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Pad Use and Patient Reported Bother From Urinary Leakage After Radical Prostatectomy
Pad Use and Patient Reported Bother From Urinary Leakage After Radical Prostatectomy Anna Wallerstedt,* Stefan Carlsson, Andreas E. Nilsson, Eva Johansson, Tommy Nyberg, Gunnar Steineck† and N. Peter Wiklund† From the Department of Molecular Medicine and Surgery, Section of Urology (AW, SC, AEN, NPW) and Department of Oncology and Pathology, Section of Clinical Cancer Epidemiology (EJ, TN, GS), Karolinska Institutet, Stockholm and Institute of Clinical Sciences, Department of Oncology, Division of Clinical Cancer Epidemiology, The Sahlgrenska Academy (GS), Gothenburg, Sweden Submitted for publication May 9, 2011. Study received ethics committee approval. * Correspondence: Department of Urology, Karolinska University Hospital, SE-171 76 Stockholm, Sweden (telephone: ⫹ 46 8 51775400; FAX: ⫹ 46 8 51773599; e-mail: anna.wallerstedt@ karolinska.se). † Equal study contribution.
Purpose: To better understand clinically significant definitions of urinary incontinence we investigated the relationship between urinary leakage and patient reported bother from urinary leakage. Materials and Methods: A consecutive series of 1,411 men who underwent radical prostatectomy at Karolinska University Hospital, Stockholm, Sweden, from 2002 to 2006 were invited to complete a study specific questionnaire with questions on pad status, urinary leakage and bother from urinary leakage. Results: Questionnaires were received from 1,179 men with a followup of greater than 1 year (median 2.2). Results showed that even a small amount of urinary leakage resulted in a high risk of urinary bother. Of 775 survivors 46 (6%) reporting 0 pads indicated moderate or much bother compared to 38 of 123 (31%) who reported using a security pad. When comparing the 2 groups, the risk of bother from urinary leakage was more than 5 times higher in the safety pad vs the 0 pad group (RR 5.2, 95% CI 3.5–7.7). As the number of pads increased, we noted a higher bother risk. Cross-tabulation of pad use and urinary leakage revealed wide variation in pad requirements despite the same answer to urinary leakage questions. Conclusions: If the definition of continence is based on pad use, for example safety pads, a certain number of men who report moderate or much bother from urinary leakage will be defined as continent. Our results also show that for each stated rate of urinary leakage men prove to have a major variation in the pad requirement. Key Words: prostate, prostatic neoplasms, prostatectomy, urinary incontinence, quality of life
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www.jurology.com
KNOWLEDGE of the risk of urinary leakage after radical prostatectomy is of major concern for the patient before radical prostatectomy.1,2 The estimated urinary incontinence rate after radical prostatectomy varies widely in published studies from 8% to 77%.3 One of several explanations for the variation could be the lack of consensus on how to quantify and define postoperative incontinence. The in-
continence rate depends on many factors, such as surgical technique, patient specific factors, time since surgery, who assesses and reports (patient, physician or other) and the means of retrieving information. An important factor may also be that different theoretical definitions of incontinence are used. There are many different continence definitions based on pad status. However, during
0022-5347/12/1871-0196/0 THE JOURNAL OF UROLOGY® © 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 187, 196-200, January 2012 Printed in U.S.A. DOI:10.1016/j.juro.2011.09.030
AND
RESEARCH, INC.
PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
the last few years a growing body of literature has underscored the need for more patient centered assessment of urinary quality of life as it relates to postoperative incontinence.4,5 Sweden offers favorable conditions for long-term followup of cancer survivors. With personal identity numbers we can trace each Swedish resident in population based registers and eliminate selection induced problems during followup. In our cancer survivorship program we established a format to develop study specific questionnaires based on qualitative information and collect quantitative data with a high participation rate.6,7 Using these methods we have followed all survivors who underwent radical prostatectomy at our center between 2002 and 2006. In this study we evaluated the definition of postoperative urinary continence after radical prostatectomy using self-reported urinary bother and urinary leakage.
