Introduction and Objective: A variety of laser sources are available to treat bladder stones. The aim of this study was to compare time and cost efficiency of the thulium fiber laser (TFL) to four holmium lasers (HLs) with different powers or technologies, including MOSES (TM) during simulated cystolithotripsy.Materials and Methods: In a benchtop simulation of laser cystolithotripsy, 25 identical 4-cm BegoStones (calcium oxalate monohydrate consistency) were placed on a grid within a 3D-printed bladder model. Lasers were operated at maximal energy, using a 550 mu m fiber. Lasers compared were as follows: 60 W TFL, 120 W HL with MOSES, and conventional 120, 100, and 30 W HLs. Five trials were performed for each laser with endpoints of laser time, total time, number of fiber strippings, and total energy. Cost-effectiveness was modeled using laser purchase price, fiber, and operating room (OR) time cost. ANOVA with Tukey's B post hoc was performed to compare outcomes. Spearman's test was used to assess correlation between laser power and procedure time.Results: The laser and total operating times were significantly different between the five systems (p < 0.001). The 120 W HL with MOSES was the fastest with 60.9 minutes of laser and 68.3 minutes of procedure times, while the 30 W HL was the slowest with 281.2 minutes of laser and 297.5 minutes of procedure times. The 60 W TFL was faster than the 30 W HL, but slower than the higher power HLs. Higher laser power was associated with shorter procedure time (Rs = -0.98; p = 0.002). When estimating cost per procedure, the MOSES HL was the cheapest, but had the highest purchase cost. The TFL was not cost-effective for large bladder stones compared with the 100 W HL.Conclusions: When treating large bladder stones, total laser power was highly correlated with laser and procedure times and the TFL was limited by its total power. The most cost-effective laser for use will depend on the case volume.

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction III (PD44)1 Apr 2020PD44-09 A BLADDER INJECTION SYSTEM AND A SPECIFIC INJECTION PROTOCOL REDUCE URINARY RETENTION FOLLOWING ONABOTULINUMTOXINA TREATMENT OF OVERACTIVE BLADDER (OAB) John Smith, Jeffrey Proctor*, Scott MacDiarmid, Bradley Jacobs, Eric Gywnn, and Lonny Green John SmithJohn Smith More articles by this author , Jeffrey Proctor*Jeffrey Proctor* More articles by this author , Scott MacDiarmidScott MacDiarmid More articles by this author , Bradley JacobsBradley Jacobs More articles by this author , Eric GywnnEric Gywnn More articles by this author , and Lonny GreenLonny Green More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000931.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Injecting onabotulinumtoxinA into the bladder wall effectively treats OAB but many patients find the risk of post procedure urinary retention unacceptable. Two recent studies report reduced incidence of urinary retention with a protocol that avoids the bladder dome and injects the lateral edges of the bladder. The objective of this post market, prospective study was to assess the safety and efficacy of a bladder injection system using this protocol. METHODS: Female patients being treated for OAB participated in the study. A cystoscope lens inserted into a single use introducer with a rotatable shape memory cannula and needle (Fig. 1), was placed into the bladder. The cannula/needle was then advanced to the wall and the drug injected into tissue in 10 - 40 sites, per the protocol. see jpgFig. 1 Bladder Injection System Patients ranked their pain, 0 (no pain) to 10 (worst pain ever), during the procedure and were contacted 5-21 days post treatment, to document outcome and the necessity of clean intermittent catheterization. Tolerance of the procedure was based on mean pain levels; safety, on procedure-related adverse events. RESULTS: 143 procedures were completed successfully. 120 patients received 100 units of Botox; 23, 200 units. 95 had 10 injections; 4, 12 injections; 37, 20 injections; and 7, 40 injections. There were no adverse events Two patients noted pain with the first injection but no pain with subsequent injections when the injection angle was adjusted tangentially. 90% of patients reported symptom relief. 1 (0.7%) patient required clean intermittent catheterization. CONCLUSIONS: This bladder injection system with its rotatable shape memory cannula/needle and a compound curved distal end enabled injecting the lateral edges of the bladder with little to no manipulation of the cystoscope/introducer. This may account for patients reporting little to no discomfort during the procedure. These results replicate those of two other studies reporting significantly reduced urinary retention associated with this protocol. A rationale for the protocol is proposed. Source of Funding: Uro 1 Medical © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e910-e910 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Smith More articles by this author Jeffrey Proctor* More articles by this author Scott MacDiarmid More articles by this author Bradley Jacobs More articles by this author Eric Gywnn More articles by this author Lonny Green More articles by this author Expand All Advertisement PDF downloadLoading ...

