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PURPOSE: The question of best surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) remains controversial. We compared the outcomes of aquablation and holmium laser enucleation of the prostate ("HoLEP") in a prospective cohort. METHODS: Patients with BPH underwent aquablation or HoLEP according to their preference between June 2020 and April 2022. Prostate volume ("PV"), laboratory results, postvoid residual volume, uroflowmetry, IPSS, ICIQ-SF, MSHQ-EjD, EES and IIEF were evaluated preoperatively and at three, six and 12 months postoperatively. We also analyzed perioperative characteristics and complications via the Clavien Dindo ("CD") classification. RESULTS: We included 40 patients, 16 of whom underwent aquablation and 24 HoLEP. Mean age was 67 years (SD 7.4). Baseline characteristics were balanced across groups, except the HoLEP patients' larger PV. IPSS fell from 20.3 (SD 7.1) at baseline to 6.3 (SD 4.2) at 12 months (p < 0.001) without differences between aquablation and HoLEP. HoLEP was associated with shorter operation time (59.5 (SD 18.6) vs. 87.2 (SD 14.8) minutes, p < 0.001) and led to better PV reduction over all timepoints. At three months, aquablation's results were better regarding ejaculatory (p = 0.02, MSHQ-EjD) and continence function (p < 0.001, ICIQ-SF). Beyond three months, erectile, ejaculatory, continence function and LUTS reduction did not differ significantly between aquablation and HoLEP. CD ≥ grade 3b complications were noted in six patients in aquablation group while only one in HoLEP group (p = < 0.01). CONCLUSIONS: While aquablation revealed temporary benefits regarding ejaculation and continence at three months, HoLEP was superior concerning operation time, the safety profile and volumetric results.
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Técnicas de Ablación , Láseres de Estado Sólido , Hiperplasia Prostática , Humanos , Hiperplasia Prostática/cirugía , Hiperplasia Prostática/complicaciones , Masculino , Anciano , Estudios Prospectivos , Láseres de Estado Sólido/uso terapéutico , Persona de Mediana Edad , Técnicas de Ablación/métodos , Terapia por Láser/métodos , Prostatectomía/métodos , Síntomas del Sistema Urinario Inferior/etiología , Síntomas del Sistema Urinario Inferior/cirugía , Agua , Resultado del TratamientoRESUMEN
PURPOSE: We aimed to assess critical temperature areas in the kidney parenchyma using magnetic resonance thermometry (MRT) in an ex vivo Holmium:YAG laser lithotripsy model. METHODS: Thermal effects of Ho:YAG laser irradiation of 14 W and 30 W were investigated in the calyx and renal pelvis of an ex vivo kidney with different laser application times (tL) followed by a delay time (tD) of tL/tD = 5/5 s, 5/10 s, 10/5 s, 10/10 s, and 20/0 s, with irrigation rates of 10, 30, 50, 70, and 100 ml/min. Using MRT, the size of the area was determined in which the thermal dose as measured by the Cumulative Equivalent Minutes (CEM43) method exceeded a value of 120 min. RESULTS: In the calyx, CEM43 never exceeded 120 min for flow rates ≥ 70 ml/min at 14 W, and longer tL (10 s vs. 5 s) lead to exponentially lower thermal affection of tissue (3.6 vs. 21.9 mm2). Similarly at 30 W and ≥ 70 ml/min CEM43 was below 120 min. Interestingly, at irrigation rates of 10 ml/min, tL = 10 s and tD = 10 s CEM43 were observed > 120 min in an area of 84.4 mm2 and 49.1 mm2 at tD = 5 s. Here, tL = 5 s revealed relevant thermal affection of 29.1 mm2 at 10 ml/min. CONCLUSION: We demonstrate that critical temperature dose areas in the kidney parenchyma were associated with high laser power and application times, a low irrigation rate, and anatomical volume of the targeted calyx.