PATIENTS AND METHODS A total of 1,411 consecutive patients at Karolinska University Hospital underwent radical prostatectomy (open surgery or robot-assisted laparoscopic surgery) for prostate cancer between January 2002 and December 2006. All patients operated on during this period were included in analysis and no exclusion criteria were set. Clinical data were prospectively collected on clinical stage, biopsy Gleason score and preoperative prostate specific antigen, and routine pathology reports provided data on prostate weight. The functional outcome was assessed postoperatively with a validated quality of life questionnaire with an emphasis on urinary and sexual function. We developed the questionnaire using the format previously developed in our cancer survivorship program.6 – 8 The questionnaire was refined after 7 in-depth interviews with patients who underwent radical prostatectomy. Face-to-face validation, in which an investigator accompanied 10 patients when completing the questionnaire, ensured that the questions and answering alternatives were understood correctly. To evaluate postoperative incontinence we analyzed answers to 3 questions on urinary leakage (see Appendix). Questions 1 and 2 were included in the main questionnaire while 541 of 1,179 survivors also answered a questionnaire with an additional question on urinary leakage (question 3). This questionnaire was sent 12 months postoperatively to patients operated on between 2005 and 2006. To evaluate the effect of postoperative urinary leakage we also evaluated urinary bother (see Appendix). An independent third party9 collected the questionnaire. Between February and December 2007 all survivors in the study group received a letter explaining the study objectives and an invitation to provide information. After they received this letter we telephoned them to ask whether they would consider participating in the study. To those who agreed to participate we sent a questionnaire. Ten days later they received a combined thank you and reminder card. As needed, an interviewer made a
197
reminder telephone call. The ethics committee approved the study. Informed consent was obtained by an interviewer during the initial telephone contact. Only patients with followup longer than 1 year were included in the study. Statistical analysis was done to calculate the proportion of patients with moderate or much bother from urinary leakage. We used SAS®, version 9.2 for all calculations. Groups were compared using relative risk, defined as the ratio of proportions, which was estimated according to the log binomial regression model and presented with the 95% CI. Subjects with missing data on 1 or more questions under consideration were excluded from each respective calculation.
RESULTS Questionnaires were returned by 1,288 patients (91%), of whom 1,179 had greater than 1-year followup. Of the 1,179 patients 411 underwent open retropubic radical prostatectomy, including 6 in the subgroup, and 768 underwent robot-assisted laparoscopic radical prostatectomy, including 535 in the subgroup. Overall and in the subgroup median age at surgery was 63 (range 37 to 78, IQR 58 – 67) and 63 years (range 43 to 78, IQR 58 – 66), median age at followup was 65 (range 41 to 79, IQR 61– 69) and 65 years (range 44 to 79, IQR 61– 68), median followup was 2.2 (range 1 to 5, IQR 1.6 –3.3) and 1.7 years (range 1 to 4, IQR 1.4 –2.4) and median preoperative prostate specific antigen was 6.9 (range 0.4 to 117, IQR 5.0 –9.7) and 6.7 ng/ml (range 0.8 to 26, IQR 4.8 –9.3). Clinical stage was T1 to T3 in 702 (60%), 422 (36%) and 55 (5%) of men overall, and in 331 (61%), 192 (35%) and 18 (3%) in the subgroup, respectively. (Percents do not equal 100% due to rounding.) Pad Use and Urinary Leakage Correlation with urinary bother. Of 1,163 patients 775 (67%) reported no pad use while 123 (11%) reported less than 1 and 143 (12%) reported 1 pad used per day. When correlating pad status with urinary bother, survivors who used security pads (fewer than 1 per day) were at higher risk for moderate or much bother from urinary leakage, that is a risk more than 5 times higher than those using no pad (RR 5.2, CI 95% 3.5–7.7, table 1). As the number of pads increased, the risk of bother increased (part A of figure). When looking at question 2 on urinary leakage, 534 of 1,160 men (46%) reported no leakage while 504 (43%) reported little leakage. The answers also showed a significant increase of bother risk for little vs no urinary leakage (RR 22.0, CI 95% 10.5– 46.7, table 1). The risk of bother increased as the leakage rate increased (part B of figure). A subgroup of 541 survivors followed more than 1 year also answered a questionnaire with the third
