Dataset Information

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

ABSTRACT: Background:"Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration" (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. Methods:Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. Results:From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=-0.18; P<0.01), history of RP (r=-0.13; P<0.01), PD as comorbidity (r=-0.16; P<0.01), venous leak (r=-0.08; P<0.01), and presence of stress incontinence (r=-0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). Conclusions:Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length.

SUBMITTER: Bennett N

PROVIDER: S-EPMC5760375 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

Bennett Nelson N Henry Gerard G Karpman Edward E Brant William W Jones LeRoy L Khera Mohit M Kohler Tobias T Christine Brian B Rhee Eugene E Kansas Bryan B Bella Anthony J AJ

Translational andrology and urology 20171201 6

<h4>Background</h4>"Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration" (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data po ...[more]

PMID: 29354506

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Project description:Erectile dysfunction (ED), the second most common male sexual disorder, has an important impact on man sexuality and quality of life affecting also female partner's sexual life. ED is usually related to cardiovascular disease or is an iatrogenic cause of pelvic surgery. Many non-surgical treatments have been developed with results that are controversial, while surgical treatment has reached high levels of satisfaction. The aim is to evaluate outcomes and complications related to prosthesis implant in patients suffering from ED not responding to conventional medical therapy or reporting side effects with such a therapy. One hundred eighty Caucasian male suffering from ED were selected. The patient population were divided into two groups: 84 patients with diabetes and metabolic syndrome (group A) and 96 patients with dysfunction following laparoscopic radical prostatectomy for prostate cancer (group B). All subjects underwent primary inflatable penile prosthesis implant with an infrapubic minimally invasive approach. During 12 months of follow-up, we reported 3 (1.67%) explants for infection, 1 (0.56%) urethral erosion, 1 (0.56%) prosthesis extrusion while no intraoperative complications were reported. Mean International Index of Erectile Function-5 (IIEF-5) was 8.2 ± 4.0 and after the surgery (12 months later) was 20.6 ± 2.7. The improvement after the implant is significant in both groups without a statistically significant difference between the two groups (P-value 0.65). Mean Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) score 1 year after the implant is 72.2 ± 20.7, and there was no statistically significant difference between groups A and B (P-value 0.55). Implantation of an inflatable prosthesis, for treatment of ED, is a safe and efficacious approach; and the patient and partner satisfaction is very high. Surgical technique should be minimally invasive and latest technology equipment should be implanted in order to decrease after surgery common complications (infection and mechanical failure).

Project description:BackgroundThe association between elevated hemoglobin A1c (HbA1c) levels and the risk of postoperative infection after penile prosthesis surgery remains controversial.AimTo examine the association between HbA1c levels and penile implant infections in men undergoing inflatable penile prosthesis (IPP) surgery for erectile dysfunction using a large insurance claims database.MethodsThis was a retrospective review using Optum's de-identified Clinformatics Data Mart Database. Male subjects 18 years and older with available laboratory data undergoing IPP insertion between 2003 and 2018 were included. Administrative diagnosis and procedural codes were used to assess subsequent penile implant revision surgery status for either infectious or noninfectious causes. Associated conditions were controlled for such as smoking status, hyperlipidemia, hypertension, obesity status, and Peyronie's disease.OutcomesThe main outcomes were risk of revision for infection and time to revision.ResultsA total of 2,363 individuals underwent initial IPP insertion and had available HbA1c data with a mean HbA1c of 6.9%. The overall IPP infection revision rate was 3.9% and the highest rate of 12.1% was seen in the highest HbA1c group (>10%). After adjusting for demographic and health factors, a higher HbA1c level was associated with a higher risk of revision for infection, with every 1 point increase in HbA1c conferring an increased risk of infection requiring revision by 29% (95% CI 17-42%). When infections did occur, they happened sooner in men with HbA1c > 10.0% with an average of 1.3 months vs 3.5 months in the HbA1c < 6.0% group.Clinical implicationsThese findings provide insight into the potential relationship between HbA1c levels and postoperative risk of infection after penile prosthesis surgery and may aid in clinical decision-making.Strengths and limitationsStrengths include the large sample size, length of data coverage, and real-world analysis of surgeries done across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact infection rates.ConclusionsWhile the overall risk of penile prosthesis infection remains modest, the current report notes an increased risk of infection for diabetic men with poor glycemic control. Chen T, Li S, Eisenberg ML. The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data. J Sex Med 2021;18:1104-1109.

