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1.
JBJS Rev ; 12(5)2024 May 01.
Article in English | MEDLINE | ID: mdl-38709859

ABSTRACT

¼ Coccydynia is a painful condition affecting many patients at the terminal caudal end of the spine.¼ An understanding of coccyx anatomy and variations of morphology is necessary for proper diagnosis. A multifactorial etiology for pain may be responsible for this clinical entity.¼ Several treatment options exist. Successful outcomes for patients depend on individual patient characteristics and the etiology of pain.


Subject(s)
Coccyx , Humans , Low Back Pain/therapy , Low Back Pain/etiology , Low Back Pain/diagnosis
2.
JBJS Case Connect ; 13(1)2023 01 01.
Article in English | MEDLINE | ID: mdl-36893291

ABSTRACT

CASE: A 68-year-old woman underwent an anterior cervical discectomy and fusion for cervical radiculopathy and subsequently developed a severe contact hypersensitivity reaction in response to Dermabond Prineo, beginning 10 days postoperatively. The Dermabond Prineo mesh was removed, and the patient was treated symptomatically with diphenhydramine, systemic steroids, and oral antibiotics, with complete resolution of her symptoms. CONCLUSION: This is the first reported contact hypersensitivity reaction to Dermabond Prineo in the context of spine surgery. Surgeons should be able to recognize this presentation and treat this appropriately.


Subject(s)
Dermatitis, Contact , Spinal Fusion , Female , Humans , Aged , Cervical Vertebrae/surgery , Spinal Fusion/adverse effects , Diskectomy/adverse effects
3.
J Forensic Sci ; 68(2): 682-687, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36604777

ABSTRACT

Ethanol stability in preserved antemortem blood has been widely studied since it is a common practice in cases involving suspected impaired driving to collect antemortem blood in evacuated blood tubes containing sodium fluoride. In some situations, antemortem blood is submitted to a forensic laboratory for ethanol analysis in evacuated blood tubes that contain only an anticoagulant. There has been limited research on ethanol stability in antemortem blood stored without a preservative. On two occasions, antemortem blood was collected from five ethanol-free individuals into 6-ml Vacutainer® tubes containing only 10.8 mg potassium EDTA. The blood tubes were spiked with ethanol to approximately either 0.08 or 0.15 g/dl. Dual-FID headspace gas chromatography was used to analyze 58 blood tubes, 29 from each session, for ethanol 1 day after sample collection and again after 1 year of refrigerated storage (~4°C). Statistically significant decreases in ethanol were detected at the 0.05 level of significance. Mean decreases in ethanol after 1 year of storage for the 0.08 and 0.15 g/dl samples were 0.013 and 0.010 g/dl, respectively. The mean ethanol decrease across all tubes was 0.012 g/dl. The range of decreases for the 58 blood tubes was 0.003-0.018 g/dl. The mean ethanol decreases measured in this unpreserved antemortem blood are comparable in magnitude to those previously observed in antemortem blood containing sodium fluoride after 1 year of refrigerated storage. Ethanol did not increase in the antemortem blood samples despite the absence of sodium fluoride.


Subject(s)
Ethanol , Sodium Fluoride , Humans , Specimen Handling/methods , Chromatography, Gas , Anticoagulants
4.
J Forensic Sci ; 68(1): 308-314, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36199211

ABSTRACT

A common defense challenge when antemortem blood ethanol results are presented at trial is the assertion that ethanol was formed in the blood tube after the blood draw through fermentation of the blood glucose by Candida albicans (C. Albicans). In contrast, decades of research into the stability of ethanol in antemortem blood collected for forensic purposes have consistently shown that any analytically significant change in ethanol concentration is a decrease and initially, ethanol-negative blood remains ethanol-negative with storage. For there to be any possibility of fermentation to occur by C. Albicans in an antemortem blood sample there must be a plausible mechanism for introduction of C. Albicans into the blood. One mechanism proffered at trial is environmental contamination resulting from ambient air drawn into the evacuated blood collection tube. Blood was drawn from ethanol-free individuals into 6 and 10-ml gray-top Vacutainer® tubes containing sodium fluoride and 6-ml Vacutainer® tubes without a preservative. Following the blood draws, the tubes were stored unstoppered at room temperature for 24 or 48 h in various locations. Following unstoppered storage, the tubes were stoppered and stored refrigerated (~4°C), left at room temperature (~22°C), or placed in an oven (37°C). The refrigerated blood was analyzed for ethanol using headspace gas chromatography after both 5 days and 32 months. Unrefrigerated blood samples were analyzed after being stored at room temperature or in an oven for up to 30 days. Ethanol was not detected in any of the blood tubes after storage regardless of storage time, storage temperature, or preservative concentration.


