Three-piece Inflatable Penile Prosthesis Research Articles

Advancements in ectopic reservoir placement for inflatable penile prostheses.

Traditional reservoir placement (RP) into the space of Retzius during three-piece inflatable penile prosthesis implantation has been associated with serious bladder, iliac vessel, and bowel complications, encouraging the development of "ectopic" RP methods. In this study we sought to document an up-to-date, comprehensive analysis of ectopic RP techniques regarding both patient satisfaction and clinical complications. A PubMed, Ovid MEDLINE, and Cochrane Library literature search of English language articles from 1966 to 2023 with keywords "inflatable," "penile prosthesis," "reservoir," and "placement" gave 179 publications, 70 of which were included in a comprehensive chronology and investigation after review. Overall, 12 retrospective studies detailing 9 ectopic RP techniques were compared for discussion. Sufficient data for comparison were found for 9 ectopic RP methods: posterior/anterior to transversalis fascia (PTF/ATF); high submuscular (HSM); HSM "Five-Step" technique (HSM-FST); lateral retroperitoneal (LR); sub-external oblique (SEO); direct vision, transfascial (DVT); low submuscular with transfascial fixation (LSM w/ TFF); and midline submuscular reservoir (MSMR). Although rare, serious complications have occurred with the use of ectopic RP techniques: 2 bladder perforations on implantation with PTF RP, a delayed bowel obstruction with HSM RP, and a colonic injury in a patient with a history of colon surgery with LR RP. Generally, herniation is the most relevant clinical complication in ectopic RP. At the time of this review there was no reported herniation with LR, SEO, LSM w/ TFF, or MSMR, likely due to fixation steps and/or reinforced spaces. Regarding patient satisfaction, HSM, HSM-FST, and LSM w/ TFF had similarly high rates of patient satisfaction while other techniques had no patient satisfaction data available. Importantly, reservoir palpability/visibility relates directly to patient satisfaction. Levels of palpability and/or visibility were reported in patients who underwent PTF/ATF, HSM, HSM-FST, SEO, and LSM w/ TFF, whereas no palpability was reported in patients who underwent LR, DVT, and MSMR. Proper comparison of ectopic methods is not possible without standardized patient surveys, consistent complication reporting, and larger sample sizes, indicating the need for a large, prospective, multisurgeon trial.

(393) Advancements in Ectopic Reservoir Placement for Inflatable Penile Prostheses

Abstract Introduction Traditional reservoir placement (RP) into the space of Retzius (SOR) during three-piece inflatable penile prosthesis (IPP) implantation has been associated with dire bladder, iliac vessel, and bowel complications, leading many surgeons to pioneer alternative, “ectopic” methods. Despite the extensive literature on ectopic RP, there is little direct comparison of these techniques to one another with respect to efficacy and/or safety. Objective To document an up-to-date, comprehensive analysis of ectopic RP techniques regarding both patient satisfaction and clinical complications. Methods A PubMed literature search of English language articles from 1986-2023 with keywords “inflatable,” “penile prosthesis,” “reservoir,” and “placement” gave 113 publications, 62 of which were included in a comprehensive chronology and investigation after abstract review (last updated 7/3/2023). Analysis of published data yielded 12 retrospective studies detailing 8 ectopic RP techniques that were included for comparison (Table 1). Results Of the ectopic RP methods explored, 8 have sufficient data for comparison: posterior & anterior to transversalis fascia (PTF & ATF); high submuscular (HSM); high submuscular ‘Five-Step’ technique (HSM-FST); lateral retroperitoneal (LR); sub-external oblique (SEO); direct vision, transfascial (DVT); low submuscular with transfascial fixation (LSM w/ TFF); and midline submuscular reservoir (MSMR). Although rare, serious complications have occurred in ectopic RP: PTF reports 2 bladder perforations on implantation, HSM reports a delayed bowel obstruction, and LR reports a colonic injury in a patient with a history of colon surgery. When unsure, a counterincision can be used to lower risk of violating fascial planes and causing visceral injury. Aside from these cases, herniation is the most relevant clinical complication in ectopic RP. There is no reported herniation with LR, SEO, LSM w/ TFF, or MSMR, likely due to fixation steps and/or reinforced spaces. Reports of newer ectopic strategies often have small sample sizes and limited follow-up which potentially under- or overestimate complication rates, indicating a need for more robust longitudinal study. In regards to patient satisfaction, HSM, HSM-FST, and LSM w/ TFF have high and similar rates of patient satisfaction while other techniques do not provide data. In addition to increased rates of reporting, a validated patient survey is needed to standardize comparison of efficacy and patient perspective between different techniques. Importantly, reservoir palpability/visibility relates directly to patient satisfaction. PTF & ATF, HSM, HSM-FST, SEO, and LSM w/ TFF report levels of palpability and/or visibility while LR, DVT, and MSMR have no reported palpability. Conclusions Without standardized patient surveys, consistency in complication reporting, and larger sample sizes, it is impossible to properly compare different ectopic methods. The prosthetic community needs a large, prospective, multisurgeon study comparing ectopic methods to each other, not just to SOR. Until such data is available, implanters should assess different methods in regards to their unique benefit and complication profiles, becoming experts in those that can best serve their patient population. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Consultant: AbbVie, Marius, Tolmar, Endo, Petros, Boston Scientific, Coloplast // Investor: Sprout.

