American Medical Systems Research Articles

Results of a Randomized Phase III Trial of Mirabegron in Patients with Overactive Bladder

Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects. Mirabegron, a β3-adrenoceptor agonist, may offer an effective and well tolerated alternative treatment for overactive bladder. A randomized, double-blind, placebo controlled trial was conducted in the United States and Canada. After a 2-week placebo run-in period, adults with overactive bladder symptoms for 3 or more months were randomized 1:1:1 to receive placebo, 50 or 100 mg mirabegron once daily for 12 weeks. Efficacy data were collected via patient completed diaries and quality of life assessments. Co-primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours. Key secondary micturition and incontinence end points were also evaluated. Safety assessments included treatment emergent adverse events, laboratory assessments, vital signs, electrocardiograms and post-void residual volume. Compared to placebo, 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases (95% CI) from baseline for incontinence episodes (-1.13 [-1.35, -0.91], -1.47 [-1.69, -1.25] and -1.63 [-1.86, -1.40]) and micturitions (-1.05 [-1.31, -0.79], -1.66 [-1.92, -1.40] and -1.75 [-2.01, -1.48]) per 24 hours (p <0.05). Significant improvements in all key secondary end points were observed for both mirabegron doses vs placebo. The incidence of frequently reported treatment emergent adverse events (hypertension, urinary tract infection, headache, nasopharyngitis) was similar in the mirabegron and placebo groups. Dry mouth was reported for 1.5%, 0.5% and 2.1% of patients in the placebo, 50 and 100 mg mirabegron groups, respectively. Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects.

Pelvic Floor Structure and Function in Women with Vesicovaginal Fistula

Vesicovaginal fistula is a catastrophic event, especially in areas with poor peripartum care, where most occur. It is usually due to severely obstructed and protracted labor. We assumed that such patients would show evidence of abnormal levator function, eg due to denervation. In an external audit at Hamlin Fistula Hospital in Addis Ababa, Ethiopia, 95 women were seen for clinical examination and 4-dimensional translabial ultrasound. Patients were examined supine and after voiding. Volume data sets were obtained upon coughing, Valsalva maneuver and pelvic floor muscle contraction. Women were seen before (22) or after (73) vesicovaginal fistula repair. Mean age was 29.5 years (range 16 to 65) and mean parity was 2.7 (range 1 to 11). Only 2 patients had a significant cystocele (stage 2), 3 had stage 2 uterine prolapse and 13 had a stage 2 rectocele. Levator biometry was done in 92 of 95 women, which showed no evidence of muscle atrophy. Mean hiatal area on Valsalva was 18.8 cm(2) (range 7.7 to 45.9) and only 6 of the 92 women (7%) fulfilled the criteria for ballooning (hiatal distention 25 cm(2) or greater). Levator avulsion was diagnosed in 27 cases (28%), of which 11 were bilateral. Reflex contraction of the levator ani was observed upon coughing in all except 2 patients. Levator contraction upon request could be performed by all except 6 women. Abnormal levator function and anatomy in patients with vesicovaginal fistula is not uncommon but no more than in unselected urogynecologic patients in the developed world. There was no evidence of permanent denervation of the levator ani.

International Variation in Artificial Urinary Sphincter Use

To analyze international trends in artificial urinary sphincter (AUS) use, indications for placement, and application by gender. We conducted a retrospective review of data derived from patient information forms sent to American Medical Systems. There were 86 140 unique cases from March 1975 through December 2008, including all indications. AUS use increased worldwide from 1975 (90 procedures) through 2008 (4818 procedures). In 2008, patients with postprostatectomy incontinence (PPI) accounted for 61% (2907/4751) of AUS use compared to 12% (8/66) in 1975. Artificial urinary sphincter annual implant rates in women were much lower than in men, decreasing from 298 procedures in 1990 to 67 in 2008. Artificial urinary sphincter implants in the United States for men alone accounted for the majority (62%, 2995/4818) of worldwide artificial urinary sphincter use in 2008. Conversely, artificial urinary sphincter use has recently started declining in other areas, including South America and Canada. Frequency of artificial urinary sphincter surgery varied dramatically from less than 0.01 per 100 000 population in Brazil to 0.99 in the United States. Of surgeons performing artificial urinary sphincter implants in 2008, case volumes in and outside of the United States were similarly low: 56% in the United States and 52% outside the United States performed only 1 artificial urinary sphincter implant, whereas 76% in the United States and 73% outside the United States did fewer than 3. Artificial urinary sphincter use has continued to increase internationally over the study period, especially for patients with PPI. However, artificial urinary sphincter use exhibits considerable regional variation, and most surgeons performed very low annual case volumes of implants.

