Evolution and current status of the management of functional and pelvic floor pathology in the hospitals of the Community of Madrid.

INTRODUCTION AND OBJECTIVE: Pelvic floor dysfunction (PFD) includes a large number of pathologies subjected to a significantly varied management, depending on the hospitals' resources and educational levels of their professionals. The aim of this study is to determine and describe the clinical variability in the management of PFD in the urology departments of the public health centers of the Community of Madrid, as well as the resources currently available in these centers. MATERIAL AND METHODS: The survey was carried out in September 2021 and was addressed to physicians specialized in functional urology in the public hospitals of the Community of Madrid. This survey is based on the one performed in 2011 by Díez et al. for the same purpose. The characteristics of the healthcare services provided in the different centers and the management of the main functional pathologies of the pelvic floor were analyzed. The results were compared with those of the 2011 survey for equivalent questions. RESULTS: The number of Pelvic Floor Units (PFUs) has remarkably increased in the last 10 years. The use of adjustable devices in the treatment of male SUI has become widespread in the centers included in the survey. Laparoscopic/robotic sacrocolpopexy has become the gold standard treatment for pelvic organ prolapse (POP). CONCLUSIONS: Multidisciplinary PFUs represent the reference framework for the management of PFD. Variability in the management of urinary incontinence, POP, bladder pain syndrome and pudendal nerve neuropathy is recognized.

Preliminary results of a national multicenter study on the treatment of LUTS secondary to benign prostatic hyperplasia using the Rezum® steam system.

INTRODUCTION AND OBJECTIVE: Rezum® system is a minimally invasive transurethral therapy that uses convective water vapor energy to ablate prostatic tissue. The objective is to report 1-year functional and security outcomes obtained by using this technique in real clinical practice. MATERIAL AND METHODS: Prospective study conducted in 5 Spanish hospitals for the treatment of LUTS secondary to BPH using the Rezum® system. Patients with prostatic medium lobe (ML) and urethral catheter carriers were also included. Pre- and post-operative data were collected using IPSS, IIEF-5 and QoL questionnaires, flowmetry and post-void residual volume. Complications and retreatment rate at one-year follow-up were also reported. RESULTS: 137 patients, including 64 with ML and 10 patients with urinary retention were treated. Median prostate volume was 50 cm3 (15-131). At 3 months follow-up, significant improvement was observed in IPSS (-6.37 points), Qmax (+4.95 mL/s) and QoL (-1.29); and was maintained until 12 months: -10.78 points, +4.62 mL/s and -2.73 respectively (p < 0.001). No significant changes were observed in the sexual sphere. All complications were mild (≤ Clavien II). Retreatment rate at one year was 4%. CONCLUSION: Short-term results of this technique are promising, showing improvement in terms of functional outcomes, with no impact on the sexual sphere or complications. Longer term follow-up should include treatment durability and comparison to standard BPH treatments.

Complex Peyronie's disease cases: surgery with or without penile prosthesis placement. / Casos complejos. Enfermedad de Peyronie: cirugía sin/con implante de prótesis de pene.

INTRODUCTION AND OBJECTIVE: Surgery is the treatment of choice for patients with Peyronie's disease presenting difficulty in penetration or erectile dysfunction without adequate response to therapy. Several techniques have been described, and urologists must be aware of their possible complications and sequelae in order to offer the patient the best possible alternative. PATIENTS AND METHODS: Three complex cases of patients with Peyronie's disease are presented. The first case exposes a complication after penile plication for the treatment of a major dorsal curve. The second case refers to difficult anal penetration secondary to a problem of erection direction after plaque incision surgery with oral mucosa grafting. The last case is a patient with a late post-operative complication of a three-piece prosthesis placement with plaque incision and equine collagen patch. RESULTS: Surgical options for each case are detailed and discussed. After patients were informed, the decision was taken in a consensual manner. CONCLUSIONS: Surgery for Peyronie's disease requires the urologist's consideration of the functional, aesthetic and psychological spheres. A systematic approach to all of these avoids complications, sequels and improves results.