INTRODUCTION AND OBJECTIVE: Currently, hospitals are under pressure to reduce hospital-acquired infections. One technique suggested to reduce infection is the use of a novel flat computer keyboard, which are easier to sterilize. In an attempt to reduce infections, our institution replaced all conventional keyboards with a flat “hygienic” keyboard covered by silicone. Although these keyboards are easily cleaned, lack of tactile feedback from conventional keys appeared to make typing more difficult and may increase the potential for errors. Medical errors cost $20 billion and kill 100 thousand people a year in the U.S. The purpose of this study is to compare accuracy, speed and error correction rates between a “hygienic” flat and conventional keyboard. METHODS: A prospective randomized study including 40 participants (physicians, nurses and medical students) was conducted in the perioperative setting. Subjects performed practice and recorded typing tests on the conventional and flat keyboard using a randomized, crossover design. Results were recorded as words per minute (WPM), accuracy, and error correction rates. Accuracy was determined by the number of incorrectly typed characters. The clinical impact of the two different keyboard types was determined by measuring the number of typed words for every patient admitted to the urology service for 30 days. The data for word count, accuracy and speed were compared between a conventional and “hygienic” keyboard when employed for a 1 year period. RESULTS: Subjects typed significantly faster using the conventional keyboard (58 WPM) compared to the flat keyboard (50 WPM; p<0.001). In addition accuracy was significantly higher using the conventional (94.5% vs. 90%; p[0.0236) compared to the flat keyboard. The percent error correction was similar (52% vs 52%; p[0.31). During the one month study period, the urology service typed an average of 526 (43-9480) words for 67 patients with a total of 35,245 words. Applying word and error rates to a one-year period, using the conventional keyboard would save 17.7 hours and 19,032 less errors compared to the flat “hygienic” keyboard. CONCLUSIONS: The optimal solution for reducing infection transmission would not compromise speed or accuracy. This study demonstrates that any potential benefit from reduced infection seen with the flat keyboard comes at the price of a 16% reduction in typing speed and 5% greater error rate.

INTRODUCTION AND OBJECTIVE: A variety of laser sources are available to treat bladder stones. The aim of this study is to compare efficacy and cost of a 120W Holmium laser with Moses technology, conventional 120W, 100W, and 30W during benchtop cystolithopaxy. METHODS: In a benchtop simulation of laser cystolithopaxy, 20 identical 4 cm BegoStones (CaOx monohydrate consistency) were placed on a 5.3 x 5.3 mm metal mesh within a 3D printed bladder model. Laser boxes were operated at maximal energy, using a 550 mm fiber. Energy settings employed were: Lumenis P120H laser with Moses at 4 J / 30 Hz, Lumenis P120H at 4 J / 30 Hz, Olympus Empower 100W at 3.3 J / 30 Hz, and a Dornier 30W at 2.5 J / 8 Hz. The cost of the laser box (Lumenis $210K, Olympus $95K, Dornier $35K), the fibers (Moses $770.4, regular 120W $610.0, 100W $313.73 and 30W $313.73/fiber), and the mean cost of OR time in California ($37/min) were used to model cost effectiveness. ANOVA was performed and subsequently, a Tukey’s B post hoc was used to compare laser time and number of laser strippings required and initial and residual stone weights between groups. RESULTS: Stone weights were similar between groups (mean 61.42 g, p=0.524). The Moses laser required less lasing time (60.85 min) compared to all other groups (conventional 120W, 69.41 min, 100W, 79.18 min, conventional 30W, 281.2 min; p=0.000). Similarly, overall operating time with the Moses laser (68.3 min) was less compared to all others (conventional 120W, 86.73 min, 100W, 102.8 min, conventional 30W, 297.5 min; p=0.000). While the 100W laser required only one fiber stripping, the Moses, conventional 120W and 30W laser fibers required a mean stripping of 6.0, 7.8, and 17.4 times, respectively (p=0.000). The Moses group had less residual stone fragments (10.76 g) compared to the regular 120W (19.10 g), the 100W (13.85 g) and the 30W laser (14.25 g) (p=0.000). Use of the Moses technology would result in an estimated cost savings of $522, $820 and $8023 per case compared to regular 120W, 100W and 30W lasers, respectively. When factoring purchase price, the P120 with Moses became cost effective after treating 140 four cm bladder stones compared to the 100W laser and after only 22 bladder stones compared to the 30W laser. In contrast, the 100W laser became cost effective after only 8 bladder stone cases compared to 30W laser. CONCLUSIONS: The Moses technology would treat bladder stones most cost effectively in high volume institutions, while, the 100W laser was cost effective in low to moderate volume centers. The 30W laser would only be cost effective in very low volume centers. Source of Funding: None