Editorial Comment

This retrospective study provides some interesting, if not surprising findings on United States and worldwide use of the American Medical Systems, Inc. artificial urinary sphincter (AUS). A potential bias in interpretation, pointed out by the authors, is the fact that the data are based on a voluntarily filled patient information leaflet. In the study by Reynolds et al (Ref. 28 in the paper) on a much smaller cohort of patients in the United States only, the number of patient information forms (PIFs) was only 89% of the sales number for the same period. Are surgeons less likely to fill PIFs on revisions and does the rate vary between countries? These facts are unknown but may conceal an even higher revision rate. The most important message is the observation that of the implanting surgeons, 72% to 76% (depending on the country) only ever performed 1 or 2 implant procedures that we know of. Unfortunately, the authors missed an opportunity to explore the interesting question of whether the revision and complication rate was related directly to the implant experience of the individual surgeon! This would pave the way for the recommendation of a threshold number of cases per year per surgeon or institution which should be achieved to reduce morbidity and cost. International Variation in Artificial Urinary Sphincter UseUrologyVol. 80Issue 3PreviewTo analyze international trends in artificial urinary sphincter (AUS) use, indications for placement, and application by gender. Full-Text PDF ReplyUrologyVol. 80Issue 3PreviewWe thank the reviewers and acknowledge the comments above. Although we agree that a voluntarily filled patient information form does not replace prospective data collection, the database that formed the basis for this study has been vetted extensively by our group to ensure it includes the vast majority of revisions. Furthermore, we have explored the effect of individual surgeon experience on outcomes of artificial urinary sphincter (AUS) surgery, and found that as surgeons gain more experience, their complication rate (measured by rate of reoperation within 5 years) decreases significantly. Full-Text PDF

Photoselective vaporization of the prostate with the 120W lithium triborate laser for the treatment of acute urinary retention

PurposeWhilst photoselective vaporization of the prostate (PVP) is used to treat benign prostatic hyperplasia, there is little reported about its performance in urinary retention. The objective of this study is to evaluate the efficacy and safety of GreenLight™ high performance system 120W lithium triborate laser (American Medical Systems, Inc, Minnetonka, MN) PVP in men with urinary retention.Patients and methodsRetrospective analysis of data of all men in urinary retention who underwent treatment with the 120W lithium triborate laser PVP by a single surgeon from November 2006 to July 2010 was performed (n = 78), median age 71 years (interquartile range, 64–80), median prostate volume 91 mL (interquartile range, 58–121). Perioperative outcomes and functional outcomes at baseline, and at 3 and 12 months post-operation were examined.ResultsPatients managed preoperatively by urethral catheterization (n = 61) and suprapubic catheterization (n = 5) were of greater age (by 8.2 years, P < 0.05) and higher American Society of Anesthesiologists scores (P = 0.000, Fisher’s exact test mid P) than patients managed by intermittent self-catheterization (n = 12), but there was no difference in outcomes. There were three Clavien grade III, two Clavien grade IV, and no Clavien grade V complications. There were also no blood transfusions. Fifty-three men (68%) voided successfully post-PVP and went home catheter-free within 24 hours. At 3 months, 62 out of 64 evaluable men (97%) were voiding well without needing any form of catheterization. At 3 months and 12 months, median International Prostate Symptom Score was 7 and 6; International Prostate Symptom Score Quality of Life Index 1 and 1; peak urinary flow 19 and 22 mL/sec; and post-void ultrasound measured residual urine volume 52 and 60 mL, respectively.ConclusionPVP for urinary retention is an efficacious and safe treatment modality.

Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse

The objective of the study was to compare extrusion (vaginal mesh exposure) rates in patients undergoing transvaginal prolapse repair with the trocar-based Apogee and/or Perigee devices (American Medical Systems, Minnetonka, MN, USA) using either the original type I polypropylene mesh (IntePro, American Medical Systems, Minnetonka, MN, USA) or a newer generation lightweight type I mesh (IntePro Lite, American Medical Systems, Minnetonka, MN, USA). Data were pooled from three similarly designed prospective multicenter studies evaluating the safety and efficacy of Perigee for correction of the anterior (AC) and/or Apogee to repair the posterior/apical (PC/A) compartments. The first two studies utilized IntePro (mesh density 50 g/m(2)) and the third utilized IntePro Lite (mesh density 25.2 g/m(2)). Data were pooled to form IntePro and IntePro Lite groups for comparison. Patient demographics were recorded. Risk factors for vaginal mesh exposure were also considered. Two hundred and sixty-three patients were implanted with Perigee and/or Apogee with IntePro for a total of 371 heavier mesh implants (174 Perigee, 197 Apogee) compared to 86 patients who underwent Perigee and/or Apogee with IntePro Lite for a total of 116 lightweight mesh implants (60 Perigee, 56 Apogee). Demographics and potential risk factors for extrusion were compared between the two groups. Mean follow-up was 2.0 years and similar between the two groups. In the AC, there were 234 implants, with mesh extrusion occurring in 8.0 % following IntePro compared to 5.0 % following IntePro Lite (p = 0.57). In the PA/C, there were 253 implants, with mesh extrusion occurring in 13.7 % following IntePro compared to 7.1 % following IntePro Lite (p = 0.25). Overall mesh extrusion rates in 487 implants in all compartments were found to be 11.1 % with IntePro versus 6.0 % with IntePro Lite with an estimated odds ratio of 1.93 (95 % confidence interval 0.84-4.44, p = 0.12). No statistically significant difference in extrusion rates were seen following use of IntePro versus IntePro Lite; however, the 46 % reduction in rate of mesh exposure observed in those receiving the lighter weight mesh may represent clinical importance.

The status of women in naturopathy: a view from the United States and Australia

Like other professionalized heterodox medical systems in Western societies, naturopathic practitioners and the leaders of naturopathic professional associations historically appear to have been predominantly males. Conversely, this situation appears to have started to change in the 1970s. Today the vast majority of naturopathic students and naturopathic practitioners in the United States and Australia, are women. While women have moved into positions of leadership in the American Association of Naturopathic Physicians, various Australian naturopathic professional associations, and naturopathic training programs in both the US and Australia, the presence of men in positions of organizational and education leadership appears to exceed their diminished numbers as practitioners. Bearing these thoughts in mind, this essay explores why women have been drawn to naturopathy in great numbers and the political-economic and socio-cultural forces that still hinder their professional development as practitioners and professional leaders within the contexts of the American and Australian dominative medical systems.

Early Aggressive Treatment of Lichen Sclerosus May Prevent Disease Progression

When not recognized and treated aggressively, lichen sclerosus may progress and cause debilitating symptoms. It also may result in significant morbidity in patients undergoing treatment for urethral strictures because unrecognized, it may result in rapid and severe recurrence after surgical treatment. We present our experience treating patients with lichen sclerosus in an equal access health care system. We performed an institutional review board approved retrospective review of all adult men with lichen sclerosus treated at our institution during a 10-year period. We analyzed all patients diagnosed with lichen sclerosus, and recorded patient demographics and therapies. We recorded characteristics of the disease process including external and internal manifestations. We also recorded the various treatments, and whether the patients experienced recurrence. A total of 43 patients were diagnosed with lichen sclerosus during the review period. Of those patients presenting with more severe (urethral) involvement and undergoing 1 or 2-stage urethroplasties, we noted 7 with recurrence. In the remainder of patients presenting with less severe disease who were treated aggressively with clobetasol and/or minor procedures, no recurrences were noted on followup examination, and all of these patients had documented normal flow patterns on noninvasive urodynamics. Our data suggest that early aggressive topical therapy plus minimally invasive surgical therapy to relieve high pressure voiding may prevent the progression of lichen sclerosus in patients who present with limited disease involving the skin and meatus.