Penoscrotal approach for inflatable penile prosthesis implant: why it should be preferred.

Inflatable penile prosthesis are the definitive treatment for erectile dysfunction. The two most used surgical approaches to position the implants are the penoscrotal and the infrapubic. Current trends showed that the penoscrotal approach is extensively preferred however, there is not conclusive evidence demonstrating the superiority of one technique over the other. The aim of this review is to summarize the scientific evidence available and to underline strengths and weaknesses of the two techniques. We conducted a comprehensive search of MEDLINE, Cochrane Library, and National Center for Biotechnology Information PubMed to identify relevant published articles. The included studies had to explicitly examine the use of three-piece inflatable penile prosthesis with a focus on the surgical access method and complications. Twenty-six articles were included in the review: seven narrative reviews, five retrospective observational studies, five prospective observational studies, and nine mixed methodology studies. The most frequent approach was the penoscrotal, which was also found more comfortable (RG1) by the operators in one study. The infrapubic approach lasts less and one study demonstrated higher satisfaction by the patients. There is no evidence of significant differences in complications among the penoscrotal and infrapubic approaches. While the infrapubic approach is faster and patients were more satisfied, the penoscrotal approach is the most used by far. This is likely related to the more straightforward procedure through this access and the excellent surgical field exposure. For these reasons, it is also preferred in the most complex cases.

Unforeseen outcome in hydrocele repair: Implications of three-piece inflatable penile prosthesis placement

Unforeseen outcome in hydrocele repair: Implications of three-piece inflatable penile prosthesis placement

Survival From Revision Surgery for New Rigicon Infla10 Three-piece Inflatable Penile Prosthesis Is Comparable to Preceding Devices

To report the incidence of the reoperation surgeries of nearly all the Rigicon Infla10 implants performed since device introduction in 1/2019. Inflatable penile prosthesis has some of the highest survival from revision surgery of any medical device implanted in humans [1]. We expand on previous Rigicon Infla10 research, adding more patients and increasing follow-up duration [2]. 535 patients had Rigicon Infla10 devices implanted from 1/2019 to 8/2022. 103 surgeons from 26 centers in 15 countries participated in the study. Patient information forms were analyzed from virtually all implantations. Explantation or revision surgery for mechanical failure, infection, other medical reasons, and patient dissatisfaction were cataloged. SPSS 25.0 (IBM) was used for the statistical analysis of Kaplan Meier survival statistics. Mean follow-up was 24.2months (7-43months). Mean patient age was 56years. Reoperation was necessary for 3.5% of subjects. Revision for mechanical failure occurred in 2.24% (12/535). The rate of explant for patient dissatisfaction was 0.56% (3/535). Revision for component out of place was 0.37% (2/535) with an infection rate and unsuccessful Peyronie's correction being 0.19% (1/535). Survival from requiring another corrective surgery at 1, 2, and 3years was 96.4%, 95.0%, and 94.0%, respectively. These initial survival rates compare favorably to devices currently available, which have been repeatedly enhanced to improve reliability. In its first 2-3years of availability, The Rigicon Infla10 inflatable penile prosthesis shows freedom from revision comparable to existing enhanced devices that have been on the market for decades.

