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Continence Definition After Radical Prostatectomy Using Urinary Quality of Life: Evaluation of Patient Reported Validated Questionnaires
Continence Definition After Radical Prostatectomy Using Urinary Quality of Life: Evaluation of Patient Reported Validated Questionnaires Michael A. Liss,* Kathryn Osann, Noah Canvasser, William Chu, Alexandra Chang, Jennifer Gan, Roger Li, Rosanne Santos, Douglas Skarecky, David S. Finley† and Thomas E. Ahlering‡ From the Departments of Urology and Medicine (KO), University of California-Irvine, Orange, California
Abbreviations and Acronyms AUAss ⫽ American Urological Association symptom score BMI ⫽ body mass index QOL ⫽ quality of life Submitted for publication June 18, 2009. Study received institutional review board approval. * Correspondence: 333 City Blvd., Suite 2100, Orange, California 92686 (telephone: 714-4567005; e-mail: [email protected]). † Financial interest and/or other relationship with Innercool Therapies. ‡ Financial interest and/or other relationship with Intuitive Surgical and Intercool Therapies.
Purpose: After radical prostatectomy continence is commonly defined as no pads except a security pad or 0 to 1 pad. We evaluated the association of pad status and urinary quality of life to determine whether security and 1 pad status differ from pad-free status to better define 0 pads as the post-prostatectomy standard. Materials and Methods: A total of 500 consecutive men underwent robot assisted radical prostatectomy from October 2003 to July 2007. Data were collected prospectively and entered into an electronic database. Postoperatively men completed self-administered validated questionnaires including questions on 1) daily pad use (0, security, 1, or 2 or more), 2) urine leakage (daily, about once weekly, less than once weekly or not at all), 3) urinary control (none, frequent dribbling, occasional dribbling or total control), 4) American Urological Association symptom score and 5) urinary quality of life. Results: Postoperatively men who indicated 0 pad use had a mean ⫾ SE symptom score of 5.8 ⫾ 0.3 and pleased quality of life (1.16 ⫾ 0.08). In contrast, men with a security pad and 1 pad had a symptom score of 7.6 ⫾ 0.7 and 9.2 ⫾ 0.6 but mixed quality of life (2.78 ⫾ 0.18 and 3.41 ⫾ 0.15, respectively, p ⬍0.0005). Conclusions: Results show a significant decrease in quality of life between no pads (1.16 or pleased), a security pad and 0 or 1 pad (2.78 and 3.41 or mixed, respectively). Findings do not support defining continence with a security pad or 0 to 1 pad. Continence should be strictly defined as 0 pads. Key Words: prostate, prostatectomy, incontinence pads, quality of life, questionnaires
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URINARY incontinence after radical prostatectomy continues to be a major factor impacting patient urinary QOL. The reported incontinence rate after radical prostatectomy is 2.9% to 87% depending on many factors, including but not limited to surgeon experience, surgical technique, baseline patient characteristics such as age, BMI, prostate weight and AUAss, and data collection method.1–9 Perhaps the most important factor confounding postoperative incontinence is
the continence definition.6–8 Various attempts have been made to unify the measurement and definition of continence after prostatectomy. The UCLA-PCI urinary function score combines objective data (number of urinary pads) and subjective urinary domains such as urinary control.6 Pad status remains a valuable objective metric that can be determined by questionnaire, and is commonly used to report continence in conjunction with a
0022-5347/10/1834-1464/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 183, 1464-1468, April 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.12.009
AND
RESEARCH, INC.
CONTINENCE DEFINITION AFTER PROSTATECTOMY USING URINARY QUALITY OF LIFE
question on leakage. However, there are different continence definitions based on pad status ranging from 0 pads to 0 pads or a security pad to 0 to 1 pad daily.9,10 We prospectively collected patient questionnaires after robotic assisted radical prostatectomy to examine urinary QOL (bother score) and the number of pads to determine differences among these patient subsets. We hypothesized that QOL and AUAss parameters would be different in men who achieved 0 pad status vs other groups historically classified according to more lenient continence definitions.
