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Urinary Continence and Quality of Life in the First Year After Radical Perineal Prostatectomy
0022-5347/03/1706-2374/0 THE JOURNAL OF UROLOGY® Copyright © 2003 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 170, 2374 –2378, December 2003 Printed in U.S.A.
DOI: 10.1097/01.ju.0000097240.99415.a7
URINARY CONTINENCE AND QUALITY OF LIFE IN THE FIRST YEAR AFTER RADICAL PERINEAL PROSTATECTOMY MATTHEW D. YOUNG, ALON Z. WEIZER, ARI D. SILVERSTEIN, ALFONSO CRISCI, DAVID M. ALBALA,* JOHANNES VIEWEG, DAVID F. PAULSON AND PHILIPP DAHM†,‡ From the Division of Urology, Department of Surgery, Duke University Medical Center, Durham, North Carolina
ABSTRACT
Purpose: We attempt to characterize the return of urinary continence and urinary domain related quality of life objectively after radical perineal prostatectomy (RPP). Materials and Methods: A total of 92 RPP candidates were prospectively enrolled in a quality of life (QOL) survey using a validated assessment tool and evaluated before surgery, and then after surgery at 1 month and subsequent 3-month intervals. The time to regain continence based on 3 different definitions and the time to recover baseline urinary domain related QOL was calculated. Results: Median time to regain continence after RPP ranged from 3.0 to 3.3 months depending on the definition of continence. Median time for patients to regain continence depending on age (younger than 55, 55 to 64 and older than 64) and medical comorbidities (none, 1 and 2 or more) varied between 1.4 ⫾ 0.3, 3.0 ⫾ 0.9 and 3.3 ⫾ 0.4 months, respectively (p ⫽ 0.028), and 1.4 ⫾ 0.2, 3.3 ⫾ 0.2 and 3.5 ⫾ 2.6 months, respectively (p ⫽ 0.009). Twelve months after RPP 84%, 66% and 82% of patients regained individual baseline urinary summary, function and bother scores, respectively. Postoperative radiation (XRT) represented the only independent predictor of the time to recover baseline urinary domain summary scores in a multivariate analysis (p ⫽ 0.042) with a median delay in the XRT (10 patients) and nonXRT group (82 patients) of 8.0 and 6.7 months, respectively. Conclusions: Based on self-reported questionnaire data, a majority of patients regain urinary continence and urinary domain related QOL within 12 months after RPP. The time course of recovery from radical prostatectomy represents an important outcome criterion that should be shared with patients considering treatment options. KEY WORDS: urinary incontinence, prostatectomy, quality of life
Urinary incontinence represents one of the principal sources of postoperative morbidity to patients undergoing radical prostatectomy for localized prostate cancer. As such, it has been an area of extensive clinical research with a variety of reported results in terms of prevalence and severity.1, 2 Much of the variability has been ascribed to the methodology used to assess continence, which was often quite variable and subject to bias. Previous investigators have suggested that patients may seek to minimize adverse outcomes when discussing them with the surgeon.3, 4 Thus, more recent investigations have used validated instruments that are self-administered to characterize urinary function more comprehensively and minimize potential bias5, 6 as well as address related quality of life (QOL) issues.7, 8 Since radical retropubic prostatectomy (RRP) is the approach used in the majority of radical prostatectomies, continence after radical perineal prostatectomy (RPP) has not been studied as extensively. In this report we attempt to characterize the return of urinary continence after RPP objectively in a prospective evaluation of urinary continence and urinary domain related QOL using a validated patient administered instrument.
MATERIALS AND METHODS
Between January 2001 and February 2002, 96 consecutive patients undergoing RPP as primary treatment for clinically organ confined prostate cancer agreed to participate in a prospective study of urinary function, bother and urinary domain related QOL. Of these, 92 patients (95.8%) completed the preoperative questionnaire and at least 2 postoperative questionnaires with a minimum followup of 6 months, and were included in the analysis. The Expanded Prostate Cancer Index Composite (EPIC), a validated QOL instrument,9 was administered to the patients before surgery, at 1 month after surgery and at subsequent 3-month intervals up to 1 year after surgery. The questionnaires were mailed to the patients from an independent third party and entered into a dedicated database. Patients who did not return the preaddressed envelope received up to a total of 3 followup phone calls as a reminder. Demographic and clinical patient variables assessed at baseline included patient age, ethnicity, relationship status, educational background, household income, employment status, past medical history, preoperative prostate specific antigen (PSA) serum level (ng/ml) and baseline urinary continence. RPP was performed with a standardized surgical technique10 by 1 of 3 attending surgeons, either with bilateral sacrifice or unilateral preservation of the neurovascular bundles. Postoperative variables included prostate size, Gleason score and pathological tumor stage. In addition, it was recorded whether patients received postoperative radiation therapy (XRT) for early biochemical failure during followup and/or adverse pathological features.