(114) Initial Safety Outcomes for Rigicon Infla 10® Inflatable Penile Prosthesis

Abstract Introduction A new three-piece inflatable penile prosthesis was introduced in 2019. The Rigicon Infla10® has been implanted in 26 centers by 103 physicians. Clinical investigation for FDA approval in United States will begin in late 2022. Objective We report initial survival from explantation and revision rates for infection, mechanical failure and medical problems. Data was obtained from analysis of Patient Information Forms (PIFs) submitted to the manufacturer. Patient information data was omitted prior to analysis. Methods 319 patients implanted from 1/06/2019 to 12/31/2021 were followed to analyze device durability from revision/removal and rates of reoperation for infection, mechanical failure or medical reason. Results Mean follow-up was 21.2 months with a range of 5-36 months. Mean age was 58.5. 4.38% required removal/revision. Mechanical failure was 2.5%. There were no infections reported and only two (0.6%) medical problems (component out of place). One Peyronie's patient required revision for inadequate straightening (0.03% Three patients (0.9%) requested device removal for dissatisfaction. A total of 95.6% of Rigicon Infla10® was free from explant or revision 13 months from the original implant date. Kaplan Meier analysis revealed cumulative survival of the device at 12, 24 and 36 months was 95.6%, 94.7% and 95.7% until surgical invention. Conclusions While this is a retrospective study derived from volunteered Patient Information Forms, we believe the vast majority of the early Rigicon Infla10® performed prior to 1/2022 were included in the analysis. Early results show initial durability from re-operation equivalent to contemporary, devices. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Rigicon, Boston Scientific, Coloplast.

Defining the incidence and management of postoperative scrotal hematoma after primary and complex three-piece inflatable penile prosthesis surgery.

Scrotal hematoma is a challenging complication of penile prosthesis surgery. We characterize the risk of hematoma formation with implementation of standardized techniques to mitigate hematomas and assess for any associated factors in a large multi-institutional penile implant cohort. This was a retrospective review from February 2018 to December 2020 of all patients who underwent inflatable penile prosthesis implantation at 2 high volume implant centers. Cases were defined as "complex" if they involved revision, salvage with removal/replacement, or were performed with concurrent penile, scrotal or intra-abdominal surgeries. The incidence of scrotal hematoma among primary and complex IPP recipients was measured and modifiable and innate risk factors associated with hematoma formation within the two cohorts were tracked. Of 246 men who underwent penile prosthesis surgery, 194 (78.9%) patients underwent primary implantation and 52 (21.1%) were complex. Although hematoma formers in the complex group had comparable drain outputs to primary patients on postoperative day 0 (66.8cc ± 32.5 vs 48.4 ± 27.7, p = 0.470) and postoperative day 1 (40.3cc ± 20.8vs 21.8 ± 11.3 p = 0.125), hematomas in the complex group had a higher propensity for OR evacuation (p = 0.03). Difference in duration of temporary device inflation between 2 (64, 26%) and 4 weeks (182, 74%) did not contribute to hematoma formation (p = 0.562). The incidence of postoperative hematoma formation in complex cases was 9.6% (5/52) and 3.6% in primary cases (7/194) (HR = 2.61, p = 0.072). Complex IPP surgery performed for revision or with ancillary procedures are more likely to result in clinically significant hematomas that require surgical management, suggesting a need for heightened caution in managing these individuals.

Complications and troubleshooting in primary penile prosthetic surgery-a review.

Penile implant surgery is the gold standard to treat erectile dysfunction with success rates of over 90%. The first penile implants were developed in the early 1900s. Since then, several types of implants have been developed including malleable implants, two-piece inflatable implants, and three-piece inflatable implants. The three-piece inflatable penile prosthesis, which was introduced in 1973, is the most widely used type of penile implant in the United States. Penile implant surgery has undergone numerous advancements over the years, improving outcomes and patient satisfaction. However, as with any surgical procedure, there are risks and complications associated with penile implant surgery. It is important for surgeons to understand these potential complications and to have strategies in place to manage and prevent them to achieve the best possible outcomes for their patients.

