Author's Accepted Manuscript How should continence and incontinence after radical prostatectomy be evaluated? A prospective study of patient-ratings and changes over time Henriette Veiby Holm, Sophie D. Fosså, Hans Hedlund, Alexander Schultz, Alv A. Dahl
PII: DOI: Reference:
S0022-5347(14)03312-6 10.1016/j.juro.2014.03.113 JURO 11377
To appear in: The Journal of Urology Accepted Date: 28 March 2014 Please cite this article as: Holm HV, Fosså SD, Hedlund H, Schultz A, Dahl AA, How should continence and incontinence after radical prostatectomy be evaluated? A prospective study of patient-ratings and changes over time, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.03.113. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
1
ACCEPTED MANUSCRIPT
How should continence and incontinence after radical prostatectomy be evaluated? A prospective study of
RI PT
patient-ratings and changes over time
Henriette Veiby Holm1,2,3, Sophie D. Fosså1,3, Hans Hedlund2,3,
SC
Alexander Schultz2, Alv A. Dahl1,3
Department of Oncology, Oslo University Hospital, Radiumhospitalet, Oslo, Norway
2
Department of Urology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
3
University of Oslo, Oslo, Norway
M AN U
1
Corresponding author:
EP
Henriette Veiby Holm, MD,
TE D
Running head: Continence and incontinence after radical prostatectomy
Department of Oncology, Oslo University Hospital HF, Radiumhospitalet P.O. Box 4953, Nydalen, N-0424 Oslo, Norway
AC C
Phone: +47 22 93 58 74 Fax: +47 22 93 45 53 E-mail, H. V. Holm: [email protected] S. D. Fosså:
[email protected]
H. Hedlund: [email protected] A. Schultz:
[email protected]
A. A. Dahl:
[email protected]
Key words: Postprostatectomy incontinence, quality of life, radical prostatectomy, survivorship, erectile dysfunction
2
ACCEPTED MANUSCRIPT ABSTRACT Purpose: We examined the prevalence rates and changes of continence and incontinence before and after radical prostatectomy (RP) for prostate cancer (PCa), comparing different definitions. We also studied the descriptive validity of Ellison et al.’s grading of
RI PT
postprostatectomy incontinence (PPI) and baseline predictors of PPI at 12 months.
Materials and methods: This national prospective study included 844 patients treated with RP between 2005 and 2009. Adverse effects, including urinary dysfunction and bother, were
SC
patient-reported by validated questionnaires (EPIC-50, UCLA-PCI) at baseline and 12-month follow-up by 735 patients (88%). Linear regression analyses examined baseline predictors and
M AN U
degree of PPI at follow-up.
Results: At 12 months after RP 74% reported PPI; 40% used pads daily and 34% reported occasional dribbling without using pads, while 26% had total urinary control. Severe PPI, when defined as total incontinence/no urinary control whatsoever, was reported by 3%, but
TE D
25% had severe PPI according to the stratification of Ellison et al. Of the patients with preoperative incontinence 14% improved postoperatively. Predictors of PPI were age ≥65 years, not working, sexual dysfunction and incontinence preoperatively, and the latter two
associated with PPI.
EP
remained the strongest predictors in multivariable analysis. PCa related variables were not
AC C
Conclusions: The prevalence of PPI varied considerably according to the definition applied. In our opinion, incontinence may be reported as any leakage, not only pad use, and grading done on a symptom scale. Preoperative sexual dysfunction and urinary incontinence were the strongest predictors of PPI at 12 month follow-up.