Subject(s)
Ethanol , Specimen Handling , Humans , Specimen Handling/methods , Fermentation , Temperature , Blood Specimen Collection
5.
J Forensic Sci ; 67(5): 2082-2088, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35766309

ABSTRACT

Chemical color tests are widely utilized as part of the analytical scheme approved to identify drugs in forensic laboratories and in the field by law enforcement officers. Although these test results are considered preliminary indications of the presence of a drug, forensic scientists sometimes use these test results to direct their confirmatory testing and law enforcement officers use these test results when making arrest decisions and decisions on how to impound evidence. The color tests commonly used to identify cocaine are aqueous cobalt thiocyanate, the Young's test, the Scott's test, and the modified Scott's test. Field testing of a white powder was reported by a law enforcement officer to be positive for cocaine hydrochloride using a commercially available test kit based on the modified Scott's test. The forensic laboratory determined that the powder contained fentanyl and mannitol; cocaine was not detected. Subsequently, the case material, fentanyl and cocaine reference materials, and cocaine cut with mannitol were tested using aqueous cobalt thiocyanate, the Young's test, the Scott's test, and the modified Scott's test. The fentanyl standard and case material produced the colors that would be interpreted as cocaine using the aqueous cobalt thiocyanate and Young's tests. The misidentification of fentanyl as cocaine with these tests could create a potentially hazardous situation. The cocaine containing samples were distinguishable from the fentanyl containing samples with the Scott's and modified Scott's test when 1 mg of cocaine material was tested, whereas a 3-mg cocaine sample produced the same color sequence as fentanyl.


Subject(s)
Cocaine , Fentanyl , Forensic Medicine , Mannitol , Powders
6.
J Forensic Sci ; 67(3): 1250-1257, 2022 May.
Article in English | MEDLINE | ID: mdl-35088902

ABSTRACT

The previous studies on ethanol stability in antemortem blood samples stored under various conditions have shown that ethanol concentration decreases with storage. The feasibility of measuring a forensically meaningful blood ethanol concentration in antemortem blood samples stored refrigerated (~4°C) from 4-7 years after the blood draw was evaluated in this research. All blood samples were collected into two 10-ml gray top Vacutainer® tubes as part of police driving under the influence investigations. In 29 cases, blood in the tube originally analyzed was retested after 5-7 years of refrigerated storage. Blood in 41 cases was analyzed in a previously unopened blood tube from the case after 4-7 years of refrigerated storage. The first analysis of blood in each case occurred within 35 days of the blood draw. Initial blood ethanol concentrations ranged from 0.094 g/dl to 0.301 g/dl. No samples showed an increase in ethanol concentration with storage that exceeded the uncertainty of the initial measurement. All decreases in ethanol concentration were less than 0.020 g/dl. The mean differences in ethanol concentration in previously opened and unopened tubes were -0.014 g/dl and -0.010 g/dl, respectively. The results of this research support that antemortem blood in previously opened and unopened refrigerated blood tubes can be analyzed for ethanol content more than 4 years and as much as 7 years after the blood draw and provide a result consistent with the amount of ethanol loss expected from a test done within 1-3 years of the blood draw.


