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Métodos Terapéuticos y Terapias MTCI
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1.
BJUI Compass ; 5(4): 506-514, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38633825

RESUMEN

Objectives: This study aimed to compare the effectiveness and safety of the adjustable trans-obturator male system (ATOMS®) to treat post-prostatectomy incontinence (PPI) in radiated patients compared with non-radiated patients, using propensity score-matching analysis to enhance the validity of the comparison. Patients and methods: Consecutive men with PPI treated with silicone-covered scrotal port ATOMS (A.M.I., Feldkirch, Austria) in nine different institutions between 2016 and 2022 were included. Preoperative assessment evaluated 24-h pad usage, urethroscopy and urodynamics, if indicated. Propensity score-matching analysis was based on age, length of follow-up, previous PPI treatment, previous bladder neck stricture, androgen deprivation and pad usage. The primary endpoint was dry rate, defined as no pads post-operatively with a security pad allowed. The secondary endpoints were complications, device removal and self-perceived satisfaction with the Patient Global Impression of Improvement (PGI-I) scale. Results: Of the 710 included patients, 342 were matched, and the study groups were balanced for the baseline matched variables. The mean baseline 24-h pad was 4.8 in both groups (p = 0.48). The mean follow-up was 27.5 ± 18.6 months, which was also equivalent between groups (p = 0.36). The primary outcome was achieved in 73 (42.7%) radiated patients and in 115 (67.3%) non-radiated patients (p < 0.0001). The mean pad count at the last follow-up was 1.5 and 0.8, respectively (p < 0.0001). There was no significant difference in complications (p = 0.94), but surgical revision and device explant rates were higher (p = 0.03 and p = 0.01, respectively), and the proportion of patients highly satisfied (PGI-I = 1) was lower in the radiated group (p = 0.01). At sensitivity analysis, the study was found to be reasonably robust to hidden bias. Conclusion: ATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

2.
J Clin Med ; 12(14)2023 Jul 17.
Artículo en Inglés | MEDLINE | ID: mdl-37510835

RESUMEN

(1) Background: Treatment of male stress incontinence in patients with prostate cancer treated with radical prostatectomy and adjuvant pelvic radiation is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is not well established, despite the general belief that outcomes are worse than in patients without radiation. (2) Methods: Retrospective multicenter study evaluating patients treated with silicone-covered scrotal port (SSP) ATOMS implant after radical prostatectomy and radiotherapy in nine different institutions between 2016 and 2022. The primary endpoint was dry patient rate, defined as pad-test ≤ 20 mL/day. The secondary endpoints were complication rate (defined using Clavien-Dindo classification), device removal and self-perceived satisfaction using the Patient Global Impression of Improvement (PGI-I) scale. Wilcoxon rank-sum test, Fisher's exact test and logistic regression were performed using stepwise method with a 0.15 entry and 0.1 stay criteria. (3) Results: 223 patients fulfilled the criteria for inclusion and 12 (5.4%) received salvage prostatectomy after radiation and 27 (12.1%) previous devices for stress incontinence. After ATOMS adjustment, 95 patients (42.6%) were dry and 36 (16.1%) had complications of any grade (grade I, n = 20; grade II, n = 11; grade III, n = 5) during the first 3 months postoperatively. At a mean of 36 ± 21 months follow-up, the device was explanted in 26 (11.7%) patients. Regarding self-perceived satisfaction with the implant, 105 of 125 patients (84%) considered themselves satisfied (PGI-I 1 to 3). In the univariate analysis, dryness was associated to younger age (p = 0.06), primary prostatectomy (p = 0.08), no previous incontinence surgery (p = 0.02), absence of overactive bladder symptoms (p = 0.04), absence of bladder neck stricture (p = 0.001), no need of surgical revision (p = 0.008) and lower baseline incontinence severity (p = 0.0003). Multivariate analysis identified absence of surgical revision (p = 0.018), absence of bladder neck stricture (p = 0.05), primary prostatectomy (p = 0.07) and lower baseline incontinence severity (p < 0.0001) were independent predictors of dryness. A logistic regression model was proposed and internally validated. (4) Conclusions: ATOMS is an efficacious and safe alternative to treat male incontinence after radical prostatectomy and adjuvant radiotherapy. Factors predictive of dryness are identified in this complex scenario to allow for better patient selection.