3
ACCEPTED MANUSCRIPT INTRODUCTION Postprostatectomy incontinence (PPI) is a feared adverse effect (AE) following radical prostatectomy (RP) for prostate cancer (PCa). If persistent, PPI can be incapacitating, leading to reduced health-related quality of life (QOL).1 Reviews have reported that up to 30%-40%
RI PT
of patients complain of persistent PPI.2,3,4 Nevertheless, there is no international consensus regarding the optimal way to define, assess, and grade PPI, which partially explains the wide range of prevalence rates reported.3,5
SC
The most commonly used definition of PPI is “any use of pads”6,7 but this definition excludes patients who report “any leakage” (without pad use) which is the definition of
M AN U
incontinence promoted by the International Continence Society (ICS).3,8 Others have endorsed the use of validated symptom scales of objective and subjective experience,9,10,11 which may be useful when grading PPI as recently proposed by Ellison et al.12 Most studies of PPI only include patients who are continent preoperatively,6 which
TE D
ignores a considerable proportion of patients with preoperative leakage. The duration needed for PPI to be considered persistent is undefined, but 12 months has significant clinical
considered.1
EP
relevance since little improvement is observed further on, and surgical treatment should be
This prospective study concerns urinary incontinence reported by a sample of
AC C
Norwegian men from preoperative status (baseline) to 12 months after RP. We had three objectives: 1) To examine the prevalence of patient-reported continence and incontinence at baseline and 12 months after RP, comparing different definitions and analyzing changes; 2) To examine the descriptive validity of Ellison et al.’s grading of PPI; and 3) To study baseline predictors of persistent PPI.
MATERIALS AND METHODS
4
ACCEPTED MANUSCRIPT Patient sampling The study population derives from two prospective studies of AEs following RP for localized PCa: 1) The Oslo University Hospital Radiumhospitalet (OUH) study of 156 patients treated between 2005 and 2007.13 2) The Norwegian Urological Cancer Group
RI PT
(NUCG) study VII of 688 patients treated at 14 urological units in Norway between 2008 and 2009.14 Both studies were initiated and analyzed at OUH. Among the total of 844 patients, 735 (87%) completed all urinary incontinence items at baseline and 12 months
SC
postoperatively.
M AN U
Questionnaires
The UCLA-PCI questionnaire was developed to assess typical AEs and QOL after treatment for PCa.11 The EPIC-50 is a modified version of the UCLA-PCI.15 and later the abbreviated EPIC-26 was developed.16,17 Norwegian versions of the UCLA-PCI was used in the OUH
TE D
study and the EPIC-50 in the NUCG-VII study.
These instruments have four identical items comprising the urinary incontinence domain (UID) (Table 1) and six items comprising the sexual domain. The latter was only
EP
analyzed at baseline. Response options for each item form a Likert scale, and the scale scores are converted to a 0-100 scale, with higher scores representing better QOL.17 The
AC C
multi-item domain scores are the mean of the four and six item scores, respectively. In our sample all internal consistencies were adequate. Based on the items urinary control and use of pads the sample was divided into three categories of continence described by Herschorn et al. for ICS: 3 1) total control and no use of pads (perfect continence); 2) occasional dribbling without use of pads; and 3) using pads daily. Preoperative continence was defined as category 1 and incontinence as including both categories 2 and 3.
5
ACCEPTED MANUSCRIPT Any change of category from baseline to 12 months was defined as either positive (better) or negative (worse). This categorization was compared with the continuous UID score. A change in UID score > ±10 on the 0-100 scale was defined as a change (better/worse).18 Ellison et al.’s stratification of PPI using the UID score, classify 0-49 as severe, 50-69
RI PT
as moderate and 70-100 as mild/no PPI.12 The changes of category were also compared to the changes of categorical continence status mentioned above, although they are not directly
SC
comparable since the latter lacks discrimination on the severe end.
Sociodemographic and cancer related variables at baseline
M AN U
Comorbidity was defined as presence of ≥1 of 12 diseases listed in the demographic part of the EPIC-50.17 Paired relationship consisted of married/cohabiting patients. Level of education was dichotomized into ≤12 years and >12 years. Work status concerned currently being in paid work or not.