PD26-03 EARLY RESULTS OF THE NEW RIGICON INFLA10® THREE-PIECE INFLATABLE PENILE PROSTHESIS IN 535 PATIENTS WITH ERECTILE DYSFUNCTION

You have accessJournal of UrologyCME1 Apr 2023PD26-03 EARLY RESULTS OF THE NEW RIGICON INFLA10® THREE-PIECE INFLATABLE PENILE PROSTHESIS IN 535 PATIENTS WITH ERECTILE DYSFUNCTION Steven K. Wilson, Mariano Rossello, Pedro Maria, and Lexiaochuan Wen Steven K. WilsonSteven K. Wilson More articles by this author , Mariano RosselloMariano Rossello More articles by this author , Pedro MariaPedro Maria More articles by this author , and Lexiaochuan WenLexiaochuan Wen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003304.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Implantation of a penile prosthesis may be considered in patients who do not respond to more conservative therapies or prefer a definitive therapy. Inflatable Penile Prosthesis implantation has been associated with high patient satisfaction rates. The aim of this study is to investigate the safety outcomes of the new Infla10® Three-Piece Inflatable Penile Prosthesis (Rigicon, New York) in patients with erectile dysfunction. METHODS: 535 patients who underwent Infla10® Three-Piece Inflatable penile prosthesis implantation between 01.06.2019 to 08.04.2022 were included in the study. 103 surgeons from 26 centers participated in the study. All patients were followed up to evaluate the safety of the device. Revision/explantation, and rates of reoperation for infection, mechanical failure, or medical reasons were recorded. SPSS 25.0 (IBM, US) was used for the statistical analysis of the patient demographics and Kaplan Meier survival statistics. RESULTS: The mean follow-up was 24.2 months with a range of 7-36 months. The mean patient age was 56.23 years. The mechanical failure rate was 2.24%, explantation due to patient dissatisfaction was 0.19 %, Peyronie’s failed correction was 0.19%, and component out of place was 0.37%, infection rate was 0.19%. Survival analysis of the device at 12, 24, and 36 months was 96.6%, 97.8%, and 96.8%, respectively, until surgical invention. CONCLUSIONS: Early results suggest that Infla10® Three-Piece Inflatable Penile Prosthesis insertion offers comparable safety outcomes in the treatment of patients diagnosed with erectile dysfunction. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e736 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven K. Wilson More articles by this author Mariano Rossello More articles by this author Pedro Maria More articles by this author Lexiaochuan Wen More articles by this author Expand All Advertisement PDF downloadLoading ...

Initial safety outcomes for the Rigicon Infla10® inflatable penile prosthesis.

To analyse data from patient information forms (PIFs) submitted to the manufacturer of a new three-piece inflatable penile prosthesis (IPP), the Rigicon Infla10®, to summarize early outcomes. A retrospective review of PIFs from 319 patients implanted with the IPP between 6 January 2019 and 31 December 2021 was performed to assess device durability and rates of reoperation for infection, mechanical failure or medical reasons. The mean ± sd (range) follow-up was 21.2± 11(5-36)months and the mean ± sd patient age was 58.5± 8.7 years. Of the total, 4.4% of devices required removal or revision. Complications included mechanical failure (2.5%) and component migration (0.7%). No infections were observed in this series. One patient (0.4%) required revision for inadequate straightening of Peyronie's disease. Three patients (0.9%) requested device removal because of dissatisfaction. A total of 95.6% of the Rigicon Infla10 devices were free from explant or revision 21months after the original implant date. Kaplan-Meier analysis showed the rates of cumulative survival of the device at 12, 24, 36months were 95.6%, 94.7% and 93.7%, respectively. The vast majority of the early Rigicon Infla10 IPPs implanted prior to January 2022 were included in this retrospective analysis of volunteered PIFs. These early results demonstrate initial durability from reoperation equivalent to that of other contemporary devices.

State-of-art review of current malleable penile prosthesis devices in the commercial market.

The malleable penile implant is often considered an inferior device to the three-piece inflatable penile prosthesis implant. Nonetheless, the malleable prosthesis has its unique advantages such as lower cost, easier to perform and fewer mechanical complications than inflatable prostheses. Furthermore, its role can be extended to patients with issues relating to poor manual hand dexterity, those undergoing a salvage for infection prosthesis and as an emergency surgical measure in patients presenting with acute ischaemic priapism. Over the past few decades, there have been numerous design and technological advancements to improve overall clinical efficacy, mechanical durability, axial rigidity and device concealability of malleable penile prostheses. The following article provides a narrative review of the six major contemporary malleable penile prosthesis devices in the commercial market, namely, the Coloplast Genesis prosthesis, the Boston Scientific Tactra prosthesis, the Zephyr ZSI 100 and 100 (female-to-male) FTM devices, the Rigi10 prosthesis, the TUBE malleable prosthesis and the Shah prosthesis and evaluates the published outcomes. Appropriate patient selection and strict counselling regarding what to expect with malleable prostheses coupled with adherence to safe surgical principles are paramount to ensure excellent clinical success and patient satisfaction rates.

