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1.
Wilderness Environ Med ; 35(1_suppl): 67S-77S, 2024 03.
Article in English | MEDLINE | ID: mdl-38425236

ABSTRACT

A panel convened to develop an evidence-based set of guidelines for the recognition and treatment of eye injuries and illnesses that may occur in the wilderness. These guidelines are meant to serve as a tool to help wilderness providers accurately identify and subsequently treat or evacuate for a variety of ophthalmologic complaints. Recommendations are graded based on the quality of their supporting evidence and the balance between risks and benefits according to criteria developed by the American College of Chest Physicians.


Subject(s)
Eye Injuries , Wilderness Medicine , Humans , Eye Injuries/etiology , Eye Injuries/therapy , Societies, Medical
2.
J Urol ; 210(1): 143-153, 2023 07.
Article in English | MEDLINE | ID: mdl-37115632

ABSTRACT

PURPOSE: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. MATERIALS AND METHODS: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. RESULTS: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. CONCLUSIONS: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).


Subject(s)
Ablation Techniques , Lower Urinary Tract Symptoms , Prostatic Hyperplasia , Transurethral Resection of Prostate , Male , Humans , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/surgery , Prostate/surgery , Transurethral Resection of Prostate/methods , Water , Prospective Studies , Prostate-Specific Antigen , Ablation Techniques/methods , Lower Urinary Tract Symptoms/surgery , Lower Urinary Tract Symptoms/complications , Treatment Outcome
3.
Int J Urol ; 29(12): 1551-1558, 2022 12.
Article in English | MEDLINE | ID: mdl-36102630

ABSTRACT

PURPOSE: Treatment of struvite kidney stones requires complete surgical stone removal combined with antibiotic therapy to eliminate urinary tract infections and preventive measures to reduce stone recurrence. The optimal duration of antibiotic therapy is unknown. We sought to determine if 2- or 12-weeks of antibiotics post percutaneous nephrolithotomy (PNL) for infection stones resulted in better outcomes for stone recurrence and positive urine cultures. MATERIAL AND METHODS: This multi-center, prospective randomized trial evaluated patients with the clinical diagnosis of infection stones. Patients were randomized to 2- or 12-weeks of postoperative oral antibiotics (nitrofurantoin or culture-specific antibiotic) and included if residual fragments were ≤4 mm on computed tomography imaging after PNL. Imaging and urine analyses were performed at 3-, 6-, and 12-months post-procedure. RESULTS: Thirty-eight patients were enrolled and randomized to either 2-weeks (n = 20) or 12-weeks (n = 18) of antibiotic therapy post-PNL. Eleven patients were excluded due to residual fragments >4 mm, and 3 patients were lost to follow-up. The primary outcome was the stone-free rate (SFR) at 6 months post-PNL. At 3-, 6-, and 12-months follow-up, SFRs were 72.7% versus 80.0%, 70.0% versus 57.1%, 80.0% versus 57.1% (p = ns), between 2- and 12-week-groups, respectively. At 3-, 6-, and 12-months follow-up, positive urine cultures were 50.0% versus 37.5%, 50.0% versus 83.3%, and 37.5% versus 100% between 2- and 12-week groups, respectively (p = ns). CONCLUSIONS: For patients with stone removal following PNL, neither 2-weeks nor 12-weeks of postoperative oral antibiotics is superior to prevent stones and recurrent positive urine cultures.


Subject(s)
Kidney Calculi , Nephrolithotomy, Percutaneous , Nephrostomy, Percutaneous , Humans , Nephrolithotomy, Percutaneous/adverse effects , Nephrolithotomy, Percutaneous/methods , Prospective Studies , Anti-Bacterial Agents/therapeutic use , Treatment Outcome , Kidney Calculi/surgery , Nephrostomy, Percutaneous/adverse effects , Nephrostomy, Percutaneous/methods , Retrospective Studies
4.
BJU Int ; 125(1): 112-122, 2020 01.
Article in English | MEDLINE | ID: mdl-31599044