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PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
Table 1. Urinary leakage bother 12 months after radical prostatectomy No. Bother Question (No.) No. pads (1): 6 or Greater 4–5 2–3 1 Less than 1 0 Leakage (2): Much Moderate Little None Leakage (3): Continuous pad change Wet pad Safety pad Physical activity pad Never
No. Pts
Not Applicable
None
Little
Moderate
Much
Moderate/Much RR (95% CI)
12 25 85 143 123 775
0 0 0 2 8 542
0 1 3 13 23 88
1 2 18 51 54 99
3 7 25 39 23 23
8 15 39 38 15 23
15.4 (11.1–21.4) 14.8 (10.8–20.3) 12.7 (9.4–17.2) 9.1 (6.6–12.5) 5.2 (3.5–7.7) 1.0 (referent)
42 80 504 534
0 0 49 499
1 1 111 15
2 12 198 13
5 25 89 2
34 42 57 5
70.8 (33.8–148.6) 63.9 (30.4–134.2) 22.0 (10.5–46.7) 1.0 (referent)
12 16 78 214 206
2 2 4 79 165
0 0 4 43 20
2 3 28 60 16
2 2 23 19 3
6 9 19 13 2
27.5 (10.6–71.3) 28.3 (11.2–71.6) 22.2 (9.1–54.0) 6.1 (2.4–15.5) 1.0 (referent)
question on urinary leakage. Of 526 men 206 (39%) reported no leakage and 214 (41%) reported using pads during physical activity. When evaluating urinary incontinence bother, 15% of survivors who had leakage during coughing or sneezing, or used pads during physical activity reported moderate or much bother compared to 2% in the no leakage group (RR 6.1, 95% CI 2.4 –15.5, table 1). In this group we also noted an increasing bother rate with increasing leakage (part C of figure). Cross-tabulation. To evaluate the responses to the 3 urinary leakage questions we compared answers using cross-tabulation (table 2). At 1-year or greater followup 776 survivors (66%) reported using 0 pads per day, including 514 (66%) who reported no and 255 (33%) who reported little urinary leakage. Of survivors who reported using fewer than 1 pad per day 14 (11%) reported no leakage and 101 (82%) reported little leakage. In the group that reported little leakage the answers on pad requirements varied widely. Of the respondents 255 (51%) used 0, 101 (20%) used fewer than 1 and 104 (21%) used 1 pad per day. Cross-tabulation of pad status and urinary leakage question 3 for the subgroup of 536 men
revealed that among survivors who reported using a safety pad the pad requirement varied widely with 18% reporting the use of 2 or 3 pads per day (table 2).
DISCUSSION If the definition of continence consists of pad use, for example use of a safety pad, a certain number of men who experience moderate or much bother from urinary leakage will nevertheless be considered continent. Even a specific fraction of those who only have occasional, small amounts of leakage are bothered moderately or much by urinary leakage. In addition, for each stated rate of urinary leakage the men reported a wide variation in the pad requirement. In 2006 Sacco et al examined the records of 985 prostate cancer survivors who underwent radical retropubic prostatectomy.10 They found a clear distinction between users of 0 pads and occasional pad users concerning a score for degree of urinary control as well as urinary bother. Liss et al evaluated the continence definition in a study of 500 consecutive men after radical prostatectomy in 2009 by examining the association of pad status and urinary bother score.11 They
A to C, urinary leakage bother, as measured by 3 questions. phys, physical.
PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
Table 2. Urinary leakage and daily pad requirement cross-tabulation Leakage Question No. 2: None Little Moderate Much Not stated 3: Never Physical activity pad Safety pad Wet pad Continuous leakage Not stated
No. 0 Pad*
No. Less No. No. No. 6 No. Than No. 1 2–3 4–5 Pads or Not Total 1 Pad Pad Pads Pads Greater Stated No.
776 514 225 3 0 4 364 201 148
123 14 101 8 0 0 67 2 43
143 5 104 31 1 2 68 1 18
85 0 37 31 17 0 29 3 4
25 0 3 5 17 0 6 0 0
12 0 3 2 7 0 2 0 0
15 3 3 0 0 9 5 3 2
1,179 536 506 80 42 15 541 210 215
6 2 2
17 2 0
38 5 4
14 5 3
3 2 1
0 0 2
0 0 0
78 16 12
5
3
2
0
0
0
0
10
* Not applicable or no pad use reported.