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Láseres de Estado Sólido , Litotripsia por Láser , Termometría , Humanos , Temperatura , Holmio , Litotripsia por Láser/métodos , Calor , Riñón , Imagen por Resonancia MagnéticaRESUMEN
BACKGROUND: Percutaneous nephrolithotomy (PNL) is the standard of care for removing large kidney stones (> 2 cm). Once the procedure is complete, different exiting strategies exist to manage the percutaneous tract opening, including placement of an external nephrostomy tube, placement of an internal ureteral stent, or no external or internal tube. The decision to place or not place a tube is handled differently among clinicians and may affect patient outcomes. OBJECTIVES: To assess the effects of tubeless PNL (with ureteral stenting), totally tubeless PNL (without ureteral stenting or nephrostomy), and standard PNL (nephrostomy only) for the treatment of kidney stones in adults. SEARCH METHODS: We performed a systematic literature search in multiple biomedical databases (CENTRAL, MEDLINE, Embase, Web of Science), as well as in two clinical trial registries. We also handsearched reference lists of relevant publications and conference proceedings. We applied no language restrictions. The latest search update was conducted in September 2022. SELECTION CRITERIA: We included randomized controlled and quasi-randomized controlled trials of adult patients who received tubeless, totally tubeless, or standard PNL for treating kidney stones. We defined tubeless PNL as no nephrostomy tube, but ureteral stenting, while totally tubeless PNL meant no nephrostomy tube or ureteral stenting. Both interventions were compared to standard PNL with placement of a nephrostomy tube (only). We considered access tubes of any sizes. We only considered unilateral PNL with single-tract access. There were no exclusions on stone composition, size, or location. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature, extracted data, assessed risk of bias, and rated the certainty of evidence using GRADE. Primary outcomes were severe adverse events and postoperative pain, and secondary outcomes were operating time, length of hospital stay, and stone-free rate. We used the random-effects model for meta-analysis. MAIN RESULTS: We included 10 studies in the review. Participant age varied among studies, ranging from 20 to 60 years. Detailed information on stone characteristics was rarely presented. Tubeless PNL versus standard PNL We are very uncertain whether there is a difference in severe adverse events (SAEs) between tubeless PNL and standard PNL (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.14 to 16.46; I2 = 42%; 2 studies, 46 participants; very low-certainty evidence). Tubeless PNL may have little to no effect on pain on postoperative day one (mean difference (MD) 0.56 lower, 95% CI 1.34 lower to 0.21 higher; I2 = 84%; 4 studies, 186 participants; low-certainty evidence), and probably results in little to no difference in operating room time (MD 0.40 longer (in minutes), 95% CI 4.82 shorter to 5.62 longer; I2 = 0%; 3 studies, 81 participants; moderate-certainty evidence). Tubeless PNL may reduce length of hospital stay (MD 0.90 shorter, 95% CI 1.45 shorter to 0.35 shorter; I2 = 84%; 6 studies, 238 participants; low-certainty evidence). We are very uncertain of the effect of tubeless PNL on blood transfusions (RR 0.64, 95% CI 0.16 to 2.52; I2 = 0%; 4 studies, 161 participants; very low-certainty evidence), sepsis or fever (RR 0.50, 95% CI 0.05 to 4.75; I2 = not applicable; 2 studies, 82 participants; very low-certainty evidence), or readmissions (RR 1.00, 95% CI 0.07 to 14.21; I2 = not applicable, 1 study, 24 participants; very low-certainty evidence). Totally tubeless versus standard PNL Totally tubeless PNL may result in lower SAE rates (RR 0.49, 95% CI 0.19 to 1.25; I2 = 0%; 2 studies, 174 participants; low-certainty evidence) and pain on postoperative day one (MD 3.60 lower, 95% CI 4.24 lower to 2.96 lower; I2 = Not applicable; 1 study, 50 participants; low-certainty evidence). Totally tubeless PNL may result in little to no difference in operating room time (MD 6.23 shorter (in minutes), 95% CI 14.29 shorter to 1.84 longer; I2 = 72%; 2 studies, 174 participants; moderate-certainty evidence) and sepsis or fever (RR 0.33, 95% CI 0.01 to 7.97; I2 = not applicable; 1 study, 90 participants; low-certainty evidence). Totally tubeless PNL likely shortens the length of hospital stay (MD 1.55 shorter, 95% CI 1.82 shorter to 1.29 shorter; I2 = 0%; 4 studies, 274 participants; moderate-certainty evidence). We are very uncertain of the effect of totally tubeless PNL on blood transfusions (RR 0.62, 95% CI 0.26 to 1.48; I2 = 0%; 4 studies, 274 participants; very low-certainty evidence) or readmissions (RR not estimable, 95% CI not estimable; I2 = not applicable; 1 study, 50 participants; very low-certainty evidence). We found no studies comparing tubeless mini versus standard mini-PNL or totally tubeless mini versus standard mini-PNL. AUTHORS' CONCLUSIONS: When comparing tubeless to standard PNL with regard to the predefined primary outcomes of this review, there may be little difference in early postoperative pain, while we are very uncertain of the effect on SAEs. People treated with tubeless PNL may benefit from a reduced length of stay compared to standard PNL. When comparing totally tubeless to standard PNL, early postoperative pain and severe adverse events may be reduced with totally tubeless PNL. The certainty of evidence by outcome was mostly very low (range: moderate to very low) for the comparison of tubeless to standard PNL and low (range: moderate to very low) for the comparison of totally tubeless to standard PNL. The most common reasons for downgrading the certainty of the evidence were study limitations, inconsistency, and imprecision. We did not find randomized trial evidence for other comparisons. Overall, further and higher-quality studies are needed to inform clinical practice.