Clinical/Photographic/Scanning Electron Microscopy Analysis of Pit and Fissure Sealants After 22 Years: A Case Series.

Pit and fissure sealant is a clinical technique adopted to prevent caries lesion development. Ionomeric and/or resin-based materials are commonly used for this purpose. This article presents a case series of sealed teeth with 22-year follow-up evaluated by clinical, photographic, and microscopic analysis. In 1992, sixteen patients (9-14 years of age) had at least three teeth sealed with one of the following materials: resin-modified glass ionomer cement (RMGIC, Vitrebond or Fuji II LC) or polyacid-modified resin composite (PMRC, VariGlass VLC), totaling 86 sealed permanent teeth. After 22 years, 10 patients were recalled, representing 41 teeth. The retention of sealants was assessed by three methods: clinical analysis by visual inspection; photography; and scanning electron microscope (SEM) images and classified as retained (pits and fissures filled by sealant material); partially retained (pits and fissures partially filled by sealant material); or totally lost (no material was found in pits and fissures). The SEM images provided a higher number of retained sealants when compared with the clinical and photographic evaluations. Also, no totally lost scores were found with SEM analysis, regardless of the sealing material. No caries lesions were found. A fully or partially retained sealant in pits and fissures was capable of preventing caries lesions after 22 years within the patient pool analyzed.

Treatment of Enamel Surfaces After Bracket Debonding: Case Reports and Long-term Follow-ups.

After bracket debonding, residual bonded material may be observed on the enamel surface. When not properly removed, this residual material can interfere with the surface smoothness of the enamel, potentially resulting in staining at the resin/enamel interface and contributing to biofilm accumulation. Clinical case reports demonstrate clinical procedures to remove residual bonded material after bracket debonding. A water-cooled fine tapered 3195 FF diamond bur was used to remove the residual bonded material. Subsequently, the enamel surface was treated with Opalustre microabrasive compound. After one week, overnight dental bleaching was initiated using 10% carbamide peroxide in custom-formed trays for four weeks. The enamel microabrasion technique was found to be effective for polishing the enamel surface and for reestablishing the dental esthetics associated with dental bleaching. Longitudinal clinical controls of other clinical cases are presented.

Accomplishing esthetics using enamel microabrasion and bleaching-a case report.

This case report describes the sequential steps that were used to treat unesthetic, white, hard-texture enamel stains of unknown etiology. A tapered fine diamond bur was used to remove superficial enamel followed by the use of an enamel microabrasion compound Opalustre (Ultradent Products Inc). This technique removed the stains and was followed by polishing with a fluoride paste to restore the enamel to a smooth finish. The teeth were subsequently bleached with carbamide peroxide (Opalescence 10%, Ultradent Products), which achieved the patient's desired esthetic results.

PDGF-B gene therapy accelerates bone engineering and oral implant osseointegration.

Platelet-derived growth factor-BB (PDGF-BB) stimulates repair of healing-impaired chronic wounds such as diabetic ulcers and periodontal lesions. However, limitations in predictability of tissue regeneration occur due, in part, to transient growth factor bioavailability in vivo. Here, we report that gene delivery of PDGF-B stimulates repair of oral implant extraction socket defects. Alveolar ridge defects were created in rats and were treated at the time of titanium implant installation with a collagen matrix containing an adenoviral (Ad) vector encoding PDGF-B (5.5 x 10(8) or 5.5 x 10(9) pfu ml(-1)), Ad encoding luciferase (Ad-Luc; 5.5 x 10(9) pfu ml(-1); control) or recombinant human PDGF-BB protein (rhPDGF-BB, 0.3 mg ml(-1)). Bone repair and osseointegration were measured through backscattered scanning electron microscopy, histomorphometry, micro-computed tomography and biomechanical assessments. Furthermore, a panel of local and systemic safety assessments was performed. Results indicated that bone repair was accelerated by Ad-PDGF-B and rhPDGF-BB delivery compared with Ad-Luc, with the high dose of Ad-PDGF-B more effective than the low dose. No significant dissemination of the vector construct or alteration of systemic parameters was noted. In summary, gene delivery of Ad-PDGF-B shows regenerative and safety capabilities for bone tissue engineering and osseointegration in alveolar bone defects comparable with rhPDGF-BB protein delivery in vivo.