Bias Due to Missing SEER Data in D'Amico Risk Stratification of Prostate Cancer

We examined the degree of exclusion bias that may occur due to missing data when grouping prostate cancer cases from the SEER (Surveillance, Epidemiology and End Results) database into D'Amico clinical risk groups. Exclusion bias may occur since D'Amico staging requires all 3 variables to be known and data may not be missing at random. From the SEER database we identified 132,606 men with incident prostate cancer from 2004 to 2006. We documented age, race, Gleason score, clinical T stage, PSA and geographic region. Men were categorized into D'Amico risk groups. Those with 1 or more unknown tumor variables (prostate specific antigen, T stage and/or Gleason score) were labeled unclassified. We compared the value of the other 2 known clinical variables for men with known vs unknown prostate specific antigen, Gleason score and T stage. Demographics were compared for those with and without missing data. Results were compared using chi-square and logistic regression. Of the men 33% had 1 or more unknown tumor variables with T stage the most commonly missing variable. There was no clinically significant difference in the value of the other 2 known tumor variables when T stage or prostate specific antigen was missing. Men older than 75 years were more likely to have unknown variables than younger men. There was significant geographic variation in the frequency of unclassified D'Amico data. In studies in which the data set is limited to men who can be classified into a D'Amico risk group 33% of eligible patients are excluded from analysis. Such men are older and from certain SEER registries but they have tumor characteristics similar to those with complete data.

239 ARTIFICIAL URINARY SPHINCTER PLACEMENT IN PATIENTS WITH ORTHOTOPIC NEOBLADDER URINARY DIVERSION AFTER RADICAL CYSTECTOMY: RETROSPECTIVE REVIEW OF CLINICAL OUTCOMES

You have accessJournal of UrologyTrauma/Reconstruction: Trauma & Reconstructive Surgery III1 Apr 2012239 ARTIFICIAL URINARY SPHINCTER PLACEMENT IN PATIENTS WITH ORTHOTOPIC NEOBLADDER URINARY DIVERSION AFTER RADICAL CYSTECTOMY: RETROSPECTIVE REVIEW OF CLINICAL OUTCOMES Michael Vainrib, Vannita Simma-Chiang, Stuart Boyd, and David Ginsberg Michael VainribMichael Vainrib Los Angeles, CA More articles by this author , Vannita Simma-ChiangVannita Simma-Chiang Los Angeles, CA More articles by this author , Stuart BoydStuart Boyd Los Angeles, CA More articles by this author , and David GinsbergDavid Ginsberg Los Angeles, CA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.294AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Stress urinary incontinence (SUI) is a known possibility after radical cystectomy (RC) and orthotopic neobladder (ONB) urinary diversion. Our primary aim was to retrospectively review the outcomes and complications of patients who have elected to undergo artificial urinary sphincter (AUS), AMS-800 (American Medical Systems, Minnetonka, MN) placement for treatment of post-ONB SUI in a single institution. The secondary objective was to evaluate possible risk factors for AUS failure. METHODS From 1994 - 2009, as part of IRB-approved Bladder Cancer Database, 64 patients (pts) who had undergone AUS placement after RC/ONB were identified. Comparative variables were analyzed using Fisher exact test. RESULTS 36 male pts were eligible to review. Mean age at RC/ONB was 70 years (range 55-82) and at AUS placement 72 years (58-79). Mean time to AUS after RC/ONB was 28 (2-120) months. Mean follow up after AUS was 3.2 years (0.5-10). TCC was the indication for RC in 94% of pts. Mean BMI was 28 kg/m2 and 19% of patients had diabetes. Pelvic floor physiotherapy was attempted in 17% of pts prior to undergoing AUS placement. Timing of incontinence in these patients included: complete (day and night) - 76%, daytime only - 10% and nighttime only - 14% pts. Post-AUS placement, 82% pts reported good (dry/social) continence. 11/36 received chemotherapy on average of 3.7 (1-10) years prior to AUS and 10/36 had radiation on average of 2.5 (0.5-10) years prior to AUS. There were no perioperative complications observed during AUS placement. Mean time to further surgical intervention was an average 2.6 (1-6) years after AUS placement and occurred due to: erosion - 9 patients, device malfunction - 5 patients, infection - 5 patients. There was no significant correlation between pathological stage of bladder cancer, presence of concomitant prostate cancer and degree of incontinence pre- or post-AUS. In addition, there was no correlation found between chemo- or radio-therapy and degree of incontinence or the need for AUS erosion or revision. CONCLUSIONS With intermediate follow-up, patients undergoing AUS after RC/ONB were found to have an acceptable complication rate that is comparable to previous series. AUS is a safe, effective treatment for high risk patients after RC/ONB with severe SUI. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e98 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Vainrib Los Angeles, CA More articles by this author Vannita Simma-Chiang Los Angeles, CA More articles by this author Stuart Boyd Los Angeles, CA More articles by this author David Ginsberg Los Angeles, CA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Outcomes of Artificial Urinary Sphincter Placement in Men After Radical Cystectomy and Orthotopic Urinary Diversions for the Treatment of Stress Urinary Incontinence: The University of Southern California Experience