TE D
PCa and surgery related variables were retrieved from the patients’ medical records and
Statistics
EP
the risk group classification of D’Amico et al. was applied.19
Descriptive statistics included mean and standard deviation (SD) for continuous variables and
AC C
proportions for categorical ones. Internal consistencies of the UID and sexual domain items were tested with Cronbach’s coefficient alpha. Linear regression analyses examined the associations between baseline sociodemographic and cancer related independent variables and degree of PPI (UID score 0-100) as dependent variable. The strengths of association were expressed as beta and standardized beta coefficients.
6
ACCEPTED MANUSCRIPT The level of significance was set at p ±10), the results show a moderate agreement (kappa 0.69) (Table 4). Comparison of changes according to Herschorn et al.’s continence categories and Ellison et al.’s stratification of PPI, showed less agreement (kappa 0.47). According to Ellison et al. a larger proportion of patients were defined as stable, compared to the two other methods (58% versus 35%-38%, p±10 on the 0-100 scale from baseline to 12 months after RP was defined as a change (improved/worsened).17 c UID stratification according to Ellison et al.11 Level of agreement: Table 3 a. Kappa 0.69 and Table 3 b. Kappa 0.47.
Table 5. Linear regression analysis of baseline and cancer related variables associated with postprostatectomy incontinence a at 12 months follow-up (N=735). a
Based on the continuous urinary incontinence domain (UID) score 0-100 at 12 months, with higher scores representing better QOL. b The variables that were significant in bivariate analysis were entered into the multivariable model, except age≥65 which is highly correlated to the continuous variable age. Additionally, the previously identified risk factors surgical approach, nerve sparing, and comorbidity were also included, independently of their p-values. Collinearity statistics showed no collinearity between age, work status, comorbidity, sexual dysfunction, and incontinence (both the variance inflation factors and the tolerance statistics were close to 1 for each of the variables, i.e. no multicollinearity).
16
ACCEPTED MANUSCRIPT c
AC C
EP
TE D
M AN U
SC
RI PT
Beta: standardized coefficient. As a decreasing value of the dependent variable (UID score 0-100) reflects increasing degree of PPI a positive beta coefficient represents a positive association and a negative beta represents an inverse association with increasing degree of PPI. d Based on the patient-report of “total urinary control” at baseline vs. not. e Based on the continuous sexual domain score 0-100 at baseline. f Based on surgeon reported unilateral and bilateral nerve sparing technique.
ACCEPTED MANUSCRIPT
Items
Responses
Value
Value
EPIC
UCLA-PCI
a) More than once a day
0
0
urine?
b) About once a day
25
25
c) More than once a week
50
50
d) About once a week
75
75
100
100
0
0
33
33
67
67
100
100
0
0
33
50
67
50
d) 3 or more pads per day
100
100
4. How big a problem, if any,
a) No problem
100
100
has dripping or leaking urine
b) Very small problem
75
75
been for you?
c) Small problem
50
50
d) Moderate problem
25
25
e) Big problem
0
0
e) Rarely or never a) No urinary control whatsoever
describes your urinary
b) Frequent dribbling
control?