You have accessJournal of UrologyGeneral & Epidemiological Trends & Socioeconomics: Quality Improvement & Patient Safety IV (MP83)1 Apr 2020MP83-20 DOES FOOT PEDAL ILLUMINATION IMPROVE SPEED, EFFICIENCY AND ACCURACY DURING UROLOGIC SURGERY? Hyelin You, Jon Maldonado*, Andrew Krause, Ashley Li, Jeremy Brown, Akin S. Amasyali, Mohammad Hajiha, Phillip Stokes, Muhannad Alsyouf, John Smith, Jason Groegler, Daniel Baldwin, and D. Duane Baldwin Hyelin YouHyelin You More articles by this author , Jon Maldonado*Jon Maldonado* More articles by this author , Andrew KrauseAndrew Krause More articles by this author , Ashley LiAshley Li More articles by this author , Jeremy BrownJeremy Brown More articles by this author , Akin S. AmasyaliAkin S. Amasyali More articles by this author , Mohammad HajihaMohammad Hajiha More articles by this author , Phillip StokesPhillip Stokes More articles by this author , Muhannad AlsyoufMuhannad Alsyouf More articles by this author , John SmithJohn Smith More articles by this author , Jason GroeglerJason Groegler More articles by this author , Daniel BaldwinDaniel Baldwin More articles by this author , and D. Duane BaldwinD. Duane Baldwin More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000975.019AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Endourologic procedures frequently use pedal activation in a low-light operating room (OR). Foot pedal activation in low-light conditions risks incorrect pedal activation, which may increase radiation exposure, cause patient burns, or start OR fires. This study compares speed, accuracy, dark adaptation, and surgeon preference for pedal activation in 4 different lighting conditions. METHODS: During a simulated percutaneous nephrolithotomy (PCNL), pedals for fluoroscopy (c-arm), holmium laser, and ultrasonic lithotripter (USL) were randomized to 3 different positions. Twenty participants activated pedals in a randomized order in 4 settings: a dark OR with black light illumination, a dark OR with glow stick illumination, a dark OR with no foot pedal lighting, and a bright OR with overhead lights on (Fig 1). Endpoints included time to pedal activation, number of attempted, incomplete, and incorrect presses, dark adaptation, and surgeon preference. Mann-Whitney U Test was used with p<0.05 considered significant. RESULTS: Compared to no illumination (8.47 s), the glow stick (6.77s; p < 0.001) and black light fluorescent illumination (5.34s; p < 0.001) were both associated with decreased combined and individual pedal activation times (p<0.05 for c-arm, laser, and USL). The black light resulted in a significant decrease in attempted (0.30 vs 3.45, p<0.001), incomplete (1.25 vs 7.75, p<0.001), and incorrect presses (0.35 vs 1.25, p=0.035) compared to the dark setting, while demonstrating no difference compared to having room lights on. Dark adaptation was significantly improved with black light illumination compared to having the room lights on (134.5 vs 140.5 luminance units, p<0.001). Subjectively, 100% of participants preferred illuminated pedals compared to the dark OR, with 90% preferring the black light. CONCLUSIONS: During a simulated PCNL, black light foot pedal illumination significantly improved accuracy and efficiency of instrument activation compared to the conventional dark OR, while also maintaining the surgeon’s dark adaptation compared to having the overhead lights on. This study demonstrates that the use of black light foot pedal illumination may reduce errors in the operating room due to inadvertent foot pedal activation while preserving the ability to operate in a low light environment. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1263-e1263 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hyelin You More articles by this author Jon Maldonado* More articles by this author Andrew Krause More articles by this author Ashley Li More articles by this author Jeremy Brown More articles by this author Akin S. Amasyali More articles by this author Mohammad Hajiha More articles by this author Phillip Stokes More articles by this author Muhannad Alsyouf More articles by this author John Smith More articles by this author Jason Groegler More articles by this author Daniel Baldwin More articles by this author D. Duane Baldwin More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction and Objectives: Fluoroscopy units are routinely operated in the automatic brightness control (ABC) mode to optimize image quality. During ureteroscopy, objects may be placed within the fluoroscopy beam and the effect upon radiation exposure is unknown. The purpose of this study is to investigate the effects of equipment within the fluoroscopy beam during simulated ureteroscopy. Methods: ABC fluoroscopy of a cadaver was performed in eight clinical scenarios, including a control (no equipment), and seven groups with different equipment within the fluoroscopy beam. Equipment tested included electrocardiogram (EKG) leads, a Kelly clamp, camera and light cords (straight and coiled configurations), flexible ureteroscope, rigid cystoscope, and the lateral table support beam. Ten 145-second fluoroscopy trials were performed for each arm. The primary outcome was radiation dose (mGy) compared using the Mann-Whitney test with p < 0.05 considered significant. Results: Compared with control (18.5 mGy), radiation exposure was significantly increased with the presence of a straight camera and light cords (19.3 mGy), Kelly clamp (19.4 mGy), coiled camera and light cords (20.2 mGy), a flexible ureteroscope (21.0 mGy), a rigid cystoscope (21.2 mGy), and when the lateral table support beam was in the path of the X-ray (25.0 mGy; a 35% increase; p < 0.007 for all). The EKG leads did not affect the radiation dose. Conclusions: Avoiding equipment within the fluoroscopy beam using ABC mode can reduce radiation exposure. Adjusting the table and patient position to exclude the lateral table support beam will reduce radiation exposure by 35%.