To examine the outcomes of male patients who have undergone artificial urinary sphincter (AUS), AMS-800 (American Medical Systems Minnetonka, MN) placement for iatrogenic stress urinary incontinence after radical cystectomy (RC) and orthotopic neobladder (ONB) diversion in a single institution. From 2002-2009, patients were prospectively randomized to undergo RC and Studer vs T-pouch neobladder reconstruction. We received IRB- approval to retrospectively review the charts of patients who underwent AUS placement for symptoms of SUI. Patients were mailed 2 validated questionnaires, International Continence Society Male-Short Form, the Incontinence Symptom Severity Index, and a pad questionnaire. Twelve male patients were identified. Average age at time of AUS placement was 73.8 years (range 52-82). Mean time between RC/ONB and AUS placement was 1.53 years (range 1-4). Mean follow-up time after initial AUS placement was 21.7 months (range 12-72). Ten patients (10/12; 83.3%) returned the validated questionnaires. In comparing pre-AUS to post-AUS continence, 90% of patients reported improvement in continence. Three patients deactivated their AUS during the day and activated it at night. There were no erosions (0%) or any mechanical malfunctions of the device (0%) in our cohort. There were no complications or injuries to the ONB during placement of the AUS components. AUS is a safe, effective continence procedure for patients with ONB and SUI. Complication rate, urinary symptoms, and quality of life these patients have as determined by validated questionnaires is acceptable.

Long-Term Results of Artificial Urinary Sphincter for Women with Type III Stress Urinary Incontinence

BackgroundThe use of the artificial urinary sphincter (AUS) in women is limited. ObjectiveTo analyse long-term results and mechanical survival of the AUS (AMS 800; American Medical Systems, Minnetonka, MN, USA) in women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD). Design, setting, and participantsWomen with SUI who were treated between January 1987 and March 2007 were included in this prospective study. Only women with low closure pressure at urethral profile and negative continence tests, indicators of severe ISD, were included. InterventionsAn AUS was implanted. The surgical technique was modified in 1999, involving opening the endopelvic fascia on both sides and dissection in contact with the vaginal wall. Outcome measurements and statistical analysisAssessment of complications was made pre- and postoperatively and continence status was based on pad usage. Kaplan-Meier survival curves were used to calculate mechanical survival of the device. Student t test and the chi-square test were used to compare continence and complication rates. Results and limitationsA total of 376 AUS were implanted in 344 patients, whose mean age was 57 yr. The mean follow-up, plus or minus standard deviation, was 9.6±4.0 yr. At last follow-up, postoperative continence rates, assessed as fully continent (no leakage), socially incontinent (some drops but no pad), or incontinent (one pad or more), were 85.6%, 8.8%, and 5.6%, respectively. The 3-, 5-, and 10-yr device survival rates were 92.0%, 88.6%, and 69.2%, respectively. The mean mechanical survival was 176 mo (14.7 yr). Three risk factors for AUS survival were the number of previous incontinence surgeries, the presence of neurogenic bladder, and simultaneous augmentation enterocystoplasty. Principal limitation of the study is the absence of validated incontinence questionnaire. ConclusionsThe AUS provides excellent outcome in women with ISD, with low explantation rate and very good device survival.