Subject(s)
Automobile Driving , Ethanol , Blood Alcohol Content , Ethanol/analysis , Specimen Handling/methods
7.
J Forensic Sci ; 66(6): 2484-2492, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34250598

ABSTRACT

Dual-column headspace gas chromatographic analysis with two flame-ionization detectors is a commonly used analytical technique for forensic blood ethanol quantitation. This technique is also applicable to the identification and quantitation of other volatile organic compounds such as methanol in biological samples. Compound identification by retention time is limited to those compounds with known retention times programmed into the instrument method. Historically, an early-eluting peak from an unidentified compound has been observed in both chromatograms from antemortem blood samples analyzed for ethanol concentration with this technique. The unidentified compound's retention time matches that of methanol on one column but not on the second column. This previously unidentified compound has been identified as isobutylene. The proposed source of the isobutylene contamination historically observed in antemortem blood samples collected in 10-ml gray-top blood collection tubes is the conventional rubber stopper. Isobutylene was detected in deionized water stored in each of the seven lots of 10-ml blood tubes tested; the expiration dates of the tubes tested spanned the years 2002-2022. Misidentification of isobutylene as methanol is possible when using a single-column gas chromatographic system. The presence of isobutylene in blood collected in a gray-top collection tube does not represent laboratory contamination, is not an interferent with blood ethanol quantitation, and does not affect the ethanol concentration in the blood. A 0.150 g/dl aqueous ethanol standard was stored in a gray-top tube to evaluate the potential impact of isobutylene on ethanol quantitation. The solution's average ethanol concentration measured after storage was 0.150 g/dl.


Subject(s)
Alkenes , Blood Specimen Collection/instrumentation , Equipment Contamination , Central Nervous System Depressants/blood , Ethanol/blood , Forensic Toxicology , Humans , Rubber
8.
J Forensic Sci ; 66(5): 1966-1972, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34318503

ABSTRACT

Ethanol stability in antemortem blood stored under various conditions has been widely studied. Most such studies have somewhat limited sample size (<50) and limited variation in the length of time between the blood draw and the first analysis and between the first analysis and the reanalysis. In the work presented here, the antemortem blood drawn for forensic purposes and stored refrigerated (~4°C) in 371 cases was analyzed for ethanol concentration using headspace gas chromatography at various times after the blood draw based on routine case flow and then also analyzed at various times within approximately 1 year after the first analysis. This methodology is intended to provide insight into the range of differences expected when cases are analyzed in the normal flow of casework and then reanalyzed at random times afterwards as occurs when reanalysis is performed by the defense or by the laboratory if the original analyst is unavailable to testify. In 22 cases, the same blood tube from the case was reanalyzed. The previously unopened blood tube from the case was analyzed in 349 cases. The 25 cases in which the blood was ethanol-negative based on the first analysis remained ethanol-negative when reanalyzed. The average difference in ethanol concentration between tests for the ethanol-positive cases was -0.004 g/dL. This decrease was statistically significant at the 0.05 level of significance. The range of differences was -0.0197 to 0.0103 g/dL. The difference measured in 85% of the ethanol-positive cases was in in the range of -0.008 to -0.001 g/dL.


Subject(s)
Central Nervous System Depressants/blood , Chromatography, Gas , Cold Temperature , Ethanol/blood , Specimen Handling/methods , Forensic Toxicology/methods , Humans , Time Factors
9.
J Forensic Sci ; 66(6): 2478-2483, 2021 11.
Article in English | MEDLINE | ID: mdl-34156093

ABSTRACT

Since the accuracy of headspace gas chromatographic analysis of blood for ethanol concentration has been so well established over the past several decades, it has become commonplace in court proceedings to attack preanalytical handling of the blood samples including the lack of measuring sample temperature prior to sample preparation. The impact on measured ethanol concentration of allowing refrigerated (~4℃) samples varying amounts of time to equilibrate with room temperature, 24, 4, 3, 2, and 1 h, prior to sample preparation was evaluated. Samples were diluted 1:10 with an internal standard using a diluter/dispenser and analyzed using headspace gas chromatography. The mean ethanol concentration measured for the sixteen samples at each of the five equilibration times was 0.153 g/dl. The F-critical from the one-way ANOVA was 2.4937. The calculated F value was 0.4209. Additionally, the effect on measured ethanol concentration of having calibrators at different temperatures than case samples was investigated. Three groups were analyzed: all calibrators, controls, and samples given 24 h to equilibrate with room temperature, all calibrators, controls, and samples prepared immediately after removal from refrigeration, and calibrators sampled immediately after removal from refrigerator with samples and controls allowed 24 h to equilibrate with room temperature. The mean ethanol concentration measured for the thirty blood samples in each of the three groups was 0.197 g/dl. The F-critical from the one-way ANOVA was 3.1013. The calculated F value was 0.0188. Measured ethanol concentrations were insensitive to the variations in preanalytical conditions evaluated in this study.