MATERIALS AND METHODS Between October 2003 and July 2007, 500 consecutive men underwent robotic assisted radical prostatectomy by a single surgeon and completed self-administered continence questionnaires. Data were prospectively collected and filed in an electronic database under institutional review board approval. Of the men 80 excluded from study due to incomplete questionnaires did not differ significantly from the study sample with respect to age, BMI, preoperative prostate specific antigen, stage or nerve sparing procedure. In large part incomplete questionnaires were due to questionnaires changing with time since initially they did not include the QOL question that was later added instead of patient noncompliance. Thus, 420 men had questionnaires analyzed that included 3 questions from the Expanded Prostate Cancer Index Composite questionnaire, including 1) daily pad use (0 pads, security, 1, or 2 or more), 2) urine leakage (daily, about once weekly, less than
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once weekly or not at all), 3) urinary control (none, frequent dribbling, occasional dribbling or total control), 4) AUAss and 5) urinary QOL. In patients who completed multiple questionnaires with time only the initial returned questionnaire was analyzed. QOL and continence are dynamic and change with time. Thus, questionnaires were also examined with adjustment for time of questionnaire completion (table 1). Each AUAss question was correlated with QOL score and pad status. To quantitate outcomes a numerical value was assigned to answers on certain questions, including 1) “Which of the following best describes your urinary control during the last 4 weeks?” (none—1, frequent dribbling—2, occasional dribbling—3 or total control— 4) and 2) “In the last 4 weeks, how often have you leaked urine?” (daily—1, about once weekly—2, less than once weekly—3 or not at all— 4). Data were analyzed using ANOVA to test for differences between groups as a function of pad status. Pairwise comparisons were made with adjustment for multiple comparisons using the Tukey method. Multiple linear regression methods were used to adjust for time from surgery to questionnaire completion. Five men with time to completion of the first questionnaire exceeding 875 days were excluded from multivariate analysis due to undue influence. Associations between pad status and AUAss, urinary control and urinary frequency were further investigated by Pearson correlations.
RESULTS A total of 420 patients had complete questionnaires. Table 2 lists patient characteristics. Table 1 lists
Table 1. First preoperative questionnaires by pad status and other urinary demains Unadjusted
Pad Status* Urinary QOL: 0 Security 1 Multiple Urinary control: 0 Security 1 Multiple Leakage frequency: 0 Security 1 Multiple Total AUAss: 0 Security 1 Multiple
No. Pts
Mean ⫾ SE
Pairwise p Value† vs Pad Free
224 54 63 74
1.16 ⫾ 0.08 2.78 ⫾ 0.16 3.41 ⫾ 0.15 4.50 ⫾ 0.14
⬍0.001 ⬍0.001 ⬍0.001
229 54 63 74
3.52 ⫾ 0.03 3.02 ⫾ 0.07 2.92 ⫾ 0.06 2.28 ⫾ 0.06
⬍0.001 ⬍0.001 ⬍0.001
224 54 63 74
2.87 ⫾ 0.06 1.41 ⫾ 0.12 1.19 ⫾ 0.11 1.08 ⫾ 0.11
⬍0.001 ⬍0.001 ⬍0.001
229 54 63 74
5.78 ⫾ 0.34 7.59 ⫾ 0.71 9.22 ⫾ 0.66 12.42 ⫾ 0.6
0.0926 ⬍0.001 ⬍0.001
* F test p ⬍0.0005. † Adjusted for multiple comparisons by Tukey method.
Adjusted for Time to Questionnaire Pairwise p Value† vs Security
0.021 ⬍0.001
0.733 ⬍0.001
0.571 0.186
0.330 0.002
Pairwise p Value† vs 1 Pad
No. Pts
Adjusted Mean
Pairwise p Value† vs Pad Free
Pairwise p Value† vs Security
Pairwise p Value† vs 1 Pad
⬍0.001
220 53 63 73
1.16 2.78 3.42 4.50
⬍0.001 ⬍0.001 ⬍0.001
0.004 ⬍0.001
⬍0.001
⬍0.001
225 53 63 73
3.51 3.02 2.92 2.27
⬍0.001 ⬍0.001 ⬍0.001
0.284 ⬍0.001
⬍0.001
0.896
220 53 63 73
2.88 1.42 1.19 1.08
⬍0.001 ⬍0.001 ⬍0.001
0.160 0.068
0.688
0.002
225 53 63 73
5.79 7.67 9.22 12.50
0.037 ⬍0.001 ⬍0.001
0.112 ⬍0.001
⬍0.001
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Table 2. Patient characteristics No. Pts Age Prostate specific antigen (ng/ml) BMI (kg/m2) Nerve sparing: Yes No Clinical stage: T1 T2 T3
420 420 388
Mean ⫾ SD (range) 60.9 ⫾ 7.2 (41–80) 6.5 ⫾ 6.2 (0.6–97.9) 26.7 ⫾ 3.4 (19.8–43.8)
415 (96.7%) 5 (3.3%) 275 (65.5%) 130 (31.0%) 15 (3.6%)
postoperative urinary questionnaires averaged over all first questionnaires submitted by pad status. Patients who achieved pad-free status (0 pads) had an associated mean ⫾ SE comprehensive QOL score of 1.16 ⫾ 0.08, corresponding to a urinary bother score of pleased and mostly satisfied. Patients wearing a security pad had a mean QOL score of 2.78 ⫾ 0.18 and a mixed bother score. Patients using an average of 1 pad daily achieved a mean QOL score of 3.41 ⫾ 0.15, corresponding to a bother score of mixed to mostly dissatisfied. Patients using multiple pads per day had a mean QOL score of 4.50 ⫾ 0.14, that is mostly dissatisfied to unhappy (table 1). In terms of subjective response 148 of 224 patients (66%) in the pad-free group were delighted or pleased but only 10 of 54 (19%) with a security pad and 2 of 63 (3%) with 1 pad were delighted or pleased. Analysis