Adjustable transobturator male system (ATOMS®) as treatment of stress urinary incontinence secondary to transurethral resection of the prostate. / Sistema masculino transobturador ajustable (ATOMS®) como tratamiento de la incontinencia urinaria de esfuerzo secundaria a resección transuretral de la próstata.

OBJECTIVES: Feasibility study to evaluate efficacy and safety of Adjustable Transobturator Male System (ATOMS®) for male stress urinary incontinence (SUI) after transurethral resection of the prostate. MATERIALS AND METHODS: Twenty patients were implanted ATOMS® for SUI caused by transurethral resection of the prostate with or without radiotherapy. Incontinence severity was evaluated as mild (2 pads/day), moderate (3-5 pads/day) or severe (≥6pads/day), and dryness as none or one security pad/day. Changes in pad-test and pad-count after adjustment were investigated, together with operative parameters, patient satisfaction with the procedure, and number and grade of complications (Clavien-Dindo). RESULTS: Median age was 76.5years. Five patients received previous pelvic radiation (3 prostate, 2 rectal cancer) and 2 (10%) previous failed artificial urinary sphincter with urethral erosion and mechanical failure, respectively. Preoperative SUI was mild in 4 (20%), moderate in 7 (35%) and severe in 9 (45%). Median filling of the system was 13.5ml. Median pad-test decreased from 375±855ml baseline to 10±31.5ml and pad-count from 4±3 to 0±1.5 after adjustment (1±3fillings). Postoperative SUI distribution was mild in 2 (10%), moderate in one (5%) and severe in 2 (10%). Satisfaction rate was 80%, equal for transurethral resection of the prostate with/without previous radiotherapy. No patient had urinary retention after catheter removal. Complications presented in 3 (15%) patients, all minor. After median 38.5mo follow-up no system has been removed, 19 (95%) self-considered better than before and 11 (55%) very much better. CONCLUSION: Based on short-term efficacy and patient satisfaction ATOMS® can be considered a realistic alternative for SUI after transurethral resection of the prostate, even after irradiation. Absence of urethral erosion and very limited problems make this alternative especially attractive for cases with diminished dexterity, advanced age and previous failed treatments.

Prospective study comparing laparoscopic and open adenomectomy: Surgical and functional results. / Estudio prospectivo comparativo entre adenomectomía laparoscópica y abierta: resultados operatorios y funcionales.

INTRODUCTION: Open adenomectomy (OA) is the surgery of choice for large volume benign prostatic hyperplasia, and laparoscopic adenomectomy (LA) represents a minimally invasive alternative. We present a long-term, prospective study comparing both techniques. PATIENTS AND METHODS: The study consecutively included 199 patients with benign prostatic hyperplasia and prostate volumes>80g who were followed for more than 12 months. The patients underwent OA (n=97) or LA (n=102). We recorded and compared demographic and perioperative data, functional results and complications using a descriptive statistical analysis. RESULTS: The mean age was 69.2±7.7 years (range 42-87), and the mean prostate volume (measured by TRUS) was 112.1±32.7mL (range 78-260). There were no baseline differences among the groups in terms of age, ASA scale, prostate volume, PSA levels, Qmax, IPSS, QoL or treatments prior to the surgery. The surgical time (P<.0001) and catheter time (P<.0002) were longer in the LA group. Operative bleeding (P<.0001), transfusion rate (P=.0015) and mean stay (P<.0001) were significantly lower in the LA group. The LA group had a lower rate of complications (P=.04), but there were no significant differences between the groups in terms of major complications (Clavien score≥3) (P=.13) or in the rate of late complications (at one year) (P=.66). There were also no differences between the groups in the functional postoperative results: IPSS (P=.17), QoL (P=.3) and Qmax (P=.17). CONCLUSIONS: LA is a reasonable, safe and effective alternative that results in less bleeding, fewer transfusions, shorter hospital stays and lower morbidity than OA. LA has similar functional results to OA, at the expense of longer surgical times and longer catheter times.

Laser transurethral resection of the prostate: Safety study of a novel system of photoselective vaporization with high power diode laser in prostates larger than 80mL.