Subject(s)
Blood Alcohol Content , Ethanol/blood , Forensic Toxicology/methods , Specimen Handling/methods , Temperature , Central Nervous System Depressants/blood , Chromatography, Gas , Humans , Time Factors
10.
J Forensic Sci ; 66(3): 1136-1142, 2021 May.
Article in English | MEDLINE | ID: mdl-33768533

ABSTRACT

Hemolysis, a common occurrence in blood collected for chemical analysis, has been reported to affect analytical test results for some analytes depending upon the material tested and the analytical technique employed. The potential for hemolysis to impact blood ethanol determinations using headspace gas chromatography of samples diluted with an internal standard was investigated. A sample of non-hemolyzed blood and a matched sample of hemolyzed blood were both analyzed thirty times for ethanol concentration using headspace gas chromatography. The mean ethanol concentration measured for the non-hemolyzed samples was 0.0639 g/dl. The mean ethanol concentration measured for the hemolyzed samples was 0.0642 g/dl. The calculated t value, 1.897, was less than the critical t value, 2.002, at a 0.05 level of significance. There was no measured statistical difference detected between the mean blood ethanol concentration determined for a hemolyzed whole blood sample and a non-hemolyzed whole blood sample.


Subject(s)
Central Nervous System Depressants/blood , Chromatography, Gas/methods , Ethanol/blood , Forensic Toxicology/methods , Hemolysis , Blood Alcohol Content , Humans
11.
J Forensic Sci ; 65(6): 2198-2200, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32692407

ABSTRACT

The stability of ethanol in antemortem blood stored under various conditions has been widely studied. Antemortem blood samples stored at refrigerated temperature, at room temperature, and at elevated temperatures tend to decrease in ethanol concentration with storage. It appears that the stability of ethanol in blood exposed to temperatures greater than 38°C has not been evaluated. The case presented here involves comparison of breath test results with subsequent analysis of blood drawn at the time of breath testing. However, the blood tubes were in a refrigerator fire followed by refrigerated storage for 5 months prior to analysis by headspace gas chromatography. The subject's breath was tested twice using an Intoxilyzer 8000. The subject's blood was tested in duplicate using an Agilent headspace gas chromatograph. The measured breath ethanol concentration was 0.103 g/210 L and 0.092 g/210 L. The measured blood ethanol concentration was 0.0932 g/dL for both samples analyzed. Although the mean blood test result was slightly lower than the mean breath test result, the mean breath test result was within the estimated uncertainty of the mean blood test result. Even under the extreme conditions of the blood kit being in a refrigerator fire, the measured blood ethanol content agreed well with the paired breath ethanol test.


Subject(s)
Blood Alcohol Content , Breath Tests , Ethanol/analysis , Chromatography, Gas , Driving Under the Influence , Fires , Humans , Specimen Handling/instrumentation
12.
Rev. bras. med. esporte ; 24(2): 135-139, Mar.-Apr. 2018. tab, graf
Article in English | LILACS | ID: biblio-959035