of urinary scores on the question, “Which of the following best describes your urinary control during the last 4 weeks?” revealed that the pad-free group was significantly different than the group using a security pad (mean 3.52 ⫾ 0.04 or total control vs 3.02 ⫾ 0.04, adjusted p ⬍0.001). No significant difference was observed between the security and 1 pad groups (mean 2.92 ⫾ 0.04, adjusted p ⫽ 0.73). Quantitative assessment of urinary leakage assessed by the question, “In the last 4 weeks, how often have you leaked urine?” showed that the pad-free group was statistically different from all other groups at a mean of 2.87 ⫾ 0.081 or less than once weekly (each p ⬍0.001 for each). The security, 1 and multiple pad groups showed no differences from each other on pairwise comparisons (mean scores 1.41, 1.19 and 1.08, respectively, adjusted p ⬎0.19). Mean AUAss in each group was 5.78, 7.59, 9.22 and 12.42, respectively. AUAss did not distinguish between the security and 1 pad groups (p ⫽ 0.33). Time from surgery to first questionnaire completion differed significantly by pad status (median 100, 75, 83 and 52 days for 0, security, 1 and multiple pads, respectively, Kruskal-Wallis test p ⬍0.001). ANOVA suggested significant improvement in scores on urinary QOL, urinary control and leakage as time from surgery to questionnaire
completion increased (p ⬍0.05). No such difference was noted for AUAss (p ⫽ 0.7). To adjust for potential confounding factors data were analyzed using multiple linear regression methods with time to questionnaire completion as an independent variable. Adjusted means differed minimally from unadjusted means in each subgroup (table 1). The statistical significance of pairwise subgroup comparisons persisted after adjusting for time to questionnaire completion. Overall means and pairwise comparisons in these subgroups showed larger differences between the pad-free and security pad groups than between the security and 1 pad groups. Differences between the pad-free and security pad groups were generally significant but those between the security and 1 pad groups did not attain statistical significance. Using Pearson correlations we investigated associations between pad status, urinary control, urinary frequency and each AUAss question. Pad status had the highest correlation to predict urinary QOL (r ⫽ 0.74, p ⬍0.001). Urinary control and leakage frequency questions were also strong predictors of urinary QOL (r ⫽ ⫺0.71, p ⬍0.001 and r ⫽ 0.68, p ⬍0.001, respectively).
DISCUSSION Incontinence may have the most important role in male QOL in the early postoperative period after radical prostatectomy. However, without a standardized continence definition it has become increasingly difficult to compare studies and correlate patient reported continence findings. Historically many techniques have been used to measure incontinence after radical prostatectomy, ranging from physician-patient discussion to patient reported questionnaires to more objective means, such as pad status or pad weight. A common definition of postoperative incontinence is 0 to 1 pad daily. Lepor et al examined incontinence definitions using self-reported questionnaires and found that questions on urinary control and pad status (0 or 1 pad) had good agreement with patient global assessment of continence but noted no superior incontinence definition.9 In a similar study Sacco et al further evaluated incontinence definitions and found that patients who reported no pads or an occasional pad requirement (0 or a security pad) were significantly different from patients using 0 to 1 pad with or without dribbling frequency.8 They did not include a definition of strict continence (0 pads) but noted that that 1 pad daily would be considered continent because most men wearing 1 pad consider themselves continent. Men were also grouped by pad status (no pad, occasional, 1, 2 or greater than 2 pads), and assessed for urinary
CONTINENCE DEFINITION AFTER PROSTATECTOMY USING URINARY QUALITY OF LIFE
control, leak frequency, wet problems and urinary bother. There was significant worsening in all categories, including QOL, between no pad and an occasional pad. Many investigators have used stricter incontinence definitions, such as no pads in the last 4 weeks or “the patient felt dry without the use of incontinence material.”10,11 Even more stringent definitions of perfect and imperfect continence have been reported in men wearing no pads but bother score differences between such groups were not statistically significant (p ⫽ 0.08).12 Another study showed a 1.9-fold higher continence rate when continence was defined as 0 to 1 pad rather than as a urinary control question (83% vs 43%).13 However, that group performed no QOL analysis to determine the patient impairment level. We agree with that group that clinically significant urinary incontinence after prostatectomy should be determined by the patient impairment level rather than by the symptom. With such a discrepancy in incontinence definitions there are likely subgroups in