Treatment of Postprostatectomy Male Urinary Incontinence With the Transobturator Retroluminal Repositioning Sling Suspension: 3-Year Follow-up

BackgroundThe AdVance male sling (American Medical Systems, Minnetonka, MN, USA) has been shown to be an efficacious device in short-term studies for postprostatectomy incontinence (PPI), but long-term studies are lacking. ObjectiveExamine the intermediate-term outcome with the AdVance sling for PPI management. Design, setting, and participantsA multicentre prospective evaluation was conducted on consecutive patients treated for PPI in three European tertiary reference centres. InterventionPatients were implanted with the AdVance male sling with no associated surgery. Outcome measurements and statistical analysisMeasurements included daily pad usage, maximum flow rate (Qmax), postvoid residual urine (PVR), the International Consultation on Incontinence Questionnaire–Short Form, the Incontinence Quality of Life questionnaires, and complications of surgery. Paired Wilcoxon signed rank test univariable and multivariable analyses were used. Results and limitationsFollow-up was available for 156 patients for the majority of parameters. Pad usage was significantly decreased compared with baseline at 12 mo and 3 yr (p<0.0001). At 12 mo, 76.9% of patients could be classified as cured or improved; this percentage was maintained at 3 yr (76.8%). Cure rates (58.6% vs 42.3%) and improvement rates (23.2% vs 25.0%) were higher in patients with mild or moderate incontinence compared with severe incontinence. Univariable analysis showed that pretreatment pad usage and severity of incontinence were both significant predictors of success (p=0.0355 and p=0.0420, respectively). However, in multivariable analysis, only pad usage was an independent predictor of success. There were no perioperative or severe postoperative complications. Most complications were Dindo grade I. Seven patients required a second treatment for stress urinary incontinence. There was no worsening over time. Limitations of this study included no comparator group, quality of life questionnaires in only two centres, and no 24-h pad test. ConclusionsThe transobturator retroluminal repositioning sling suspension is effective and safe in the longer term for treating PPI.

Bone-anchored Sling Created with the InVance&lt;sup&gt;TM&lt;/sup&gt; System for the Treatment of Incontinence after Radical Prostatectomy: Initial Experience in Japan

This report describes creation of a bone-anchored sling with the InVance™ system (American Medical Systems, Minnetonka, MN, USA) for the treatment of 2 patients with incontinence after radical prostatectomy. The InVance™ system uses a silicon-coated polyester sling positioned under the bulbar urethra via a perineal incision. The sling is attached to both ischiopubic rami by 3 titanium screws. Operative times were 157 minutes (patient 1) and 240 minutes (patient 2). Blood loss was 70 mL (patient 1) and 10 mL (patient 2). The patients used 7 and 5 absorbent pads/day, respectively, before surgery and 1 and 0 pads/day after surgery (this datum does not appear in the main text, although the absence of incontinence is mentioned). The only major adverse event encountered was mesh infection necessitating mesh removal in patient 2. This operation appears comparatively simple and useful.

New Artificial Urinary Sphincter Devices in the Treatment of Male Iatrogenic Incontinence

Severe persistent stress incontinence following radical prostatectomy for prostate cancer treatment, although not very common, remains the most annoying complication affecting patient's quality of life, despite good surgical oncological results. When severe incontinence persists after the first postoperative year and conservative treatment has been failed, surgical treatment has to be considered. In these cases it is generally accepted that artificial urinary sphincter is the gold standard treatment. AUS 800 by American Medical Systems has been successfully used for more than 35 years. Recently three more sphincter devices, the Flow-Secure, the Periurethral Constrictor, and the ZSI 375, have been developed and presented in the market. A novel type of artificial urinary sphincter, the Tape Mechanical Occlusive Device, has been inserted in live canines as well as in human cadavers. These new sphincter devices are discussed in this paper focusing on safety and clinical results.