OBJECTIVE: To present the feasibility of photoselective vaporization of the prostate (PVP) with of a new diode laser-resection system. Surgical treatment of benign prostatic hyperplasia (BPH) is constantly evolving. Laser techniques are increasingly used in prostates of large size. METHODS: A prospective study was performed to evaluate operative data and patient outcomes with PVP using high-power diode laser (HPD) and a novel quartz-head fiber with shovel shape in patients with prostate>80mL. Demographic data, operative time, hemoglobin loss, operative results (IPSS, quality of life (QoL), Qmax, post void residue (PVR), IIEF-5 and micturition diary) and complications following Clavien-Dindo classification are described. RESULTS: Thirty-one patients were included in the study. Sixteen (51.6%) were on active antiplatelet treatment and 12 (38.7%) had received anticoagulants before surgery. All cases were followed at least 6mo. No intraoperative or postoperative major complications occurred. Three patients (9.7%) had minor complications according to Clavien-Dindo classification. Twenty-seven (87.1%) were discharged on postoperative day one without catheter. There were significant improvements in IPSS, QoL, Qmax and PVR, both at 3 and 6mo (P<.0001), but sexual function according to IIEF-5 showed no differences. Urgency (any grade) increased at 3mo (48.4%; P=.002) and considerably decreased at 6mo (9.7%; P<.0001). CONCLUSION: This pilot experience with shovel shape fiber and HPD is encouraging. It shows that laser-resection is a safe procedure, achieving excellent results in terms of IPSS, QoL and Qmax in large prostates even in high-risk patients. Longer follow-up, comparative and randomized controlled studies are needed to widespread these results.

Virtual reality simulator for training on photoselective vaporization of the prostate with 980 nm diode laser and learning curve of the technique.

OBJECTIVE: The utility of a virtual reality simulator for training of the photoselective vaporization of the prostate with diode laser was studied. MATERIAL AND METHOD: Two experiments were performed with a simulator (VirtaMed AG, Zürich, Switzerland) with software for specific training in prostate vaporization in contact mode with Twister fiber (Biolitec AG, Jena, German). Eighteen surgeons performed ablation of the prostate (55 cc) twice and compared the score obtained (190 points efficacy and 80 safety) in the second one of them by experience groups (medical students, residents, specialists). They also performed a spatial orientation test with scores of 0 to 6. After, six of these surgeons repeated 15 ablations of the prostate (55 and 70 ml). Improvement of the parameters obtained was evaluated to define the learning curve and how experience, spatial orientation skills and type of sequences performed affects them. RESULTS: Global efficacy and safety score was different according to the grade of experience (P=.005). When compared by pairs, specialist-student differences were detected (p=0.004), but not specialist-resident (P=.12) or resident-student (P=.2). Regarding efficacy of the procedure, specialist-student (p=0.0026) and resident-student (P=.08) differences were detected. The different partial indicators in terms of efficacy were rate of ablation (P=.01), procedure time (P=.03) and amount of unexposed capsule (p=0.03). Differences were not observed between groups in safety (P=.5). Regarding the learning curve, percentage median on the total score exceeded 90% after performing 4 procedures for prostates of 55 ml and 10 procedures for prostate glands of 70 ml. This course was not modified by previous experience (resident-specialist; P=.6). However, it was modified according to the repetition sequence (progressive-random; P=.007). Surgeons whose spatial orientation was less than the median of the group (value 2.5) did not surpass 90% of the score in spite of repetition of the procedure. CONCLUSION: Simulation for ablation of the prostate with contact diode laser is a good learning model with discriminative validity, as it correlates the metric results with levels of experience and sills. The sequential repetition of the procedure on growing levels of difficulty favors learning.

Efficacy and safety of fosfomycin-trometamol in the prophylaxis for transrectal prostate biopsy. Prospective randomized comparison with ciprofloxacin.

OBJECTIVE: Prostate biopsy is the standardized diagnostic method for prostate cancer. However, although there is not a standardized protocol, there are recommendations in order to reduce the incidence of complications. The objective of the present work is to assess the efficacy and safety of antibiotic prophylaxis in the prostate biopsy by comparing two antibiotic regimes: two doses of fosfomycin-trometamol 3g (FMT) every 48 hours with 10 doses of oral ciprofloxacin 500 mg every 12 hours during 5 days. MATERIAL AND METHODS: Randomized prospective study was performed with 671 patients who had undergone to walking transrectal ultrasound guided prostate biopsy. Patients of group A (n=312) were treated with ciprofloxacin, and patients of group B (n=359) with FMT. Efficacy and tolerability of two prophylactic regimes were compared. Urine culture was carried out at 2 weeks after biopsy. Initially, patients with asymptomatic bacteriuria were not treated with antibiotics; urine culture was repeated after 1 month, persistent bacteriuria was treated according to antibiogram. RESULTS: No differences between groups were found in age (P=.78), cancer presence (P=.9) or number of biopsy cylinders (P=.93). The mean number of cores obtained was 11.3 ± 3.25 (range 6-20). Digestive intolerance was observed for 9 patients (2.9%) of group A and 10 patients (2.8%) in group B. One patient (.3%) of group A showed severe allergic reaction. In total, 167 patients (24.6%) had complications: 16 (2.4%) fever, 47 (6.9%) hemospermia, 81 (11.9%) hematuria, 7 (1%) rectal bleeding and 16 (2.4%) urinary retention. No statistically differences between groups were observed (27.6% vs. 22.6%; P=.17). However, hemospermia was more frequent in group A (9.9% vs. 4.5%; P=.006). Bacteriuria after biopsy was detected in 44 patients (6.6%), being more frequent in group B patients (4.2% vs. 8.6%; P=.02) although a higher number of second treatment cycles were not needed (53.9% vs. 29%; P=.17). The likelihood of resistance to ciprofloxacin in patients with bacteriuria in A was greater than that of FMT in B (69.2% vs. 41.9%; P=.0004). CONCLUSIONS: Antibiotic prophylaxis with FMT (2 doses of 3g) in prostate biopsy is an alternative as effective and safe as ciprofloxacin (10 doses of 500 mg), which carries lower rate of resistance. According to our experience, this drug is a safe, well-tolerated, and easily manageable prophylactic option, facilitating patient compliance. More prospective multicenter studies are necessary to confirm these findings.