Accepted for publication June 27, 2003. * Financial interest and/or other relationship with Applied Medical, Thermatrix, Merck, Lilly-ICOS and Ethicon. † Recipient of the American Foundation for Urological Research Award. ‡ Corresponding author: Duke University Medical Center, Box 2626, Durham, North Carolina 27710 (telephone: 919-684-9949; FAX: 919-681-7414; e-mail: [email protected]). 2374
URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
Statistical data analysis was performed using commercially available software. Three different definitions of urinary continence based on patient responses to different questionnaire items were selected to reflect the range of incontinence severity. Definitions 1, 2 and 3 were based on the respective answers to the questions “Do you have a problem with dripping or leaking urine?”, “Over the last 4 weeks how often have you leaked urine?” and “How many pads or adult diapers per day did you usually use to control leakage over the last 4 weeks?” According to these definitions and the questionnaire responses, individual patient continence status was determined at baseline as well as at each interval after surgery. Time to regain continence after surgery was measured in months and represented the interval for a patient to respond with “very small” or “none” to item 1, “once a day” or “less than once a day” to item 2 and “one pad” or “no pad” to item 3. EPIC questionnaire responses were used to calculate average urinary function, bother, continence and irritation/ obstruction subscale scores, as well as urinary domain summary health related quality of life (HRQOL) scores. These were tabulated at various intervals as means ⫾ SD on 0 to 100 scales to facilitate comparison with previous studies.8 Higher scores represented better HRQOL. All other means were reported ⫾ SEM. Baseline pretreatment HRQOL scores obtained from each patient allowed patients to serve as their own controls. For the longitudinal followup analysis patients were considered to have returned to baseline when their HRQOL scores returned to within 10 points of preoperative score. These 10 point windows were used based on earlier studies suggesting that 0.3 to 0.5 SD represents a clinically meaningful change.8, 11 Kaplan-Meier analysis and comparison with the log rank test were used for univariate analysis of time to regain continence and time to regain individual baseline HRQOL scores. For this part of the analysis a patient was considered to have returned to baseline only when the followup score actually returned to at least the actual pretreatment score.8 Preoperative, intraoperative and postoperative variables were analyzed. The Cox proportional hazards regression model was used to determine predictors of time to regain continence as well as regain actual HRQOL scores, and p ⬍ 0.05 was considered statistically significant. RESULTS
Demographic and clinical characteristics of the patient population are summarized in tables 1 and 2. Mean patient age was 60.2 ⫾ 0.8 years (range 43 to 78). Baseline levels of urinary
TABLE 1. Distribution of case variables Variable Preop PSA (ng/ml): 0–4.0 4.1–10.0 10.1–20.0 Greater than 20.0 Prostatectomy specimen size (cc): Less than 35 35 or Greater Nerve sparing RPP: No Yes Prostatectomy Gleason score: 4–6 7 8–10 Pathological tumor stage: pT2 pT3 Postop radiation: No Yes
No. Pts (%) 16 (17.4) 58 (63.0) 11 (12.0) 7 (7.6) 49 (53.3) 43 (46.7) 72 (78.3) 20 (21.7) 40 (43.5) 37 (40.2) 15 (16.3) 54 (58.7) 38 (41.3) 82 (89.1) 10 (10.9)
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TABLE 2. Demographic and clinical characteristics of 92 patients at baseline No. Pts (%) Age: Younger than 55 55–64 Older than 64 Ethnicity: Black White Other Annual household income: Less than $10,000 $10,001–$30,000 $30,001–$100,000 Greater than $100,000 Education: High school diploma or less Some college training after high school College degree Graduate or professional degree Marital or relationship status: Married or living with spouse or partner Unmarried or not in significant relationship Working full or part-time Comorbidity reported: Diabetes Cardiovascular disease Respiratory disease Gastrointestinal disease Renal disease Major depression Cigarette smoking Alcohol abuse No. reported comorbidities: 0 1 2 or Greater