Microdeletion 15q13.3: a locus with incomplete penetrance for autism, mental retardation, and psychiatric disorders.

BACKGROUND: Microdeletions within chromosome 15q13.3 are associated both with a recently recognised syndrome of mental retardation, seizures, and dysmorphic features, and with schizophrenia. METHODS AND RESULTS: Based on routine diagnostic testing of approximately 8200 samples using array comparative genomic hybridisation, we identified 20 individuals (14 children and six parents in 12 families) with microdeletions of 15q13.3. Phenotypes in the children included developmental delay, mental retardation, or borderline IQ in most and autistic spectrum disorder (6/14), speech delay, aggressiveness, attention deficit hyperactivity disorder, and other behavioural problems. Both parents were available in seven families, and the deletion was de novo in one, inherited from an apparently normal parent in four, and inherited from a parent with learning disability and bipolar disorder in two families. Of the 14 children, six in five families were adopted, and DNA was available for only one of these 10 biological parents; the deletion was very likely inherited for one of these families with two affected children. Among the unavailable parents, two mothers were described as having mental retardation, another mother as having "mental illness", and one father as having schizophrenia. We hypothesise that some of the unavailable parents have the deletion. CONCLUSIONS: The occurrence of increased adoption, frequent autism, bipolar disorder, and lack of penetrance are noteworthy findings in individuals with deletion 15q13.3. A high rate of adoption may be related to the presence of the deletion in biological parents. Unconfirmed histories of antisocial behaviours in unavailable biological parents raise the concern that future research may show that deletion 15q13.3 is associated with such behaviours.

A PK/PD approach on the effects of clarithromycin against oral and nasal microbiota of healthy volunteers.

OBJECTIVE: To assess the pharmacokinetics of clarithromycin (CLR) and its effects on oral and nasal microbiota in healthy volunteers in an open, randomized, two-period crossover design. METHODS: A single 500 mg oral dose of CLR (Group 1: Merck; Group 2: Klaricid) was administered observing a 1-week interval between doses. Blood samples were collected from pre-dose to 24 h. Plasmatic concentrations of CLR were quantified by the LC-MS-MS method. Saliva and nasal mucosa swabs were obtained previously and after 1.33, 2, 6 and 12 h of drug administration. Pharmacokinetics and PK/PD (t > MIC, %t > MIC and AUC0-24/MIC ratio) parameters were estimated. The microorganism counts were obtained on different culture media. RESULTS: No statistically significant differences were observed between the two formulations (p > 0.05) regarding the pharmacokinetic parameters. Total microorganisms, staphylococci and streptococci counts did not show statistical differences (p > 0.05) between the two groups during each sampling time. Considering the microorganisms of each group, no statistically significant differences were found after drug administration, but all differed from pre-dose counts (p < 0.05). The observed t > MIC ranged from 14.45 h (+/- 1.69) to 1.19 h (+/- 2.17) considering MICs of 0.25 microg/ml and 2.0 microg/ml, respectively. There was no correlation between any t > MIC, %t > MIC or AUC0-24 and bacterial reduction (between 0- and 12-h periods). However, the profile of reduction of microorganisms in both saliva and nasal samples were compatible with high values of t > MIC verified for both clarithromycin formulations. CONCLUSION: Both formulations of clarithromycin had similar pharmacokinetics and efficacy.

Plasma and salivary amoxicillin concentrations and effect against oral microorganisms.