the 0 to 1 pad group that may be defined by patient QOL in relation to pad status and other urinary domains. Litwin et al noted substantial differences in QOL scores between patient reported questionnaires and surgeon reported scores, in that physicians underestimated symptoms impairing QOL. Thus, patient reported questionnaires formed the basis of our data.14 We used validated patient questionnaires on urinary control, leakage frequency, urinary QOL and pad status extrapolated from UCLA-PCI and AUAss.15–17 It is paramount that self administered questionnaires are easy for patients to understand, perform well in validity studies and have good psychometric properties. In our series pad status was the best predictor of urinary QOL, that is bother score (r ⫽ 0.740). Sacco et al reported a urinary bother correlation of 0.800 as a function of pad status but the greatest correlation in that study was leakage frequency (r ⫽ 0.859).8 We found that patient QOL was negatively associated with the number of pads daily. When questionnaires were examined subjectively, 148 of 224 men (66%) with pad-free status were delighted or pleased but only 10 of 54 (19%) and 2 of 63 (3%) in the security and 1 pad groups, respectively, were delighted or pleased. Men wearing a pad for reassurance were affected as much as men wearing 1 pad as a necessity. However, one could argue for a difference in QOL between these 2 groups, making them a distinct category. Beyond subjective QOL terms AUAss, urinary control and leakage fre-
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quency questions in men with a security pad were more closely associated with those in men with 1 pad daily and not with pad-free men (table 1). Some studies suggest that postoperative urinary continence 12 months after prostatectomy is more accurate than at earlier time points.8 Thus, we evaluated the change in urinary domains with time by pad status. All domains except AUAss changed significantly with time to indicate improvement. Urinary QOL improved with time in each pad status group. Specifically the 0 and security pad groups continued to have a statistically significant difference in QOL. A few reasonable assumptions on incontinence may be made besides natural improvement in incontinence after prostatectomy. This improvement is different in each man, in that those who are worse off at the start with multiple pads daily may be less bothered when they achieve 1 pad daily compared to those who remain at 1 pad daily without improvement. Most men are unhappy with wearing pads for urinary incontinence after prostatectomy no matter what the baseline AUAss. Patient QOL is the most important correlate when assessing patient urinary status and it is significantly associated with pad status. Patient urinary QOL would be the most pertinent information before offering surgical management with a male sling or artificial urinary sphincter to correct urinary incontinence. Using an umbrella term such as 0 to 1 pad to describe urinary continence after radical prostatectomy is inaccurate and dismissive of patient QOL. These results show that men in the pad-free, security pad and 1 pad groups are significantly different. Some men may wear a security pad although they are dry, and some men leak urine and do not wear a security pad. Nevertheless, urinary leakage and urinary control validated questions did not distinguish between security and 1 pad status but consistently distinguished the pad-free group from all other pad status groups.
CONCLUSIONS Standardized patient questionnaires to measure outcomes after radical prostatectomy are an invaluable tool to evaluate postoperative incontinence and assist with counseling patients on expectations. In addition to pad status, using AUAss, urinary control and incontinence frequency questions provides accurate assessment of incontinence and correlates with QOL. Findings support the pad-free definition of post-prostatectomy continence to exclude men using security pads since they are more comparable to men wearing 1 pad.
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REFERENCES 1. Bauer RM, Bastian PJ, Gozzi C et al: Postprostatectomy incontinence: all about diagnosis and management. Eur Urol 2009; 55: 322. 2. Catalona WJ, Carvalhal GF, Mager DE et al: Potency, continence and complication rates in 1,870 consecutive radical retropubic prostatectomies. J Urol 1999; 162: 433. 3. Grise P and Thurman S: Urinary incontinence following treatment of localized prostate cancer. Cancer Control 2001; 8: 532. 4. Stanford JL, Feng Z, Hamilton AS et al: Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA 2000; 283: 354. 5. Olsson LE, Salomon L, Nadu A et al: Prospective patient-reported continence after laparoscopic radical prostatectomy. Urology 2001; 58: 570. 6. Krupski TL, Saigal CS and Litwin MS: Variation in continence and potency by definition. J Urol 2003; 170: 1291.
7. Wei JT, Dunn RL, Marcovich R et al: Prospective assessment of patient reported urinary continence after radical prostatectomy. J Urol 2000; 164: 744.