ABSTRACT

ABSTRACT Introduction: Improving strength levels is important to women with osteoporosis. Resistance and aerobic exercise are effective means of reaching this goal; however, the use of low-load exercises with blood flow restriction is an alternative to traditional methods of exercise to achieve the same strength gains in this population. Objective: To analyze the chronic effects of aerobic and resistance training combined with blood flow restriction on the maximal dynamic strength (MDS) of women with osteoporosis. Methods: Twenty women (61.40±4.63 years of age, 61.82±12.54 kg, 1.51±0.05 m, 27.16±5.55 kg/m²) were randomly assigned to four groups: 1 - high-intensity resistance training (HI); 2 - low-intensity resistance training with blood flow restriction (LI-BFR); 3 - aerobic training with blood flow restriction (ABFR); and 4 - control group (CG). Unilateral knee extension MDS was assessed using the one-repetition maximum (1RM) strength test before and after the 6th and 12th weeks of intervention. The data were analyzed using repeated measures analysis of variance (ANOVA) with a Bonferroni post-hoc test performed using SPSS (version 21.0), considering a significance level of P<0.05 for all tests. Results: Baseline comparisons showed that HI and CG had lower strength levels than LI-BFR and ABFR groups (P<0.05). The ABFR group exhibited a significant increase in MDS between the 1st and the 6th week (9%, P=0.001) and between the 1st and the 12th week (21.6%, P=0.008). The LI-BFR group exhibited increased MDS between the 1st and the 6th week (10.1%, P=0.001), between the 1st and the 12th week (24.2%, P=0.003) and between the 6th and 12th week (12.8%, P=0.030). The HI group exhibited a significant difference between the 1st and the 6th week (38.7%, P<0.001), between the 1st and the 12th week (62%, P<0.001) and between the 6th and 12th weeks (17.4%, P=0.020), whereas the CG had no significant differences between the timepoints (P>0.05). Conclusions: ABFR and LI-BFR effectively increased the MDS of women with osteoporosis.


RESUMO Introdução: Melhorar os níveis de força é importante para as mulheres com osteoporose. Os exercícios de força e aeróbicos são eficazes para atingir esse objetivo; no entanto, o uso de exercícios de baixa carga com restrição do fluxo sanguíneo é uma alternativa aos métodos tradicionais de exercício para atingir os mesmos ganhos de força nessa população. Objetivo: Analisar o efeito crônico do treinamento aeróbico e de força combinado com a restrição de fluxo sanguíneo sobre a força dinâmica máxima (FDM) de mulheres com osteoporose. Métodos: Vinte mulheres (61,40 ± 4,63 anos; 61,82 ± 12,54 kg; 1,51 ± 0,05 m; 27,16 ± 5,55 kg/m²) foram randomizadas em quatro grupos: 1 - treinamento de força de alta intensidade (AI); 2 - treinamento de força de baixa intensidade com restrição de fluxo sanguíneo (BIRFS); 3 - treinamento aeróbico com restrição de fluxo sanguíneo (ARFS) e 4 - controle (GC). A avaliação da força dinâmica máxima (FDM) da extensão unilateral do joelho foi realizada pelo teste de 1RM antes e depois da 6ª e 12ª semanas de intervenção. Para a análise dos dados realizou-se o teste ANOVA de medidas repetidas com teste de Bonferroni post-hoc no software SPSS (versão 21.0), considerando um nível de significância de P < 0,05 em todas as análises. Resultados: As comparações antes da intervenção mostraram que os grupos AI e GC tinham menores níveis de força que os grupos ARFS e BIRFS (P < 0,05). O grupo ARFS apresentou aumento significativo na FDM entre a 1ª e a 6ª (9%; P = 0,001) e entre a 1ª e a 12ª semana (21,6%; P = 0,008). O grupo BIRFS teve aumento da FDM entre a 1ª e a 6ª (10,1%; P = 0,001), entre a 1ª e a 12ª semana (24,2%; P = 0,003) e entre a 6ª e 12ª semana (12,8%; P = 0,030). O grupo AI teve diferença significativa entre a 1ª e a 6ª semana (38,7%; P < 0,001), entre a 1ª e a 12ª semana (62%; P < 0,001) e entre a 6ª e a 12ª semana (17,4%; P = 0,020), enquanto o GC não apresentou diferença entre os pontos do tempo (P > 0,05). Conclusões: ARFS e BIRFS aumentaram efetivamente a FDM em mulheres com osteoporose.