ABSTRACT

OBJECTIVE: To compare the outcomes of Aquablation in 30-80 mL prostates with those in 80-150 mL prostates. Surgical options, especially with short learning curves, are limited when treating large prostates for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) could solve this issue with global reproducibility, independent of prostate volume. PATIENTS AND METHODS: Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue (WATER [W-I]; NCT02505919) is a prospective, double-blind, multicentre, international clinical trial comparing Aquablation and transurethral resection of the prostate (TURP) for the treatment of LUTS/BPH in prostates between 30 and 80 mL. WATER II (W-II; NCT03123250) is a prospective, multicentre, single-arm international clinical trial of Aquablation in prostates between 80 and 150 mL. We compare baseline parameters and 12-month outcomes in 116 W-I and 101 W-II study patients. Students' t-test or Wilcoxon tests were used for continuous variables and Fisher's test for binary variables. RESULTS: The mean (SD) operative time was 33 (17) and 37 (13) min in W-I and W-II, respectively. Actual treatment time was 4 and 8 min in W-I and W-II, respectively. The mean change in the International Prostate Symptom Score was substantial averaging (at 12 months) 15.1 in W-I and 17.1 in W-II (P = 0.605). By 3 months, Clavien-Dindo grade ≥II events occurred in 19.8% of W-I patients and 34.7% of W-II patients (P = 0.468). CONCLUSION: Aquablation clinically normalises outcomes between patients with 30-80 mL prostates and patients with 80-150 mL prostates treated for LUTS/BPH, with an expected increase in the risk of complications in larger prostates. Long-term outcomes of procedure durability are needed.


Subject(s)
Ablation Techniques/methods , Endoscopy , Lower Urinary Tract Symptoms/surgery , Prostate/pathology , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/surgery , Aged , Aged, 80 and over , Double-Blind Method , Humans , Lower Urinary Tract Symptoms/etiology , Male , Middle Aged , Organ Size , Prospective Studies , Prostatic Hyperplasia/complications , Water
5.
Can J Urol ; 27(2): 10147-10153, 2020 04.
Article in English | MEDLINE | ID: mdl-32333733

ABSTRACT

INTRODUCTION: To report 2-year safety and effectiveness of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume 80-150 cc prostates. MATERIALS AND METHODS: Between September-December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent an ultrasound-guided robotically executed Aquablation procedure in a prospective multicenter international clinical trial (WATER II). Baseline, procedural and follow up parameters were recorded at baseline and scheduled postoperative visits. Herein we report 2-year safety and efficacy for this cohort. RESULTS: Mean prostate volume was 107 cc (range 80-150 cc). Mean IPSS improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p < .0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p < .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors. CONCLUSIONS: Two-year prospective multicenter follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS due to BPH and prostates 80-150 cc with durable treatment efficacy, acceptable safety profile and a low retreatment rate. ClinicalTrials.gov number, NCT03123250.


Subject(s)
Ablation Techniques/methods , Prostate/pathology , Prostatectomy/methods , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/surgery , Ablation Techniques/adverse effects , Aged , Humans , Male , Middle Aged , Organ Size , Prospective Studies , Time Factors , Treatment Outcome , Water
6.
BJU Int ; 123(1): 106-112, 2019 01.
Article in English | MEDLINE | ID: mdl-29694702

ABSTRACT

OBJECTIVES: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). METHODS: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. RESULTS: The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. CONCLUSIONS: Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).


Subject(s)
Ablation Techniques/methods , Adenoma/surgery , Postoperative Hemorrhage/etiology , Prostate/pathology , Prostatic Hyperplasia/surgery , Prostatic Neoplasms/surgery , Water , Ablation Techniques/adverse effects , Aged , Endosonography , Hemostasis, Surgical/methods , Humans , Length of Stay , Male , Middle Aged , Operative Time , Organ Size , Prospective Studies , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/diagnostic imaging , Prostatic Hyperplasia/pathology , Prostatism/etiology , Prostatism/surgery , Severity of Illness Index , Surveys and Questionnaires
7.
BJU Int ; 124(2): 321-328, 2019 08.
Article in English | MEDLINE | ID: mdl-30734990

ABSTRACT

OBJECTIVE: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. METHODS: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. RESULTS: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. CONCLUSIONS: Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.