c) Occasional dribbling d) Total control a) None
diapers per day did you
b) 1 pad per day a
M AN U
3. How many pads or adult
EP
TE D
usually use to control leakage? c) 2 pads per day a
AC C
SC
2. Which of the following best
RI PT
1. How often have you leaked
ACCEPTED MANUSCRIPT
RI PT
513 (70) 62.8 (5.5) 282 (39) 374 (51) 683 (93) 425 (63) 283 (39) 71 (35) 10.0 (7.4) 387 (53)
SC
583 (80) 110 (15) 37 (5)
231 (32) 338 (46) 164 (22)
AC C
EP
TE D
M AN U
Baseline variables Continent a, N (%) Age, mean (SD) Age ≥ 65 years, N (%) Education >12 years, N (%) Married/living with partner, N (%) Currently working, N (%) Comorbidity present, N (%) Sexual domain score b, median (interquartile range) c Cancer related variables PSA, mean (SD) Gleason score on biopsy ≥7, N (%) Clinical T stage, N (%) ≤T2a T2b-T2c ≥T3 D’Amico risk group, N (%) Low Intermediate High Surgical approach, N (%) RARP RRP Perineal Nerve sparing, N (%) d Pathological T stage, N (%) ≤T2a T2b-T2c ≥T3 Positive margins, N (%)
507 (69) 221 (30) 7 (1) 446 (61) 92 (12) 387 (53) 254 (35) 192 (26)
ACCEPTED MANUSCRIPT
UID score, mean (SD) 12 months
All patients
94 (12)
70 (28)
Total control, no pads
100 (3)
99 (3)
Occasional dribbling, no pads
83 (11)
81 (10)
Use of ≥1 pad/d
46 (26)
42 (20)
AC C
EP
TE D
M AN U
SC
RI PT
Baseline
ACCEPTED MANUSCRIPT Change in continuous UID score b
4 a. Change in continence
Stable
Worsened
Total
Improved
14 (44)
18 (56)
0 (0)
32 (100)
Stable
12 (5)
208 (81)
36 (14)
256 (100)
Worsened
0 (0)
51 (11)
396 (89)
447 (100)
Total
26 (4)
277 (38)
432 (59)
735 (100)
Change in continence
Stable
Improved
7 (22)
25 (78)
Stable
6 (2)
Worsened
0 (0)
Total
13 (2)
TE D EP AC C
Worsened
Total
0 (0)
32 (100)
234 (91)
16 (6)
256 (100)
169 (38)
278 (62)
447 (100)
428 (58)
294 (40)
735 (100)
M AN U
Improved
categories a, N (%)
SC
Change in UID stratification c
4 b.
RI PT
Improved
categories a, N (%)
ACCEPTED MANUSCRIPT Univariate analysis
AC C
p-value
B
Beta c
p-value
-10.0 0.73 8.89 -1.59 2.29 -8.31 3.90 0.23
-0.17 0.14 0.16 -0.03 0.02 -0.15 0.07 0.21
PII: DOI: Reference:
S0022-5347(14)03312-6 10.1016/j.juro.2014.03.113 JURO 11377
To appear in: The Journal of Urology Accepted Date: 28 March 2014 Please cite this article as: Holm HV, Fosså SD, Hedlund H, Schultz A, Dahl AA, How should continence and incontinence after radical prostatectomy be evaluated? A prospective study of patient-ratings and changes over time, The Journal of Urology® (2014), doi: 10.1016/j.juro.2014.03.113. DISCLAIMER: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our subscribers we are providing this early version of the article. The paper will be copy edited and typeset, and proof will be reviewed before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to The Journal pertain. All press releases and the articles they feature are under strict embargo until uncorrected proof of the article becomes available online. We will provide journalists and editors with full-text copies of the articles in question prior to the embargo date so that stories can be adequately researched and written. The standard embargo time is 12:01 AM ET on that date.
1
ACCEPTED MANUSCRIPT
How should continence and incontinence after radical prostatectomy be evaluated? A prospective study of
RI PT
patient-ratings and changes over time
Henriette Veiby Holm1,2,3, Sophie D. Fosså1,3, Hans Hedlund2,3,
SC
Alexander Schultz2, Alv A. Dahl1,3
Department of Oncology, Oslo University Hospital, Radiumhospitalet, Oslo, Norway
2
Department of Urology, Oslo University Hospital, Rikshospitalet, Oslo, Norway
3
University of Oslo, Oslo, Norway
M AN U
1
Corresponding author:
EP
Henriette Veiby Holm, MD,
TE D
Running head: Continence and incontinence after radical prostatectomy
Department of Oncology, Oslo University Hospital HF, Radiumhospitalet P.O. Box 4953, Nydalen, N-0424 Oslo, Norway
AC C
Phone: +47 22 93 58 74 Fax: +47 22 93 45 53 E-mail, H. V. Holm: [email protected] S. D. Fosså:
[email protected]
H. Hedlund: [email protected] A. Schultz:
[email protected]
A. A. Dahl:
[email protected]
Key words: Postprostatectomy incontinence, quality of life, radical prostatectomy, survivorship, erectile dysfunction
2
ACCEPTED MANUSCRIPT ABSTRACT Purpose: We examined the prevalence rates and changes of continence and incontinence before and after radical prostatectomy (RP) for prostate cancer (PCa), comparing different definitions. We also studied the descriptive validity of Ellison et al.’s grading of
RI PT
postprostatectomy incontinence (PPI) and baseline predictors of PPI at 12 months.