You have accessJournal of UrologyStone Disease: Surgical Therapy I (PD01)1 Apr 2019PD01-10 EFFECTIVENESS OF LEAD APRONS IN SHIELDING THE SURGEON DURING PERCUTANEOUS NEPHROLITHOTOMY John Smith, Mohammad Hajiha*, Akin Amasyali, Zahabiya Campwala, Hyelin You, Muhannad Alsyouf, Jon Ewald, Andrew Krause, Daniel Baldwin, Reihaneh Moghisi, and D. Duane Baldwin John SmithJohn Smith More articles by this author , Mohammad Hajiha*Mohammad Hajiha* More articles by this author , Akin AmasyaliAkin Amasyali More articles by this author , Zahabiya CampwalaZahabiya Campwala More articles by this author , Hyelin YouHyelin You More articles by this author , Muhannad AlsyoufMuhannad Alsyouf More articles by this author , Jon EwaldJon Ewald More articles by this author , Andrew KrauseAndrew Krause More articles by this author , Daniel BaldwinDaniel Baldwin More articles by this author , Reihaneh MoghisiReihaneh Moghisi More articles by this author , and D. Duane BaldwinD. Duane Baldwin More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555022.34835.cbAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Although surgeons wear lead to protect themselves from scattered radiation, the effect of shielding upon scattered radiation has not been well characterized. In addition, conventional lead aprons still leave other body parts including the legs and head unprotected. The aim of this study is to determine the surgeon radiation exposure at multiple sites with and without shielding during a simulated percutaneous nephrolithotomy (PCNL). METHODS: A cadaver “patient” (BMI 24.6) was positioned supine and a cadaver “surgeon” (BMI 20.7) was placed upright 11 inches from the radiation source to simulate the position of the surgeon during PCNL. Ten total trials of 20 minutes were completed, 5 trials with the surgeon wearing a 0.35 mm lead body apron and thyroid shield and 5 trials without lead. Dosimeters were placed in the “surgeon” over sensitive organs divided into three groups, upper body (thyroid, lung, sternum), lower body (liver, kidney, bladder, sigmoid and male gonads) and unshielded areas (Tibia, head). A T-test was used with statistical significance level set at p<0.05. RESULTS: A 96% reduction (p<0.001) in radiation was recorded between shielded (12.8 mrem) and unshielded (323.1 mrem) organs. For shielded trials, the organs with highest radiation exposure were the sigmoid colon (19.6 mrem), bladder (15.6 mrem), and sternum (13.6 mrem). Organs showing the lowest exposure were the thyroid (9 mrem), lungs (10.2 mrem), and liver (10.4 mrem). In shielded groups, upper body organs had 22% lower radiation dose than those in the lower body (10.9 mrem vs. 14.0 mrem, p=0.02). In the unshielded group, the upper body received 25% lower dose than the lower body (264.3 mrem vs. 356.3 mrem, p=0.02). When comparing shielded vs. unshielded groups, radiation exposure of the head (102.6 mrem vs. 100.4, p=.938) and tibia (268.4 mrem vs. 284.6 mrem, p=0.723) was similar. CONCLUSIONS: Although standard radiation protection measures dramatically reduce exposure, they may not be adequate in protecting certain radiation sensitive organs like the sigmoid and bladder. Furthermore, body parts like the tibia and head continue to receive large radiation exposure whether or not the surgeon wears conventional radiation protection. Therefore, in addition to wearing lead shielding, surgeons should take measures to reduce the fluoroscopy time and dose. Source of Funding: none Loma Linda, CA; Loma Linda, CA; Loma Linda, CA; Loma Linda, CA; Loma Linda, CA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e60-e60 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Smith More articles by this author Mohammad Hajiha* More articles by this author Akin Amasyali More articles by this author Zahabiya Campwala More articles by this author Hyelin You More articles by this author Muhannad Alsyouf More articles by this author Jon Ewald More articles by this author Andrew Krause More articles by this author Daniel Baldwin More articles by this author Reihaneh Moghisi More articles by this author D. Duane Baldwin More articles by this author Expand All Advertisement PDF downloadLoading ...