Subject(s)
Ablation Techniques , Hydrotherapy , Prostatic Hyperplasia/pathology , Prostatic Hyperplasia/therapy , Aged , Aged, 80 and over , Humans , Male , Middle Aged , Organ Size , Prospective Studies , Treatment Outcome
10.
Clin J Sport Med ; 25(5): 412-7, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26340733

ABSTRACT

Climbing is a popular wilderness sport among a wide variety of professional athletes and amateur enthusiasts, and many styles are performed across many environments. Potential risks confront climbers, including personal health or exacerbation of a chronic condition, in addition to climbing-specific risks or injuries. Although it is not common to perform a preparticipation evaluation (PPE) for climbing, a climber or a guide agency may request such an evaluation before participation. Formats from traditional sports PPEs can be drawn upon, but often do not directly apply. The purpose of this article was to incorporate findings from expert opinion from professional societies in wilderness medicine and in sports medicine, with findings from the literature of both climbing epidemiology and traditional sports PPEs, into a general PPE that would be sufficient for the broad sport of climbing. The emphasis is on low altitude climbing, and an overview of different climbing styles is included. Knowledge of climbing morbidity and mortality, and a standardized approach to the PPE that involves adequate history taking and counseling have the potential for achieving risk reduction and will facilitate further study on the evaluation of the efficacy of PPEs.


Subject(s)
Altitude , Mountaineering , Physical Exertion , Wilderness Medicine , Wounds and Injuries/prevention & control , Humans , Risk Assessment/methods
11.
Wilderness Environ Med ; 26(4 Suppl): S40-6, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26617377

ABSTRACT

Climbing is a popular wilderness sport among a wide variety of professional athletes and amateur enthusiasts, and many styles are performed across many environments. Potential risks confront climbers, including personal health or exacerbation of a chronic condition, in addition to climbing-specific risks or injuries. Although it is not common to perform a preparticipation evaluation (PPE) for climbing, a climber or a guide agency may request such an evaluation before participation. Formats from traditional sports PPEs can be drawn upon, but often do not directly apply. The purpose of this article was to incorporate findings from expert opinion from professional societies in wilderness medicine and in sports medicine, with findings from the literature of both climbing epidemiology and traditional sports PPEs, into a general PPE that would be sufficient for the broad sport of climbing. The emphasis is on low altitude climbing, and an overview of different climbing styles is included. Knowledge of climbing morbidity and mortality, and a standardized approach to the PPE that involves adequate history taking and counseling have the potential for achieving risk reduction and will facilitate further study on the evaluation of the efficacy of PPEs.


Subject(s)
Physical Examination/methods , Sports Medicine/methods , Sports , Wilderness , Wounds and Injuries/prevention & control , Athletes , Humans , Physician-Patient Relations , Risk Assessment , Societies, Medical , Sports/physiology , Sports Nutritional Sciences
12.
Wilderness Environ Med ; 25(4 Suppl): S19-29, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25498259

ABSTRACT

A panel convened to develop an evidence-based set of guidelines for the recognition and treatment of eye injuries and illnesses that may occur in the wilderness. These guidelines are meant to serve as a tool to help wilderness providers accurately identify and subsequently treat or evacuate for a variety of ophthalmologic complaints. Recommendations are graded on the basis of the quality of their supporting evidence and the balance between risks and benefits according to criteria developed by the American College of Chest Physicians. This is an updated version of the original guidelines published in Wilderness & Environmental Medicine 2012;23(4):325-336.


Subject(s)
Eye Diseases/therapy , Eye Injuries/therapy , Practice Patterns, Physicians' , Wilderness Medicine , Acute Disease , Humans , Societies, Medical , Wilderness Medicine/standards
13.
High Alt Med Biol ; 2024 Jul 10.
Article in English | MEDLINE | ID: mdl-38984416

ABSTRACT

Strickland, Brian, Elan Small, Mary Ryan, and Ryan Paterson. Effectiveness of continuous positive airway pressure in alleviating hypoxemia and improving exertional capacity at altitude. High Alt Med Biol. 00:000-000, 2024. Introduction: Decreased oxygen saturation and exercise tolerance are commonly experienced at high altitude. Continuous positive airway pressure (CPAP) devices have become increasingly portable and battery powered, providing a potentially unique new therapeutic modality for treatment of altitude-related illnesses. This study evaluated the potential use of CPAP devices to improve and maintain oxygen saturation at altitude, both at rest and with exertion, to evaluate the feasibility of using this device at altitude. Methods: Subjects were taken to Mount Blue Sky and monitored while they hiked to the summit (4,350 m), maintaining a consistent level of exertion. Subjects hiked for 0.7 km both with and without CPAP set to 10 cmH2O pressure. Continuous vital signs were collected during the hike and recovery period. Results: All subjects completed the hike wearing CPAP devices at a vigorous level of exertion. Mean oxygen saturation of the CPAP group (M = 83.8%, SD = 3.72) was significantly higher than that of the control group during exertion (M = 78.7%, SD = 2.97); p = 0.005. Recovery after exertion was quicker in the CPAP group than the control group. Three subjects experienced claustrophobia requiring a brief pause, but were able to complete their exercise trial without removing equipment or experiencing adverse events. When pauses from claustrophobia were excluded, there was no difference in completion time between the groups (p = 0.06). Conclusion: CPAP reliably improved oxygen saturation at rest and during vigorous exertion at high altitude. Its ability to correct hypoxemia, even with physical exertion, may prove useful after further study as a portable self-carried device to prevent and treat altitude-related illness, or to improve safety in high-altitude rescues.

