Buckley BS, Lapitan MCM, Glazener CM, for the MAPS Trial Group. The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery. Neurourol Urodynam 2012; 31 (4): 465-469.
Men who have surgery for benign prostate disease or prostate cancer are at risk of post-operative urinary incontinence (UI). The post-operative prevalence of UI after trans-urethral resection of the prostate (TURP) for benign disease is about 1% at 1 year. Radical prostatectomy (RP) is associated with much higher prevalence rates of UI after surgery than TURP: 13%- 16.3% at 1 year. Associations between UI and reduced quality of life are well established in the general population and in women in particular. The effect of UI on quality of life in men following prostate surgery is less certain with many studies measuring incontinence outcomes and quality of life outcomes separately and reporting inconsistent findings. The current study assessed the specific association between UI and health-related quality of life (HRQoL) in men at 1 year after prostate surgery using uniform, prospectively collected data set from two parallel randomized controlled trials.
This study reports a priori planned secondary analysis of the association between UI and HRQoL outcomes at 1 year after surgery in the 853 men who participated in the Men After Prostate Surgery (MAPS) study in UK. The MAPS study comprised two parallel randomized controlled trials of active conservative treatment for UI in men following RP (abdominal, perineal, or laporoscopic) or TURP in 34 centers. Men of any age were recruited in the MAPS study for possible participation before surgery between January 2005 and September 2008. Only those who had UI 6 weeks after their surgery were randomized. Incontinence was deﬁned as was the presence of any UI (even a small amount once a week or less often) indicated by a positive response to one of two questions on a questionnaire administered 6 weeks after surgery: ‘‘how often do you leak urine?’’ and ‘‘how much urine do you leak?’’ Men were excluded where radiotherapy was planned or given during the ﬁrst 3 months following surgery, where endoscopic resection of the prostate was carried out palliatively for outﬂow obstruction in advanced prostate cancer and if they had multiple sclerosis or Parkinson’s disease. The active conservative treatment intervention for UI in both trials involved pelvic ﬂoor muscle training and lifestyle advice with selective biofeedback (digital or machine-mediated) with or without bladder training. The control intervention included normal care with lifestyle advice.
Outcome measures included HRQoL and self-reported UI at 12 months. The International Consultation on Incontinence Questionnaire (ICIQ) score was used to measure severity of UI. The ICIQ-UI Short Form is a validated questionnaire that assesses the impact of symptoms of incontinence on quality of life. It measures self-reported frequency and volume of urinary leakage and produces a measure of how much leaking interferes with everyday life, ranging from 0 (‘‘not at all’’) to 10 (‘‘a great deal’’). Health status and HRQoL was measured by two validated and widely used questionnaires: the SF-12 and the EQ-5D. The SF-12 questionnaire measures health status in 12 dimensions and produces scale variables reﬂecting mental and physical health status, with higher scores reﬂecting better health status. The EQ-5D questionnaire measures health status in ﬁve dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which has three response levels so that 243 possible health status can be represented. Responses were transformed using a standard algorithm to produce a scale measure of ‘‘health utility,’’ a number between 0 and 1 where 1 represents perfect health and 0 death. Statistical analysis focused on the association between UI and health utility and HRQoL.
Of the 780 originally recruited for the RP trial, 411 men who were incontinent at 6 weeks after surgery entered the trial. Of 2,838 men undergoing TURP, 442 who were incontinent at 6 weeks after surgery entered the trial. Data relating to both UI and quality of life outcomes were available at 12 months for over 90% of those randomized: 390/411 in the RP trial and 397/442 in the TURP trial. Within the separate trials, there were no signiﬁcant differences at baseline or at 12 months between intervention and control groups in clinical or demographic variables, UI outcomes or EQ-5D or SF-12 scores so that it was possible to combine the groups’ data for analysis. In the RP trial, mean age at surgery was 62.3 years (SD= 5.7) and in the TURP trial, 68.0 (SD= 7.9).
Of the men who were randomized because of postoperative UI at 6 months, 76.7% were still experiencing UI at 12 months after RP and 63.2% after TURP. More clinically signiﬁcant incontinence-a moderate or large amount of leakage at least once a day—was experienced by 38.9% 12 months after RP and 24.4% after TURP. In the RP group, the mean (SD) ICIQ score was 5.2 (4.3), indicating more severe UI than among those who underwent TURP, 3.9 (4.0; P < 0.001).
Among those who underwent RP, all three measures of HRQoL, EQ-5D ,health utility scores and SF-12 were signiﬁcantly worse in men who still had UI at 12 months compared with those who were dry. Among men who underwent TURP, the association between UI and lower scores for QoL measures was statistically signiﬁcant for EQ-5D and SF-12 Mental Component Scores. Both associations persisted after using multivariate linear regression to control for confounding variables such as age, obesity and UI prior to surgery. No signiﬁcant association was also detected between UI prior to surgery and HRQoL at 12 months in either group.
Urinary incontinence is a common complication after prostate surgery that is associated with an adverse effect on the quality of life with serious consequences on sexual functioning, cognitive performance and social interactions that may also affect health and mortality. Comparison of results from various studies estimating the prevalence of UI after prostate surgery, however, is limited by differences in the definition of UI, particularly its onset, severity, frequency and whether or not it poses a social or hygienic problem, the type of patient population whether community- or hospital-based, and the standards and methods of data collection.
This secondary analysis of MAPS study focused on the association between HRQoL and UI, defined as any degree of UI, 1 year after prostate surgery. The results clearly shows that UI was signiﬁcantly associated with reductions in health utility as measured by EQ-5D and both physical and mental aspects of HRQoL as measured by SF-12, particularly in the younger group of men who had undergone RP. Of men who were urinary incontinent at 6 weeks after prostate surgery, very signiﬁcant numbers were still experiencing incontinence at 12 months (76.7% after RP and 63.2% after TURP). This prevalence is much higher than that reported in previous studies using deﬁnitions of UI with higher thresholds—such as the need for absorbent pads or a weighed pad test.
The most important finding was the consistent strong
association between UI and reduced quality of life in the
younger group who underwent RP is in contrast to previous
research that suggested that it was not regarded as a
major problem by a majority of those affected.
The MAPS trials randomized only men who had UI after surgery, it was not possible to study the quality of life in men whose prostate surgery did not initially result in UI. Further prospective studies are required to compare the quality of life of both continent and incontinent men after prostate surgery in order to determine the precise contribution of other post-operative complications, besides UI, to reduced quality of life.
The presence of any UI (even a small amount once a week or less often) is abnormal. When this definition is used, UI was found to be a highly prevalent condition and a signiﬁcant factor in reduced health utility and health-related quality of life after 1 year in men who have had prostate surgery. The results of this study highlight the importance of standardizing the definition of UI and how this condition can be a common surgical morbidity following prostate surgery. Therefore, the occurrence of UI as an adverse outcome in prostate surgery should not be underestimated and all efforts should be made to avoid, identify and treat it. In particular, younger main undergoing radical prostatectomy should be specifically informed about the higher risk of post-operative UI with discussion of the available treatment options. More research is needed, however, to measure the pathogenesis and true prevalence of de-novo UI following prostate surgery and to evaluate the most effective therapeutic approach to this complication.