Incidence of Extrusion Following Type I Polypropylene Mesh “Kit” Repairs in the Correction of Pelvic Organ Prolapse

Introduction and Hypothesis. We sought to determine the mesh extrusion (vaginal exposure) rates and subject outcomes following IntePro (Type I polypropylene) mesh “kit” repairs for vaginal prolapse. Methods. Data were pooled from two prospective multicenter studies evaluating the safety and efficacy of the Perigee and Apogee (American Medical Systems, Minnetonka, Minn, USA) to treat anterior and posterior/apical prolapses, respectively. Extrusions involving the anterior compartment (AC) or posterior compartment/apex (PC/A) were recorded. Results. Two hundred sixty women underwent mesh placement, with a total of 368 mesh units inserted (173 in the AC and 195 in the PC/A). Extrusions were noted in 13 (7.5%) of AC implants and 27 (13.8%) of PC/A implants through 12 months. No difference was seen between those with and without extrusion in regard to anatomic cure, postoperative painor quality of life at 1 year. Conclusions. Extrusion had no apparent effect on short-term outcomes. Given the unknown long-term sequellae of vaginal mesh exposure, a thorough assessment of risks and benefits of transvaginal mesh placement should be considered at the time of preoperative planning.

Anti‐Infection Dip Suggestions for the Coloplast Titan Inflatable Penile Prosthesis in the Era of the Infection Retardant Coated Implant

Infection is the worst complication seen with inflatable penile prosthesis (IPP). Both the American Medical Systems (AMS) and Coloplast IPP have infection retardant coatings. AMS is coated at the factory with rifampicin and minocycline (InhibiZone). The Coloplast IPP has a hydrophilic coating covalently bonded to its components that will absorb any aqueous solution before implantation and provides increased surface lubricity to decrease bacterial adherence. We tested several antibiotic dips comparing zones of inhibition (ZOI) against five commonly infecting bacteria with coated Coloplast implants. Results were compared with those ZOI created with strips of an AMS IPP precoated with InhibiZone. Pieces of sterile Coloplast Titan IPP were dipped in (i) trimethoprim/polymixin B ophthalmic solution; (ii) trimethoprim/sulfamethoxazole infusion solution; (iii) bacitracin; (iv) rifampicin/minocycline; and (v) rifampin/trimehtoprim/sulfamethoxazole. ZOI for the Titan strips and for AMS InhibiZone coated strips were tested against Staphylococcus epidermidis, Staphylococcus lugdunensis, Staphylococcus aureus, Pseudomonas, and Enterococcus. ZOIs of the Coloplast Titan for each of the medicated solutions were compared with ZOI created by undipped strips of a sterile InhibiZone coated IPP placed on plates of the identical bacteria. All dips except bacitracin showed ZOI≥InhibiZone (P≥0.005) for most organisms. Because of broad-spectrum effectiveness, ease of handling, and cost, infusion vial of trimehtoprim/sulfamethoxazole seemed optimal at this time. If trimehtoprim/sulfamethoxazole is unavailable; the ZOI with Polytrim ophthalmic solution zones were almost as good. The Coloplast strips when dipped in several solutions showed equal or significantly larger ZOI against commonly infecting organisms than the InhibiZone coated strips. At the present time using off the shelf trimethoprim sulfamethoxazole infusion solution seems optimum. The flexibility of choosing the drug eluting from the Coloplast device seems promising in the changing bacterial environment.