14.
Nat Protoc ; 19(7): 2085-2116, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38671208

ABSTRACT

In temperate and subtropical regions, ancient proteins are reported to survive up to about 2 million years, far beyond the known limits of ancient DNA preservation in the same areas. Accordingly, their amino acid sequences currently represent the only source of genetic information available to pursue phylogenetic inference involving species that went extinct too long ago to be amenable for ancient DNA analysis. Here we present a complete workflow, including sample preparation, mass spectrometric data acquisition and computational analysis, to recover and interpret million-year-old dental enamel protein sequences. During sample preparation, the proteolytic digestion step, usually an integral part of conventional bottom-up proteomics, is omitted to increase the recovery of the randomly degraded peptides spontaneously generated by extensive diagenetic hydrolysis of ancient proteins over geological time. Similarly, we describe other solutions we have adopted to (1) authenticate the endogenous origin of the protein traces we identify, (2) detect and validate amino acid variation in the ancient protein sequences and (3) attempt phylogenetic inference. Sample preparation and data acquisition can be completed in 3-4 working days, while subsequent data analysis usually takes 2-5 days. The workflow described requires basic expertise in ancient biomolecules analysis, mass spectrometry-based proteomics and molecular phylogeny. Finally, we describe the limits of this approach and its potential for the reconstruction of evolutionary relationships in paleontology and paleoanthropology.


Subject(s)
Dental Enamel , Phylogeny , Proteomics , Dental Enamel/chemistry , Dental Enamel/metabolism , Proteomics/methods , Animals , Humans , Paleontology/methods , Mass Spectrometry/methods , Fossils
15.
J Urol ; 189(2): 719-25, 2013 Feb.
Article in English | MEDLINE | ID: mdl-22982432

ABSTRACT

PURPOSE: Ureteral stents are prone to irritation, encrustation and infection, and they require additional procedures for removal. Furthermore, indwelling polymer stents are often forgotten with devastating consequences to the patient. We describe the degradation time, and physiological and histological responses elicited by a novel biodegradable ureteral stent in a porcine model. MATERIALS AND METHODS: A total of 16 female Yorkshire pigs were used in the study. Ten biodegradable Uriprene™ stents and 6 biostable Polaris™ stents were cystoscopically inserted unilaterally in 2 groups of animals. Excretory urogram, and blood and urine tests were performed on different days until day 28. Biostable stents were removed on day 21. On day 28 all pigs underwent necropsy for microscopic and histological evaluation. RESULTS: Nine of the 10 biodegradable stents (90%) degraded completely by 4 weeks, while 1 pig had 3 fragments smaller than 1.5 cm in the bladder. Excretory urogram showed equivalent drainage and significantly less hydronephrosis in biodegradable stented kidneys. Blood and urine parameters were similar in the 2 groups. A transient increase in serum creatinine on day 7 in 40% of the pigs with a degradable stent resolved by day 10. There were significantly fewer abnormal histological findings in the degradable stent group. We evaluated drainage characteristics in an unobstructed ureter and results may not be representative of what develops in obstructed ureters. CONCLUSIONS: The third generation biodegradable stent is a safe, effective alternative to conventional polymer stents, resulting in equivalent drainage and less hydronephrosis.