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Cálculos Renales , Nefrolitotomía Percutánea , Uréter , Adulto , Humanos , Adulto Joven , Persona de Mediana Edad , Nefrolitotomía Percutánea/efectos adversos , Cálculos Renales/cirugía , Tiempo de Internación , Dolor Postoperatorio/epidemiologíaRESUMEN
BACKGROUND: Mass spectrometry imaging (MSI) derives spatial molecular distribution maps directly from clinical tissue specimens and thus bears great potential for assisting pathologists with diagnostic decisions or personalized treatments. Unfortunately, progress in translational MSI is often hindered by insufficient quality control and lack of reproducible data analysis. Raw data and analysis scripts are rarely publicly shared. Here, we demonstrate the application of the Galaxy MSI tool set for the reproducible analysis of a urothelial carcinoma dataset. METHODS: Tryptic peptides were imaged in a cohort of 39 formalin-fixed, paraffin-embedded human urothelial cancer tissue cores with a MALDI-TOF/TOF device. The complete data analysis was performed in a fully transparent and reproducible manner on the European Galaxy Server. Annotations of tumor and stroma were performed by a pathologist and transferred to the MSI data to allow for supervised classifications of tumor vs. stroma tissue areas as well as for muscle-infiltrating and non-muscle infiltrating urothelial carcinomas. For putative peptide identifications, m/z features were matched to the MSiMass list. RESULTS: Rigorous quality control in combination with careful pre-processing enabled reduction of m/z shifts and intensity batch effects. High classification accuracy was found for both, tumor vs. stroma and muscle-infiltrating vs. non-muscle infiltrating urothelial tumors. Some of the most discriminative m/z features for each condition could be assigned a putative identity: stromal tissue was characterized by collagen peptides and tumor tissue by histone peptides. Immunohistochemistry confirmed an increased histone H2A abundance in the tumor compared to the stroma tissues. The muscle-infiltration status was distinguished via MSI by peptides from intermediate filaments such as cytokeratin 7 in non-muscle infiltrating carcinomas and vimentin in muscle-infiltrating urothelial carcinomas, which was confirmed by immunohistochemistry. To make the study fully reproducible and to advocate the criteria of FAIR (findability, accessibility, interoperability, and reusability) research data, we share the raw data, spectra annotations as well as all Galaxy histories and workflows. Data are available via ProteomeXchange with identifier PXD026459 and Galaxy results via https://github.com/foellmelanie/Bladder_MSI_Manuscript_Galaxy_links . CONCLUSION: Here, we show that translational MSI data analysis in a fully transparent and reproducible manner is possible and we would like to encourage the community to join our efforts.
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PURPOSE: Retrograde intrarenal surgery (RIRS) may require extensive X-ray usage. We evaluated the impact of preoperative surgeon briefing regarding the inclusion and evaluation of fluoroscopy time (FT) and dose area product (DAP) in a multicenter study on the applied X-ray usage. METHODS: A prospective multicenter study of 6 tertiary centers was performed. Each center recruited up to 25 prospective patients with renal stones of any size for RIRS. Prior to study´s onset, all surgeons were briefed about hazards of radiation and on strategies to avoid high doses in RIRS. Prospective procedures were compared to past procedures, as baseline data. FT was defined as the primary outcome. Secondary parameters were stone-free rate (SFR), complications according to the Clavien, SATAVA and postureteroscopic lesion scale. Results were analyzed using T test, chi-squared test, univariate analysis and confirmed in a multivariate regression model. RESULTS: 303 patients were included (145 retro- and 158 prospective). Mean FT and DAP were reduced from 130.8 s/565.8 to 77.4 s/357.8 (p < 0.05). SFR was improved from 85.5% to 93% (p < 0.05). Complications did not vary significantly. Neither stone position (p = 0.569), prestenting (p = 0.419), nor surgeons' experience (> 100 RIRS) had a significant impact on FT. Significant univariate parameters were confirmed in a multivariate model, revealing X-ray training to be radiation protective (OR - 44, p = 0.001). CONCLUSIONS: Increased surgeon awareness of X-ray exposure risks has a significant impact on FT and DAP. This "awareness effect" is a simple method to reduce radiation exposure for the patient and OR staff without the procedures´ outcome and safety being affected.
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Cálculos Renales/cirugía , Riñón/cirugía , Exposición a la Radiación/estadística & datos numéricos , Procedimientos Quirúrgicos Urológicos/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
INTRODUCTION: It is unclear whether endoscopic assessment of the stone-free rate after flexible ureteroscopy (fURS) is as effective as assessment with low-dose computed tomography (CT) scan. METHODS: Prospective documentation of patients with kidney stones > 10 mm diameter from 2 different centers (Freiburg, Regensburg), who underwent fURS and were declared to be endoscopically completely stone-free. Low-dose CT control performed 4-8 weeks postoperatively. RESULTS/CONCLUSION: Thirty-eight patients were treated between October 2015 and August 2016 (12 F, 26 M). Average age was 55.9 years (range 19-82, SD 17.24), and body mass index was 29.7 kg/m2 (range 23.5-42.5, SD 4.37). There were 2.0 (range 1-7, SD 1.55) stones with a mean diameter of 15 mm (range 10-40, SD 6.78) per kidney. Mean surgery time was 74 min (range 38-124, SD 24.28), and lithotripsy was necessary in 33 cases. CT was performed 5.4 weeks afterwards (range 4-8, SD 1.43). One patient had a 2 mm residual which was extracted by URS. Strictly speaking, endoluminal stone removal control failed in only that patient, yielding a negative predictive value of 97%. A routine postoperative CT scan would thus appear unnecessary in the case of negative endoscopic control for residual fragments and should be avoided to reduce radiation exposure. Further investigations with larger patient populations are necessary.
