guidance once a month for six months using PureSpin double spin system (60cc blood drawn) Centrifuge technical data show an average platelet recovery of 84% and average concentration of 6.6 times that of the whole blood sample. Using this data, the injection of 10cc of PRP, assuming a starting platelet count of 250K/microliter, would contain approximately 1.65 billion platelets. Traction with RestoreX 20 minutes bid and suction with Joel Kaplan penis pump (pressure 5-10 for 12 minutes bid (1 minute x 2 and 5 minutes x 2.) Nitric Oxide boosting supplement (trade name AFFIRM) with a dose of 3 gm L-Citrulline and 1 gm beet extract (nitrate). Results 29 men have completed treatment. The mean age was 32 and mean baseline erect penile length was 5.70 and girth was 5.25. Erect penis length was 0.805 inch greater after six months from baseline (N=29, paired t-test t=13.641 p value=0.000). Circumference was 0.469 inch greater (N=29, paired t-test t=13.498 p value=0.000). Using a Likert scale, all participants reported better erectile function. Conclusions The P-Long Protocol is potentially a safe way to improve erect penile length 0.81 inches and girth 0.47 inches over a period of six months and subjectively improve function in a healthy penis. The P-Long Protocol does not require any synthetic injectables or foreign bodies or extensive penile traction. The P-Long Protocol ultrasound-guided PRP injection can be taught to urologists and sexual medicine practitioners. It does not preclude additional augmentation procedures and is potentially an acceptable first option for men interested in penile enhancement. This study provides a guide for expectations for growth for men using the protocol. The slope of the growth curve indicates possible continued growth with additional treatments. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.