22 (23.9) 44 (47.8) 26 (28.3) 12 (13.0) 74 (80.4) 6 (6.6) 3 (3.3) 7 (7.6) 54 (58.7) 23 (25.0) 20 (21.7) 16 (17.4) 28 (30.4) 27 (29.3) 79 (85.9) 12 (13.2) 61 (66.3) 13 (14.1) 2 (2.2) 4 (4.3) 9 (9.8) 5 (5.4) 2 (2.2) 13 (14.1) 4 (4.3) 50 (54.3) 29 (31.5) 12 (13.1)
continence measured by preoperative questionnaire responses differed according to the definition of continence applied. Definition 1 was the most sensitive definition (greater than “very small problem” with dripping or leaking urine) of urinary incontinence reported by 6.5% of patients (6 of 92). According to definitions 2 (“leakage more than once a day”) and 3 (“more than one pad per day”) only 3.3% and 2.2% of patients, respectively, were categorized as incontinent before surgery. Time to regain urinary continence according to definitions 1, 2 and 3 was 3.2 ⫾ 0.1, 3.3 ⫾ 0.4 and 3.0 ⫾ 0.7 months (fig. 1), respectively. After 6 months of followup 34.8% ⫹ 5.0%, 37.4% ⫾ 5.2% and 23.9% ⫾ 4.5% of patients, respectively, remained incontinent. Among the variables listed in tables 1 and 2, patient age (younger than 55, 55 to 64, older than 64) and the number of medical comorbidities (none, 1 and 2 or more) were correlated with the time to regain continence by the 3 different definitions (fig. 2). Median time to regain continence for patients with none, 1 and 2 or more medical comorbidities was 1.4 ⫾ 0.2, 3.3 ⫾ 0.2 and 3.5 ⫾ 2.6 months, respectively. Figure 3 illustrates the effect of age on necessary time to regain urinary continence according to definition 3. Median time to regain continence for patients younger than 55, 55 to 64 and older than 64 years was 1.4 ⫾ 0.3, 3.0 ⫾ 0.9 and 3.3 ⫾ 0.4 months, respectively. PSA was correlated with time to regain continence according to definition 1 only. Meanwhile, none of the other demographic or clinical variables such as preoperative continence status (p ⫽ 0.383), tumor stage (p ⫽ 0.838) or prostate size (p ⫽ 0.890) were correlated with time to regain continence according to definition 3 (or any of the other definitions). A trend toward earlier return of continence was seen in patients undergoing a unilateral nerve sparing (2.9 ⫾ 0.1 months) vs a nonnerve sparing approach (3.2 ⫾ 0.2 months), yet this difference was not significant (p ⫽ 0.329). The difference in median time to regain urinary continence (definition 3) of patients who received or did not receive postoperative XRT (3.4 ⫾ 0.8 vs 3.0 ⫾ 2.2 months)
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URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
FIG. 1. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 92) according to definition 1 (greater than “very small” or “no problem” with urinary leakage), definition 2 (leakage frequency greater than “once per day”) and definition 3 (daily use of greater than “one” or “no” protective pad).
FIG. 3. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 92) according to definition 3 (daily use of greater than “one” or “no” protective pad) comparing patients grouped by age (younger than 55, 55 to 64, older than 64 years) with log rank test (p ⫽ 0.028).
(table 3) yet increasing mean urinary bother scores of 67.6, 74.8, 78.2 and 79.2 points, respectively. A multivariate analysis revealed no significant correlation of patient characteristics with time to regain baseline urinary function, bother or incontinence scores. Meanwhile, XRT after RPP was associated with delayed recovery of the urinary domain summary score (p ⫽ 0.042), as well as for the subscale for irritation/obstruction (p ⫽ 0.037). Urinary domain summary scores for patients who did (10) or did not (82) receive XRT were significantly different after 12 months (74.8 ⫾ 9.0 vs 87.5 ⫾ 1.5, p ⫽ 0.018) yet not at baseline (83.7 ⫾ 4.2 vs 86.5 ⫾ 1.6, p ⫽ 0.561). XRT represented the only independent predictor of time to recover baseline urinary domain summary scores in a multivariate analysis (p ⫽ 0.042) with medians of 8.0 and 6.7 months, respectively. DISCUSSION
FIG. 2. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 91) according to definition 3 (daily use of greater than “one” or “no” protective pad) comparing patients grouped by number of medical comorbidities (none, 1, 2 or more) with log rank test (p ⫽ 0.009).