Materials and methods: This national prospective study included 844 patients treated with RP between 2005 and 2009. Adverse effects, including urinary dysfunction and bother, were
SC
patient-reported by validated questionnaires (EPIC-50, UCLA-PCI) at baseline and 12-month follow-up by 735 patients (88%). Linear regression analyses examined baseline predictors and
M AN U
degree of PPI at follow-up.
Results: At 12 months after RP 74% reported PPI; 40% used pads daily and 34% reported occasional dribbling without using pads, while 26% had total urinary control. Severe PPI, when defined as total incontinence/no urinary control whatsoever, was reported by 3%, but
TE D
25% had severe PPI according to the stratification of Ellison et al. Of the patients with preoperative incontinence 14% improved postoperatively. Predictors of PPI were age ≥65 years, not working, sexual dysfunction and incontinence preoperatively, and the latter two
associated with PPI.
EP
remained the strongest predictors in multivariable analysis. PCa related variables were not
AC C
Conclusions: The prevalence of PPI varied considerably according to the definition applied. In our opinion, incontinence may be reported as any leakage, not only pad use, and grading done on a symptom scale. Preoperative sexual dysfunction and urinary incontinence were the strongest predictors of PPI at 12 month follow-up.
3
ACCEPTED MANUSCRIPT INTRODUCTION Postprostatectomy incontinence (PPI) is a feared adverse effect (AE) following radical prostatectomy (RP) for prostate cancer (PCa). If persistent, PPI can be incapacitating, leading to reduced health-related quality of life (QOL).1 Reviews have reported that up to 30%-40%
RI PT
of patients complain of persistent PPI.2,3,4 Nevertheless, there is no international consensus regarding the optimal way to define, assess, and grade PPI, which partially explains the wide range of prevalence rates reported.3,5
SC
The most commonly used definition of PPI is “any use of pads”6,7 but this definition excludes patients who report “any leakage” (without pad use) which is the definition of
M AN U
incontinence promoted by the International Continence Society (ICS).3,8 Others have endorsed the use of validated symptom scales of objective and subjective experience,9,10,11 which may be useful when grading PPI as recently proposed by Ellison et al.12 Most studies of PPI only include patients who are continent preoperatively,6 which
TE D
ignores a considerable proportion of patients with preoperative leakage. The duration needed for PPI to be considered persistent is undefined, but 12 months has significant clinical
considered.1
EP
relevance since little improvement is observed further on, and surgical treatment should be
This prospective study concerns urinary incontinence reported by a sample of
AC C
Norwegian men from preoperative status (baseline) to 12 months after RP. We had three objectives: 1) To examine the prevalence of patient-reported continence and incontinence at baseline and 12 months after RP, comparing different definitions and analyzing changes; 2) To examine the descriptive validity of Ellison et al.’s grading of PPI; and 3) To study baseline predictors of persistent PPI.
MATERIALS AND METHODS
4
ACCEPTED MANUSCRIPT Patient sampling The study population derives from two prospective studies of AEs following RP for localized PCa: 1) The Oslo University Hospital Radiumhospitalet (OUH) study of 156 patients treated between 2005 and 2007.13 2) The Norwegian Urological Cancer Group
RI PT
(NUCG) study VII of 688 patients treated at 14 urological units in Norway between 2008 and 2009.14 Both studies were initiated and analyzed at OUH. Among the total of 844 patients, 735 (87%) completed all urinary incontinence items at baseline and 12 months
SC
postoperatively.