found a significant difference in the urinary bother score between men who reported using 0 pads vs a security pad (mean ⫾ SEM score 2.78 ⫾ 0.16 vs 1.16 ⫾ 0.08). They stated that continence should be strictly defined as 0 pads and our data support this. At a mean of 75 weeks postoperatively Cooperberg et al investigated 168 men who underwent radical retropubic prostatectomy.5 Bother was significantly lower in the 0 pad group than in the group using 1 pad. Reynolds et al recently examined the records of 1,005 survivors after robot-assisted radical prostatectomy for continence variables and urinary bother scores 1, 3, 6, 12 and 24 months after surgery.12 Leak-free, padfree continence was defined by combining answers to 2 urinary incontinence questions on which survivors had answered “urinary leakage—not at all” plus “no use of pads.” The urinary bother score was significantly lower at 12 months of followup than at baseline in survivors who were leak and pad free preoperatively (82 vs 90, p ⫽ 0.002). We noted a highly increased risk of bother at a low frequency of urinary leakage. When evaluating pad status, 31% of men in the less than 1 pad group reported much or moderate bother compared to 6% in the 0 pad group. The relative high bother in the 0 pad group might be explained by simply recognizing that no pad use is not always equivalent to no leakage. Of the combination leak-free and pad-free survivors in our study only 5 of 514 (1%) reported moderate or much bother. This confirms that the definition of continence requiring that the survivor be leak and pad free results in the classification of only a few men as continent who are bothered by leakage. Pad-free status was proposed as a universal definition of post-prostatectomy continence.13 Rodriguez et al found that 69% of men who reported
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pad-free status claimed occasional leakage.14 Preoperatively they were older and had greater prostate weight, higher preoperative and postoperative American Urological Association symptom scores, and urinary bother scores. Krupski et al evaluated 269 men who underwent radical prostatectomy for early stage prostate cancer to determine how well 6 definitions of continence corresponded with each other.15 The correspondence varied widely. Of men who reported no pad use only 42% responded no leakage. They also looked at other definitions with higher concordance with 98% of survivors who used no pads claiming total control. They concluded that continence varies greatly depending on the specific definition used. Our cross-tabulation of the relationship between pad use and urinary leakage reveals a wide variation in pad use despite the same answer to urinary leakage questions. This indicates that pad use and changing depends on many factors, of which the degree of urinary leakage is only 1 factor. Of survivors who reported no pad use 33% also reported little urinary leakage. Pad-free status according to the available data does not always imply continence. Another important aspect, which is seldom discussed, that could explain the major variation in pad use is pad size. The question of pad status does not deal with the size of the pad. Such information may refine our possibilities of describing how pad use and urinary bother are associated. Our results indicate difficulty in interpreting the answers based on pad status since survivors tend to change pads differently, often quite independently of the rate of urinary leakage and without reference to the size of the pad in question. These factors would be less important if the definition of continence were 0 pads. Litwin et al noted substantial differences between patient reported quality of life scores and surgeon reported scores.4 An explanation could be that some patients tend to withhold their symptoms when speaking to a surgeon. We used patient reported and not surgeon reported outcomes. Questionnaires were mailed by the patient directly to a third party so that surgeons were unaware of the answers. The strengths of our study are the large population evaluated, the high participation rate and the questionnaire based method. The main study limitation is that we did not use an objective method to evaluate urinary leakage. However, due to the large study population performing urodynamic assessment or a pad test would have been difficult. We used no study exclusion criteria and, thus, included a mixture of modifying factors (if they existed), as they presented at our center. Future studies may address the extent to which concomitant treatment, eg postoperative radiation therapy, or intercurrent disease modifies the relation between having urinary leakage and having urinary bother.
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PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
CONCLUSIONS Results reveal that no pad use is not equivalent to complete urinary continence. When considering this, pad status as a definition of continence is not without limitations. Each definition has its pros and cons. Our data show wide variation in pad use for a certain degree of urinary leakage as well as a highly increased risk of urinary bother even at a small rate of urinary leakage. The bother from urinary leakage can be considered more clinically important than the actual grade of urinary leakage. Thus, to evaluate urinary incontinence we recommend measuring urinary leakage and the bother from urinary leakage. We believe that our data demonstrate that comparing the incontinence rate in different populations requires using identical definitions and the same means of questioning survivors.
APPENDIX Study Questionnaire Urinary Leakage and Bother Questions Leakage 1) During the past 6 months how often did you change your protective pad during a typical day? Not applicable, I don’t use any protective pad
Less than 1 pad/day About 1 pad/day About 2–3 pads/day About 4 –5 pads/day About 6 pads or more/day 2) During the past 6 months how much urine did you leak in the daytime? Not applicable, I don’t leak urine in the daytime Little Moderate Much 3) Do you have urinary leakage? Never Leakage when coughing, sneezing or using pad during physical activity Pad used continuously but not always wet Pad used continuously and had to be changed because they are wet Continuous leakage and need to change pads continuously Bother 1) During the past 6 months, if you have had urinary leakage daytime and you would have to live with it the rest of your life, how would you find that? Not applicable—I don’t have any leakage It wouldn’t bother me at all It would bother me slightly It would bother me moderately It would bother me much
REFERENCES 1. Holmboe ES and Concato J: Treatment decisions for localized prostate cancer: asking men what’s important. J Gen Intern Med 2000; 15: 694.
6. Steineck G, Helgesen F, Adolfsson J et al: Quality of life after radical prostatectomy or watchful waiting. N Engl J Med 2002; 347: 790.
2. Litwin MS, Hays RD, Fink A et al: Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 1995; 273: 129.
7. Kreicbergs U, Valdimarsdóttir U, Onelöv E et al: Talking about death with children who have severe malignant disease. N Engl J Med 2004; 351: 1175.