RESUMEN Introducción: Mejorar los niveles de fuerza es importante para las mujeres con osteoporosis. Los ejercicios de fuerza y aeróbicos son eficaces para alcanzar ese objetivo; sin embargo, el uso de ejercicios de baja carga con restricción del flujo sanguíneo es una alternativa a los métodos tradicionales de ejercicio para alcanzar los mismos aumentos de fuerza en esa población. Objetivo: Analizar el efecto crónico del entrenamiento aeróbico y de fuerza combinado con la restricción de flujo sanguíneo sobre la fuerza dinámica máxima (FDM) de mujeres con osteoporosis. Métodos: Veinte mujeres (61,40 ± 4,63 años; 61,82 ± 12,54 kg, 1,51 ± 0,05 m; 27,16 ± 5,55 kg / m²) fueron aleatorizadas en cuatro grupos: 1 - entrenamiento de fuerza de alta intensidad (AI); 2 - entrenamiento de fuerza de baja intensidad con restricción del flujo sanguíneo (BIRFS); 3 - entrenamiento aeróbico con restricción del flujo sanguíneo (ARFS) y 4 - Control (GC). La evaluación de la fuerza dinámica máxima (FDM) de extensión unilateral de la rodilla se realizó mediante la prueba de 1RM antes y después de la 6ª y 12ª semana de intervención. Para el análisis de los datos se realizó la prueba ANOVA de medidas repetidas con prueba de Bonferroni post hoc en el software SPSS (versión 21.0), considerando un nivel de significación de P < 0,05 en todos los análisis. Resultados: Las comparaciones antes de la intervención mostraron que los grupos AI y GC tenían menores valores de fuerza que ARFS y BIRFS (P < 0,05). El grupo ARFS presentó un aumento significativo de la FDM entre las semanas 1 y 6 (9%; P = 0,001) y entre las semanas 1 y 12 (21,6%; p = 0,008). El BIRFS tuvo un aumento de la FDM entre las semanas 1 y 6 (10,1%; p = 0,001), entre las semanas 1 y 12 (24,2%; p = 0,003) y las semanas 6 y 12 (12,8%; P = 0,030). El grupo AI tuvo una diferencia significativa entre las semanas 1 y 6 (38,7%; P < 0,001), entre las semanas 1 y 12 (62%, P < 0,001) y entre las semanas 6 y 12 (17,4%; p = 0,020), mientras que el GC no presentó diferencia entre los puntos del tiempo (P > 0,05). Conclusiones: ARFS y BIRFS aumentaron efectivamente la FDM en mujeres con osteoporosis.

14.
Can J Urol ; 13(3): 3127-38, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16813704

ABSTRACT

OBJECTIVE: To develop the first Canadian guidelines for the management of adult urinary incontinence (UI). METHOD: Following a mandate of the Canadian Urological Association, six Canadian urologists collaborated to produce these guidelines after having extensively reviewed existing foreign guidelines and literature from 1966 to June 2005. RESULTS: The terminology proposed by the standardization committee of the International Continence Society (ICS) is recommended. Basic evaluation must include a history, physical examination, evaluation of post void residual volume, urinalysis and voiding diary. A more detailed evaluation is recommended for complex cases or if initial management fails. As non-pharmacological treatments, devices (catheters, pessaries, etc...) play an important role in selected patients. Lifestyle adjustments are recommended to be implemented first before considering other forms of treatment. Pelvic exercises can be helpful for the mildest cases of pelvic relaxation, in motivated compliant patients. In highly selected patients neuromodulation can improve the patient's quality of life. Probantheline, oxybutinin and tolterodine have a proven efficacy in the treatment of UI. Imipramine and oestrogens are suggested while flavoxate has an unproven efficacy. Surgery in women is indicated when the degree of incontinence is sufficiently troublesome to the patient, the incontinence has been observed by the examiner, its causes adequately evaluated and conservative therapies have been reviewed. Primary stress urinary incontinence in the female is effectively treated by a retropubic suspension (Burch or Marshall- Marchetti-Krantz), or a pubovaginal sling procedure. Pubovaginal slings are the procedure of choice in the presence of significant intrinsic sphincteric deficiency (ISD), the absence of hypermobility, or in the treatment following a failed retropubic suspension. Peri urethral injectables are recommended first line treatment of SUI when available. In men, artificial sphincter is the treatment of choice in neurogenic and non-neurogenic SUI. In neurogenic bladders and sometimes in non neurogenic bladders other forms of surgeries such as bladder denervation, bladder augmentations, neurostimulation, urinary diversion can be considered as the treatment of choice for individual patients. CONCLUSION: Canadian guidelines on incontinence have been completed in 2005 reflecting the Canadian health environment. This field of UI is in constant progression and, when of proven efficacy, new medications and devices have to be included in the proposed algorithm of care.