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Cálculos Renales/patología , Cálculos Renales/cirugía , Tomografía Computarizada por Rayos X , Ureteroscopios , Ureteroscopía , Adulto , Anciano , Anciano de 80 o más Años , Diseño de Equipo , Femenino , Humanos , Cálculos Renales/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Dosis de Radiación , Inducción de Remisión , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: To evaluate long-term efficacy and safety of low-pressure transurethral resection of the prostate for prostates < 70 cc (group 1) vs. > 70 cc (group 2). PATIENTS AND METHODS: In this study patients operated with monopolar TURP between 2009 and 2012 were evaluated retrospectively. During surgery a specially designed trocar (18 Fr) was placed suprapubically and connected to a suction pump to maintain stable low-pressure conditions. After sample size calculations, long-term follow-up was completed for 70 invited patients in each group up to 9/2015. RESULTS: Follow-up period was 57 vs. 56 months for group 1 and 2, respectively (p = 0.56). At baseline there was no significant difference in age, IPSS, peak flow, and post void residual (PVR). Mean prostate volume was 47 cc (15-65) vs. 100 cc (70-163). Mean operating time was 55.4 vs. 82.6 min (p = 0.00). Blood transfusion was necessary in 0.0 vs. 2.9% (p = 0.16), and 0.0 vs. 1.4% developed TUR syndrome (p = 0.32). At follow-up mean relative improvement in IPSS was 63 vs. 57% (p = 0.29), QoL 64 vs. 64% (p = 0.93), peak flow 139 vs. 130% (p = 0.85), and PVR 58 vs. 63% (p = 0.80). Long-term complications included recurring adenoma in 1.4 vs. 4.3% (p = 0.31), and stricture in 7.2 vs. 5.8% (p = 0.73). 1 patient in each group reported worsening incontinence symptoms. CONCLUSIONS: In terms of safety and efficacy, the aforementioned modality of standardized monopolar TURP using suprapubic suction was non-inferior for prostates > 70 cc compared to the same procedure for prostates < 70 cc. This technique is a potential low-cost alternative for clinics that cannot afford modern laser approaches. STUDY REGISTER NUMBER: DRKS00006527.
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Electrocirugia/métodos , Síntomas del Sistema Urinario Inferior/cirugía , Complicaciones Posoperatorias/epidemiología , Próstata/cirugía , Hiperplasia Prostática/cirugía , Succión/métodos , Resección Transuretral de la Próstata/métodos , Obstrucción del Cuello de la Vejiga Urinaria/cirugía , Adenoma/complicaciones , Adenoma/cirugía , Anciano , Anciano de 80 o más Años , Estudios de Seguimiento , Humanos , Síntomas del Sistema Urinario Inferior/etiología , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/cirugía , Tempo Operativo , Tamaño de los Órganos , Presión , Estudios Prospectivos , Próstata/patología , Hiperplasia Prostática/complicaciones , Neoplasias de la Próstata/complicaciones , Neoplasias de la Próstata/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Obstrucción del Cuello de la Vejiga Urinaria/etiología , Incontinencia Urinaria/epidemiologíaRESUMEN
PURPOSE: The aim of the study was to evaluate the feasibility and safety of combining prostatic urethral lift (PUL) and a limited resection of the prostatic middle lobe or bladder neck incision in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: Twenty-eight patients were treated at two tertiary centers and followed prospectively. Patient evaluations included patient characteristics, relief of LUTS symptoms, erectile and ejaculatory function, continence, operative time and adverse events. Patients were followed for a mean of 10.9 months. RESULTS: Patient characteristics were as follows: age 66 years (46-85), prostate volume 39.6 cc (22-66), preoperative IPSS/AUASI 20 (6-35)/QoL 3.9 (1-6)/peak flow 10.5 mL/s (4.0-19)/post-void residual volume (PVR) 123 mL (0-500). Mean operating time was 31 min (9-55). Postoperative complications were minor except for the surgical retreatment of one patient for blood clot retention (Clavien 3b). One patient required catheterization due to urinary retention. Reduction of symptoms (IPSS - 59.6%), increase in QoL (+ 49.0%), increase in flow (+ 111.5%), and reduction of PVR (- 66.8%) were significant. Antegrade ejaculation was always maintained. CONCLUSION: Our data suggest that a combination of PUL and transurethral surgical techniques is feasible, safe, and effective. This approach may be offered to patients with moderate size prostates including those with unfavorable anatomic conditions for PUL. This procedure is still 'minimally invasive' and preserves sexual function. In addition, it may add to a higher functional efficacy compared to PUL alone. STUDY REGISTER NUMBER: DRKS00008970.