3. Klingler HC and Marberger M: Incontinence after radical prostatectomy: surgical treatment options. Curr Opin Urol 2006; 16: 60. 4. 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. 5. Cooperberg MR, Master VA and Carroll PR: Health related quality of life significance of single pad urinary incontinence following radical prostatectomy. J Urol 2003; 170: 512.
8. Bergmark K, Åvall-Lundqvist E, Dickman PW et al: Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med 1999; 340: 1383. 9. Månsson A, Henningsohn L, Steineck G et al: Neutral third party versus treating institution for evaluating quality of life after radical cystectomy. Eur Urol 2004; 46: 195. 10. 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 follow-up. BJU Int 2006; 97: 1234.
11. Liss MA, Osann K, Canvasser N et al: Continence definition after radical prostatectomy using urinary quality of life: evaluation of patient reported validated questionnaires. J Urol 2010; 183: 1464. 12. Reynolds WS, Shikanov SA, Katz MH et al: Analysis of continence rates following robot-assisted radical prostatectomy: strict leak-free and padfree continence. Urology 2010; 75: 431. 13. Box GN and Ahlering TE: Robotic radical prostatectomy: long-term outcomes. Curr Opin Urol 2008; 18: 173. 14. Rodriguez E Jr, Skarecky DW and Ahlering TE: Post-robotic prostatectomy urinary continence: characterization of perfect continence versus occasional dribbling in pad-free men. Urology 2006; 67: 785. 15. Krupski TL, Saigal CS and Litwin MS: Variation in continence and potency by definition. J Urol 2003; 170: 1291.
Purpose: To better understand clinically significant definitions of urinary incontinence we investigated the relationship between urinary leakage and patient reported bother from urinary leakage. Materials and Methods: A consecutive series of 1,411 men who underwent radical prostatectomy at Karolinska University Hospital, Stockholm, Sweden, from 2002 to 2006 were invited to complete a study specific questionnaire with questions on pad status, urinary leakage and bother from urinary leakage. Results: Questionnaires were received from 1,179 men with a followup of greater than 1 year (median 2.2). Results showed that even a small amount of urinary leakage resulted in a high risk of urinary bother. Of 775 survivors 46 (6%) reporting 0 pads indicated moderate or much bother compared to 38 of 123 (31%) who reported using a security pad. When comparing the 2 groups, the risk of bother from urinary leakage was more than 5 times higher in the safety pad vs the 0 pad group (RR 5.2, 95% CI 3.5–7.7). As the number of pads increased, we noted a higher bother risk. Cross-tabulation of pad use and urinary leakage revealed wide variation in pad requirements despite the same answer to urinary leakage questions. Conclusions: If the definition of continence is based on pad use, for example safety pads, a certain number of men who report moderate or much bother from urinary leakage will be defined as continent. Our results also show that for each stated rate of urinary leakage men prove to have a major variation in the pad requirement. Key Words: prostate, prostatic neoplasms, prostatectomy, urinary incontinence, quality of life
196
www.jurology.com
KNOWLEDGE of the risk of urinary leakage after radical prostatectomy is of major concern for the patient before radical prostatectomy.1,2 The estimated urinary incontinence rate after radical prostatectomy varies widely in published studies from 8% to 77%.3 One of several explanations for the variation could be the lack of consensus on how to quantify and define postoperative incontinence. The in-
continence rate depends on many factors, such as surgical technique, patient specific factors, time since surgery, who assesses and reports (patient, physician or other) and the means of retrieving information. An important factor may also be that different theoretical definitions of incontinence are used. There are many different continence definitions based on pad status. However, during
0022-5347/12/1871-0196/0 THE JOURNAL OF UROLOGY® © 2012 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION
Vol. 187, 196-200, January 2012 Printed in U.S.A. DOI:10.1016/j.juro.2011.09.030
AND
RESEARCH, INC.
PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
the last few years a growing body of literature has underscored the need for more patient centered assessment of urinary quality of life as it relates to postoperative incontinence.4,5 Sweden offers favorable conditions for long-term followup of cancer survivors. With personal identity numbers we can trace each Swedish resident in population based registers and eliminate selection induced problems during followup. In our cancer survivorship program we established a format to develop study specific questionnaires based on qualitative information and collect quantitative data with a high participation rate.6,7 Using these methods we have followed all survivors who underwent radical prostatectomy at our center between 2002 and 2006. In this study we evaluated the definition of postoperative urinary continence after radical prostatectomy using self-reported urinary bother and urinary leakage.