13. Kielb S, Dunn DL, Rashid MG et al: Assessment of early continence recover after radical prostatectomy: patient reported symptoms and impairment. J Urol 2001; 166: 958.
8. Sacco E, Prayer-Galetti T, Pinto F et al: Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long-term followup. BJU Int 2006; 97: 1234.
14. Litwin MS, Lubeck DP, Henning JM et al: Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database. J Urol 1998; 159: 1988.
9. Lepor H, Kaci L and Xue X: Continence following radical retropubic prostatectomy using self-reporting instruments. J Urol 2004; 171: 1212.
15. Barry MJ, Fowler FJ, O’Leary MP et al: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 1992; 148: 1549.
10. Walsh PC, Marschke P, Ricker D et al: Patientreported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000; 55: 58. 11. van Kampen M, De Weerdt W, van Poppel H et al: Prediction of urinary continence following radical prostatectomy. Urol Int 1998; 60: 80. 12. Rodriguez E, Skarecky DW and Ahlering TE: Postrobotic prostatectomy urinary continence: characterization of perfect continence versus occasional dribbling in pad-free men. Urology 2006; 67: 785.
16. Fowler F, Marry M, Lu-Yao G et al: Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a Medicare survey. Urology 1995; 45: 1007. 17. Lepor H and Kaci L: The impact of open radical retropubic prostatectomy on continence and lower urinary tract symptoms: a prospective assessment using validated self-administered outcome instruments. J Urol 2004; 171: 1216.
Abbreviations and Acronyms AUAss ⫽ American Urological Association symptom score BMI ⫽ body mass index QOL ⫽ quality of life Submitted for publication June 18, 2009. Study received institutional review board approval. * Correspondence: 333 City Blvd., Suite 2100, Orange, California 92686 (telephone: 714-4567005; e-mail: [email protected]). † Financial interest and/or other relationship with Innercool Therapies. ‡ Financial interest and/or other relationship with Intuitive Surgical and Intercool Therapies.
Purpose: After radical prostatectomy continence is commonly defined as no pads except a security pad or 0 to 1 pad. We evaluated the association of pad status and urinary quality of life to determine whether security and 1 pad status differ from pad-free status to better define 0 pads as the post-prostatectomy standard. Materials and Methods: A total of 500 consecutive men underwent robot assisted radical prostatectomy from October 2003 to July 2007. Data were collected prospectively and entered into an electronic database. Postoperatively men completed self-administered validated questionnaires including questions on 1) daily pad use (0, security, 1, or 2 or more), 2) urine leakage (daily, about once weekly, less than once weekly or not at all), 3) urinary control (none, frequent dribbling, occasional dribbling or total control), 4) American Urological Association symptom score and 5) urinary quality of life. Results: Postoperatively men who indicated 0 pad use had a mean ⫾ SE symptom score of 5.8 ⫾ 0.3 and pleased quality of life (1.16 ⫾ 0.08). In contrast, men with a security pad and 1 pad had a symptom score of 7.6 ⫾ 0.7 and 9.2 ⫾ 0.6 but mixed quality of life (2.78 ⫾ 0.18 and 3.41 ⫾ 0.15, respectively, p ⬍0.0005). Conclusions: Results show a significant decrease in quality of life between no pads (1.16 or pleased), a security pad and 0 or 1 pad (2.78 and 3.41 or mixed, respectively). Findings do not support defining continence with a security pad or 0 to 1 pad. Continence should be strictly defined as 0 pads. Key Words: prostate, prostatectomy, incontinence pads, quality of life, questionnaires
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URINARY incontinence after radical prostatectomy continues to be a major factor impacting patient urinary QOL. The reported incontinence rate after radical prostatectomy is 2.9% to 87% depending on many factors, including but not limited to surgeon experience, surgical technique, baseline patient characteristics such as age, BMI, prostate weight and AUAss, and data collection method.1–9 Perhaps the most important factor confounding postoperative incontinence is
the continence definition.6–8 Various attempts have been made to unify the measurement and definition of continence after prostatectomy. The UCLA-PCI urinary function score combines objective data (number of urinary pads) and subjective urinary domains such as urinary control.6 Pad status remains a valuable objective metric that can be determined by questionnaire, and is commonly used to report continence in conjunction with a
0022-5347/10/1834-1464/0 THE JOURNAL OF UROLOGY® © 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 183, 1464-1468, April 2010 Printed in U.S.A. DOI:10.1016/j.juro.2009.12.009
AND
RESEARCH, INC.
