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:BackgroundFrailty is common among urology patients in general as well as among men seeking evaluation for stress urinary incontinence (SUI), with 6.1% of men undergoing artificial urinary sphincter placement considered frail. It is unclear if and how patient views on frailty and incontinence severity impact decision-making with regards to SUI treatment.MethodsWe undertook a mixed methods analysis to evaluate the intersection of frailty, incontinence severity, and treatment decision-making is presented. To do so, we utilized a previously published cohort of men undergoing evaluation for SUI at the University of California, San Francisco between 2015 and 2020, selecting those who had evaluation with timed up and go test (TUGT), objective measures of incontinence, and patient-reported outcome measures (PROMs). A subset of these participants had additionally undergone semi-structured interviews, and these interviews were re-examined to thematically code them with a focus on the impact of frailty and incontinence severity on SUI treatment decision-making.ResultsAmong the original cohort of 130 patients, 72 had an objective measure of frailty and were included in our analysis; 18 of these individuals had corresponding qualitative interviews. Common themes identified included (I) impact of incontinence severity on decision-making; (II) the interaction between frailty and incontinence; (III) the impact of comorbidity on treatment decision-making; and (IV) age as a construct of frailty and impact on surgical choice and/or recovery. Direct quotations regarding each theme provides insight into patients' views and drivers of SUI treatment decision-making.ConclusionsThe impact of frailty on treatment decision-making for patients with SUI is complex. This mixed methods study highlights the variety of patient views on frailty with regards to surgical intervention for male SUI. Urologists should make a concerted effort to personalize patient counseling for SUI management and take time to understand each patient's perspective in order to individualize SUI treatment decision-making. More research is needed to help identify factors that influence decision-making for frail male patients with SUI.

Project description:PurposeOne of the most frequent side effects of radical prostatectomy (RP) is urinary incontinence. The primary cause of urine incontinence is usually thought to be impaired urethral sphincter function; nevertheless, the pathophysiology and recovery process of urine incontinence remains unclear. This study aimed to identify potential risk variables, build a risk prediction tool that considers preoperative urodynamic findings, and direct doctors to take necessary action to reduce the likelihood of developing early urinary incontinence.MethodsWe retrospectively screened patients who underwent radical prostatectomy between January 1, 2020 and December 31, 2023 at the First People 's Hospital of Nantong, China. According to nomogram results, patients who developed incontinence within three months were classified as having early incontinence. The training group's general characteristics were first screened using univariate logistic analysis, and the LASSO method was applied for the best prediction. Multivariate logistic regression analysis was carried out to determine independent risk factors for early postoperative urine incontinence in the training group and to create nomograms that predict the likelihood of developing early urinary incontinence. The model was internally validated by computing the performance of the validation cohort. The nomogram discrimination, correction, and clinical usefulness were assessed using the c-index, receiver operating characteristic curve, correction plot, and clinical decision curve.ResultsThe study involved 142 patients in all. Multivariate logistic regression analysis following RP found seven independent risk variables for early urinary incontinence. A nomogram was constructed based on these independent risk factors. The training and validation groups' c-indices showed that the model had high accuracy and stability. The calibration curve demonstrates that the corrective effect of the training and verification groups is perfect, and the area under the receiver operating characteristic curve indicates great identification capacity. Using a nomogram, the clinical net benefit was maximised within a probability threshold of 0.01-1, according to decision curve analysis (DCA).ConclusionThe nomogram model created in this study can offer a clear, personalised analysis of the risk of early urine incontinence following RP. It is highly discriminatory and accurate, and it can help create efficient preventative measures and identify high-risk populations.

Project description:BackgroundMale stress urinary incontinence (SUI) is a known complication following surgical intervention on the prostate, particularly following surgery for prostate cancer. Effective surgical treatments for SUI include artificial urinary sphincter (AUS) and male urethral sling. Prior data suggest that men may forego available treatment despite bothersome symptoms. The objective was to explore how men who underwent surgical correction for post-prostatectomy SUI navigated SUI treatment decisions.MethodsMixed method study was employed. Semi-structured interviews, participant surveys and objective clinical assessment of SUI were performed among a group of men living with incontinence after prostate cancer surgery who underwent surgery for SUI at the University of California in 2017.ResultsEleven men were interviewed after consultation for SUI and all had complete quantitative clinical data. Surgery for SUI included AUS (n=8) and sling (n=3). There was a decrease in pads per day from 3.2 to 0.9 and no major complications. Most patients found that the impact on activities and their treating urologist were of great importance. Sexual and relationships played a variable role with some participants ranking these as "great deal of influence" and others "little or no influence". Participants who underwent AUS were more likely to cite a higher importance on "being very dry" in choosing that surgery while sling patients had more variable ranking of important factors. Participants found a variety of inputs helpful in hearing information about SUI treatment options.ConclusionsAmong a group of 11 men who underwent surgical correction for post-prostatectomy SUI, there were identifiable themes on how men make decisions, evaluate quality of life (QoL) changes and approach treatment options. Men value more than being dry with measures of individual success that can include sexual and relationship health. Furthermore the role of the Urologist remains crucial as patients relied heavily on input and discussion with their Urologist to assist in treatment decisions. These findings can be used to inform future studies of the experience of men with SUI.

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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