PATIENTS AND METHODS A total of 1,411 consecutive patients at Karolinska University Hospital underwent radical prostatectomy (open surgery or robot-assisted laparoscopic surgery) for prostate cancer between January 2002 and December 2006. All patients operated on during this period were included in analysis and no exclusion criteria were set. Clinical data were prospectively collected on clinical stage, biopsy Gleason score and preoperative prostate specific antigen, and routine pathology reports provided data on prostate weight. The functional outcome was assessed postoperatively with a validated quality of life questionnaire with an emphasis on urinary and sexual function. We developed the questionnaire using the format previously developed in our cancer survivorship program.6 – 8 The questionnaire was refined after 7 in-depth interviews with patients who underwent radical prostatectomy. Face-to-face validation, in which an investigator accompanied 10 patients when completing the questionnaire, ensured that the questions and answering alternatives were understood correctly. To evaluate postoperative incontinence we analyzed answers to 3 questions on urinary leakage (see Appendix). Questions 1 and 2 were included in the main questionnaire while 541 of 1,179 survivors also answered a questionnaire with an additional question on urinary leakage (question 3). This questionnaire was sent 12 months postoperatively to patients operated on between 2005 and 2006. To evaluate the effect of postoperative urinary leakage we also evaluated urinary bother (see Appendix). An independent third party9 collected the questionnaire. Between February and December 2007 all survivors in the study group received a letter explaining the study objectives and an invitation to provide information. After they received this letter we telephoned them to ask whether they would consider participating in the study. To those who agreed to participate we sent a questionnaire. Ten days later they received a combined thank you and reminder card. As needed, an interviewer made a
197
reminder telephone call. The ethics committee approved the study. Informed consent was obtained by an interviewer during the initial telephone contact. Only patients with followup longer than 1 year were included in the study. Statistical analysis was done to calculate the proportion of patients with moderate or much bother from urinary leakage. We used SAS®, version 9.2 for all calculations. Groups were compared using relative risk, defined as the ratio of proportions, which was estimated according to the log binomial regression model and presented with the 95% CI. Subjects with missing data on 1 or more questions under consideration were excluded from each respective calculation.
RESULTS Questionnaires were returned by 1,288 patients (91%), of whom 1,179 had greater than 1-year followup. Of the 1,179 patients 411 underwent open retropubic radical prostatectomy, including 6 in the subgroup, and 768 underwent robot-assisted laparoscopic radical prostatectomy, including 535 in the subgroup. Overall and in the subgroup median age at surgery was 63 (range 37 to 78, IQR 58 – 67) and 63 years (range 43 to 78, IQR 58 – 66), median age at followup was 65 (range 41 to 79, IQR 61– 69) and 65 years (range 44 to 79, IQR 61– 68), median followup was 2.2 (range 1 to 5, IQR 1.6 –3.3) and 1.7 years (range 1 to 4, IQR 1.4 –2.4) and median preoperative prostate specific antigen was 6.9 (range 0.4 to 117, IQR 5.0 –9.7) and 6.7 ng/ml (range 0.8 to 26, IQR 4.8 –9.3). Clinical stage was T1 to T3 in 702 (60%), 422 (36%) and 55 (5%) of men overall, and in 331 (61%), 192 (35%) and 18 (3%) in the subgroup, respectively. (Percents do not equal 100% due to rounding.) Pad Use and Urinary Leakage Correlation with urinary bother. Of 1,163 patients 775 (67%) reported no pad use while 123 (11%) reported less than 1 and 143 (12%) reported 1 pad used per day. When correlating pad status with urinary bother, survivors who used security pads (fewer than 1 per day) were at higher risk for moderate or much bother from urinary leakage, that is a risk more than 5 times higher than those using no pad (RR 5.2, CI 95% 3.5–7.7, table 1). As the number of pads increased, the risk of bother increased (part A of figure). When looking at question 2 on urinary leakage, 534 of 1,160 men (46%) reported no leakage while 504 (43%) reported little leakage. The answers also showed a significant increase of bother risk for little vs no urinary leakage (RR 22.0, CI 95% 10.5– 46.7, table 1). The risk of bother increased as the leakage rate increased (part B of figure). A subgroup of 541 survivors followed more than 1 year also answered a questionnaire with the third