CONTINENCE DEFINITION AFTER PROSTATECTOMY USING URINARY QUALITY OF LIFE
question on leakage. However, there are different continence definitions based on pad status ranging from 0 pads to 0 pads or a security pad to 0 to 1 pad daily.9,10 We prospectively collected patient questionnaires after robotic assisted radical prostatectomy to examine urinary QOL (bother score) and the number of pads to determine differences among these patient subsets. We hypothesized that QOL and AUAss parameters would be different in men who achieved 0 pad status vs other groups historically classified according to more lenient continence definitions.
MATERIALS AND METHODS Between October 2003 and July 2007, 500 consecutive men underwent robotic assisted radical prostatectomy by a single surgeon and completed self-administered continence questionnaires. Data were prospectively collected and filed in an electronic database under institutional review board approval. Of the men 80 excluded from study due to incomplete questionnaires did not differ significantly from the study sample with respect to age, BMI, preoperative prostate specific antigen, stage or nerve sparing procedure. In large part incomplete questionnaires were due to questionnaires changing with time since initially they did not include the QOL question that was later added instead of patient noncompliance. Thus, 420 men had questionnaires analyzed that included 3 questions from the Expanded Prostate Cancer Index Composite questionnaire, including 1) daily pad use (0 pads, security, 1, or 2 or more), 2) urine leakage (daily, about once weekly, less than
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once weekly or not at all), 3) urinary control (none, frequent dribbling, occasional dribbling or total control), 4) AUAss and 5) urinary QOL. In patients who completed multiple questionnaires with time only the initial returned questionnaire was analyzed. QOL and continence are dynamic and change with time. Thus, questionnaires were also examined with adjustment for time of questionnaire completion (table 1). Each AUAss question was correlated with QOL score and pad status. To quantitate outcomes a numerical value was assigned to answers on certain questions, including 1) “Which of the following best describes your urinary control during the last 4 weeks?” (none—1, frequent dribbling—2, occasional dribbling—3 or total control— 4) and 2) “In the last 4 weeks, how often have you leaked urine?” (daily—1, about once weekly—2, less than once weekly—3 or not at all— 4). Data were analyzed using ANOVA to test for differences between groups as a function of pad status. Pairwise comparisons were made with adjustment for multiple comparisons using the Tukey method. Multiple linear regression methods were used to adjust for time from surgery to questionnaire completion. Five men with time to completion of the first questionnaire exceeding 875 days were excluded from multivariate analysis due to undue influence. Associations between pad status and AUAss, urinary control and urinary frequency were further investigated by Pearson correlations.
RESULTS A total of 420 patients had complete questionnaires. Table 2 lists patient characteristics. Table 1 lists
Table 1. First preoperative questionnaires by pad status and other urinary demains Unadjusted
Pad Status* Urinary QOL: 0 Security 1 Multiple Urinary control: 0 Security 1 Multiple Leakage frequency: 0 Security 1 Multiple Total AUAss: 0 Security 1 Multiple
No. Pts
Mean ⫾ SE
Pairwise p Value† vs Pad Free
224 54 63 74
1.16 ⫾ 0.08 2.78 ⫾ 0.16 3.41 ⫾ 0.15 4.50 ⫾ 0.14
⬍0.001 ⬍0.001 ⬍0.001
229 54 63 74
3.52 ⫾ 0.03 3.02 ⫾ 0.07 2.92 ⫾ 0.06 2.28 ⫾ 0.06
⬍0.001 ⬍0.001 ⬍0.001
224 54 63 74
2.87 ⫾ 0.06 1.41 ⫾ 0.12 1.19 ⫾ 0.11 1.08 ⫾ 0.11
⬍0.001 ⬍0.001 ⬍0.001
229 54 63 74
5.78 ⫾ 0.34 7.59 ⫾ 0.71 9.22 ⫾ 0.66 12.42 ⫾ 0.6
0.0926 ⬍0.001 ⬍0.001
* F test p ⬍0.0005. † Adjusted for multiple comparisons by Tukey method.