The International Penile Prosthesis Implant Consensus Forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant.

Despite significant scientific advances in the modern three-piece inflatable penile prosthesis implant surgery, it is not without surgical risks and can carry additional cosmetic and psychosocial consequences in poorly selected and consented individuals. To address this problem, an international group of key opinion leaders and high-volume prosthetic surgeons reviewed the current guidelines and clinical evidence, discussed their experiences, and formed a consensus regarding inflatable penile prosthesis surgery. The findings of this consensus panel were presented at the 17th biennial Asia Pacific Society of Sexual Medicine scientific meeting. The experts concluded that proper patient selection, informed consent and strict adherence to safe surgical principles are important to optimize clinical outcomes. Furthermore, most intraoperative complications, if recognized, can be addressed intraoperatively to enable placement of the device at the time of initial surgery. Men with significant corporal fibrosis due to Peyronie's disease, prior prosthesis explantation and priapism, and men who have undergone construction of a neophallus, as well as men who receive concurrent continence surgery, are complex cases requiring additional care and advanced techniques to obtain optimal surgical outcomes. Variability in patient care - in terms of postoperative antibiotic use, pain management, scrotal care, and cycling of the penile prosthesis implant - must be reduced to enable optimization and assessment of outcomes across patient groups.

Electrophysiological evaluation of alterations in penile sensation due to penile prosthesis implantation in patients with erectile dysfunction

ObjectiveThe present study was aimed to determine the effect of penile prosthesis implantation (PPI) surgery on penile sensation by evaluating the penile electromyography (EMG) variables. MethodsThe research was designed as a prospective study. Thirty patients who were diagnosed with organic erectile dysfunction and had underwent PPI surgery between January 2017 and January 2018 in the Urology Clinic of Antalya Training and Research Hospital were included in this study. Penile sensory EMG was performed on each patient 1 day prior to the surgery by the Physical Therapy and Rehabilitation clinic. Additionally, the control EMG study was also performed in the 3rd and 6th postoperative months. ResultsWe included 27 patients in this study who attended regular follow-ups and had complete EMG results. Out of the 27 patients, 23 (85.2%) patients had received malleable (ProMedon) penile prosthesis, one (3.7%) patient had received a two-piece inflatable (Ambicor) penile prosthesis, and three (11.1%) patients had received a three-piece inflatable (AMS 700 CXR) penile prosthesis. The mean nerve conduction value (NCV) of the patients was 29.85 (standard derivation: 22.54; range: 0–78.4) m/s during the preoperative period, whereas it was 27.64 (standard derivation: 24.72; range: 0–83.3) m/s in the 3rd postoperative month and 24.80 (standard derivation: 22.31; range: 0–88.4) m/s in the 6th postoperative month. There was no significant difference between preoperative NCV and 3rd postoperative month NCV (p=0.607). Similarly, no significant difference was observed between preoperative NCV and 6th postoperative month NCV (p=0.276). Additionally, the change between NCV values at postoperative 3rd and 6th months was not statistically significant (p=0.553). ConclusionSignificant loss of penile sensation does not occur in patients who undergo PPI surgery.

