Safety and tolerability of biodegradable balloon spacers in patients undergoing radiotherapy for organ-confined prostate cancer

Introduction: Radiotherapy is a common treatment for prostate cancer, and can be administered in various ways, including 3D conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT) and hypo-fractionated radiation therapy. During treatment the gastrointestinal tract may be exposed to radiation and the rectal wall may be exposed to high doses of ionizing radiation, which can lead to rectal bleeding, ulcers or fistulas, and an increased risk of rectum cancer. Various strategies to minimize these complications have been developed in the last decade; one of the most promising is to use a rectal balloon to fixate the prostate gland during treatment or to inject biodegradable spacers between the prostate and rectum to reduce the rectal dose of radiation. Aim of our paper is to evaluate the safety and tolerability of spacers implantation. Materials and methods: From January 2021 to June 2022 all patients with a diagnosis of prostate cancer with unfavorable/ intermediate risk - poor prognosis and programmed hypofractionated radiation therapy were enrolled. In all patients biodegradable balloons spacers were placed posteriorly to the prostate to increase the separation between prostate and rectum. The duration of the procedure, observation time, the appearance of early and late complications and their severity (according to Charlson comorbidity index) and tolerability of the device were recorded at the time of positioning and after 10 days. Results: 25 patients were enrolled in our study. Two patients (8%) underwent acute urine retention resolved with catheterization and one patient (4%) developed a mild perineal hematoma that did not require any treatment. As regards late complications 1 patient (4%) developed hyperpyrexia (> 38°C) the day after the procedure requiring continuation of antibiotic regimen. At T1 visit we recorded no medium-high grade complications. As for the tolerability of the device, it was optimal with no perineal discomfort or alterations of bowel function. Conclusions: Biodegradable balloon spacers appears to be safe and well tolerated and its positioning does not present any technical difficulties or risks of major complications

Urodynamics useless before surgery for female stress urinary incontinence: Are you sure? Results from a multicenter single nation database

Aims: The role of urodynamics (UDS) before surgery for stress urinary incontinence (SUI) remains a debated issue in female urology as well as in urogynaecology and it has been recently questioned on the basis of data coming from selected population of patients defined as \u201cuncomplicated.\u201d The aim of this study was to investigate the percentage of \u201cuncomplicated\u201d patients undergoing urodynamic evaluations in six referral Italian centers. The secondary aim was to assess the prevalence of women, for whom the urodynamic evaluation could add new information to the pre-urodynamic picture and in how many cases these findings had a significant impact on patient management. Methods: The data of women who underwent urodynamic evaluation prior to surgery for stress urinary incontinence between 2008 and 2013 were retrospectively analyzed. According to the definition of the Value of Urodynamic Evaluation (ValUE) trial criteria, patients presenting with SUI were classified as \u201cuncomplicated\u201d or \u201ccomplicated.\u201d Urodynamic observations were then compared with pre-urodynamic data. Results: Overall, 2,053 female patients were considered. Only 740/2,053 (36.0%) patients were defined \u201cuncomplicated\u201d according to the definition used in the ValUE trial. The urodynamic observations were not consistent with the pre-urodynamic diagnosis in 1,276 out of 2,053 patients (62.2%). Voiding dysfunctions were urodynamically diagnosed in 394 patients (19.2%). Planned surgery was cancelled or modified in 304 patients (19.2%), due to urodynamic findings. Conclusions: \u201cUncomplicated\u201d patients represent a minority among female SUI patients evaluated before surgery. In \u201ccomplicated\u201d patients, the role of urodynamic has not been challenged yet and UDS seems still mandatory. Neurourol. Urodynam. 35:809\u2013812, 2016. \ua9 2015 Wiley Periodicals, Inc

Abiraterone Acetate for Treatment of Metastatic Castration-resistant Prostate Cancer in Chemotherapy-naive Patients: An Italian Analysis of Patients' Satisfaction

This article highlights the possible role of \u201cpatient-reported outcomes\u201d in the evaluation of a new therapy. Abiraterone acetate is a novel treatment for metastatic prostate cancer characterized by good safety and oncologic efficacy. Few studies have investigated patients' satisfaction with treatment. Our data show that abiraterone acetate is associated with good satisfaction with treatment and that patient's satisfaction can be a predictor of good oncologic outcomes. Introduction Abiraterone acetate (AA) gives a significant improvement in survival for patients with metastatic castration-resistant prostate cancer (mCRPC) before and after chemotherapy and has a favorable effect on patients' health-related quality of life and pain. Only a few studies have investigated patient-reported outcomes (PROs) in AA treatment for mCRPC. The aim of this study was to investigate patients' satisfaction in men affected by mCRPC treated with AA. Materials and Methods This was a retrospective analysis of a database of consecutive chemonaive patients with progressive mCRPC. Patients were treated with AA until disease progression, death, or unacceptable toxicity. Evaluation was performed at baseline and every 4 weeks by means of physical examination and laboratory studies. Eastern Cooperative Oncology Group score, pain symptoms, treatment-related toxicity, prostate-specific antigen (PSA), and overall and progression-free survival were recorded. Satisfaction with treatment was investigated at 6 months by means of a 4-point arbitrary scale. Results One-hundred twenty-eight patients were enrolled. Patients' satisfaction with treatment was \u201cgreatly improved\u201d in 36.1% of patients and \u201cimproved\u201d in 32.4% of them. Patients with higher satisfaction had lower baseline and final PSA values (P < .05), lower PSA levels at 12 weeks (P = .080), and less pain symptoms and lower Brief Pain Inventory scores (P = .001). Satisfaction with treatment was significantly correlated with baseline PSA level (P = .018), presence of pain (P = .007), duration of androgen deprivation therapy >12 months (P = .025), and number of hormonal manipulations (P = .051). Progression-free survival significantly correlated with patient satisfaction (P < .001). Conclusion AA is safe and well tolerated in chemonaive mCRPC patients, ensures good oncological and PROs. Patient's satisfaction is a predictor of progression-free survival