You have accessJournal of UrologyStone Disease: Surgical Therapy II (MP17)1 Apr 2019MP17-18 STRUCTURAL AND MECHANICAL CHANGES OF SOFT AND FIRM POLYURETHANE STENTS: A BENCHTOP STUDY Ashley Li, Jeremy Brown, John Smith, Hyelin You, Andrew Krause, Williamson Le, Muhannad Alsyouf, Phillip Stokes*, Mohammad Hajiha, Akin Amasyali, and D. Duane Baldwin Ashley LiAshley Li More articles by this author , Jeremy BrownJeremy Brown More articles by this author , John SmithJohn Smith More articles by this author , Hyelin YouHyelin You More articles by this author , Andrew KrauseAndrew Krause More articles by this author , Williamson LeWilliamson Le More articles by this author , Muhannad AlsyoufMuhannad Alsyouf More articles by this author , Phillip Stokes*Phillip Stokes* More articles by this author , Mohammad HajihaMohammad Hajiha More articles by this author , Akin AmasyaliAkin Amasyali More articles by this author , and D. Duane BaldwinD. Duane Baldwin More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555443.60593.5eAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Ureteral stents relieve obstruction and maintain renal drainage. However, chronic indwelling stents carry complications including fragmentation, migration, and encrustation. Other than indwelling time, factors contributing to stent encrustation are unknown. A donor urine bath model for studying stent encrustation has previously been presented. The purpose of this study is to compare the risk for encrustation and force required for removal in soft, firm, multi-length, and fixed length stents in a controlled artificial urine bath. METHODS: Twenty-four double pigtail stent coils (6 firm multi-length, 6 soft multi-length soft, 6 firm fixed length, 6 soft fixed length stent coils) were bathed in an in vitro artificial urine solution to simulate a rapid encrustation model. The stents were bathed for 15 days in an incubator at human body temperature. The urine bath was exchanged every 3 days and the length and diameter of the stent coils were measured. The force required for stent extraction from a ureteral benchtop model was measured in newtons (N) using a force gauge before and after the urine bath. Mann-Whitney U test was used for statistical analysis with p<0.05 considered significant. RESULTS: After 15 days, all stents showed evidence of encrustation on gross evaluation and scanning electron microscopy. The mean force required for stent removal after the urine bath was 0.664 N (firm fixed), 0.549N (firm multi), 0.502N (soft fixed), 0.475N (soft multi). Firm stents required significantly more force for removal than soft stents prior to the urine bath (0.290N vs 0.162N respectively; p<0.001) and after the urine bath (0.606N vs 0.488N respectively; p=0.01) regardless of whether these stents were fixed or multi-length. Soft stents increased in both length (9.5 to 12.7 cm; p<0.001) and diameter (1.4 to 3.3 mm; p<0.001) while firm stents only increased in diameter (1.4 to 2.3 mm; p<0.001). CONCLUSIONS: This benchtop study validates an artificial urine bath as a model for studying stent encrustation. Signs of stent encrustation occurred as early as 15 days. While firm stents required more force for removal, soft stents demonstrated significant spatial changes in vitro. These should be considered at the time of stent selection to optimize patient comfort and quality of life. Source of Funding: None Loma Linda, CA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e262-e262 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ashley Li More articles by this author Jeremy Brown More articles by this author John Smith More articles by this author Hyelin You More articles by this author Andrew Krause More articles by this author Williamson Le More articles by this author Muhannad Alsyouf More articles by this author Phillip Stokes* More articles by this author Mohammad Hajiha More articles by this author Akin Amasyali More articles by this author D. Duane Baldwin More articles by this author Expand All Advertisement PDF downloadLoading ...