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Hiperplasia Prostática/cirugía , Resección Transuretral de la Próstata/métodos , Uretra/cirugía , Obstrucción del Cuello de la Vejiga Urinaria/cirugía , Vejiga Urinaria/cirugía , Anciano , Anciano de 80 o más Años , Terapia Combinada/métodos , Estudios de Factibilidad , Alemania , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Hiperplasia Prostática/complicaciones , Calidad de Vida , Resultado del Tratamiento , Obstrucción del Cuello de la Vejiga Urinaria/etiologíaRESUMEN
In cancer, extracellular vesicles (EV) contribute to tumor progression by regulating local and systemic effects. Being released into body fluids, EV may be used in nanomedicine as a valuable source for diagnostic biomarkers. In this work, infrared and Raman spectroscopy were used for comprehensive comparative analysis of cancer versus non-cancer EV and patient screening. Two different EV fractions enriched in exosomes and microvesicles were isolated by differential centrifugation from serum and plasma of cancer and non-cancer patients and from serum and plasma of a healthy donor. The EV fractions were then subjected to drop-coating deposition and drying on calcium fluoride substrates. Reduction of alpha-helix-rich proteins and enhancement of beta-sheet-rich proteins as a cancer-specific blood EV signature was determined, and subsequently this feature was applied for a pilot study aiming to detect prostate cancer in a test cohort of patients with high-grade prostate carcinoma and benign hypoplasia.
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Micropartículas Derivadas de Células/patología , Vesículas Extracelulares/patología , Neoplasias de la Próstata/sangre , Neoplasias de la Próstata/diagnóstico , Espectrofotometría Infrarroja/métodos , Espectrometría Raman/métodos , Micropartículas Derivadas de Células/química , Vesículas Extracelulares/química , Humanos , Masculino , Proyectos Piloto , Próstata/patología , Hiperplasia Prostática/sangre , Hiperplasia Prostática/diagnóstico , Hiperplasia Prostática/patología , Neoplasias de la Próstata/química , Neoplasias de la Próstata/patologíaRESUMEN
Subcutaneous pyelovesical bypass graft (SPBG) is a urinary diversion treatment option for ureteral obstruction. Initially its use was limited to palliative care patients. However, the indication profile has been extended to selected patients with benign conditions causing ureteral obstruction and hydronephrosis. Occlusion of SPBGs is rarely reported and mostly related to infections. We describe the clinical case of a patient with SPBG after iatrogenic ureteral stricture who was not suitable for other reconstructive treatment forms due to distinct retroperitoneal scarring after multiple previous surgeries. Several months after the SPBG insertion, the patient developed complete occlusion of the system with uric acid stone material. Sufficient endoscopic intervention was not feasible. After forced chemolitholysis, the stone mass could be completely dissolved. Since then the patient has remained symptom-free.
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Hidronefrosis/complicaciones , Uréter/cirugía , Obstrucción Ureteral/cirugía , Ácido Úrico/química , Derivación Urinaria/efectos adversos , Procedimientos Quirúrgicos Vasculares , Constricción Patológica , Endoscopía , Humanos , Persona de Mediana Edad , Tomografía Computarizada por Rayos X , Procedimientos Quirúrgicos UrológicosRESUMEN
PURPOSE: Residual fragments related to endoscopic intracorporeal lithotripsy are a challenging problem. The impact of residual fragments remains a subject of discussion and growing evidence highlights that they have a central role in recurrent stone formation. Therefore, we developed a novel bioadhesive system for intrarenal embedding and retrieval of residual fragments after endoscopic lithotripsy in an ex vivo porcine kidney model. MATERIALS AND METHODS: In a standardized setting 30 human stone fragments 1 mm or less were inserted in the lower pole of an ex vivo porcine kidney model. We assessed the extraction efficacy of flexible ureteroscopy using the bioadhesive system in 15 preparations and a conventional retrieval basket in 15. Outcomes were compared regarding the endoscopic and macroscopic stone-free rate, and overall time of retrieval. RESULTS: Embedding and retrieving the residual fragment-bioadhesive complex were feasible in all trial runs. We observed no adverse effects such as adhesions between the adhesive and the renal collecting system or the instruments used. The stone-free rate was 100% and 60% in the bioadhesive and conventional retrieval groups, respectively (p = 0.017). Mean retrieval time was significantly shorter at 10 minutes 33 seconds vs 36 minutes 56 seconds in the bioadhesive group vs the conventional group (p = 0.001). CONCLUSIONS: This novel method involving adhesive based complete removal of residual fragments from the collecting system has proved to be feasible. Our evaluation in a porcine kidney model revealed that this technology performed well. Further tests, including inpatient studies, are required to thoroughly evaluate the benefit and potential drawbacks of bioadhesive based extraction of residual fragments after intracorporeal lithotripsy.