Photoselective vaporization of the prostate for treating benign prostatic hyperplasia

Benign prostatic hyperplasia (BPH) commonly occurs in older men. Traditionally, the gold standard for treatment of BPH has been the electrocautery-based transurethral resection of the prostate (TURP). However, TURP is associated with several complications and side effects. Therefore, there is an interest in a number of emerging minimally invasive therapies as alterative treatment options. Advancements in laser technology have led to the introduction of photoselective vaporization of the prostate (PVP) using the GreenLight™ laser (American Medical Systems, MN, USA). PVP uses a 532-nm laser to remove obstructive prostatic tissue. The laser energy is selectively absorbed by hemoglobin in the prostate tissue and results in tissue destruction. The GreenLight PVP laser system has gone through several evolutions from the original 60-W laser to the most recent 180-W GreenLight XPS™ system with MoXy™ Fiber. With the increasing use of GreenLight to treat BPH, there is a need to review the evidence regarding its use. We review the clinical implications of using GreenLight laser therapy for the treatment of BPH.

Comparison of a New Length Measurement Technique for Inflatable Penile Prosthesis Implantation to Standard Techniques: Outcomes and Patient Satisfaction

Within a study evaluating the redesigned AMS 700MS inflatable penile prosthesis (IPP) (American Medical Systems, Minnetonka, MN, USA), one site used new length measurement technique (NLMT), a more aggressive dilation and measurement of the corpora cavernosa on a stretched penis, to address penile shortening. To compare cylinder size and patient satisfaction, between a NLMT and traditional sizing for IPP implantation. Fourteen men received IPPs using NLMT, and 55 with traditional sizing. Nationwide sales data from 2005 to 2008 for AMS 700 IPPs was obtained from AMS for comparison; additional surveys captured patient satisfaction. Demographic data, cylinder sizes, and patient satisfaction were compared between the NLMT and standard techniques. The Fisher's exact test (P<0.001) showed a significant difference between the cylinder sizes with NLMT as compared with standard techniques. Of the 14 NLMT patients, 71.4% (10) received cylinders>21 cm long and 28.6% (4) received cylinders<21 cm long, as compared with 12.7% (7) and 87.3% (48), respectively, for patients implanted by traditional techniques. There were ethnic differences between the samples: 42.9% (6) NLMT patients were of African-American descent, as compared with 10.9% (6) in the standard technique group. However, longer cylinders were utilized more often, with 83.3% (5) of African-Americans treated using the NLMT; as compared with 33.3% (2) of the standard technique group. Nationwide data reveal 12.3% of patients routinely receive 21 cm cylinders. At 6 months postimplantation, patient satisfaction with NLMT was no different than standard techniques. There were no distal erosions, complications, infections, or pain concerns reported through 24 months among the NLMT patients. The NLMT resulted in a larger number of subjects implanted with larger cylinders. Satisfaction with performance and complication rates for NLMT patients was comparable to those implanted using standard techniques.

Assessing Internet Health Information on Female Pelvic Floor Disorders

While health information on the Internet on female pelvic floor disorders is abundant, to our knowledge there has been no comprehensive evaluation of the quality of this material. We assessed health information on the Internet using Health on the Net Foundation principles as they pertain to female pelvic floor disorders. Web sites were searched using the key words urinary incontinence, vaginal, uterine or pelvic organ prolapse and overactive bladder. The first 150 websites identified for each female pelvic disorder were assessed for Health on the Net Foundation certification using an automated toolbar function. The specific sponsorship of each web site was also recorded. All searched domains for female pelvic floor disorders revealed that most websites were not certified. The certification rate for urinary incontinence, pelvic organ prolapse and overactive bladder was 29%, 27% and 27%, respectively. Overall websites were sponsored by for profit commercial entities (44%), urologist/specialty societies (30%), government/educational organizations (16%), nonprofit organizations (9%) and law firms (1%). Nonprofit organizations (40%) and government/educational organization (38%) sponsored websites were more likely to be certified than those sponsored by commercial entities (25%) and urologist/specialty societies (23%) (p=0.036). The Internet has become a heavily used resource for the distribution and acquisition of health information. Availability notwithstanding, certification and validation are lacking for most sites related to information on female pelvic floor disorders. As we move forward, improvement in the quality of information on the Internet is imperative along with proper guidance to patients using the Internet as a reference.