Urethral bulking to improve urinary stress continence has been available on a routine basis for almost two decades. A myriad number of agents are available, an indication that no one material is superior. Good results have been achieved in properly selected patients. This chapter will review the present status of the technique and materials in an effort to afford the reader a better understanding of the role urethral bulking can play in improving a patient's quality of life.

The US Food and Drug Administration (FDA) enjoys a broad legal mandate to ensure that medical products are safe and effective for their intended uses, authority that extends to the medical devices that make modern radiology possible. Under FDA's regulatory framework, medical devices are cleared or approved for specific indications for use that are described in the labeling provided with the devices. This article outlines this framework as well as the regulatory and legal implications of using medical devices in a manner inconsistent with their FDA-cleared or FDA-approved labeling.

INTRODUCTION AND HYPOTHESIS:We hypothesized that self-reported pad use per day (PPD) after pubovaginal sling (PVS) correlated with postoperative quality of life (QOL) scores.METHODS:Two hundred fifteen women completed the incontinence impact questionnaire 7 (IIQ-7) and urogenital distress inventory 6 (UDI-6) before PVS and during follow-up. Starting 3 days before a visit, women recorded the number of protective urinary pad changes per day. Analysis of variance and Pearson correlation tests were used to determine if women reporting zero, one, or greater than or equal to two urinary pads per day after PVS had significantly different changes in baseline QOL scores.RESULTS:Over a mean 8.5 months follow-up after PVS, 131, 56, and 28 women reported zero, one, and greater than or equal to two pad changes/day. Each pad group showed progressively less improvement from baseline IIQ-7 and UDI-6 scores after PVS. Change in IIQ-7 and UDI-6 scores negatively correlated with PPD (p < 0.0001).CONCLUSIONS:Self-reported PPD after PVS reflects patient perception of urinary-specific QOL.