3.
Curr Oncol ; 30(4): 4153-4165, 2023 04 12.
Artículo en Inglés | MEDLINE | ID: mdl-37185429

RESUMEN

(1) Background: The adjustable trans-obturator male system (ATOMS) is a surgical device developed to treat post-prostatectomy incontinence (PPI) after prostate cancer treatment. We review the current literature on this anti-incontinence device with the intention of assessing the effectiveness, safety and duration of the silicone-covered scrotal port (SSP) ATOMS, the only generation of the device that is currently available. (2) Material and Methods: Non-systematic literature review is performed. Forty-eight full-text articles are assessed for eligibility. Case reports, expert opinions or commentaries without specific data reported (n = 6), studies with patients who underwent intervention before 2014 (IP or SP ATOMS; n = 10), and studies with incontinence after transurethral resection of the prostate (TUR-P; n = 2) are excluded for analysis. Thirty studies with SSP ATOMS are included in a qualitative synthesis that incorporates systematic reviews (n = 3), articles partially overlapping with other previously published studies (e.g., follow-up or series updates; n = 9), and studies focusing on specific populations (n = 8). Only articles revealing outcomes of SSP ATOMS were included in the quantitative synthesis of results (n = 10). (3) Results: the pooled data of 1515 patients from the 10 studies with SSP ATOMS confirmed very satisfactory results with this device after adjustment: dry rate: 63-82%, improved rate: 85-100%, complication rate: 7-33%, device infection rate: 2.7-6.2% and explant rate: 0-19%. The durability of the device is reassuring, with 89% of devices in place 5 years after implantation. (4) Conclusion: Despite the absence of randomized controlled studies, the literature findings confirm results of SSP ATOMS appear equivalent to those of artificial urinary sphincters (AUSs) in terms of continence, satisfaction and complications, but with a lower rate of revision in the long-term. A prospective study identified that patients with daily pad test results <900 mL and a Male Stress Incontinence Grading Scale (MSIGS) of not 4 (i.e., early and persistent stream or urine loss) are the best candidates. Future studies centered on the elder population at higher risk of impaired cognitive ability and in patients including radiation as prostate cancer treatment are needed.


Asunto(s)
Neoplasias de la Próstata , Cabestrillo Suburetral , Resección Transuretral de la Próstata , Humanos , Masculino , Anciano , Estudios Prospectivos , Resultado del Tratamiento , Diseño de Prótesis , Neoplasias de la Próstata/cirugía
5.
MULTIMED ; 22(1)2018. tab
Artículo en Español | CUMED | ID: cum-74571

RESUMEN

Se realizó un estudio experimental, controlado, fase lll, aleatorizado, a doble ciegas, en dos ramas, con el objetivo de evaluar la eficacia del ozono en pacientes atendidos con alveolitis dentaria, en el periodo comprendido de abril 2015 a abril 2016, atendidos en la consulta de urgencias del policlínico René Vallejo del municipio Bayamo. Los individuos quedaron distribuidos aleatoriamente en dos grupos: grupo 1 o estudio, que fueron tratados con oleozón y grupo 2 o control, tratados con alvogil. Las variables de inflamación, cicatrización y respuesta al tratamiento se evaluaron en las consultas, luego de aplicados los dos tratamientos, a las 48 horas como primera consulta, 72 horas como segunda consulta, 96 horas como tercera consulta y a los 7 días. En la tercera consulta se hizo un corte final. Los resultados mostraron para el grupo estudio 40 pacientes (80 por ciento) alivio el dolor a los 5 minutos de aplicado el medicamento, 40 pacientes, (80 por ciento) no estaban inflamados en la tercera consulta, así como 46 pacientes (92 por ciento) tuvieron cicatrización y 43 pacientes (86 por ciento) respondieron favorablemente al tratamiento, en el grupo control, los resultados mostraron que 13 pacientes (26 por ciento) aliviaron el dolor a los 5 minutos de aplicado el medicamento, 35 pacientes (70 por ciento) no estaban inflamados, 44 pacientes (88 por ciento) tuvieron cicatrización total y 40 pacientes (80 por ciento) tuvieron una respuesta favorable al tratamiento. No existieron diferencias significativas en la aplicación del tratamiento con ozono con relación al tratamiento convencional(AU)


An experimental, controlled, phase III, randomized, double blind study was conducted in two branches, with the aim of evaluating the effectiveness ofozone in patients treated with dental alveolitis, in the period from April 2015 to April 2016, attended the emergency department of the Rene Vallejo polyclinic in Bayamo municipality. Individuals were randomized into two groups: group 1 or study, which was treated with oleozon and group 2 or control, treated with alvogil. The variables of inflammation, healing and response to treatment were evaluated in the consultations, after the two treatments were applied, at 48 hours as first consultation, 72 hours as second consultation, 96 hours as third consultation and at 7 days. In the third consultation a final cut was made. The results showed 40 patients for the study group (80 percent) pain relief 5 minutes after the medication was applied, 40 patients (80 percent) were not inflamed in the third consultation, as well as 46 patients (92 percent) had scarring and 43 patients (86 percent) responded favorably to treatment, in the control group, the results showed that 13 patients (26 percent) relieved the pain 5 minutes after applying the medication, 35 patients (70 percent) were not inflamed, 44 patients (88 percent) had total healing and 40 (80 percent) patients had a favorable response to treatment. There were no significant differences in the application of ozone treatment in relation to conventional treatment(EU)


Asunto(s)
Humanos , Extracción Dental , Alveolo Seco/terapia , Ozono/uso terapéutico , Ensayo Clínico , Ensayos Clínicos Controlados Aleatorios como Asunto
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