Toxicity and Biochemical Outcomes of Dose-Intensified Postoperative Radiation Therapy for Prostate Cancer: Results of a Randomized Phase III Trial.

PURPOSE: Our purpose was to compare toxicity and biochemical control in postprostatectomy patients treated with conventional (66 Gy) or dose-intensified (72 Gy) radiation therapy. METHODS AND MATERIALS: Patients who had stage pT3-4, positive surgical margins, or rising prostate-specific antigen ≥ 0.2 ng/mL after radical prostatectomy were randomly assigned to receive either 66 Gy in 33 fractions or 72 Gy in 36 fractions. A primary endpoint was to assess the difference in biochemical progression-free survival (bPFS) between these 2 cohorts, and secondary endpoints were to assess differences in genitourinary (GU), gastrointestinal (GI), and hematologic toxicities between these 2 cohorts. bPFS was estimated by the Kaplan-Meier method and toxicities were compared using the χ2 test. RESULTS: Between September 2011 and November 2016, 144 patients were enrolled: 71 patients to the 66 Gy cohort and 73 patients to the 72 Gy cohort. The median follow-up time was 48.5 months (range, 14-79 months). There was no difference in 4-year bPFS between the 66 Gy and 72 Gy cohorts (75.9% vs 82.6%; P = .299). However, in patients with a higher Gleason score (8-10), the 72 Gy cohort had statistically significant improvement in bPFS compared with the 66 Gy cohort (79.7% vs 55.7%; P = .049). Toxicity analysis showed no difference in ≥2 acute or late GI or GU toxicities between these 2 cohorts. A total of 48 patients were scored as urinary incontinence before radiation therapy, of which 39 (81.3%) reported incontinence recovery or stable at 1-year follow-up, and only 9 (18.8%) patients reported worsening. There was no difference between the 2 cohorts in urinary incontinence either at baseline or at 1-year follow-up. CONCLUSIONS: Dose escalation (72 Gy) demonstrated no improvement in 4-year bPFS compared with the 66 Gy regimen. However, the dose escalation was not associated with greater acute or late GU or GI toxicities and did not increase urinary incontinence.

New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial.

To describe the clinical response and side effects of radiofrequency treatment in patients with urinary incontinence after radical prostatectomy. This is a phase 1 clinical trial with 10 men up to 65 years of age who had urinary incontinence after radical prostatectomy, post void residual volume < 50 ml verified by ultrasonography, pad test ≥ 1 g, and PSA < 0.2 ng/ml. pad test and self-administered questionnaires were used to assess clinical response. Scales were used to measure treatment satisfaction and improvement in symptoms. Participants underwent five sessions of 2 min of non-ablative endoanal radiofrequency (41 °C). The evaluated co-primary endpoints were urinary incontinence volume and urinary symptoms, analyzed by the Wilcoxon nonparametric test; residual volume, and self-reports to assess safety. The participants' mean age was 57.5 ± 4.9. The initial pad test score was 6.5 g (1.7-50.0) with a final score of 2.0 g (0.0-9.0) (p < 0.01). Ultrasonography showed no alteration of residual volume. A decrease of urinary loss was found in nine patients, three of them showed a complete resolution of urinary loss. A decrease in irritative micturition symptoms was found as well, but no improvement in the quality of life was shown. Regarding treatment satisfaction, two patients were neutral, six satisfied, and two very satisfied. Limitations included pain while the endoanal electrode was inserted. Four patients indicated pain during treatment, but overall results were positive. The reduction of urinary loss and irritative micturition symptoms increased patients' satisfaction scores, without improving their perception of quality of life.

Electroestimulación del suelo pélvico en mujeres con incontinencia urinaria y/o síndrome de vejiga hiperactiva: una revisión sistemática / Pelvic Floor Electrostimulation in Women With Urinary Incontinence and/or Overactive Bladder Syndrome: A Systematic Review