Clinical studies of new imaging technologies conducted for regulatory purposes have traditionally focused on satisfying the standards of the US Food and Drug Administration (FDA) for marketing clearance or approval of a new product. However, given the increased scrutiny that is being directed at diagnostic imaging by third-party payers, obtaining clinical data that can support Medicare coverage of a new imaging technology is increasingly important to ensure the maximum diffusion of that technology. This article describes the regulatory requirements of both the FDA and Centers for Medicare and Medicare Services and explains how sponsors may approach clinical studies to secure both FDA clearance or approval and Centers for Medicare and Medicare Services coverage and payment.

Implantable sensors are gaining considerable attention in the research and medical communities due to their potential to enhance the detection and monitoring of medical conditions such as cancer, diabetes, and heart disease. The use of implantable sensors for these exciting applications bring them under the regulatory oversight of the United States Food and Drug Administration (FDA). As medical devices intended for long-term implantation that inherently involve some risk, the FDA will carefully evaluate these products prior to allowing them to enter the U.S. market. This paper provides a brief overview of the FDA medical device regulatory framework under which implantable sensors for medical purposes are regulated. It also addresses particular concerns the FDA may raise with respect to these products including, potential sensor breakage and migration in vivo , biocompatibility, electromagnetic compatibility, electromagnetic interference, wireless telemetry, risk/benefit, and clinical utility.

The radiology community has an ever-expanding array of technologies to use in the care of patients. Regulated by the US Food and Drug Administration, these technologies often raise complex regulatory and legal questions in everyday practice that can be daunting for practicing radiologists. This article reviews the federal medical device regulatory framework pertinent to the practice of radiology, with the aims of highlighting the potential impact of federal regulation on everyday practice and minimizing misunderstandings about enforcement exposure.

Molecular imaging, which combines the use of traditional imaging modalities with pharmaceutical and biologic imaging agents, holds considerable promise, particularly in light of recent advances in genomics and new applications beyond diagnosis toward the earlier detection and characterization of disease, the reliable assessment of treatment efficacy, and imaging-link therapeutic applications. Its potential notwithstanding, the current U.S. Food and Drug Administration (FDA) regulatory framework governing imaging agents sets a high bar for marketing approval, which may slow the pace at which molecular imaging becomes routinely available. Understanding the FDA's regulatory framework, the issues surrounding molecular imaging agents, and potential opportunities will allow the radiology community to more effectively collaborate with the FDA to address these regulatory barriers and ensure that the full potential of molecular imaging is realized.

In order to investigate how cells recognize biomaterials, mRNA that was expressed in attached human fibroblasts on various substrates was evaluated. The expressed oncogenes (c-fos and c-myc) and tumor suppressor gene (p53) mRNA were then isolated and detected using the RT-PCR method. As a result, c-fos and c-myc mRNA expression varied with respect to differences in the hydrophilicity–hydrophobicity of the substrates. Both c-fos and c-myc mRNA expression were low in the fibroblasts that had adhered to hydrophilic surfaces. The tendency of c-fos mRNA expression was similar to the adhesion curve of the cells. c-myc mRNA was largely induced in fibroblasts that had adhered to hydrophobic surfaces. p53 mRNA were largely induced in fibroblasts that had adhered to hydrophilic surfaces, while in the cells that had adhered to hydrophobic surfaces, p53 mRNA expression was low. We concluded that the expression of oncogenes and p53 mRNA is a powerful method for studying cell–polymer interactions or the evaluation of the carcinogenic activity of biomaterials.