Estudio comparativo aleatorizado para la evaluación de un nuevo esquema terapéutico de fosfomicina trometamol en mujeres posmenopáusicas con infección no complicada del tracto urinario inferior / Randomized Comparative Study for the Assessment of a New Therapeutic Schedule of Fosfomycin Trometamol in Postmenopausal Women with Uncomplicated Lower Urinary Tract Infection

Objetivos: Comparación de 2 regímenes terapéuticos en términos de erradicación bacteriana para mujeres posmenopáusicas con cistitis aguda no complicada, que completan el tratamiento antibiótico. Material y método: Estudio multicéntrico prospectivo aleatorizado y controlado entre 2 pautas de antibioterapia corta: fosfomicina trometamol (FMT) 3g, 2 dosis cada 72h y ciprofloxacino 250mg cada 12h durante 3 días. Se incluyeron 118 mujeres posmenopáusicas en el estudio. Se practicó cultivo de orina inicial para conocer el microorganismo responsable y la sensibilidad al tratamiento, y se repitió 5-7 días y 4 semanas después del tratamiento, para evaluar erradicación bacteriana. También se evaluaron los síntomas clínicos y la seguridad del tratamiento. Resultados: Existen datos microbiológicos al inicio del tratamiento en 82 mujeres (69,49%), 27 no presentaron cultivo positivo en la primera visita (30,51%), completaron todos los requisitos del protocolo 76 (64,41%) y se recogieron los efectos adversos del tratamiento en 113 (95,76%) de los pacientes inicialmente incluidos en el estudio. Los gérmenes aislados con mayor frecuencia fueron Escherichia coli (E. coli) (76,83%), Klebsiella pneumoniae (K. pneumoniae) (7,32%), Proteus mirabilis (P. mirabilis) (4,89%) y Enterococo sp. (3,66%). En términos de eficacia no se detectaron diferencias en la proporción de pacientes que consiguieron erradicación bacteriana entre los 2 brazos del estudio: 62,16% de los pacientes que recibieron FMT y 58,97% de los tratados con ciprofloxacino (Chi-cuadrado, p=0,78). La proporción de pacientes que consiguieron curación clínica fue también parecido (86,49% para FMT y 82,05% para ciprofloxacino; Chi-cuadrado, p=0,59). Estos resultados indican una eficacia parecida de ambos antibióticos en el tratamiento de la infección urinaria de vías bajas no complicada en mujeres posmenopáusicas. En lo que respecta a los datos de seguridad la proporción de efectos adversos globales asociados a los tratamientos fueron 3,45% para FMT y 9,09% para ciprofloxacino. La adherencia al tratamiento fue del 100% para FMT y del 83,64% para ciprofloxacino. Conclusiones: La FMT administrada en dosis de 3g cada 72h (2 dosis total) y ciprofloxacino en dosis de 250mg cada 12h durante 3 días (6 dosis total) tienen un perfil de eficacia equiparable en la infección del tracto urinario inferior de la mujer posmenopáusica que completa apropiadamente el tratamiento, con una seguridad también equiparable, la FMT presenta un mejor perfil de sensibilidad antimicrobiana y mejor tasa de adherencia terapéutica (AU)