Subject(s)
Absorbable Implants , Foreign Bodies/prevention & control , Stents , Ureter , Animals , Female , Prosthesis Design , Swine , Syndrome
16.
Wilderness Environ Med ; 24(2): 105-11, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23425353

ABSTRACT

OBJECTIVE: Increased intracranial pressure (ICP) may contribute to acute mountain sickness (AMS). Measuring optic nerve sheath diameter (ONSD) by ultrasound (US) is a noninvasive technique to detect elevated ICP, and increased ONSD has been associated with AMS. We hypothesized that ONSD would increase with acute, rapid ascent to 4300 m and that increased ONSD would be associated with symptoms of AMS. We further hypothesized that treatment with oxygen at 4300 m would reduce symptoms and ONSD. METHODS: A cohort study was performed comparing US measurement of ONSD in healthy subjects at 1400 m and 18 hours after rapid ascent to 4300 m, both before and after oxygen treatment and between subjects with and without AMS (Lake Louise Score ≥3). RESULTS: Among 57 subjects, 29 (51%) experienced AMS after rapid ascent to 4300 m. In subjects without AMS, mean ONSD did not increase at 4300 m. In subjects with AMS, mean ONSD increased at 4300 m and was higher than in those without AMS. Treatment with oxygen lowered mean ONSD in subjects with AMS but not in those without AMS. Individual responses to altitude and oxygen varied greatly within groups, and the relationship between ONSD and AMS symptoms was weak. CONCLUSIONS: In this controlled study, mean ONSD increased in subjects with AMS at high altitude. However, individual variation was high, and most ONSD values were below the clinical threshold for raised ICP. Observed differences were small, of questionable clinical importance, and within the range of precision of the US machine. Overall, our data do not support a role for increased ICP in mild to moderate AMS.


Subject(s)
Altitude Sickness/diagnosis , Altitude Sickness/therapy , Optic Nerve/anatomy & histology , Oxygen Inhalation Therapy , Acute Disease , Adolescent , Adult , Aged , Case-Control Studies , Cohort Studies , Humans , Intracranial Hypertension/diagnosis , Intracranial Pressure/physiology , Middle Aged , Optic Nerve/diagnostic imaging , Treatment Outcome , Ultrasonography , Young Adult
17.
Can Urol Assoc J ; 17(7): E194-E201, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37068147

ABSTRACT

INTRODUCTION: Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP. METHODS: This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature. RESULTS: There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study. CONCLUSIONS: This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.

18.
PLoS One ; 18(12): e0291308, 2023.
Article in English | MEDLINE | ID: mdl-38100471

ABSTRACT

Pleistocene Pongo teeth show substantial variation in size and morphology, fueling taxonomic debates about the paleodiversity of the genus. We investigated prominent features of the enamel-dentine-junction junction (EDJ)-phylogenetically informative internal structures-of 71 fossil Pongo lower molars from various sites by applying geometric morphometrics and conducted paleoproteomic analyses from enamel proteins to attempt to identify extinct orangutan species. Forty-three orangutan lower molars representing Pongo pygmaeus and Pongo abelii were included for comparison. The shape of the EDJ was analyzed by placing five landmarks on the tip of the main dentine horns, and 142 semilandmarks along the marginal ridges connecting the dentine horns. Paleoproteomic analyses were conducted on 15 teeth of Late Pleistocene Pongo using high-resolution tandem mass spectrometry. The geometric morphometric results show variations in EDJ shape regarding aspects of the height and position of the dentine horns and connecting ridges. Despite the issue of molar position and sample size, modern molars are distinguished from fossil counterparts by their elongated tooth outline and narrowly positioned dentine horns. Proteomic results show that neither a distinction of P. pygmaeus and P. abelii, nor a consistent allocation of fossil specimens to extant species is feasible. Based on the EDJ shape, the (late) Middle to Late Pleistocene Pongo samples from Vietnam share the same morphospace, supporting the previous allocation to P. devosi, although substantial overlap with Chinese fossils could also indicate close affinities with P. weidenreichi. The hypothesis that both species represent one chronospecies cannot be ruled out. Two fossil specimens, one from Tam Hay Marklot (Laos, Late Pleistocene), and another from Sangiran (Java, Early to Middle Pleistocene), along with some specimens within the Punung sample (Java), exhibit affinities with Pongo abelii. The Punung fossils might represent a mix of early Late Pleistocene and later specimens (terminal Pleistocene to Holocene) related to modern Pongo. The taxonomy and phylogeny of the complete Punung sample needs to be further investigated.