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Adhesivos , Cálculos Renales/patología , Cálculos Renales/terapia , Litotricia , Ureteroscopía , Animales , Materiales Biocompatibles , Modelos Animales de Enfermedad , Femenino , PorcinosRESUMEN
OBJECTIVES: To evaluate published trials on urolithiasis regarding level of evidence, type of sponsorship and declared conflicts of interest (COIs), and to elucidate a potential commercial impact. MATERIALS AND METHODS: We performed a systematic PubMed(®) literature search using a predefined Boolean search term to identify PubMed-listed clinical research studies on urolithiasis in 2014 (fourth quarter). All authors screened the results for eligibility criteria and two independent reviewers evaluated and performed data extraction of predefined endpoints, including level of evidence, declaration of COI and sponsorship/funding (as indicated in the published print version), and commercial impact. RESULTS: A total of 110 clinical trials in urolithiasis listed in PubMed met the inclusion criteria. Levels of evidence 1, 2, 3 and 4 were found in 15%, 14%, 21% and 51% of trials, respectively. A COI was indicated in a total of 90% of publications, 93% of which declared no existing conflict of interest. Sponsorship was indicated in 36% of publications, 55% of which stated public funding, 33% institutional funding, 10% industrial funding and 2% both public and industrial funding. A total of 11% of the published trials were rated as having a high commercial impact. CONCLUSION: The present study provides evidence of increasing levels of evidence for published clinical trials on urolithiasis in 2014 (as compared with earlier data). Ninety percent of publications indicated conflicts of interest, whereas sponsoring of studies was declared only by one-third. A considerable number of trials involved issues of high commercial impact. Recently established legal programmes and voluntary acts on self-reporting of financial relationships will enhance transparency in the future; however, increased public funding will be needed to further promote the quality of trials on urolithiasis.
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Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Conflicto de Intereses , Medicina Basada en la Evidencia , Apoyo Financiero , PubMed , Urolitiasis , Ensayos Clínicos como Asunto/normas , Estudios Transversales , HumanosRESUMEN
PURPOSE: To compare task performances of novices and experts using advanced high-definition 3D versus 2D optical systems in a surgical simulator model. METHODS: Fifty medical students (novices in laparoscopy) were randomly assigned to perform five standardized tasks adopted from the Fundamentals of Laparoscopic Surgery (FLS) curriculum in either a 2D or 3D laparoscopy simulator system. In addition, eight experts performed the same tasks. Task performances were evaluated using a validated scoring system of the SAGES/FLS program. Participants were asked to rate 16 items in a questionnaire. RESULTS: Overall task performance of novices was significantly better using stereoscopic visualization. Superiority of performances in 3D reached a level of significance for tasks peg transfer and precision cutting. No significant differences were noted in performances of experts when using either 2D or 3D. Overall performances of experts compared to novices were better in both 2D and 3D. Scorings in the questionnaires showed a tendency toward lower scores in the group of novices using 3D. CONCLUSIONS: Stereoscopic imaging significantly improves performance of laparoscopic phantom tasks of novices. The current study confirms earlier data based on a large number of participants and a standardized task and scoring system. Participants felt more confident and comfortable when using a 3D laparoscopic system. However, the question remains open whether these findings translate into faster and safer operations in a clinical setting.
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Competencia Clínica , Educación Médica/métodos , Evaluación Educacional/métodos , Laparoscopios , Laparoscopía/educación , Modelos Anatómicos , Dispositivos Ópticos , Urología/educación , Diseño de Equipo , Humanos , Imagenología TridimensionalRESUMEN
PURPOSE: Residual fragments are common after stone treatment. Little is known about clinical outcomes relevant to the patient. This comprehensive review of the literature highlights the impact of residual fragments, modes of detection, and treatment strategies to avoid residual fragments in shock wave therapy, ureteroscopy, and percutaneous nephrolithotomy. METHODS: A comprehensive review of current literature was performed using PubMed(®), MEDLINE(®), Embase™, Ovid(®), Google Scholar™, and the Cochrane Library. Publications relevant to the subject were retrieved and critically appraised. RESULTS: Residual fragments after treatment for urinary stones have a significant impact on a patient's well-being and future course. (Ultra-) low-dose non-contrast computed tomography detects small residuals most reliably. In shock wave lithotripsy, adherence to basic principles helps to improve results. Various techniques and devices facilitate complete stone clearance in conventional and miniaturized percutaneous nephrolithotomy and (flexible) ureteroscopy. Promising new technologies in shock waves, lasers, and robotics (and potentially microrobotics) are on the horizon. CONCLUSIONS: Residual fragments are relevant to patients. Contemporary treatment of urolithiasis should aim at complete stone clearance.
