Increases in serum levels of prostate-specific antigen (PSA) occur commonly in prostate cancer after radical prostatectomy and are designated "biochemical recurrence." Because the phytochemical sulforaphane has been studied extensively as an anticancer agent, we performed a double-blinded, randomized, placebo-controlled multicenter trial with sulforaphane in 78 patients (mean age, 69 AE 6 years) with increasing PSA levels after radical prostatectomy. Treatment comprised daily oral administration of 60 mg of a stabilized free sulforaphane for 6 months (M0-M6) followed by 2 months without treatment (M6-M8). The study was designed to detect a 0.012 log (ng/mL)/month decrease in the log PSA slope in the sulforaphane group from M0 to M6. The primary endpoint was not reached. For secondary endpoints, median log PSA slopes were consistently lower in sulforaphanetreated men. Mean changes in PSA levels between M6 and M0 were significantly lower in the sulforaphane group (þ0.099 AE 0.341 ng/mL) than in placebo (þ0.620 AE 1.417 ng/mL; P ¼ 0.0433). PSA doubling time was 86% longer in the sulforaphane than in the placebo group (28.9 and 15.5 months, respectively). PSA increases >20% at M6 were significantly greater in the placebo group (71.8%) than in the sulforaphane group (44.4%); P ¼ 0.0163. Compliance and tolerance were very good. Sulforaphane effects were prominent after 3 months of intervention (M3-M6). After treatment, PSA slopes from M6 to M8 remained the same in the 2 arms. Daily administration of free sulforaphane shows promise in managing biochemical recurrences in prostate cancer after radical prostatectomy. Cancer Prev Res; 8(8); 712-9. Ó2015 AACR.
Study Type – Therapy (case series) Level of Evidence 4 Artificial urinary sphincter (AUS) implantation is one of several surgical options for the treatment of female stress urinary incontinence. It is indicated for women with both clinically and urodynamically defined intrinsic sphincter deficiency that significantly affects quality of life. The erosion/revision risk increases after several previous surgical interventions. Therefore, women believed to be candidates for AUS implantation should be rapidly (after the failure of a maximum of two previous surgical procedures) referred to specialized centres, where the knowledge and experience concerning the diagnosis, surgery and management of female stress urinary incontinence is concentrated. To refer correctly, non‐academic urologists/gynaecologists should also be well informed about AUS implantation. Only in this way can the patient weigh the high long‐term success rate and high quality of life improvement of AUS implantation against the greater complication/revision risk and take a well‐considered decision.
Study Type – Therapy (outcomes research) Level of Evidence 2c OBJECTIVE To assess the safety, feasibility and efficacy of laparoscopic implantation of the artificial urinary sphincter (AUS) in women with genuine stress urinary incontinence (SUI). PATIENTS AND METHODS From April 2005 to July 2009, 25 women (mean age 66.8 years) with genuine SUI had a laparoscopic implantation of the AUS (AMS 800TM, American Medical Systems, Minnetonka, MN, USA). Patients had a negative Marshall test and urodynamic studies showed decreased closure pressure. All patients had a history of urogynaecological surgery. Transperitoneal laparoscopic access was created with two midline 10‐mm and two lateral 5‐mm trocars. One of the lateral port incisions was later extended to facilitate urethrovaginal dissection with scissors and dissector, and the insertion and assembly of the AUS. In six cases of concomitant genito‐urinary prolapse, laparoscopic anterior and posterior mesh promontofixation was also performed. RESULTS The AUS was successfully implanted in all cases with no conversion to open surgery. There were no intra‐ or perioperative complications, except one vaginal perforation which was repaired during surgery. The mean operative duration was 92 min (71 min without and 123 min with simultaneous promontofixation). Five patients developed urinary retention, which was managed with re‐insertion of the urethral catheter for 2 days in four and with insertion of a suprapubic catheter for 4 weeks in a patient with spina bifida. During the mean follow‐up of 26.1 months, two treatment failures were diagnosed due to vaginal erosion and were managed with removal of the AUS. All the remaining 23 patients reported continence, either complete (in 19) or social (in four). However, this was not a randomized comparative study. CONCLUSION Laparoscopic implantation of the AUS in women with genuine SUI is safe, feasible and efficient.
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