Boston Scientific vs. Coloplast: A Prospective Analysis of a Single High-volume Surgeon's Inflatable Penile Prosthesis Experience

ABSTRACT Introduction Surgical implantation of a penile prosthesis may be offered to patients with erectile dysfunction (ED) as primary treatment or after failed therapy. The two FDA approved three-piece inflatable penile prostheses (IPPs) on the market, the AMS (American Medical Systems) 700TM series (Boston Scientific, Massachusetts) and the Coloplast Titan® (Coloplast, Minnesota), differ in their overall design and anti-microbial coating. However, little is known as to whether these differences have an impact on risk of infection or revision. Objective To compare the likelihood of infection and short-term revision in IPP placements performed by a single high-volume surgeon when using Boston Scientific's AMS 700TM series versus Coloplast Titan® implants. Methods We performed a prospective analysis of a single IPP surgeon's experience with AMS 700TM and Titan® at two private hospitals between January 2017 and December 2019. The surgeon alternated the implants every other week for comparison. Data was collected on patient demographics, implant characteristics, case duration, and complications. Results A total of 542 patients (mean age 69.2 years) underwent 548 IPP implantations during the two-year period. Of the 548 cases, 303 (55.3%) implantations were performed using Boston Scientific AMS 700TM while 245 (44.7%) were with Coloplast Titan®. Only one (0.18%) case was complicated by post-operative infection despite drain placement for three days in all 548 cases. This infection occurred in a Coloplast Titan® placed as a revision for SST deformity. Seven (1.3%) cases ultimately required revision by the time of review. Although five of the seven cases requiring revision were done using AMS 700TM implants, this did not amount to a statistically significant increase in risk compared to Titan® (p=0.39). First revisions of AMS 700TM were noted to be done earlier than Titan® on average (225 days vs. 450 days postoperatively, p=0.42). Overall, the most common reason for revision was tube fracture (n=3). Diabetes, case time, performing hospital, reservoir type, and reservoir location were not significant prognostic factors for revision (p>0.05). Conclusions Risk of infection or short-term revision is not impacted by whether the IPP is manufactured by Coloplast or Boston Scientific. A high-volume IPP surgeon has a significantly decreased risk of infection and revision compared to those currently published in the literature. Disclosure No

Patient Risk Factors for Prolonged Opioid Dependence Following Primary Inflatable Penile Prosthesis Placement Managed with Multimodal Analgesia

ABSTRACT Introduction Multimodal analgesia (MMA) following inflatable penile prosthesis (IPP) placement has previously demonstrated substantially improved pain control with reduced opioid burden both in the acute and prolonged postoperative period. However, some patients receiving MMA still require opioid pain management beyond the immediate postoperative recovery, placing them at risk for developing prolonged opioid dependence. Objective In this analysis, we examine patient-specific and perioperative factors predicting increased pain and prolonged use of opioids in the recovery period following primary IPP surgery in those managed with MMA only. Methods This is a multicenter retrospective review of 165 primary three-piece IPP recipients from 12/2018 to 12/2020 managed with a standardized MMA protocol. Patients on narcotics preoperatively were excluded. Prolonged opioid dependence was defined as active opioid prescriptions in the Prescription Drug Monitoring Program (PDMP) 90 days after surgery in previously opioid-naïve patients. Preoperative, intraoperative and immediate postoperative factors were analyzed to assess correlative risk for increased pain and development of opioid dependence in the MMA cohort. Results The prolonged opioid use group (2/165) demonstrated substantially higher Visual Analog Scale (VAS) pain scores in PACU (p=0.014) with trends towards higher total morphine equivalents (TME) in PACU (p=0.076). Also seen were higher total morphine equivalents (TME) in postoperative day 0 (p=0.0425), while VAS scores on POD1 (p=0.123) and total TME prescribed at discharge (p=0.646) did not reach statistical significance. In assessing preoperative factors associated with developing opioid-dependence, age (p=0.194), race (p=0.414), BMI (p=0.202) and prevalence of diabetes (p=0.656) and chronic pain (p=0.291) did not demonstrate statistical significance. Intraoperative factors analyzed including operative time (p=0.719), surgical approach (p=1.00), cylinder size (p=0.938), use of rear-tip extenders (p=1.00), reservoir size (p=0.346) and use of drain (p=1.00) also did not yield significance. Conclusions Patients who developed prolonged postoperative opioid dependence tended to experience higher PACU VAS scores and increased TME requirements throughout their hospitalization. MMA appears to reduce risk of prolonged postoperative opioid dependence in this series. We found no clear preoperative or operative trends for prolonged opioid dependence in MMA patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

Innovative Findings Characterizing the Location and Severity of Postoperative Pain Following Inflatable Penile Prosthesis Surgery Managed With Multimodal Analgesia