Subject(s)
Urinary Incontinence/therapy , Exercise , Female , Humans , Life Style , Male , Muscarinic Antagonists/therapeutic use , Parasympatholytics/therapeutic use , Urinary Incontinence/classification , Urinary Incontinence/diagnosis , Urologic Surgical Procedures
15.
BJU Int ; 97(3): 520-7, 2006 Mar.
Article in English | MEDLINE | ID: mdl-16469019

ABSTRACT

OBJECTIVE: To assess the efficacy, incidence of dry mouth and overall satisfaction with initial doses of 5, 10 and 15 mg of a new, once-daily, controlled-release (CR) form of oxybutynin for treating urge urinary incontinence (UUI). PATIENTS AND METHODS: Patients who reported urinary incontinence (UI) (one or more episodes/diary) and voiding frequency (eight or more voids/day) or urgency (one or more episodes/diary) during a 2-week baseline were randomized to once-daily 5, 10 or 15 mg CR oxybutynin for 4 weeks. Daily episodes of UI, voids, urgency, adverse events, dry mouth and satisfaction were recorded in a 3-day diary at baseline and after 4 weeks of treatment. In all, 237 patients were randomized and evaluated. RESULTS: Episodes of UI, voids and urgency were significantly reduced over the study period at all doses. Daily UI episodes were significantly lower with 15 mg/day than 5 and 10 mg/day. Dry mouth symptoms were similar in the 10 and 15 mg/day groups, and higher than in the 5 mg/day group. However, significantly greater overall satisfaction was reported with 15 than 5 mg/day. CONCLUSIONS: There were significant dose-response relationships with CR oxybutynin for both UI episodes and dry mouth. The greatest satisfaction was with 15 mg/day, and the severity of dry mouth was comparable at 10 mg/day, indicating that greater efficacy at the higher dose did not compromise tolerability.


Subject(s)
Mandelic Acids/administration & dosage , Urinary Incontinence/drug therapy , Xerostomia/chemically induced , Adult , Aged , Delayed-Action Preparations/administration & dosage , Delayed-Action Preparations/adverse effects , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Mandelic Acids/adverse effects , Middle Aged , Patient Satisfaction , Severity of Illness Index , Treatment Outcome
16.
Urology ; 62(4): 614-7, 2003 Oct.
Article in English | MEDLINE | ID: mdl-14550427

ABSTRACT

OBJECTIVES: To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS. METHODS: Men with a National Institutes of Health (NIH) diagnosis of CP/CPPS (specifically, no infection localized to the prostate) were randomized to levofloxacin (500 mg/day) or placebo for 6 weeks in 11 Canadian centers. Patients were assessed at baseline and at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and global patient assessments (subjective global assessment and patient assessment questionnaire). RESULTS: Eighty men (average age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range 0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo (n = 35). All were evaluated in an intent-to-treat analysis. Both groups experienced progressive improvement in symptoms as measured by the NIH-CPSI. However, the difference in response was not statistically or clinically significant at end of treatment (6 weeks) or at the end of the follow-up visits (12 weeks). No patients withdrew because of adverse events. One patient withdrew before the 6-week assessment. Adverse events (all mild) were reported in 20% of the levofloxacin group and 17% of the placebo group. CONCLUSIONS: This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.


Subject(s)
Anti-Infective Agents/therapeutic use , Levofloxacin , Ofloxacin/therapeutic use , Pelvic Pain/drug therapy , Prostatitis/drug therapy , Adult , Aged , Anti-Infective Agents/adverse effects , Chronic Disease , Double-Blind Method , Humans , Male , Middle Aged , Ofloxacin/adverse effects , Pilot Projects , Safety , Treatment Outcome
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