Subject(s)
Hominidae , Pongo abelii , Tooth , Animals , Pongo/anatomy & histology , Hominidae/anatomy & histology , Proteomics , Molar/anatomy & histology , Pongo pygmaeus , Fossils
19.
J Endourol ; 37(6): 617-622, 2023 06.
Article in English | MEDLINE | ID: mdl-36960704

ABSTRACT

Background: Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) have a significant impact on patients' quality of life and clinical course. There is a paucity of studies that evaluate the natural history of RFs after PCNL. The objective of this study is to compare rates of reintervention, complications, stone growth, and passage in patients with RFs >4, ≤4, and ≤2 mm after PCNL. Methods: Sites from the Endourologic Disease Group for Excellence (EDGE) research consortium examined data of PCNL patients from 2015 to 2019 with at least 1-year follow-up. RF passage, regrowth, reintervention, and complications were recorded and RFs were stratified into >4 and ≤4 mm groups, as well as >2 and ≤2 mm groups. Potential predictors for stone-related events after PCNL were determined using multivariable logistic regression analysis. It was hypothesized that larger RF thresholds would result in lower passage rates, faster regrowth, and greater clinically significant events (complications and reinterventions) than smaller RF thresholds. Results: A total of 439 patients with RFs >1 mm on CT postoperative day 1 were included in this study. For RFs >4 mm, rates of reintervention were found to be significantly higher and Kaplan-Meier curve analysis showed significantly higher rates of stone-related events. Passage and RF regrowth were not found to be significantly different compared with RFs ≤4 mm. However, RFs ≤2 mm had significantly higher rates of passage, and significantly lower rates of fragment regrowth (>1 mm), complications, and reintervention compared with RFs >2 mm. On multivariable analysis, older age, body mass index, and RF size were found to be predictive of stone-related events. Conclusions: With the largest cohort to date, this study by the EDGE research consortium further confirms that clinically insignificant residual fragment is problematic for patients after PCNL, particularly in older more obese patients with larger RFs. Our study underscores the importance of complete stone clearance post-PCNL and challenges the use of Clinically insignificant residual fragment (CIFR).


Subject(s)
Kidney Calculi , Nephrolithotomy, Percutaneous , Nephrostomy, Percutaneous , Humans , Aged , Nephrolithotomy, Percutaneous/adverse effects , Nephrolithotomy, Percutaneous/methods , Kidney Calculi/complications , Quality of Life , Kaplan-Meier Estimate , Postoperative Period , Treatment Outcome , Retrospective Studies , Nephrostomy, Percutaneous/adverse effects
20.
BJU Int ; 109(3): 444-9, 2012 Feb.
Article in English | MEDLINE | ID: mdl-21635683

ABSTRACT

OBJECTIVES: To compare the prevalence of hypertension and diabetes mellitus (DM) in patients treated with an unmodified HM-3 lithotripter (USWL) and a second-generation modified HM-3 lithotripter (MSWL) 20 years ago at our Centre with that in the provincial population. To determine whether the type of lithotripter was differentially associated with the development of these sequelae. PATIENTS AND METHODS: Retrospective review of 727 patients at Vancouver General Hospital who underwent shock-wave lithotripsy (SWL) between 1985 and 1989. Our study group was compared with Statistics Canada data describing the provincial prevalence of these diseases. Multivariate analysis was performed. RESULTS: The response rate was 37.3%. There was a greater proportion of overweight and obese individuals in the study group compared with the provincial average. In univariate analysis, lithotripsy with an unmodified HM-3 (USWL) was associated with a higher rate of DM than the provincial rate, whereas lithotripsy with the modified HM-3 (MSWL) was not. Hypertension was more prevalent in all lithotripsy subjects. On multivariate analysis the type of lithotripter was not associated with the development of either sequela. CONCLUSIONS: No association between lithotripsy and the development of either DM or hypertension in a multivariate analysis Metabolic syndrome may have elevated the prevalence of DM and hypertension observed in our subjects on univariate analysis, which is in keeping with the fact that our study population had statistically higher body mass indices than the provincial rate. Lithotripsy using the HM-3 was not associated with increased DM or hypertension.


Subject(s)
Diabetes Mellitus/etiology , Hypertension/etiology , Lithotripsy/adverse effects , Urolithiasis/therapy , Aged , Body Mass Index , Diabetes Mellitus/epidemiology , Female , Humans , Hypertension/epidemiology , Male , Middle Aged , Multivariate Analysis , Obesity/complications , Prevalence , Retrospective Studies , Risk Factors
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