Dataset Information

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

ABSTRACT: INTRODUCTION:Incontinence (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. METHODS:A 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 the T 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 OUTCOMES:The 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 this randomized exploration study defines the conditions to assess the efficacy and safety of HAM application during RP in order to improve the postoperative functional outcome. This trial should pave the way for future studies of tissue engineering in an effort to reduce the morbidity of RP. TRIAL REGISTRATION:Clinicaltrials.gov, identifier NCT03864939.

SUBMITTER: Barski D

PROVIDER: S-EPMC6979451 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Barski Dimitri D Gerullis Holger H Ecke Thorsten T Boros Mihaly M Brune Jan J Beutner Ulrich U Tsaur Igor I Ramon Albert A Otto Thomas T

Advances in therapy 20191128 1

<h4>Introduction</h4>Incontinence (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.<h4>Methods</h4>A protocol is developed for ...[more]

PMID: 31782131

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Project description:We developed an objective clinical grading scale to characterize post-prostatectomy incontinence (PPI) and evaluated its use as a tool to facilitate male anti-incontinence procedure selection. Between September 2014 and July 2015, we prospectively implemented a novel Male Stress Incontinence Grading Scale (MSIGS) to stratify PPI patients based on incontinence severity. Patients included were those referred for PPI who had no prior anti-incontinence surgery. During the initial outpatient consultation, each patient was prospectively assigned an incontinence grade score of 0 through 4 based on the consensus of 2 examiners performing a standing cough test (SCT). All patients refrained from voiding for at least 60 minutes prior to the SCT. Men with mild SUI (MSIGS grades 0-2) were offered AdVance sling surgery while those with heavier SUI (MSIGS grades 3-4) were offered artificial urinary sphincter (AUS). MSIGS grade was correlated to patient-reported pads-per-day (PPD), and patient-reported outcomes of anti-incontinence surgery were assessed. Of 62 consecutive new PPI patients, 20 were graded as mild based on SCT [five (8%) grade 0, 10 (16%) grade 1, five (8%) grade 2] while 42 were graded as moderate-severe [10 (16%) grade 3, 32 (52%) grade 4]. MSIGS grade demonstrated a strong correlation with preoperative PPD (r=0.74). Among the 53 patients who underwent surgical intervention for PPI, 14 with mild SUI were treated with AdVance® male urethral sling (MSIGS grade 0, 1, or 2) while 39 more severe cases received AUS (MSIGS grade 3 or 4). Patient-reported improvement was high overall (median 95%) and similar for sling and AUS patients (95% and 96.5% respectively, p=0.596). The median time from radical prostatectomy to anti-incontinence surgery was 5.4 years (range 1-20). The Male Stress Incontinence Grading Scale provides a rapid, simple, non-invasive, objective assessment of PPI severity which strongly correlates with patient-reported pads-per-day and appears to facilitate anti-incontinence surgical procedure selection.

Project description:Objective: To investigate predictors of patient-reported urinary incontinence (PRUI) in the first 2 years after post-prostatectomy radiotherapy (PORT) with particular emphasis on possible dose-effect relationships. Patients and Methods: Two-hundred-thirteen patients, whose clinical and dosimetric data were prospectively collected within a registered multi-institutional cohort study, underwent PORT with adjuvant (n = 106) or salvage (n = 107) intent with conventional (n = 123, prescribed dose to the prostatic bed: 66.6-79.8Gy in 1.8-2.0Gy/fr) or moderately hypo- (n = 90, 65.8-76.8Gy in 2.1-2.7Gy/fr) fractionation during the period 2011-2017. PRUI was evaluated through the ICIQ-SF questionnaire filled in at baseline and every 6 months thereafter. The analysis focused on three ICIQ-based clinically relevant endpoints: (a) very frequent leakage (FREQUENCY, ICIQ3 score >3), (b) moderate to severe amount of urine loss (AMOUNT, ICIQ4>2) (c) objective severe symptoms (OBJECTIVE, ICIQ3+4>5). Predictors of the incidence within 2 years for the three endpoints were investigated focusing only on patients without endpoint symptoms at baseline. A uni-variable logistic regression analysis was performed in order to determine the best dose metrics describing PRUI risk in terms of 2-Gy equivalent dose (EQD2) calculated with different α/β values reported in the literature (0.8, 3, 5Gy), and to identify the most significant clinical variables. Variables showing p < 0.20 at uni-variable analysis were entered into a backward stepwise multi-variable logistic regression analysis. Lastly, the goodness of fit and model calibration were evaluated and internally validated. Results: Patients without symptoms at baseline experienced (a), (b), and/or (c) within 2 years in 41/130 (32%), 40/192 (21%), and 41/129 (32%) of the cases, respectively. EQD2 for α/β = 0.8Gy was the best dose metric associated with PRUI. Multi-variable analysis identified baseline incontinence levels as the strongest predictor for all endpoints (p < 0.006). Both FREQUENCY and OBJECTIVE were significantly influenced also by EQD2(α/β = 0.8Gy). The goodness of fit was excellent, as was the calibration; internal calibration confirmed apparent performance. Conclusion: Baseline mild urinary incontinence symptoms strongly modulate the 2-year risk of PRUI. In addition, FREQUENCY is characterized by a marked dose-effect relationship also influencing the trend of OBJECTIVE, with results more reliable than AMOUNT as an objective index. A strong impact of fractionation on severe PRUI after post-prostatectomy radiotherapy also emerged.

Dataset Information

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

Publications

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

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