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Nefrostomía Percutánea , Cálculos Urinarios/terapia , Humanos , Resultado del TratamientoRESUMEN
PURPOSE: To compare ultra-mini PCNL (UMP) and flexible ureteroscopy (fURS) for the treatment of medium- to large-sized renal stones with a focus on patients' postsurgical cumulative analgesic consumption and treatment-related satisfaction. METHODS: Twenty-five patients treated by UMP between April 2013 and October 2014 were matched to data of 25 fURS patients from an existing database. Clinical outcome parameters were recorded prospectively. Postoperative analgesic consumption was assessed using the Cumulative Analgesic Consumption Score (CACS), and satisfaction was measured with the Freiburg Index of Patient Satisfaction (FIPS) questionnaire. RESULTS: Perioperative outcome parameters showed no significant differences except for mean operating times (fURS 98.52 min, UMP 130.12 min [p = 0.002]) and hospital stay (fURS 67.2 h, UMP 91.5 h [p = 0.04]). Primary stone-free rate was 96 % in fURS and 92 % in UMP. Complications Clavien grade 2 or 3 occurred in 16 % of UMP patients and in 4 % of fURS patients. Postsurgical cumulative analgesic consumption was almost identical in both groups with CACSs of 6.96 (0-15) for fURS and 6.8 (0-23) for UMP. Patients' satisfaction was high in both techniques: FIPS score in fURS 1.67 (1-3) and 1.73 (1-4) in UMP (scale 1-6). CONCLUSIONS: Treatment of medium- to large-sized renal stones is safe and highly effective by both UMP and fURS. Moreover, both treatments yield comparable postsurgical analgesic requirements and high patient satisfaction scores. Patient-related factors (anatomical and stone related) and availability of technical equipment and surgical expertise appear to be the most important determining factors in treatment planning.
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Analgésicos/uso terapéutico , Cálculos Renales/cirugía , Nefrostomía Percutánea , Dolor Postoperatorio/tratamiento farmacológico , Ureteroscopía , Adolescente , Adulto , Anciano , Femenino , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Tempo Operativo , Dolor Postoperatorio/etiología , Satisfacción del Paciente , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: Latest publications state equal efficacy of a recently introduced new percutaneous technique ("ultra-mini PCNL", UMP) and flexible ureteroscopy (fURS) in the treatment of medium-size urinary stones. Today we face challenges concerning cost-effectiveness and reduction of in-hospital length of stay. In this retrospective study, we compare clinical outcome parameters and costs of treatment (endoscopes and disposables) of both techniques. METHODS: Thirty patients treated by UMP at two tertiary university centres were matched to 30 fURS patients from previously recorded databases. Data analysis included operating time, length of stay, stone-free rates (SFR), complications (>Clavien II), ancillary procedures (presurgical ureteral stenting, secondary ureteral stenting or placement of a nephrostomy tube, secondary procedures) and costs for disposable materials and instruments (endoscopes, as calculated per procedure). RESULTS: We found no significant differences in operating times (UMP vs. fURS: 121/102 min), hospital length of stay (2.3/2.0 days), SFR (84/87 %) and complications (7/7 %). Costs for disposable materials and endoscopes were 656 euro (UMP) and 1,160 euro (fURS) per procedure. CONCLUSIONS: UMP and fURS are both safe and effective in the treatment of medium-size urinary stones. Costs for endoscopes and disposable materials are significantly lower in UMP.
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Cálculos Renales/cirugía , Nefrostomía Percutánea/instrumentación , Ureteroscopios , Ureteroscopía/instrumentación , Adolescente , Adulto , Anciano , Diseño de Equipo , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Retrospectivos , Adulto JovenRESUMEN
PURPOSE: Raman spectroscopy allows immediate analysis of stone composition. In vivo stone analysis during endoscopic treatment may offer advantages concerning surgical strategy and metaphylaxis. Urinary stone components were evaluated utilizing an experimental setup of a Raman system coupled to commercial laser fibers. METHODS: Samples of paracetamol (acetaminophen) and human urinary stones with known Raman spectra were analyzed using an experimental Raman system coupled to common commercial lithotripsy laser fibers (200 and 940 µm). Two different excitation lasers were used at wavelengths of 532 and 785 nm. Numerical aperture of the fibers, proportion of reflected light reaching the CCD chip, and integration times were calculated. Mathematical signal correction was performed. RESULTS: Both the laser beam profile and the quality of light reflected by the specimens were impaired significantly when used with commercial fibers. Acquired spectra could no longer be assigned to a specific stone composition. Subsequent measurements revealed a strong intrinsic fluorescence of the fibers and poor light acquisition properties leading to a significant decrease in the Raman signal in comparison with a free-beam setup. This was true for both investigated fiber diameters and both wavelengths. Microscopic examination showed highly irregular fiber tip surfaces (both new and used fibers). CONCLUSIONS: Our results propose that laser excitation and light acquisition properties of commercial lithotripsy fibers impair detectable Raman signals significantly in a fiber-coupled setting. This study provides essential physical and technological information for the development of an advanced fiber-coupled system able to be used for immediate stone analysis during endoscopic stone therapy.
