Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol

AbstractIntroductionIncontinence (up to 20%) and erectile dysfunction (up to 70%) occur frequently after radical prostatectomy (RP) in patients with localized prostate cancer. Human amniotic membrane (HAM) can improve tissue regeneration and functional outcome after RP owing to the growth factors and unique immune tolerance. Preliminary studies showed the potential value of HAM in the reconstruction of the urinary tract and nerve protection during RP.MethodsA protocol is developed for a prospective, randomized, single-blind, single-surgeon, placebo-controlled exploration study of the efficacy and safety of dehydrated human amnion membrane placed around the neurovascular bundle (NVB) and vesicourethral anastomosis (VUA) during RP for the treatment of localized prostate cancer. Eligible for inclusion are patients with localized prostate cancer, requiring a surgical procedure and exclusion of preoperative incontinence and erectile dysfunction. The patients are randomized 1:1 to HAM vs. placebo and blinded during the study period. According to theT test with an alpha of 0.05 and a power of 80% and expecting a dropout of 20% of the patients, an adjusted sample size per arm of 164 patients is required.Planned OutcomesThe primary outcome is a postoperative continence measured as 24-h pad test up to 12  months postoperatively. Secondary outcomes are potency, time of postoperative catheter removal, postoperative complications, and biochemical recurrence. The protocol for thi...
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research

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CONCLUSIONS: There was no impact of timing between RP and RT on urinary, bowel, and erectile adverse events related to RT. Thus, our RTOG 9601 post hoc analysis challenges the current belief that early postsurgical RT compromises functional outcomes more than late RT and support additional research to evaluate the perceived benefit in terms of adverse effects by prolonging the time between RP and RT. PMID: 31653564 [PubMed - as supplied by publisher]
Source: Urologic Oncology - Category: Urology & Nephrology Authors: Tags: Urol Oncol Source Type: research
Medical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approval is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies don’t make it through. In this case study, I discuss the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S.&Aci...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news
CONCLUSIONS: In our study a comprehensive evaluation of preoperative patient's QL, assessed by the EORTC QLQ-C30 questionnaire, can predict the early and long-term moderate/severe incontinence risk in RARP treated patients. Further studies should confirm our results. PMID: 31326315 [PubMed - as supplied by publisher]
Source: Urologic Oncology - Category: Urology & Nephrology Authors: Tags: Urol Oncol Source Type: research
AbstractTo evaluate if diffusion tensor imaging (DTI) is able to detect morphological changes of peri-prostatic neurovascular fibers (PNF) before and after robot-assisted radical prostatectomy (RARP) and if these changes are related to urinary incontinence (UI) and erectile dysfunction (ED). From October 2014 and August 2017, 26 patients with biopsy-proven prostate cancer underwent prostatic multiparametric magnetic resonance imaging (mp-MRI) including DTI sequencing before, and 6 months after, RARP. Images were analyzed by placing six regions of interest (ROI), respectively, at base, mid gland, and apex, one for each side...
Source: Journal of Robotic Surgery - Category: Surgery Source Type: research
CONCLUSION: CaP patients who sustain higher BL during RP showed worse functional outcomes. High BL during ORP or RALP represented an independent predictor of erectile dysfunction and incontinence after surgery. However, the effect of high BL on the continence was temporarily and not present at 1 year after surgery in ORP and after 3 months in RALP. PMID: 30857988 [PubMed - as supplied by publisher]
Source: Urologic Oncology - Category: Urology & Nephrology Authors: Tags: Urol Oncol Source Type: research
Background:Men with locally advanced prostate cancer (LAPCa) or regionally advanced prostate cancer (RAPCa) are at high risk for death from their disease. Clinical guidelines support multimodal approaches, which include radical prostatectomy (RP) followed by radiotherapy (XRT) and XRT plus androgen deprivation therapy (ADT). However, there are limited data comparing these substantially different treatment approaches. Using Surveillance, Epidemiology, and End Results (SEER) –Medicare data, this study compared survival outcomes and adverse effects associated with RP plus XRT versus XRT plus ADT in these men.Methods:SEE...
Source: Cancer - Category: Cancer & Oncology Authors: Tags: Original Article Source Type: research
ConclusionsOverall, receipt of genitourinary prosthetic surgery for incontinence (1.5%) or erectile dysfunction (1.6%) was rare following radical prostatectomy. However, diabetic and older men demonstrated a greater likelihood of device placement.

Source: Urology Practice - Category: Urology & Nephrology Source Type: research
AbstractMale Stress Urinary Incontinence is a complication post robotic radical prostatectomy. This is a major problem that needs to be solved, since it has great impact on quality of life affecting the patient ’s physical activity and social well-being. A systematic review relating to literature on impact of preoperative PFE on continence outcomes for patients undergoing prostatectomy was conducted. The search strategy aimed to identify all references related to pelvic floor exercises and post-prostatec tomy. Search terms used were as follows: (Pelvic floor exercises) AND (incontinence) AND (prostatectomy). The foll...
Source: Journal of Robotic Surgery - Category: Surgery Source Type: research
Abstract OBJECTIVE: To evaluate if diffusion tensor Imaging (DTI) is able to detect changes of periprostatic neurovascular fibers (PNFs) before and after radical prostatectomy (RP), and if these changes are related to post-surgical urinary incontinence and erectile dysfunction. METHODS: 22 patients (mean age 62.6 years) with biopsy-proven prostate cancer underwent 1.5-T DTI before and after radical prostatectomy (RP). The number, fractional anisotropy (FA) values and length of PNFs before and after RP were compared using Student's t-test. Each patient filled out two questionnaires before and after RP, one for...
Source: The British Journal of Radiology - Category: Radiology Authors: Tags: Br J Radiol Source Type: research
CONCLUSIONS: Endoscopic extraperitoneal radical prostatectomy after radical resection of rectal carcinoma appears promising, with feasibility in experienced hands. The operative data, postoperative urinary incontinence and oncological outcomes appear encouraging, but the rate of erectile dysfunction seems to be disappointing. PMID: 28446934 [PubMed - in process]
Source: Videosurgery and Other Miniinvasive Techniques - Category: Surgery Tags: Wideochir Inne Tech Maloinwazyjne Source Type: research
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