| BackgroundUrinary incontinence is one of the key factors affecting quality of life of patients after radical prostatectomy(RP).Although continence rates 12-month after robot-assisted radical prostatectomy can be more than 90%,it is reported that only about 30% to 60% patients can be continent at 3-month after surgery and the difference between patients was significant.Because of this,the early recovery of urinary continence(UC)is an intractable clinical problem,which is a major cause of lower quality of life for patients.It is believed that postoperative urinary incontinence is directly related to the damage of anatomical structures related to UC.How to improve the surgical skills to promote the early recovery of UC has become a research hot spot.As the gradual deepening of understanding of anatomical and pathophysiological knowledge of UC,it is believed that functional urethral length and the stability of the urethral sphincter complex are two key factors affecting the early recovery of UC after RP.Most of the existed modified surgical procedure aiming at improving early recovery of UC focus on these two points.However,there are some shortcomings,such as narrow applicable population(patients of early clinical stage and low risk stratification),low level of research evidence(descriptive or retrospective studies).So,there is no consensus on the modified RARP.In order to solve the above problems,our center proposed a new modified RARP,named Sustainable Functional Urethral Reconstruction(SFUR)in 2018,and then it is routinely carried out in our center.SFUR exert its function through two steps,the first is reshaping the anterior lip of the bladder as a tube for the new bladder opening to create an adequate length of the functional urethra,and reduces tension to the anastomosis and the second is making the periurethral support with use of peritoneal flap to increase periurethral stability.Together,the two maneuvers synergistically contribute to providing a sustainable support to the sphincteric muscular complex.Initial observation suggests that SFUR may improve the early recovery of UC and may be suitable for a wider range of Chinese patients.ObjectiveⅠ.To explore the safety and short-term functional outcomes of sustainable functional urethral reconstruction(SFUR)in RARP,to discuss its anatomical foundation and to provide basic data for future prospective study.Ⅱ.To analyze the impact of SFUR on early recovery of UC,tumor control,complication,urinary function(UF)and UF-related quality of life after RARP in a prospective randomized controlled trial.Materials and MethodsThe research strictly followed the CONSORT(Consolidated Standards of Reporting Trials)standard.Firstly,a retrospective study was conducted which is important for sample size determination.According to the CONSORT,the sample size was calculated,the inclusion and exclusion criteria were clarified,the randomized and blinded were conducted,the study endpoints were determined,the data collection strategy was improved,the statistical scheme was formulated,and then a prospective randomized controlled trial was conducted.Moreover,the ethical approval was passed and the clinical registration was completed.Ⅰ.162 consecutive prostate cancer patients who underwent RARP were retrospectively analyzed,in which 53 had undergone SFUR while the other 109 had undergone conventional RARP procedures.Immediate,2-week,1-month and 3-month continence recovery and other perioperative data were compared to evaluate short-term surgical and functional outcome.Continence is defined as 0-1 pad/per day and 24 h pad weight≤50g.Ⅱ.During December 2019 to September 2020,a total of 96 patients with locally or locally advanced prostate cancer were randomly assigned to the experimental group(n =48)or the control group(n = 48)to receive the modified RARP or standard RARP respectively.Primary outcome was UC rate(defined as 0-1 pad/per day and 24 h pad weight≤50g)1 month after catheter removal.Secondary outcomes were UC rate at 1-week,2-week and 3-month after catheter removal,24-hour urine leakage at 1-week,2-week,1-month and 3-month,time of UC and its influencing factors,the influence of surgical experience on urine leakage,postoperative UF and UF-related quality of life,positive surgical margins rates and complications.Modified intention to treat was used to analyze the results in this study.The number of pads per day and 24-hour weight gain were used to objectively evaluate the recovery of UC.The International Prostate Symptom Score(IPSS)and IPSS quality of life scores(Qo L)were used to evaluate the UF and UF-related bother.ResultsⅠ.The median age was 68 and 67 years and the median BMI was 25.00kg/m2 and23.95kg/m2 in SFUR group and standard RALP group,respectively,with a median prostate specific antigen(PSA)of 13.6 ng/m L in SFUR group and 13.84 ng/m L in standard RALP group(all p>0.05).Immediate,2-week,1-month and 3-month continence recovery rates between the groups were 34.0% vs.3.7%,50.9% vs.14.7%,62.3% vs.27.5%,and 79.2%vs.63.3%(all p<0.05).Adoption of the new reconstruction technique were significantly relevant to continence recovery on Logistic regression model(p<0.001).There was no significant difference between SFUR group and standard RARP group in the rate of positive surgical margins(20.8% vs 25.7%,p=0.491).There was only one Clavien-Dindo 3grade complication which is in SFUR group.The patient occurred urinary retention after catheter removal.Ⅱ.The results of prospective randomized controlled trial showed that the recovery rate of UC in the experimental group was 73.3%,which was significantly higher than that in the control group(48.9%),and the difference was statistically significant(p= 0.017).The results were still valid after correction of multivariate Logistic regression(OR=3.095,95%CI 1.183-8.099,p=0.021).The recovery rates of UC 1-week,2-week and 3-month after catheter removal in the experimental group were 53.3%,55.6% and 93.3%respectively,which were significantly higher than those in the control group(23.4%,31.9% and 76.6%)(P < 0.05).The median 24-hour urine leakage was 0 g in the experimental group and 47 g in the control group at 1-month.The median urine leakage in the experimental group was less than that in the control group,and the difference was statistically significant(p=0.002).The median recovery time of urinary control in the experimental group and the control group were 5 days and 34 days respectively(log rank p= 0.006).The recovery time of the experimental group was shorter than that of the control group and multivariate Cox regression showed that the application of SFUR had a significant effect on the recovery time of urinary control(HR = 1.784,95% CI 1.129-2.818,p=0.013).LOESS curves showed that there was no significant change in urine leakage with the increasing of operation cases.GEE analyses showed that there was no difference in IPSS and Qo L scores between two groups at 1-week,2-week,1-month and 3-month after catheter removal.The median operation time of the experimental group was 22minutes(95% CI 0-30min)longer than that of the control group.There was no significant difference in the complication rates(6.7% vs 6.4%,P = 0.956)and the positive surgical margin rates(27.1% vs 14.6%,P = 0.132)between the experimental group and the control group.ConclusionSFUR is a safe and easy-to-handle modification which can effectively improve the early recovery rate of UC,reduce postoperative urine leakage and significantly accelerate the recovery of continence,without declining UF and UF-related quality of life.This modification may prolong the operation time to a certain extent,but it is safe and has good postoperative tumor control.Above all,SFUR is worthy of clinical application and promotion.These results require long-term validation and reproduction by other centers. |
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