Objectives. This study sought to evaluate the relation between antiplatelet agent (APA) use and survival and morbidity from cardiac disease in patients with left ventricular (LV) systolic dysfunction.Background. APAs play an important role in the prevention and treatment of coronary disease. Their effects in patients with LV systolic dysfunction are unknown.Methods. We reviewed data on APA use in 6,797 patients enrolled in the Studies of Left Ventricular Dysfunction (SOLVD) trial and analyzed the relation between their use and all-cause mortality as well as the combined end point of death or hospital admission for heart failure (HF), We used Cox regression to adjust for differences in baseline characteristics and to test for the interaction between APA use and selected patient variables in relation to outcome.Results. APA use (46.3% of patients) was associated with significantly reduced mortality from all causes (adjusted hazard ratio [HR] 0.82, 95% confidence interval [CI] 0.73 to 0.92, p = 0.0005) and reduced risk of death or hospital admission for HF (adjusted HR 0.81, 95% CI 0.74 to 0.89, p < 0.0001) but was not influenced by trial assignment, gender, LV ejection fraction, New York Heart Association class or etiology, A strong interaction was observed among APA use, randomization group and all-cause mortality, The association between APA use and survival was not observed in the enalapril group, nor was an enalapril benefit on survival detectable in patients receiving APAs at baseline. However, randomization to enalapril therapy significantly reduced the combined end point of death or hospital admission for HF in APA users.Conclusions. In patients with LV systolic dysfunction, use of APAs is associated with improved survival and reduced morbidity. This association is retained after adjustment for baseline characteristics. APA use is associated with retained but reduced benefit from enalapril. (C) 1998 by the American College of Cardiology.

Patients with heart failure and left ventricular systolic dysfunction exhibit increased adrenergic activity but blunted adrenergic responsiveness. We studied patients enrolled in the Studies of Left Ventricular Dysfunction, examining exercise responses of heart rate (HR) and plasma norepinephrine (PNE). Eighty-seven patients were studied before randomization; 65 of these were examined 1 year after randomization to placebo or enalapril. Compared with prevention trial (asymptomatic) patients, patients in the treatment trial (symptomatic) had higher resting HR and PNE levels and less increase in HR with a greater increase in PNE with exercise. Acute administration of enalapril increased the resting HR in patients in the prevention trial only but had no significant effect on PNE. After 1 year of therapy, patients in the prevention trial exhibited no change. Within the treatment trial, the placebo group displayed both a higher peak PNE and increase in PNE with exercise than did the enalapril group, whose HR response was maintained in spite of a reduction of exercise PNE. We conclude that (1) compared with asymptomatic patients, symptomatic patients with reduced left ventricular ejection fraction manifest greater resting and exercise adrenergic activity, with blunted HR response; and (2) in symptomatic patients, 1 year of enalapril treatment effected an augmented HR response to adrenergic stimulation, supporting an interaction between the renin/angiotensin and adrenergic nervous systems. Normalization of adrenergic tone and response likely contributes to the benefits of long-term angiotensin-converting enzyme inhibitor therapy. (Am Heart J 1997;134: 37-43.)

We investigated the effects of inhibiting endogenous atrial natriuretic factor (ANF) metabolism on renal hemodynamics, sodium excretion and neurohormones in 12 patients with New York Heart Association functional class II congestive heart failure (CHF) due to left ventricular systolic dysfunction. In a randomized, placebo-controlled, double-blinded fashion, 8 patients received a single oral dose of candoxatril, an inhibitor of renal neutral endopeptidase, and 4 patients received placebo. Candoxatril treatment increased plasma ANF by 70 +/- 71 pg/ml (p < 0.015 vs. placebo) and plasma cGMP by 7.9 +/- 2.7 pmol/ml (p < 0.001 vs. placebo), with maximal effects at 3.5 h. Urinary cGMP more than doubled (p = 0.025 vs. placebo). Candoxatril increased urinary sodium by 2.7 +/- 2.0 mEq/h (p < 0.05 vs. placebo) and significantly elevated filtration fraction with no significant effect on glomerular filtration rate, renal plasma flow or lithium clearance. A significant reduction in aldosterone concentration with a similar trend in plasma renin activity was noted in candoxatril-treated patients. Thus in patients with moderate heart failure, renal neutral endopeptidase inhibition increases urinary sodium excretion. The lack of an effect on renal hemodynamics suggests that this natriuresis results from ANF-mediated inhibition of tubular sodium reabsorption. These findings justify additional investigation into potential clinical benefit of endopeptidase inhibition in patients with CHF.