Adjusted for Time to Questionnaire Pairwise p Value† vs Security
0.021 ⬍0.001
0.733 ⬍0.001
0.571 0.186
0.330 0.002
Pairwise p Value† vs 1 Pad
No. Pts
Adjusted Mean
Pairwise p Value† vs Pad Free
Pairwise p Value† vs Security
Pairwise p Value† vs 1 Pad
⬍0.001
220 53 63 73
1.16 2.78 3.42 4.50
⬍0.001 ⬍0.001 ⬍0.001
0.004 ⬍0.001
⬍0.001
⬍0.001
225 53 63 73
3.51 3.02 2.92 2.27
⬍0.001 ⬍0.001 ⬍0.001
0.284 ⬍0.001
⬍0.001
0.896
220 53 63 73
2.88 1.42 1.19 1.08
⬍0.001 ⬍0.001 ⬍0.001
0.160 0.068
0.688
0.002
225 53 63 73
5.79 7.67 9.22 12.50
0.037 ⬍0.001 ⬍0.001
0.112 ⬍0.001
⬍0.001
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Table 2. Patient characteristics No. Pts Age Prostate specific antigen (ng/ml) BMI (kg/m2) Nerve sparing: Yes No Clinical stage: T1 T2 T3
420 420 388
Mean ⫾ SD (range) 60.9 ⫾ 7.2 (41–80) 6.5 ⫾ 6.2 (0.6–97.9) 26.7 ⫾ 3.4 (19.8–43.8)
415 (96.7%) 5 (3.3%) 275 (65.5%) 130 (31.0%) 15 (3.6%)
postoperative urinary questionnaires averaged over all first questionnaires submitted by pad status. Patients who achieved pad-free status (0 pads) had an associated mean ⫾ SE comprehensive QOL score of 1.16 ⫾ 0.08, corresponding to a urinary bother score of pleased and mostly satisfied. Patients wearing a security pad had a mean QOL score of 2.78 ⫾ 0.18 and a mixed bother score. Patients using an average of 1 pad daily achieved a mean QOL score of 3.41 ⫾ 0.15, corresponding to a bother score of mixed to mostly dissatisfied. Patients using multiple pads per day had a mean QOL score of 4.50 ⫾ 0.14, that is mostly dissatisfied to unhappy (table 1). In terms of subjective response 148 of 224 patients (66%) in the pad-free group were delighted or pleased but only 10 of 54 (19%) with a security pad and 2 of 63 (3%) with 1 pad were delighted or pleased. Analysis of urinary scores on the question, “Which of the following best describes your urinary control during the last 4 weeks?” revealed that the pad-free group was significantly different than the group using a security pad (mean 3.52 ⫾ 0.04 or total control vs 3.02 ⫾ 0.04, adjusted p ⬍0.001). No significant difference was observed between the security and 1 pad groups (mean 2.92 ⫾ 0.04, adjusted p ⫽ 0.73). Quantitative assessment of urinary leakage assessed by the question, “In the last 4 weeks, how often have you leaked urine?” showed that the pad-free group was statistically different from all other groups at a mean of 2.87 ⫾ 0.081 or less than once weekly (each p ⬍0.001 for each). The security, 1 and multiple pad groups showed no differences from each other on pairwise comparisons (mean scores 1.41, 1.19 and 1.08, respectively, adjusted p ⬎0.19). Mean AUAss in each group was 5.78, 7.59, 9.22 and 12.42, respectively. AUAss did not distinguish between the security and 1 pad groups (p ⫽ 0.33). Time from surgery to first questionnaire completion differed significantly by pad status (median 100, 75, 83 and 52 days for 0, security, 1 and multiple pads, respectively, Kruskal-Wallis test p ⬍0.001). ANOVA suggested significant improvement in scores on urinary QOL, urinary control and leakage as time from surgery to questionnaire
completion increased (p ⬍0.05). No such difference was noted for AUAss (p ⫽ 0.7). To adjust for potential confounding factors data were analyzed using multiple linear regression methods with time to questionnaire completion as an independent variable. Adjusted means differed minimally from unadjusted means in each subgroup (table 1). The statistical significance of pairwise subgroup comparisons persisted after adjusting for time to questionnaire completion. Overall means and pairwise comparisons in these subgroups showed larger differences between the pad-free and security pad groups than between the security and 1 pad groups. Differences between the pad-free and security pad groups were generally significant but those between the security and 1 pad groups did not attain statistical significance. Using Pearson correlations we investigated associations between pad status, urinary control, urinary frequency and each AUAss question. Pad status had the highest correlation to predict urinary QOL (r ⫽ 0.74, p ⬍0.001). Urinary control and leakage frequency questions were also strong predictors of urinary QOL (r ⫽ ⫺0.71, p ⬍0.001 and r ⫽ 0.68, p ⬍0.001, respectively).
