Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

PURPOSE: To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized US Food and Drug Administration (FDA) 522 cohort study. MATERIALS AND METHODS: Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. RESULTS: Three hundred fifty-five women underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty (76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95% CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine (81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. CONCLUSION: Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction.

BACKGROUND: Most of the published literature addressing the satisfaction postinflatable penile implant (IPP) placement includes non-validated surveys. AIM: The study aims to report the survey outcomes of the English version of The QoLSPP and to evaluate the different factors that could influence these results. METHODS: Patients who underwent inflatable penile implant placement from January 2017 to December 2019 received a survey by phone and had a visit scheduled no sooner than 27 months after surgery. In the clinic, they were inquired about the penile size and underwent measurements of postoperative penile length and diameter. The survey responses were rated from zero to 5 following QoLSPP, and answers ≥3 were considered positive. An evaluation of the factors influencing the quality-of-life score of patients post-IPP placement was performed. Variables included age (<60, 60-70, >70), BMI classification, Charlson Comorbidity Index, diabetes diagnosis, implant type (AMS 700CX vs Titan), ED etiology, revisions, postoperative time in months (<30, 30-40, >40) and preoperative vs postoperative penile dimensions in those who attended the clinic. OUTCOMES: The primary outcome was to obtain accurate patient-reported satisfaction after inflatable penile implantation. RESULTS: Within the timeframe, 542 patients underwent first-time IPP placements. Of that group, 322(n) completed the surveys, and 109 patients attended the clinic to compare preoperative vs postoperative dimensions. Of note, 67 (61.4%) and 54 (49.4 %) demonstrated enlargement in length and diameter, respectively. Conversely, 12 (11%) and 4 (3.7%) experienced a shortening in length and girth. We found 66 (60.5%) patients who complained about a penile size decrease after the intervention. The survey had a positive response in 93.1% of the cases. There were no statistically significant differences in positive responses concerning the variables investigated. The subpopulation analysis of the penile-sized group neither showed response variations. CLINICAL IMPLICATIONS: The investigation allowed a better understanding of patient-reported satisfaction post-IPP placement. STRENGTHS & LIMITATIONS: The performance of all the procedures in a high-volume center by a single surgeon limits its generalization. CONCLUSION: The overall results after IPP surgery are positive in most patients who underwent the procedure and the variables investigated did not influence the overall outcomes of the QoLSPP survey in the study. Luna E, Rodriguez D, Barrios D, et al. Evaluation of Quality of Life After Inflatable Penile Implantation and Analysis of Factors Influencing Postsurgery Patient Satisfaction. J Sex Med 2022;19:1472-1478.

Permanent Deactivation of Inflatable Penile Prosthesis via Puncture.

OBJECTIVE: To describe our technique and early results for inflatable penile prosthesis (IPP) deactivation via puncture and drainage in the office setting to avoid penile explanting interventions in high-risk surgical patients. METHODS: A retrospective chart review of patients with high perioperative risk who had undergone IPP prosthesis puncture in the office setting between March 2020 and May 2021 was performed. Variables included age, the reason for penile prosthesis implantation and deactivation, time frame from implantation to deactivation, type of penile implant, follow-up time, and complications. Clinical information and procedural consent from patients with mental impairment were obtained from caretakers or legal guardians. RESULTS: In all the cases, the implants were in a good position and cycled well without difficulty before undergoing the drainage. Ten patients underwent the deactivation procedure, with ages ranging from 81 to 93 years old (mean 88 ± 3.74), 9 cases had a dementia diagnosis, and 1 case of penile implant aversion. Mean follow-up was 8.4 months ± 2.3, and there were no reported complications during the follow-up period. CONCLUSION: Permanent deactivation of IPP via in-office puncture and drainage represents a safe, feasible, and reliable option for those patients with multiple comorbidities and caretakers who desire removal of normally cycling, well-positioned, and uninfected penile implants. We strongly recommend all our patients with severe cognitive decline have their implants devices punctured to prevent any potential complications.

A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence.

STUDY OBJECTIVE: The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. DESIGN: Postmarket, prospective, multicenter, nonrandomized cohort design. SETTING: The study was performed at 23 hospitals in the United States and Canada. PATIENTS: Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). INTERVENTIONS: Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling. MEASUREMENTS AND MAIN RESULTS: Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. CONCLUSION: At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.

Multicenter investigation on the influence of climate in penile prosthesis infection.