Project description:Background:Scrotal hematoma formation is a dreaded complication of penile prosthesis surgery that increases patient pain and healthcare costs, as well the risk for eventual device infection and failure. The efficacy of hemostatic agents in reducing the incidence of scrotal hematoma development has not been extensively studied in urologic prosthetic surgery. In this paper we further evaluate our experience with oxidized regenerated cellulose (ORC; Surgicel Fibrillar™) as an adjunct to standard hemostatic practices in inflatable penile prosthesis (IPP) implantation. Methods:From April 2016 onward, intracorporal ORC pledgets were placed during corporotomy closure in all patients undergoing IPP implantation or revision by a single surgeon using an identical surgical technique. Perioperative parameters and outcomes-primarily postoperative cumulative drain output, secondarily patient phone calls in the postoperative period-were compared among successive cases with ORC (April 2016 to February 2019) and without ORC (April 2013 to March 2016). Results:A total of 274 men underwent IPP implantation during the study period; 175 (64%) had ORC included in their corporotomy closures. Median drain output was significantly reduced in the ORC patients relative to the non-ORC group (50 vs. 65 mL; P=0.0001). A significant reduction in patient-initiated phone calls regarding scrotal pain, swelling, or discomfort in the first 4 weeks following surgery was also observed in the ORC group (average 0.69 vs. 1.1 calls per patient; P=0.03). A total of 9 patients underwent IPP explantation during the study period, all due to device infection; 5 of these were in the ORC group, while 4 were in the non-ORC group (P=0.73). ORC use did not constitute any additional infection risk. Conclusions:Bilateral incorporation of ORC pledgets during corporotomy closure in IPP surgery significantly decreases postoperative scrotal drain output, a well-documented risk factor for scrotal hematoma formation.

Project description:Background and objectiveMale stress urinary incontinence (SUI) and erectile dysfunction (ED) are well established diagnoses within Men's Health, often more specifically within the prostate cancer survivorship cohort. Taken individually, well defined treatment algorithms exist with which many surgeons are comfortable; however, treatment of both in a single setting or staged fashion introduces complexity. Emerging treatment options also exist, and there is immature or minimal data when these are combined with inflatable penile prosthesis (IPP) insertion, radiation history, and/or variable degrees of incontinence. Our objective was to describe and summarize the currently available treatment options for SUI particularly at the time of IPP insertion.MethodsA literature review was performed to summarize contemporary treatment of SUI at time of IPP placement. Anecdotal experience was added from high volume, subspecialty trained Men's Health and Reconstructive Urologists.Key content and findingsNon-invasive approaches such as pelvic floor muscle training (PFMT), behavioral modification, and external compression devices play some limited role in treatment and/or management of SUI, particularly in the early post operative period, or for those unwilling or unable to undergo more definitive intervention. More invasive options such as artificial urinary sphincter (AUS) implantation, male sling, or other implantable devices are more appropriate for good surgical candidates with higher bother and/or more severe incontinence. These options can be concomitant or staged relative to IPP placement. Climacturia, particularly with mild or no bothersome SUI, can successfully be addressed at the time of penile prosthesis placement with the utilization of the Mini-Jupette suburethral sling.ConclusionsA variety of treatment options exist for concomitant treatment of SUI at time of IPP, and both safety and efficacy have been demonstrated for many in the same operative setting. As with treatment of ED or SUI in isolation, patient selection, careful counseling, and management of expectations can lead to high patient satisfaction.

Dataset Information

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

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Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study.

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