ABSTRACT Introduction Adoption of multimodal analgesia (MMA) in inflatable penile prosthesis (IPP) surgery has changed the management landscape by decreasing reliance on opioid usage for postoperative pain. However, there remains a paucity of literature characterizing severity, location and duration of postoperative pain following inflatable penile prosthesis (IPP) placement. Objective We rigorously characterized postoperative pain throughout the recovery period following IPP implantation in patients managed with multimodal analgesia (MMA). We aimed to provide an innovative and detailed analysis to better understand the pain profile experienced by implant recipients. Methods This is a single-center prospective analysis of 64 patients who underwent penoscrotal approach, primary three-piece IPP surgery from 9/2019 to 8/2020. All revision cases, infrapubic and combination anti-incontinence cases were excluded along with chronic pain patients. Interval follow-up was conducted via telephone with a standardized, validated pain questionnaire, executed on a scheduled timeline. A flow chart of the timeline and survey components are illustrated in Figure 1. Patient pain scores were assessed with the Wong-Baker visual analog scale (VAS). Results Pain locations and trends are illustrated in Image 1. Average VAS improved over the entire recovery period from 5.16 on POD2, to 5.28 on POD7, 3.55 on POD14 and 2.31 on POD30 (p=0.039). Patients were most bothered by scrotal pain followed closely by incisional pain (p=0.381) throughout the thirty days at each time interval. 20/27 (74%) patients indicated adequate pain management with MMA while 7/27 (26%) reported poorly controlled pain. No patients required additional narcotics. 27/64 (42.2%) patients had a 100% phone response rate and another 8/64 (12.5%) responded to three of the four postoperative calls. Barriers included no response to voicemail (12/64, 18.7%), full voicemail box (5/64, 7.8%) and wrong/nonfunctioning number (3/64, 4.7%). Conclusions This is the first descriptive analysis of the pain profile experienced by IPP patients during the first postoperative month. Although most patients experienced incisional and scrotal pain following penile implantation, multimodal analgesia provides reasonable pain relief for most patients. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast

The Urethral Microbiome During Inflatable Penile Prosthesis Placement

ABSTRACT Introduction Foley catheter placement prior to inflatable penile prosthesis (IPP) implantation permits drainage of the bladder to ensure safe retropubic reservoir placement and allows for palpation of the urethra to prevent inadvertent injury. The urethra is often colonized with commensal organisms mostly concentrated at the meatus and fossa navicularis to which the Foley catheter is exposed during placement. Following placement, the catheter remains on the sterile field during surgery. Objective We sought to investigate if the microbiome of the urethra could contaminate the Foley catheter during IPP placement. Methods Data was retrospectively reviewed on all patients who underwent three-piece IPP placement at a single institution from 2/2020 to 6/2021. Patient demographics, clinical characteristics, and comorbidities were recorded. Culture swabs from the fossa navicularis and exposed Foley catheter were collected intra-operatively after Foley catheter placement. Growth of aerobic, anaerobic, and fungal organisms was assessed. Univariate analyses with chi-square tests were performed to compare baseline demographic and clinical data with isolation of organisms from culture swabs. Results A total of 50 patients were included in this study. All surgeries were performed via penoscrotal approach by a single surgeon. 22% (n = 11) were revision procedures, all of which were due to mechanical device malfunction. The median age of our cohort was 66.5 years (range: 42-78 years) and 30% (n = 15) had a BMI of 30 kg/m² or greater. Three patients (6%) were current smokers and 46% (n = 23) were diabetic. Two patients (4%) had isolation of aerobic organisms and five patients (10%) had isolation of anaerobic organisms. No patients had isolation of fungal organisms. There was no statistically significant relationship between obese BMI, diabetes diagnosis, or current smoking and the isolation of organisms. Three patients (6%) ultimately developed a device infection; notably, none of these patients had isolation of organisms from their culture swabs at initial implant. Conclusions A number of patients had isolation of aerobic and anaerobic organisms from their intra-operatively collected urethral swabs, but none of these patients have currently shown evidence of a device infection. This is the first study to examine the urethral microbiome and its potential effect on Foley catheter contamination at the time of IPP placement. Further study is needed to determine if this could be a significant source of device infection. Disclosure No

MRI of Penile Prostheses: The Challenge of Diagnosing Postsurgical Complications.