198
PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
Table 1. Urinary leakage bother 12 months after radical prostatectomy No. Bother Question (No.) No. pads (1): 6 or Greater 4–5 2–3 1 Less than 1 0 Leakage (2): Much Moderate Little None Leakage (3): Continuous pad change Wet pad Safety pad Physical activity pad Never
No. Pts
Not Applicable
None
Little
Moderate
Much
Moderate/Much RR (95% CI)
12 25 85 143 123 775
0 0 0 2 8 542
0 1 3 13 23 88
1 2 18 51 54 99
3 7 25 39 23 23
8 15 39 38 15 23
15.4 (11.1–21.4) 14.8 (10.8–20.3) 12.7 (9.4–17.2) 9.1 (6.6–12.5) 5.2 (3.5–7.7) 1.0 (referent)
42 80 504 534
0 0 49 499
1 1 111 15
2 12 198 13
5 25 89 2
34 42 57 5
70.8 (33.8–148.6) 63.9 (30.4–134.2) 22.0 (10.5–46.7) 1.0 (referent)
12 16 78 214 206
2 2 4 79 165
0 0 4 43 20
2 3 28 60 16
2 2 23 19 3
6 9 19 13 2
27.5 (10.6–71.3) 28.3 (11.2–71.6) 22.2 (9.1–54.0) 6.1 (2.4–15.5) 1.0 (referent)
question on urinary leakage. Of 526 men 206 (39%) reported no leakage and 214 (41%) reported using pads during physical activity. When evaluating urinary incontinence bother, 15% of survivors who had leakage during coughing or sneezing, or used pads during physical activity reported moderate or much bother compared to 2% in the no leakage group (RR 6.1, 95% CI 2.4 –15.5, table 1). In this group we also noted an increasing bother rate with increasing leakage (part C of figure). Cross-tabulation. To evaluate the responses to the 3 urinary leakage questions we compared answers using cross-tabulation (table 2). At 1-year or greater followup 776 survivors (66%) reported using 0 pads per day, including 514 (66%) who reported no and 255 (33%) who reported little urinary leakage. Of survivors who reported using fewer than 1 pad per day 14 (11%) reported no leakage and 101 (82%) reported little leakage. In the group that reported little leakage the answers on pad requirements varied widely. Of the respondents 255 (51%) used 0, 101 (20%) used fewer than 1 and 104 (21%) used 1 pad per day. Cross-tabulation of pad status and urinary leakage question 3 for the subgroup of 536 men
revealed that among survivors who reported using a safety pad the pad requirement varied widely with 18% reporting the use of 2 or 3 pads per day (table 2).
DISCUSSION If the definition of continence consists of pad use, for example use of a safety pad, a certain number of men who experience moderate or much bother from urinary leakage will nevertheless be considered continent. Even a specific fraction of those who only have occasional, small amounts of leakage are bothered moderately or much by urinary leakage. In addition, for each stated rate of urinary leakage the men reported a wide variation in the pad requirement. In 2006 Sacco et al examined the records of 985 prostate cancer survivors who underwent radical retropubic prostatectomy.10 They found a clear distinction between users of 0 pads and occasional pad users concerning a score for degree of urinary control as well as urinary bother. Liss et al evaluated the continence definition in a study of 500 consecutive men after radical prostatectomy in 2009 by examining the association of pad status and urinary bother score.11 They
A to C, urinary leakage bother, as measured by 3 questions. phys, physical.
PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
Table 2. Urinary leakage and daily pad requirement cross-tabulation Leakage Question No. 2: None Little Moderate Much Not stated 3: Never Physical activity pad Safety pad Wet pad Continuous leakage Not stated
No. 0 Pad*
No. Less No. No. No. 6 No. Than No. 1 2–3 4–5 Pads or Not Total 1 Pad Pad Pads Pads Greater Stated No.
776 514 225 3 0 4 364 201 148
123 14 101 8 0 0 67 2 43
143 5 104 31 1 2 68 1 18
85 0 37 31 17 0 29 3 4
25 0 3 5 17 0 6 0 0
12 0 3 2 7 0 2 0 0
15 3 3 0 0 9 5 3 2
1,179 536 506 80 42 15 541 210 215
6 2 2
17 2 0
38 5 4
14 5 3
3 2 1
0 0 2
0 0 0
78 16 12
5
3
2
0
0
0
0
10
* Not applicable or no pad use reported.