M AN U
Questionnaires
The UCLA-PCI questionnaire was developed to assess typical AEs and QOL after treatment for PCa.11 The EPIC-50 is a modified version of the UCLA-PCI.15 and later the abbreviated EPIC-26 was developed.16,17 Norwegian versions of the UCLA-PCI was used in the OUH
TE D
study and the EPIC-50 in the NUCG-VII study.
These instruments have four identical items comprising the urinary incontinence domain (UID) (Table 1) and six items comprising the sexual domain. The latter was only
EP
analyzed at baseline. Response options for each item form a Likert scale, and the scale scores are converted to a 0-100 scale, with higher scores representing better QOL.17 The
AC C
multi-item domain scores are the mean of the four and six item scores, respectively. In our sample all internal consistencies were adequate. Based on the items urinary control and use of pads the sample was divided into three categories of continence described by Herschorn et al. for ICS: 3 1) total control and no use of pads (perfect continence); 2) occasional dribbling without use of pads; and 3) using pads daily. Preoperative continence was defined as category 1 and incontinence as including both categories 2 and 3.
5
ACCEPTED MANUSCRIPT Any change of category from baseline to 12 months was defined as either positive (better) or negative (worse). This categorization was compared with the continuous UID score. A change in UID score > ±10 on the 0-100 scale was defined as a change (better/worse).18 Ellison et al.’s stratification of PPI using the UID score, classify 0-49 as severe, 50-69
RI PT
as moderate and 70-100 as mild/no PPI.12 The changes of category were also compared to the changes of categorical continence status mentioned above, although they are not directly
SC
comparable since the latter lacks discrimination on the severe end.
Sociodemographic and cancer related variables at baseline
M AN U
Comorbidity was defined as presence of ≥1 of 12 diseases listed in the demographic part of the EPIC-50.17 Paired relationship consisted of married/cohabiting patients. Level of education was dichotomized into ≤12 years and >12 years. Work status concerned currently being in paid work or not.
TE D
PCa and surgery related variables were retrieved from the patients’ medical records and
Statistics
EP
the risk group classification of D’Amico et al. was applied.19
Descriptive statistics included mean and standard deviation (SD) for continuous variables and
AC C
proportions for categorical ones. Internal consistencies of the UID and sexual domain items were tested with Cronbach’s coefficient alpha. Linear regression analyses examined the associations between baseline sociodemographic and cancer related independent variables and degree of PPI (UID score 0-100) as dependent variable. The strengths of association were expressed as beta and standardized beta coefficients.
6
ACCEPTED MANUSCRIPT The level of significance was set at p ±10), the results show a moderate agreement (kappa 0.69) (Table 4). Comparison of changes according to Herschorn et al.’s continence categories and Ellison et al.’s stratification of PPI, showed less agreement (kappa 0.47). According to Ellison et al. a larger proportion of patients were defined as stable, compared to the two other methods (58% versus 35%-38%, p±10 on the 0-100 scale from baseline to 12 months after RP was defined as a change (improved/worsened).17 c UID stratification according to Ellison et al.11 Level of agreement: Table 3 a. Kappa 0.69 and Table 3 b. Kappa 0.47.
Table 5. Linear regression analysis of baseline and cancer related variables associated with postprostatectomy incontinence a at 12 months follow-up (N=735). a
Based on the continuous urinary incontinence domain (UID) score 0-100 at 12 months, with higher scores representing better QOL. b The variables that were significant in bivariate analysis were entered into the multivariable model, except age≥65 which is highly correlated to the continuous variable age. Additionally, the previously identified risk factors surgical approach, nerve sparing, and comorbidity were also included, independently of their p-values. Collinearity statistics showed no collinearity between age, work status, comorbidity, sexual dysfunction, and incontinence (both the variance inflation factors and the tolerance statistics were close to 1 for each of the variables, i.e. no multicollinearity).