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Endoscopía/métodos , Litotripsia por Láser/instrumentación , Cálculos Urinarios/terapia , Diseño de Equipo , Estudios de Factibilidad , HumanosRESUMEN
PURPOSE: The international guidelines on urolithiasis state that the percutaneous approach is superior for kidney stones ≥20 mm. Nevertheless, several groups have reported high stone-free rates (SFRs) with low morbidity for ureteroscopic treatment of calculi >15 mm. We hereby describe a new technique including the combined use of semirigid and flexible ureteroscopy via a large ureteral access sheath (UAS). METHODS: The proposed technique includes (a) preoperative ureteral stenting, (b) use of a large lumen UAS (14/16F, 35 cm), (c) use of a semirigid ureteroscope, (d) holmium laser lithotripsy, (e) passive and (f) active fragment extraction, and finally, the removal of caliceal stones (g) using a flexible scope. We conducted a prospective outcome analysis for 38 patients treated at two tertiary university centers. RESULTS: Perioperative data were as follows: median cumulative stone size 24.5 mm (20-60), median operating time 95 min (50-205), post-operative ureteral stenting (2-35 days) in 33 patients (86.8 %), Clavien complications 2 and 3 in 7.9 %, primary SFR 63.2 %, and overall computed tomography (CT) controlled SFR after 3 months 81.8 % (including staged procedures). No late complications were observed. CONCLUSIONS: The combined use of semirigid ureteroscopy and an UAS further develops the endoscopic treatment of kidney stones. This is the first series of this kind that confirms high SFRs by CT. The approach has significant advantages: Superior irrigation and outflow enhance both vision and stone clearance, and multiple ureteral passages without putting the ureter at injury risk. These encouraging results make this modality an appealing alternative to percutaneous nephrolithotomy.
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Cálculos Renales/terapia , Ureteroscopios , Ureteroscopía/métodos , Adulto , Anciano , Diseño de Equipo , Femenino , Fluoroscopía , Estudios de Seguimiento , Humanos , Imagenología Tridimensional , Cálculos Renales/diagnóstico , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: To validate and evaluate the applicability of a new score to describe postsurgical analgesic consumption in urological and surgical patients across different categories of pain medications and the invasiveness of medical interventions. MATERIALS AND METHODS: The cumulative analgesic consumption score (CACS) was determined for two cohorts of patients split into three groups with surgeries involving clinically distinct levels of invasiveness (n = 2 x 60). Nonparametric statistical analyses were performed to determine differences between the CACS among the different groups and to assess the correlation between CACS and numeric rating scale (NRS) values for pain intensity. RESULTS: The score was determined for postoperative days 1 and 2 and revealed median scores of 0 (0-11), 3 (0-22) and 10 (6-17) for UA (urological patients from group A), UB (group B) and UC (group C), respectively, and 4 (0-20), 8 (0-38) and 17 (7-68) for SA (surgical patients from group A, SB (group B) and SC (group C), respectively. CACS enabled reliable differentiation between groups involving different levels of invasiveness (p < 0.001). CACS and peak NRS values showed variable degrees of correlation, as expressed by levels of significance ranging from p < 0.001 to p = 0.34 (NS). CONCLUSIONS: The CACS is a valid and easily applicable tool to describe postsurgical analgesic consumption in urological and surgical patients. It can be used as a surrogate parameter to assess postsurgical pain and the invasiveness of surgical procedures. These aspects may be measured to compare surgical procedures, in both clinical trials and clinical practice settings.
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Analgésicos/uso terapéutico , Dimensión del Dolor/métodos , Dolor Postoperatorio/tratamiento farmacológico , Procedimientos Quirúrgicos Urológicos/efectos adversos , Femenino , Humanos , Masculino , Valores de Referencia , Reproducibilidad de los Resultados , Estadísticas no ParamétricasRESUMEN
Computed tomography (CT) is used to diagnose urolithiasis, a prevalent condition. In order to establish the strongest foundation for the quantifiability of urolithiasis, this study aims to develop semi-automated urolithiasis segmentation methods for CT images that differ in terms of surface-partial-volume correction and adaptive thresholding. It also examines the diagnostic accuracy of these methods in terms of volume and maximum stone diameter. One hundred and one uroliths were positioned in an anthropomorphic phantom and prospectively examined in CT. Four different segmentation methods were developed and used to segment the uroliths semi-automatically based on CT images. Volume and maximum diameter were calculated from the segmentations. Volume and maximum diameter of the uroliths were measured independently by three urologists by means of electronic calipers. The average value of the urologists´ measurements was used as a reference standard. Statistical analysis was performed with multivariate Bartlett's test. Volume and maximum diameter were in very good agreement with the reference measurements (r>0.99) and the diagnostic accuracy of all segmentation methods used was very high. Regarding the diagnostic accuracy no difference could be detected between the different segmentation methods tested (p>0.55). All four segmentation methods allow for accurate characterization of urolithiasis in CT with respect to volume and maximum diameter of uroliths. Thus, a simple thresholding approach with an absolute value may suffice for robust determination of volume and maximum diameter in urolithiasis.