found a significant difference in the urinary bother score between men who reported using 0 pads vs a security pad (mean ⫾ SEM score 2.78 ⫾ 0.16 vs 1.16 ⫾ 0.08). They stated that continence should be strictly defined as 0 pads and our data support this. At a mean of 75 weeks postoperatively Cooperberg et al investigated 168 men who underwent radical retropubic prostatectomy.5 Bother was significantly lower in the 0 pad group than in the group using 1 pad. Reynolds et al recently examined the records of 1,005 survivors after robot-assisted radical prostatectomy for continence variables and urinary bother scores 1, 3, 6, 12 and 24 months after surgery.12 Leak-free, padfree continence was defined by combining answers to 2 urinary incontinence questions on which survivors had answered “urinary leakage—not at all” plus “no use of pads.” The urinary bother score was significantly lower at 12 months of followup than at baseline in survivors who were leak and pad free preoperatively (82 vs 90, p ⫽ 0.002). We noted a highly increased risk of bother at a low frequency of urinary leakage. When evaluating pad status, 31% of men in the less than 1 pad group reported much or moderate bother compared to 6% in the 0 pad group. The relative high bother in the 0 pad group might be explained by simply recognizing that no pad use is not always equivalent to no leakage. Of the combination leak-free and pad-free survivors in our study only 5 of 514 (1%) reported moderate or much bother. This confirms that the definition of continence requiring that the survivor be leak and pad free results in the classification of only a few men as continent who are bothered by leakage. Pad-free status was proposed as a universal definition of post-prostatectomy continence.13 Rodriguez et al found that 69% of men who reported
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pad-free status claimed occasional leakage.14 Preoperatively they were older and had greater prostate weight, higher preoperative and postoperative American Urological Association symptom scores, and urinary bother scores. Krupski et al evaluated 269 men who underwent radical prostatectomy for early stage prostate cancer to determine how well 6 definitions of continence corresponded with each other.15 The correspondence varied widely. Of men who reported no pad use only 42% responded no leakage. They also looked at other definitions with higher concordance with 98% of survivors who used no pads claiming total control. They concluded that continence varies greatly depending on the specific definition used. Our cross-tabulation of the relationship between pad use and urinary leakage reveals a wide variation in pad use despite the same answer to urinary leakage questions. This indicates that pad use and changing depends on many factors, of which the degree of urinary leakage is only 1 factor. Of survivors who reported no pad use 33% also reported little urinary leakage. Pad-free status according to the available data does not always imply continence. Another important aspect, which is seldom discussed, that could explain the major variation in pad use is pad size. The question of pad status does not deal with the size of the pad. Such information may refine our possibilities of describing how pad use and urinary bother are associated. Our results indicate difficulty in interpreting the answers based on pad status since survivors tend to change pads differently, often quite independently of the rate of urinary leakage and without reference to the size of the pad in question. These factors would be less important if the definition of continence were 0 pads. Litwin et al noted substantial differences between patient reported quality of life scores and surgeon reported scores.4 An explanation could be that some patients tend to withhold their symptoms when speaking to a surgeon. We used patient reported and not surgeon reported outcomes. Questionnaires were mailed by the patient directly to a third party so that surgeons were unaware of the answers. The strengths of our study are the large population evaluated, the high participation rate and the questionnaire based method. The main study limitation is that we did not use an objective method to evaluate urinary leakage. However, due to the large study population performing urodynamic assessment or a pad test would have been difficult. We used no study exclusion criteria and, thus, included a mixture of modifying factors (if they existed), as they presented at our center. Future studies may address the extent to which concomitant treatment, eg postoperative radiation therapy, or intercurrent disease modifies the relation between having urinary leakage and having urinary bother.
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PAD USE AND BOTHER FROM URINARY LEAKAGE AFTER PROSTATECTOMY
CONCLUSIONS Results reveal that no pad use is not equivalent to complete urinary continence. When considering this, pad status as a definition of continence is not without limitations. Each definition has its pros and cons. Our data show wide variation in pad use for a certain degree of urinary leakage as well as a highly increased risk of urinary bother even at a small rate of urinary leakage. The bother from urinary leakage can be considered more clinically important than the actual grade of urinary leakage. Thus, to evaluate urinary incontinence we recommend measuring urinary leakage and the bother from urinary leakage. We believe that our data demonstrate that comparing the incontinence rate in different populations requires using identical definitions and the same means of questioning survivors.
APPENDIX Study Questionnaire Urinary Leakage and Bother Questions Leakage 1) During the past 6 months how often did you change your protective pad during a typical day? Not applicable, I don’t use any protective pad
Less than 1 pad/day About 1 pad/day About 2–3 pads/day About 4 –5 pads/day About 6 pads or more/day 2) During the past 6 months how much urine did you leak in the daytime? Not applicable, I don’t leak urine in the daytime Little Moderate Much 3) Do you have urinary leakage? Never Leakage when coughing, sneezing or using pad during physical activity Pad used continuously but not always wet Pad used continuously and had to be changed because they are wet Continuous leakage and need to change pads continuously Bother 1) During the past 6 months, if you have had urinary leakage daytime and you would have to live with it the rest of your life, how would you find that? Not applicable—I don’t have any leakage It wouldn’t bother me at all It would bother me slightly It would bother me moderately It would bother me much
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