Plasma and salivary amoxicillin (AMO) concentrations were quantified following a single oral dose (875 mg) of two formulations of AMO (Amoxicillin-EMS Sigma Pharma and Amoxil BD 875 mg). In addition, the effect of amoxicillin against oral microorganisms was accessed. The open, randomized, two-period crossover study was carried out in 20 volunteers. Saliva and blood samples were collected at 0, 0.5, 1, 2, 4, 8 and 12 h after drug administration, and quantified using HPLC-ESI-MS and HPLC, respectively. Streptococci counts, anaerobe counts and total microorganism counts were obtained. No differences were observed between formulations (p > 0.05) in the plasma and salivary AMO concentrations and the pharmacokinetic parameters (C(max), t(max), AUC(0-8), and AUC(0-infinity)) also showed no statistically significant differences between formulations (p > 0.05). Microorganism counts for the two formulations at all sampling times did not differ (p > 0.05) but all microorganism counts at 60 min post-dose showed a significant decrease (p < 0.05). Amoxicillin was effective in reducing oral microorganism levels up to 12 h post-dose.

Comparative bioavailability of clarithromycin formulations in healthy brazilian volunteers.

OBJECTIVE: To compare the bioavailability of clarithromycin 500 mg tablets (Merck S.A Industrias Quimicas, Sao Paulo, SP, Brazil, used as test formulation) and Klaricid (Abbott Laboratórios do Brasil Ltda, Sao Paulo, SP, Brazil, used as reference formulation) in 24 healthy volunteers. MATERIAL AND METHODS: The study was conducted using an open, randomized, two-period crossover design with one-week interval between doses. Blood samples were collected at pre-dose, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hours after the administration. AUC was calculated by the trapezoidal rule extrapolation method. Cmax and tmax were compiled from the plasmatic concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC(0-inf), AUC(0-24 h), Cmax and untransformed tmax. RESULTS: Intraindividual coefficient of variation (CV%) values were 14.25% and 12.62%, respectively for Cmax and AUC(0-24 h). The geometric mean values (+/- SD) for AUC(0-24 h) (microg x h/ml), AUC(0-inf) (microg x h/ml), and Cmax (microg/ml) for test medication were 18.56 (+/- 6.87), 18.8 (+/- 5.70) and 2.45 (+/- 0.88); the obtained values for reference medication were 18.29 (+/- 5.39), 19.10 (+/- 7.21) and 2.5 (+/- 0.69). 90% Cl for clarithromycin geometric mean of AUC(0-24 h), AUC(0-inf) and Cmax ratios (test/reference) were: 93.6-105.9%, 93.8-106.2% and 89- 103.2%. CCONCLUSION The test medication was considered bioequivalent to the reference medication based on the rate and extent of absorption.

Comparative bioavailability of 875 mg amoxicillin tablets in healthy human volunteers.

OBJECTIVE: To compare the bioavailability of amoxicillin 875 mg tablets (EMS Sigma Pharma used as test formulation) and Amoxil BD 875 mg tablets (GlaxoSmithKline used as reference formulation) in 26 healthy volunteers. MATERIAL AND METHODS: 26 healthy volunteers (13 males and 13 females) received each formulation in an open, 2 x 2 crossover, randomized study with seven days of washout period between doses. Plasma samples were obtained over a 12-hour interval after administration. Plasmatic amoxicillin concentrations were obtained by combined reversed-phase liquid chromatography and mass spectrometry with positive ion electrospray ionization using the select ion monitoring method. AUC was calculated by the trapezoidal rule extrapolation method. Cmax and tmax were compiled from the plasmatic concentration-time data. Analysis of variance was carried out using logarithmically transformed AUC0-inf, AUC0-12 h, Cmax and untransformed tmax. RESULTS: The mean values (+/- SD) for AUC0-12 h (microg x h x ml(-1)), AUC0-inf (microg x h x ml(-1)), Cmax (microg x ml(-1)), t1/2 (h) and tmax (h), were, respectively: 55.42 (+/- 16.85), 55.42 (+/- 16.85), 18.59 (+/- 6.3), 1.49 (+/- 1.57) and 2.04 (+/- 0.75) concerning the test formulation, and 51.11 (+/- 18.9), 51.29 (+/- 19.12), 17.83 (+/- 5.86), 1.52 (+/- 1.31) and 2.02 (+/- 0.87) concerning the reference formulation. Confidence intervals (90%) of amoxicillin means of AUC0-12 h and Cmax ratios (test/reference) were: 0.961-1.149 and 0.914-1.142, respectively, agreeing with the bioequivalence criteria established by the Brazilian National Health Surveillance Agency. CONCLUSION: Both formulations were bioequivalent based on both the rate and extent of absorption.