16
ACCEPTED MANUSCRIPT c
AC C
EP
TE D
M AN U
SC
RI PT
Beta: standardized coefficient. As a decreasing value of the dependent variable (UID score 0-100) reflects increasing degree of PPI a positive beta coefficient represents a positive association and a negative beta represents an inverse association with increasing degree of PPI. d Based on the patient-report of “total urinary control” at baseline vs. not. e Based on the continuous sexual domain score 0-100 at baseline. f Based on surgeon reported unilateral and bilateral nerve sparing technique.
ACCEPTED MANUSCRIPT
Items
Responses
Value
Value
EPIC
UCLA-PCI
a) More than once a day
0
0
urine?
b) About once a day
25
25
c) More than once a week
50
50
d) About once a week
75
75
100
100
0
0
33
33
67
67
100
100
0
0
33
50
67
50
d) 3 or more pads per day
100
100
4. How big a problem, if any,
a) No problem
100
100
has dripping or leaking urine
b) Very small problem
75
75
been for you?
c) Small problem
50
50
d) Moderate problem
25
25
e) Big problem
0
0
e) Rarely or never a) No urinary control whatsoever
describes your urinary
b) Frequent dribbling
control?
c) Occasional dribbling d) Total control a) None
diapers per day did you
b) 1 pad per day a
M AN U
3. How many pads or adult
EP
TE D
usually use to control leakage? c) 2 pads per day a
AC C
SC
2. Which of the following best
RI PT
1. How often have you leaked
ACCEPTED MANUSCRIPT
RI PT
513 (70) 62.8 (5.5) 282 (39) 374 (51) 683 (93) 425 (63) 283 (39) 71 (35) 10.0 (7.4) 387 (53)
SC
583 (80) 110 (15) 37 (5)
231 (32) 338 (46) 164 (22)
AC C
EP
TE D
M AN U
Baseline variables Continent a, N (%) Age, mean (SD) Age ≥ 65 years, N (%) Education >12 years, N (%) Married/living with partner, N (%) Currently working, N (%) Comorbidity present, N (%) Sexual domain score b, median (interquartile range) c Cancer related variables PSA, mean (SD) Gleason score on biopsy ≥7, N (%) Clinical T stage, N (%) ≤T2a T2b-T2c ≥T3 D’Amico risk group, N (%) Low Intermediate High Surgical approach, N (%) RARP RRP Perineal Nerve sparing, N (%) d Pathological T stage, N (%) ≤T2a T2b-T2c ≥T3 Positive margins, N (%)
507 (69) 221 (30) 7 (1) 446 (61) 92 (12) 387 (53) 254 (35) 192 (26)
ACCEPTED MANUSCRIPT
UID score, mean (SD) 12 months
All patients
94 (12)
70 (28)
Total control, no pads
100 (3)
99 (3)
Occasional dribbling, no pads
83 (11)
81 (10)
Use of ≥1 pad/d
46 (26)
42 (20)
AC C
EP
TE D
M AN U
SC
RI PT
Baseline
ACCEPTED MANUSCRIPT Change in continuous UID score b
4 a. Change in continence
Stable
Worsened
Total
Improved
14 (44)
18 (56)
0 (0)
32 (100)
Stable
12 (5)
208 (81)
36 (14)
256 (100)
Worsened
0 (0)
51 (11)
396 (89)
447 (100)
Total
26 (4)
277 (38)
432 (59)
735 (100)
Change in continence
Stable
Improved
7 (22)
25 (78)
Stable
6 (2)
Worsened
0 (0)
Total
13 (2)
TE D EP AC C
Worsened
Total
0 (0)
32 (100)
234 (91)
16 (6)
256 (100)
169 (38)
278 (62)
447 (100)
428 (58)
294 (40)
735 (100)
M AN U
Improved
categories a, N (%)
SC
Change in UID stratification c
4 b.
RI PT
Improved
categories a, N (%)
ACCEPTED MANUSCRIPT Univariate analysis
AC C
p-value
B
Beta c
p-value
-10.0 0.73 8.89 -1.59 2.29 -8.31 3.90 0.23
-0.17 0.14 0.16 -0.03 0.02 -0.15 0.07 0.21