DISCUSSION Incontinence may have the most important role in male QOL in the early postoperative period after radical prostatectomy. However, without a standardized continence definition it has become increasingly difficult to compare studies and correlate patient reported continence findings. Historically many techniques have been used to measure incontinence after radical prostatectomy, ranging from physician-patient discussion to patient reported questionnaires to more objective means, such as pad status or pad weight. A common definition of postoperative incontinence is 0 to 1 pad daily. Lepor et al examined incontinence definitions using self-reported questionnaires and found that questions on urinary control and pad status (0 or 1 pad) had good agreement with patient global assessment of continence but noted no superior incontinence definition.9 In a similar study Sacco et al further evaluated incontinence definitions and found that patients who reported no pads or an occasional pad requirement (0 or a security pad) were significantly different from patients using 0 to 1 pad with or without dribbling frequency.8 They did not include a definition of strict continence (0 pads) but noted that that 1 pad daily would be considered continent because most men wearing 1 pad consider themselves continent. Men were also grouped by pad status (no pad, occasional, 1, 2 or greater than 2 pads), and assessed for urinary
CONTINENCE DEFINITION AFTER PROSTATECTOMY USING URINARY QUALITY OF LIFE
control, leak frequency, wet problems and urinary bother. There was significant worsening in all categories, including QOL, between no pad and an occasional pad. Many investigators have used stricter incontinence definitions, such as no pads in the last 4 weeks or “the patient felt dry without the use of incontinence material.”10,11 Even more stringent definitions of perfect and imperfect continence have been reported in men wearing no pads but bother score differences between such groups were not statistically significant (p ⫽ 0.08).12 Another study showed a 1.9-fold higher continence rate when continence was defined as 0 to 1 pad rather than as a urinary control question (83% vs 43%).13 However, that group performed no QOL analysis to determine the patient impairment level. We agree with that group that clinically significant urinary incontinence after prostatectomy should be determined by the patient impairment level rather than by the symptom. With such a discrepancy in incontinence definitions there are likely subgroups in the 0 to 1 pad group that may be defined by patient QOL in relation to pad status and other urinary domains. Litwin et al noted substantial differences in QOL scores between patient reported questionnaires and surgeon reported scores, in that physicians underestimated symptoms impairing QOL. Thus, patient reported questionnaires formed the basis of our data.14 We used validated patient questionnaires on urinary control, leakage frequency, urinary QOL and pad status extrapolated from UCLA-PCI and AUAss.15–17 It is paramount that self administered questionnaires are easy for patients to understand, perform well in validity studies and have good psychometric properties. In our series pad status was the best predictor of urinary QOL, that is bother score (r ⫽ 0.740). Sacco et al reported a urinary bother correlation of 0.800 as a function of pad status but the greatest correlation in that study was leakage frequency (r ⫽ 0.859).8 We found that patient QOL was negatively associated with the number of pads daily. When questionnaires were examined subjectively, 148 of 224 men (66%) with pad-free status were delighted or pleased but only 10 of 54 (19%) and 2 of 63 (3%) in the security and 1 pad groups, respectively, were delighted or pleased. Men wearing a pad for reassurance were affected as much as men wearing 1 pad as a necessity. However, one could argue for a difference in QOL between these 2 groups, making them a distinct category. Beyond subjective QOL terms AUAss, urinary control and leakage fre-
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quency questions in men with a security pad were more closely associated with those in men with 1 pad daily and not with pad-free men (table 1). Some studies suggest that postoperative urinary continence 12 months after prostatectomy is more accurate than at earlier time points.8 Thus, we evaluated the change in urinary domains with time by pad status. All domains except AUAss changed significantly with time to indicate improvement. Urinary QOL improved with time in each pad status group. Specifically the 0 and security pad groups continued to have a statistically significant difference in QOL. A few reasonable assumptions on incontinence may be made besides natural improvement in incontinence after prostatectomy. This improvement is different in each man, in that those who are worse off at the start with multiple pads daily may be less bothered when they achieve 1 pad daily compared to those who remain at 1 pad daily without improvement. Most men are unhappy with wearing pads for urinary incontinence after prostatectomy no matter what the baseline AUAss. Patient QOL is the most important correlate when assessing patient urinary status and it is significantly associated with pad status. Patient urinary QOL would be the most pertinent information before offering surgical management with a male sling or artificial urinary sphincter to correct urinary incontinence. Using an umbrella term such as 0 to 1 pad to describe urinary continence after radical prostatectomy is inaccurate and dismissive of patient QOL. These results show that men in the pad-free, security pad and 1 pad groups are significantly different. Some men may wear a security pad although they are dry, and some men leak urine and do not wear a security pad. Nevertheless, urinary leakage and urinary control validated questions did not distinguish between security and 1 pad status but consistently distinguished the pad-free group from all other pad status groups.
CONCLUSIONS Standardized patient questionnaires to measure outcomes after radical prostatectomy are an invaluable tool to evaluate postoperative incontinence and assist with counseling patients on expectations. In addition to pad status, using AUAss, urinary control and incontinence frequency questions provides accurate assessment of incontinence and correlates with QOL. Findings support the pad-free definition of post-prostatectomy continence to exclude men using security pads since they are more comparable to men wearing 1 pad.
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