Hepatocellular carcinoma in glycogen storage disease type Ia: a case series.

We present a series of 8 patients (6 males, 2 females) with hepatocellular carcinoma (HCC) and glycogen storage disease type Ia (GSD Ia). In this group, the age at which treatment was initiated ranged from birth to 39 years (mean 9.9 years). All patients but one were noncompliant with treatment. Hepatic masses were first detected at an age range of 13-45 years (mean 28.1 years). Age at diagnosis of HCC ranged from 19 to 49 years (mean 36.9 years). Duration between the diagnosis of liver adenomas and the diagnosis of HCC ranged from 0 to 28 years (mean 8.8 years, SD = 11.5). Two patients had positive hepatitis serologies (one hepatitis B, one hepatitis C). Alpha-fetoprotein (AFP) was normal in 6 of the 8 patients. Carcinoembryonic antigen (CEA) was normal in the 5 patients in which it was measured. Current guidelines recommend abdominal ultrasonography with AFP and CEA levels every 3 months once patients develop hepatic lesions. Abdominal CT or MRI is advised when the lesions are large or poorly defined or are growing larger. We question the reliability of AFP and CEA as markers for HCC in GSD Ia. Aggressive interventional management of masses with rapid growth or poorly defined margins may be necessary to prevent the development of HCC in this patient population.

Estudo da utilização de antimicrobianos e outros fármacos para distúrbios do trato respiratório em pecientes pediátricos hospitalizados / The study of medication in respiratory and antimicrobian treatment in hospitalized pediatrics patients

O tratamento das doenças respiratórias requerem a utilização de antibióticos, corticosteróides e broncodilatadores. Todavia é desejável que, na pediatria, estas medicações sejam restritas e se utilize uma via de administração confortável. O objetivo deste trabalho foi avaliar a utilização dos medicamentos do trato respiratório e antimicrobianos em pacientes pediátricos hospitalizados, por meio da análise de seus prontuários. Os dados foram coletados durante 120 dias, observando-se os medicamentos prescritos, as doses, as vias de administração e as medidas não farmacológicas prescritas. O critério de inclusão na pesquisa foi estar o paciente internado na pediatria, ter na prescrição um antimicrobiano ou medicamento para o trato respiratório. As análises dos 136 prontuários mostrou que 97,06% continham um antimicrobiano, sendo o mais prescrito ampicilina e o fenoterol e ipratrópio como broncodilatadores. Destaca-se que 21,35% das prescrições apresentaram dosagem abaixo do mínimo e em, 21,89% acima do máximo. Embora em 93,75% dos casos tenha havido prescrição de dieta por via oral, 70,59% dos pacientes tiveram prescrição de medicação por via intravenosa. Esses dados revelam o uso de doses subterapêuticas, prescrição excessiva de antimicrobianos e o uso freqüente da via parenteral que encarecem o tratamento, predispõem ao aparecimento de efeitos indesejáveis como superinfecção, prolongando o tempo de permanência no hospital

Quality of case management of sexually transmitted diseases: comparison of the methods for assessing the performance of providers.

This article examines the reliability and validity of direct observation of patient-provider encounters, interviews with providers, and use of patients simulating sexually transmitted diseases (STD) as methods for assessing the quality of STD case management in developing countries. Data were collected during an STD health facility survey in Malawi; the performance of 49 providers was observed, and the providers were also interviewed; 20 of them were visited by a simulated patient complaining of urethral discharge. Agreement (based on the kappa statistic) was generally poor between direct observation and provider-interview data, and also between direct observation and simulated-patient data. In contrast, percentage agreements between direct observation and simulated-patient data were often high. Multiple observations on providers indicated that a provider's behaviour is not consistent across several patients. Simulated-patient data are probably the best in reflecting normal performance, but their feasibility for routine quality assessment is limited because the provider's behaviour is not consistent and would require multiple data points. Direct observation data are the best option for assessing quality if the results are assumed to reflect better than normal levels of quality of care. Data from interviews with providers should be viewed with caution, because they may reflect provider knowledge and not necessarily performance.