The purpose of this study is to investigate the relationship between inflatable penile prosthesis (IPP) infection, time of year, climate, temperature and humidity. This is a retrospective IRB-approved analysis of 211 patients at 25 institutions who underwent salvage procedure or device explant between 2001 and 2016. Patient data were compiled after an extensive review of all aspects of their electronic medical records. Climate data were compiled from monthly norms based on location, as well as specific data regarding temperature, dew point, and humidity from dates of surgery. Rigorous statistical analysis was performed. We found that penile prosthesis infections occurred more commonly in June (n = 24) and less frequently during the winter months (n = 39), with the lowest number occurring in March (n = 11). One-hundred thirty-nine infections occurred at average daily temperatures greater than 55 °F, compared to 72 infections at less than 55 °F. The incidence rate ratio for this trend was 1.93, with a p-value of <0.001. Humidity results were similar, and fungal infections correlate with daily humidity. Infected implants performed in the fall and summer were over 3 and 2.3 times, respectively, more likely to grow Gram-positive bacteria compared to implants performed in spring (p = 0.004; p = 0.039). This was consistent across geographic location, including in the Southern hemisphere. We found trends between climate factors and IPP infection like those seen and proven in other surgical literature. To our knowledge these data represent the first exploration of the relationship between temperature and infection in prosthetic urology.

Effect of operative local anesthesia on postoperative pain outcomes of inflatable penile prosthesis: prospective comparison of two medications.

Few studies have examined the roles of dorsal penile nerve block (DPNB) and penile ring block (PRB) in surgery of inflatable penile prosthesis (IPP) placement. We sought to compare the postoperative pain outcomes of two different medications used in DPNB plus PRB. We thus carried out a prospective study of patients with erectile dysfunction who underwent "de novo" IPP placement between January 2013 and June 2013. Patients were divided to one of three groups: 1-DPNB plus PRB with bupivacaine injection; 2-DPNB plus PRB with ropivacaine injection and, 3-Control group without DPNB or PRB injection. Postoperative pain score and pain medication usage were recorded 2 h postoperatively, and every 24 h, for a week. The Visual Analog Scale (VAS) was used as pain scale measurement. A total of 131 patients were included in this study: 40 to bupivacaine, 47 to ropivacaine, and the rest were controls. Two hours postoperatively, mean VAS was significantly different (p < 0.0001) between medicated patients and the control group, however, no significant differences were observed between medication groups. Mean VAS was not significantly different among the groups from post-surgical day 2 thru 7. In conclusion, DPNB plus PRB during IPP provided effective analgesia in the immediate post-operative recovery.

Experience With Prophylactic Gentamicin During Penile Prosthesis Surgery: A Retrospective Comparison of Two Different Doses.

BACKGROUND: Gentamicin has been determined to be active against a wide range of bacterial infections and has been commonly used as a preoperative antibiotic for inflatable penile prosthesis (IPP) implantation. However, the best dosing regimen to produce the safest optimal prophylactic effect remains to be determined. AIM: To compare low- and high-dose gentamicin as prophylaxis during IPP implantation. METHODS: We retrospectively analyzed two groups of patients who underwent IPP placement from April 14, 2012 through April 13, 2016. Group 1 was composed of 490 patients who underwent IPP placement from April 14, 2012 through April 13, 2014 and received a low dose of preoperative gentamicin at 80 mg every 8 hours for 1 day. Group 2 was composed of 407 patients who underwent IPP placement from April 14, 2014 through April 13, 2016 and received a single high dose of preoperative gentamicin at 5 mg/kg. We compared the infection rates of IPP and any gentamicin-related toxicities. The same surgeon performed all procedures. All patients received additional vancomycin 1 g before incision and at 12 hours postoperatively. OUTCOME: Demographic data and IPP infection rate were compared and potential toxicities from the higher dose of gentamicin were closely monitored. RESULTS: There were no significant differences in mean age, mean body mass index, and mean interval for IPP placement and IPP infection between the two groups. No toxicity was seen with the higher gentamicin dose. Six cases in group 1 (five de novo cases and one redo case, infection rate = 1.22%) and three cases in group 2 (two de novo cases and one redo case, infection rate = 0.74%) were found to have IPP infection. The infection rate in group 2 appeared to be lower than that in group 1, although a significant statistical difference was not achieved (P = .057). CLINICAL IMPLICATIONS: These findings would help guide urologists in choosing an optimal preoperative gentamicin dose for IPP surgery. STRENGTHS AND LIMITATIONS: This is the first study to report on the usage of high-dose preoperative gentamicin for IPP surgery but with limitations as a retrospective study. CONCLUSIONS: Although not achieving a statistical difference, there was a trend for patients receiving a higher dose of preoperative gentamicin to have a lower IPP infection rate. No toxicity was encountered from the 5-mg/kg gentamicin dose. We recommend following prophylactic high-dose gentamicin guidelines. Xie D, Gheiler V, Lopez I, et al. Experience With Prophylactic Gentamicin During Penile Prosthesis Surgery: A Retrospective Comparison of Two Different Doses. J Sex Med 2017;14:1160-1164.