Objectives: To compare two therapeutic regimes in terms of bacterial eradication of post-menopausal with uncomplicated acute cystitis who complete antibiotic treatment. Materials and method: A multicenter, randomized, prospective and controlled study between two short antibiotic regimes: fosfomycin trometamol (FMT) 3g, 2 doses separated by 72hours and ciprofloxacin 250mg every 12hours for 3 days. A total of 118 post-menopausal women were enrolled in the study. They underwent an initial urine culture to know the responsible microorganism and susceptibility to treatment. This was repeated 5-7 days and 4 weeks after the treatment to evaluate bacterial eradication. Clinical symptoms and treatment safety were also evaluated. Results: There were microbiological data at the onset of the treatment in 82 women (69.49%). Of these, 27 did not have positive culture at the first visit (30.51%), 76 (64.41%) fulfilled all the protocol requirements and adverse effects from the treatment were collected in 113 (95.76%) of the patients enrolled in the study. The germs isolated most frequently were Escherichia coli (E. coli) (76.83%), Klebsiella pneumoniae (K. pneumoniae) (7.32%), Proteus mirabilis (P. mirabilis) (4.89%) and Enterococo sp. (3.66%). In terms of efficacy, no differences were detected in the proportion of patients who achieved bacterial eradication between the two study arms: 62.16% of the patients who received FMT and 58.97% of those treated with ciprofloxacin (chi-square, p=0.78). The proportion of patients who achieved clinical cure was also similar (86.49% for FMT and 82.05% for ciprofloxacin; square, p=0.59). These results indicate similar efficacy of both antibiotics in the treatment of uncomplicated lower tract urinary infection in post-menopausal women. In regards to safety data, the proportion of global adverse effects associated to the treatments was 3.45% for FMT and 9.09% for ciprofloxacin. Treatment compliance was 100% for FMT and 83.64% for ciprofloxacin. Conclusions: The FMT administered at a dose of 3g every 72hours (2 total doses) and ciprofloxacin at a dose of 250mg every 12hours during 3 days (6 total doses) have a comparable efficacy profile in lower tract urinary infection in post-menopausal women who adequately comply with the treatment, also having comparable safety. The FMT has a better antimicrobial susceptibility profile and better rate of treatment compliance (AU)

[Randomized comparative study for the assessment of a new therapeutic schedule of fosfomycin trometamol in postmenopausal women with uncomplicated lower urinary tract infection]. / Estudio comparativo aleatorizado para la evaluación de un nuevo esquema terapéutico de fosfomicina trometamol en mujeres posmenopáusicas con infección no complicada del tracto urinario inferior.

OBJECTIVES: To compare two therapeutic regimes in terms of bacterial eradication of post-menopausal with uncomplicated acute cystitis who complete antibiotic treatment. MATERIALS AND METHOD: A multicenter, randomized, prospective and controlled study between two short antibiotic regimes: fosfomycin trometamol (FMT) 3g, 2 doses separated by 72hours and ciprofloxacin 250mg every 12hours for 3 days. A total of 118 post-menopausal women were enrolled in the study. They underwent an initial urine culture to know the responsible microorganism and susceptibility to treatment. This was repeated 5-7 days and 4 weeks after the treatment to evaluate bacterial eradication. Clinical symptoms and treatment safety were also evaluated. RESULTS: There were microbiological data at the onset of the treatment in 82 women (69.49%). Of these, 27 did not have positive culture at the first visit (30.51%), 76 (64.41%) fulfilled all the protocol requirements and adverse effects from the treatment were collected in 113 (95.76%) of the patients enrolled in the study. The germs isolated most frequently were Escherichia coli (E. coli) (76.83%), Klebsiella pneumoniae (K. pneumoniae) (7.32%), Proteus mirabilis (P. mirabilis) (4.89%) and Enterococo sp. (3.66%). In terms of efficacy, no differences were detected in the proportion of patients who achieved bacterial eradication between the two study arms: 62.16% of the patients who received FMT and 58.97% of those treated with ciprofloxacin (chi-square, p=0.78). The proportion of patients who achieved clinical cure was also similar (86.49% for FMT and 82.05% for ciprofloxacin; square, p=0.59). These results indicate similar efficacy of both antibiotics in the treatment of uncomplicated lower tract urinary infection in post-menopausal women. In regards to safety data, the proportion of global adverse effects associated to the treatments was 3.45% for FMT and 9.09% for ciprofloxacin. Treatment compliance was 100% for FMT and 83.64% for ciprofloxacin. CONCLUSIONS: The FMT administered at a dose of 3g every 72hours (2 total doses) and ciprofloxacin at a dose of 250mg every 12hours during 3 days (6 total doses) have a comparable efficacy profile in lower tract urinary infection in post-menopausal women who adequately comply with the treatment, also having comparable safety. The FMT has a better antimicrobial susceptibility profile and better rate of treatment compliance.

El síndrome de reabsorción posresección transuretral de próstata / Absorption syndrome after transurethral

La resección transuretral de la próstata (RTUp) es el tratamiento quirúrgico de elección para la hiperplasia prostática benigna que no responde a tratamiento farmacológico. La absorción de líquidos hipotónicos empleados durante el procedimiento, sigue siendo una de las principales complicaciones del mismo y se conoce como síndrome post-RTUp y conlleva importantes alteraciones que conlleva (hiponatremia e hipoosmolaridad) deben prevenirse, diagnosticarse tempranamente y tratarse de forma eficiente. Esta revisión describe el problema de forma práctica, tanto desde un punto de vista diagnóstico como terapéutico (AU)