PIP: The quality of health care delivery in developing countries has been assessed by many studies using the following methods: direct observation of patient-provider encounters, review of records, exit interviews with clients, interviews with providers, and inventories of facilities, drugs, and supplies. This paper assesses the reliability and validity of the following methods used in a nationwide survey of STD case management conducted in health facilities in Malawi in 1994: the direct observation of provider-patient encounters, interviews with providers, and the use of people who pretend to be patients. The performance of 49 providers was observed. All of the providers were also interviewed and 20 were visited by a simulated patient complaining of urethral discharge. Multiple observations of providers indicated that any given provider does not behave in the same manner with all patients. Simulated-patient data can probably give the most accurate view of a provider's typical performance, but the approach has only limited use in routine quality assessment because the inconsistent nature of providers' behavior would require multiple data points per provider. Direct observation data are the best when measuring quality if the results are thought to be of higher quality than normal care. Data from interviews with providers should be carefully interpreted since they may reflect only provider knowledge and not his or her actual performance.

Comparative bioavailability of two suspension formulations of potassium diclofenac in healthy male volunteers.

The bioavailability of two suspension formulations of potassium diclofenac (Flogan, Merck and Cataflam, Ciba-Geigy) were compared in eighteen healthy male volunteers who received a single dose of 7 ml of each suspension (equivalent to 105 mg of potassium diclofenac) in an open randomized two period crossover design, with a fourteen-day washout period between doses. Serum samples were obtained over a 24 hour interval and diclofenac concentrations were determined by HPLC with ultraviolet detection. From the serum diclofenac concentration vs time curves, AUC[0-24] (area under the concentration vs time curves from 0-24 h), Cmax (maximum achieved concentration), Tmax (time to achieve Cmax) and Ke (terminal first order elimination constant) were obtained. Overlapping of Tmax intervals for both formulations was observed, but the important inter-subject variation observed in Cmax ratios did not allow equivalence conclusion for the rate of absorption. Equivalence in the extent of bioavailability between both potassium diclofenac suspension brands was concluded from the analysis of AUC[0-24] ratios.

[Levels of contaminant zinc in solutions routinely used in rehydration and/or parenteral feeding]. / Conteúdo do zinco contaminante nas soluções rotineiramente utilizadas em hidratação e/ou alimentação parenteral.

With the objective to evaluate the zinc needs of children submitted to rehydration and/or parenteral nutrition, the content of contaminating zinc was determined in intravenous solutions utilized at University Hospital of Ribeirão Preto, SP, Brazil. Zinc was measured in 40 bottles containing deionized water and submitted to the routine treatment for industrialization of serum for parenteral use, according to the standards of the University Hospital of Ribeirão Preto, Industrial Pharmacy. The effect of the sealing material employed (polished red stopper and unpolished black stopper) was observed, as well as time of contact between the solutions and rubber stoppers and latex slides, and the method of bottle conditioning (vertical or horizontal position) which permits contact of the solutions with the rubber stoppers. The gluco-saline solutions prepared in our Hospital and stored in glass bottles with unpolished black rubber stoppers and latex slide showed substantial zinc levels (1,220 to 4,860 micrograms/ml, n = 30). The same solutions kept in glass vials or plastic bottles were zinc free. The highest zinc levels were observed in the amino acid solutions placed in sealed bottles with unpolished black rubber stoppers (11,690 to 24,310 micrograms/ml, n = 20). It is important to be aware of these contaminating zinc levels to provide proper treatment involving this micronutrient.

Cerebral contusion: a prototype for head injury.

Cerebral contusions occur as a result of traumatic head injury. These lesions may consist of tissue necrosis, hemorrhage, and edema. The patient with a cerebral contusion is at risk to develop increased ICP and brain tissue displacement that may cause a rapid deterioration in his clinical condition.