A prospective evaluation of penile measures and glans penis sensory changes after penile prosthetic surgery.

BACKGROUND: With better designed devices and lower infection rates, satisfaction with inflatable penile prosthesis (IPP) placement is increasingly high. However, dissatisfaction is still present and there is disagreement regarding length and sensation changes after the IPP placement. The aim of this study was to evaluate changes in penile length, girth and sensitivity after IPP placement. METHODS: From August 2012 to January 2013 all patients undergoing "de novo" IPP surgery were invited to participate in this study. Eighty six patients met inclusion criteria while 62 agreed to participate in this observational study. A week before surgery, penile length and circumference, and glans/elbow biothesiometer readings were recorded 15 minutes after Trimix induced erection. Same measures were taken at postoperative week 6 and month 6. RESULTS: Amperage from Glans biothesiometer readings showed statistically significant shorter readings than elbow biothesiometer preoperatively, 6 weeks and 6 months after surgery (P<0.001 each). No significant sensory difference in the glans penis after IPP was noted. However, compared to preoperative Trimix induced erections, penile length and circumference were greater after IPP placement (P=0.04 and P=0.001, respectively). CONCLUSIONS: We observed statistically significant increase in penile length and girth after IPP placement without significant changes in sensory conduction.

Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis.

INTRODUCTION: Penile prosthesis infections remain challenging despite advancements in surgical technique, device improvements, and adoption of antibiotic prophylaxis guidelines. AIM: To investigate penile prosthesis infection microbiology to consider which changes in practice could decrease infection rates, to evaluate current antibiotic prophylaxis guidelines, and to develop a proposed algorithm for penile prosthesis infections. METHODS: This retrospective institutional review board-exempt multi-institutional study from 25 centers reviewed intraoperative cultures obtained at explantation or Mulcahy salvage of infected three-piece inflatable penile prostheses (IPPs). Antibiotic usage was recorded at implantation, admission for infection, and explantation or salvage surgery. Cultures were obtained from purulent material in the implant space and from the biofilm on the device. MAIN OUTCOME MEASURES: Intraoperative culture data from infected IPPs. RESULTS: Two hundred twenty-seven intraoperative cultures (2002-2016) were obtained at salvage or explantation. No culture growth occurred in 33% of cases and gram-positive and gram-negative organisms were found in 73% and 39% of positive cultures, respectively. Candida species (11.1%), anaerobes (10.5%) and methicillin-resistant Staphylococcus aureus (9.2%) constituted nearly one third of 153 positive cultures. Multi-organism infections occurred in 25% of positive cultures. Antibiotic regimens at initial implantation were generally consistent with American Urological Association (AUA) and European Association of Urology (EAU) guidelines. However, the micro-organisms identified in this study were covered by these guidelines in only 62% to 86% of cases. Antibiotic selection at admissions for infection and salvage or explantation varied widely compared with those at IPP implantation. CONCLUSION: This study documents a high incidence of anaerobic, Candida, and methicillin-resistant S aureus infections. In addition, approximately one third of infected penile prosthesis cases had negative cultures. Micro-organisms identified in this study were not covered by the AUA and EAU antibiotic guidelines in at least 14% to 38% of cases. These findings suggest broadening antibiotic prophylaxis guidelines and creating a management algorithm for IPP infections might lower infection rates and improve salvage success. Gross MS, Phillips EA, Carrasquillo RJ, et al. Multicenter Investigation of the Micro-Organisms Involved in Penile Prosthesis Infection: An Analysis of the Efficacy of the AUA and EAU Guidelines for Penile Prosthesis Prophylaxis. J Sex Med 2017;14:455-463.

Two-year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence.

AIMS: Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months. METHODS: This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement. RESULTS: Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value <0.0001) and 52.0 in Incontinence Impact Questionnaire scores (P-value <0.0001) were observed. Additionally, 90.4% (85/94) of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement. No new device- or procedure-related adverse events occurred between the 12 and 24 month visits. CONCLUSIONS: The Altis single-incision sling is a durable and effective treatment with a favorable safety profile for surgical treatment of women with stress or stress-predominant mixed urinary incontinence.

The safety and efficacy of a new adjustable single incision sling for female stress urinary incontinence.

PURPOSE: We describe the safety and efficacy of the Altis(®) Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months. MATERIALS AND METHODS: In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events. RESULTS: Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months. CONCLUSIONS: The Altis sling appears to be safe and efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months.