Contexto: La electroestimulación (EE) es una de las técnicas empleadas en el tratamiento conservador de la incontinencia urinaria (IU) y/o síndrome de vejiga hiperactiva (SVH). Sin embargo, existe controversia en la literatura científica acerca de su eficacia como monoterapia. Objetivo: Evaluar la evidencia científica sobre la EE del suelo pélvico en mujeres con IU y/o SVH. Adquisición de evidencia: Se realizó una revisión sistemática de ensayos clínicos en las bases de datos PubMed, Cochrane, PEDro, Elsevier (Doyma) y EnFisPo (1980-2011). Se evaluó la calidad de los estudios y se extrajo la información de los que reunieron los criterios de inclusión establecidos. Síntesis de evidencia: Un total de 27 ensayos clínicos han sido incluidos en la revisión: 13 ensayos controlados aleatorizados, 11 ensayos aleatorizados no controlados y 3 ensayos no aleatorizados. Conclusión: La mayor parte de los ensayos clínicos concluyen que la EE es eficaz en el tratamiento de la IU y el SVH en mujeres. Sin embargo, son necesarios más estudios de buena calidad metodológica para obtener un mayor nivel de evidencia científica y conocer cuál es la modalidad, tipo y parámetros de corriente óptimas para cada tipo de IU y el SVH (AU)

Context: Electrostimulation (ES) is one of the techniques employed in conservative treatment of urinary incontinence (UI) and/or overactive bladder syndrome (OAB). Nevertheless, there is controversy in the scientific literature regarding its effectiveness as monotherapy. Objective: To evaluate the scientific evidence on ES of the pelvic floor in women with UI and with/without OAB. Evidence acquisition: A systematic review of clinical trials was carried out in the following databases: PubMed, Cochrane, PEDro, Elsevier (Doyma) and EnFisPo (1980-2011). Quality of study registries was evaluated and information was obtained from those that presented the inclusion criteria established in the review. Evidence synthesis: The 27 clinical trials were included in the review: 13 randomized controlled trials, 11 randomized non-controlled trials and 3 non-randomized trials. Conclusion: Most of the clinical trials conclude that ES is effective in the treatment of UI and OAB in women. However, better methodological quality studies are needed to obtain a higher level of scientific evidence and to know the optimal current modality, type and parameters for each type of UI and OAB (AU)

Influência da atividade física na qualidade de vida e auto-imagem de mulheres incontinentes / Influence of physical activity in the quality of life and self image of incontinent women

Nosso objetivo foi verificar a influência de uma proposta de atividades físicas na qualidade de vida e na auto-imagem de mulheres incontinentes. Constituiu-se de um estudo comparativo e exploratório realizado durante 16 semanas. Participaram 37 mulheres com e sem incontinência urinária (IU). Após o estudo observamos melhora significativa nos domínios relacionados com a percepção geral de saúde (p < 0,001), impacto da IU (p = 0,035), limitações físicas (p = 0,015), relações pessoais (p = 0,048), sono e disposição (p = 0,012) e em relação às medidas de gravidade (p = 0,011). Na auto-imagem não foram verificadas alterações quanto à aparência; todavia, quanto à satisfação corporal, observamos que as mulheres passaram a sentir-se menos satisfeitas com seu corpo (p = 0,007). Foi relatada diminuição no número de regiões onde sentiam dores (p = 0,0003) e de que não gostavam (p = 0,0017). Conclui-se que os profissionais de Educação Física, por meio de uma proposta de atividades físicas sistematizada e integrada, podem levar mulheres com IU a melhora significativa na percepção de sua qualidade de vida e de sua saúde, em aspectos relacionados à sua auto-imagem e à melhora nos sintomas de IU, com a diminuição da frequência e quantidade da perda urinária.

Our aim was to verify the influence of a physical activities proposal in the quality of life and self image of incontinent women. This study was comparative and exploratory and was developed in 16 weeks. Thirty-seven women with and without urinary incontinence (IU) participated in the study. After the study, significant improvement in general health perception (p < 0.001), UI impact (p = 0.035), physical limitations (p = 0.015), personal relations, (p = 0.048), sleep and disposition (p = 0.012) and concerned with the gravity measurements (p = 0.011) was observed. Concerning self image, alterations in appearance were not observed; however, concerning body satisfaction, the women felt less satisfied with their bodies (p = 0.007). There was a reduction in the number of regions where they felt pain (p = 0.0003) and that they did not like (p = 0.0017). In conclusion, the Physical Education professionals using a systematized and integrated physical activities program can lead the women with IU to significant improvement in the perception of their quality of life and health concerning their self image with improvement of the IU symptoms and reduction of frequency and amount of urinary loss.