Penile implants are surgically inserted devices used for the treatment of erectile disfunction. Improvements in surgical techniques and in the manufacturing of these implants have reduced the risk of intra- and postoperative complications and increased the popularity and use of this therapeutic option. Routine imaging is not recommended before penile prosthesis surgery. Malleable penile prostheses use noninflatable shafts inserted into each corpus cavernosum, which appear hypointense on T1- and T2-weighted MR images. Inflatable penile prostheses (IPPs) may consist of two or three parts and are composed of two cylinders inserted into the corpora cavernosa that are filled with a saline solution to produce rigidity. These appear homogeneously T2 hyperintense and the silicone-based covering of the cylinders appears T2 hypointense, thereby clearly delineating the cylinders. In the case of three-piece IPPs, a reservoir containing the fluid may be placed in the pelvis. The most frequent complications are related to infection and mechanical failure, the latter being more common in IPPs because more components are involved. Less common complications include malpositioning. Detection and management of postoperative complications are challenging, and MRI plays a crucial role as it permits evaluation of the positioning and configuration of the prosthesis components, as well as assists in functional evaluation of IPPs when images are obtained of both the flaccid and inflated states. ©RSNA, 2021.

MP57-04 A 15 YEAR ANALYSIS OF THE “SURVIVAL” TIME OF THE 3-PIECE INFLATABLE PENILE PROSTHESIS IN THE OUTPATIENT SETTING

INTRODUCTION AND OBJECTIVE:Technological innovations of hydrophilic and antibiotic coated materials in the construction of the three-piece inflatable penile prosthesis (IPP) have resulted in decrea...

MP57-06 THE URETHRAL MICROBIOME DURING INFLATABLE PENILE PROSTHESIS PLACEMENT

You have accessJournal of UrologySexual Function/Dysfunction: Surgical Therapy (MP57)1 Sep 2021MP57-06 THE URETHRAL MICROBIOME DURING INFLATABLE PENILE PROSTHESIS PLACEMENT John Williams, Hayden Hill, Eric Wendel, and Eric Laborde John Williams John Williams More articles by this author , Hayden HillHayden Hill More articles by this author , Eric WendelEric Wendel More articles by this author , and Eric LabordeEric Laborde More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002087.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Foley catheter placement prior to inflatable penile prosthesis (IPP) implantation permits drainage of the bladder to ensure safe retropubic reservoir placement and allows for palpation of the urethra to prevent inadvertent injury. The urethra is often colonized with commensal organisms mostly concentrated at the meatus and fossa navicularis to which the Foley catheter is exposed during placement. Following placement, the catheter remains on the sterile field during surgery. We sought to investigate if the microbiome of the urethra could contaminate the Foley catheter during IPP placement. METHODS: Data was retrospectively reviewed on all patients who underwent three-piece IPP placement at a single institution from 2/2020 to 2/2021. Patient demographics, clinical characteristics, and comorbidities were recorded. Culture swabs from the fossa navicularis and exposed Foley catheter were collected intra-operatively after Foley catheter placement. Growth of aerobic, anaerobic, and fungal organisms was assessed. Univariate analyses with chi-square tests were performed to compare baseline demographic and clinical data with isolation of organisms from culture swabs. RESULTS: A total of 40 patients were included in this study. All surgeries were performed via penoscrotal approach by a single surgeon. 20% (n=8) were revision procedures, all of which were due to mechanical device malfunction. The mean age of our cohort was 65 years (range: 42-78 years) and 35% (n=14) had a BMI of 30 kg/m2 or greater. Three patients (8%) were current smokers and 48% (n=19) were diabetic. Two patients (5%) had isolation of aerobic organisms and five patients (13%) had isolation of anaerobic organisms. No patients had isolation of fungal organisms. There was no statistically significant relationship between obese BMI, diabetes diagnosis, or current smoking and the isolation of organisms. No patients have currently shown evidence of device infection. CONCLUSIONS: A number of patients had isolation of aerobic and anaerobic organisms from their intra-operatively collected cultures. This is the first study to examine the urethral microbiome and its potential effect on Foley catheter contamination at the time of IPP placement. Further study is needed to determine if this could be a significant source of device infection. Source of Funding: N/A © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e980-e980 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Williams More articles by this author Hayden Hill More articles by this author Eric Wendel More articles by this author Eric Laborde More articles by this author Expand All Advertisement Loading ...