approached but did not meet statistical significance (p ⫽ 0.052). In a subsequent multivariate analysis only advanced age (definitions 1 and 2) and an increased number of comorbidities (definition 3) were associated with prolonged time to regain urinary continence after RPP. Actual HRQOL scores before surgery, and after 1, 3, 6, 9 and 12 months are reported in table 3. The proportion of patients who returned to preoperative baseline levels within 12 months of followup are reported in table 4. With regard to the urinary summary score, 69.3% and 83.8% of patients returned to within 10 points of individual baseline scores after 6 and 12 months, respectively. The subscale score for urinary continence was the slowest to normalize. A dissociation of patients regaining baseline levels of urinary function and bother was observed, with percentages of 66.2% and 82.4% at 12 months, respectively. The subset of patients who had not regained individual baseline HRQOL scores for urinary function at 3, 6, 9 and 12 months had below average
While recent studies have emphasized the favorable functional results of RPP with continence rates of 93% to 95%,12, 13 a majority of RPP studies have relied on physician based assessments of outcome. However, studies by Litwin et al have raised concerns that urologists may underestimate the severity of patient symptoms and the degree of resulting quality of life impairment.3 Longitudinal studies using validated self-assessment questionnaires have since provided detailed recovery profiles of urinary continence14 and urinary domain related quality of life5, 8 after RRP. To our knowledge comparable data for RPP cases have thus far not been reported. We found that the median time to regain urinary continence and continence rates after 12 months varied according to the definition applied, yet to a lesser extent than in a previous study by Wei et al.14 In that study the first to evaluate the return of continence in a large cohort of patients in a prospective fashion using validated self-assessment tools, median time to regain continence ranged from 2 to 11 months. Urinary continence was achieved by 81% to 98.5% of patients by 24 months after RRP according to the particular definition. Results of these studies emphasize the importance of using strict definitions of continence when discussing outcomes of surgical series. In addition, different thresholds may yield different results. In this study we characterized urinary continence according to definition 1 as “no problem” or “very small problem” with urinary leakage. Had we broadened the definition of continence to include patients with
URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
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TABLE 3. Reported HRQOL scores after RPP Physical component summary Mental component summary Urinary function Urinary bother Urinary incontinence Urinary irritation/obstruction Urinary summary score
Baseline 92 Pts
1 Mo 89 Pts
3 Mos 85 Pts
6 Mos 88 Pts
9 Mos 74 Pts
12 Mos 69 Pts
101.6 ⫾ 18.6 102.4 ⫾ 18.0 92.6 ⫾ 11.4 81.6 ⫾ 18.1 91.1 ⫾ 16.6 84.5 ⫾ 15.2 86.2 ⫾ 14.3
77.2 ⫾ 20.8 100.4 ⫾ 21.4 51.2 ⫾ 22.5 58.9 ⫾ 20.7 40.6 ⫾ 28.8 65.9 ⫾ 19.3 55.7 ⫾ 19.9
95.6 ⫾ 20.0 104.0 ⫾ 20.8 69.4 ⫾ 20.2 72.8 ⫾ 19.2 55.4 ⫾ 29.0 82.4 ⫾ 15.4 71.3 ⫾ 18.3
100.4 ⫾ 17.2 106.6 ⫾ 17.4 84.9 ⫾ 17.1 81.9 ⫾ 14.1 78.1 ⫾ 25.1 87.2 ⫾ 11.8 83.2 ⫾ 13.7
101.8 ⫾ 17.0 108.6 ⫾ 15.0 88.0 ⫾ 13.9 84.8 ⫾ 11.8 82.9 ⫾ 21.4 88.9 ⫾ 10.5 86.4 ⫾ 10.8
101.6 ⫾ 18.6 107.2 ⫾ 17.2 87.0 ⫾ 15.4 85.2 ⫾ 16.0 82.7 ⫾ 20.6 88.1 ⫾ 13.2 86.0 ⫾ 14.4
TABLE 4. Patients who regained individual preoperative baseline HRQOL scores within 12 months after RPP % Pts Reaching Baseline
Physical component summary Mental component summary Urinary function Urinary bother Incontinence Irritation/obstruction Urinary summary score
1 Mo
3 Mos
6 Mos
9 Mos
12 Mos
22.5 70.1 10.1 29.2 9.0 39.3 19.1
66.7 75.6 29.4 51.2 18.8 72.9 45.2
80.5 81.2 62.5 70.5 56.8 87.5 69.3
82.4 84.7 74.3 79.5 62.2 85.1 78.1
88.4 80.6 66.2 82.4 58.8 80.9 83.8
“small problems” with urinary leakage, as used by Kielb et al6 the percentage of patients considered incontinent at 6 months after RPP would have been decreased from 34.8% to 19.6%, thereby making our results appear much more favorable. However, we believe that the applied threshold on which we based our analysis of “no problem/very small problem” is more clinically valid. Contrary to previous studies, a nerve sparing approach did not affect time to regain urinary continence.14 To explain the association of urinary continence and nerve preservation Wei et al suggested that a nerve sparing approach aids in preserving the yet poorly characterized motor innervation of the urethral sphincter.14 Since other studies, all based on RRP cases, have also failed to demonstrate an association of a nerve sparing approach and the recovery of urinary continence,15, 16 it is possible that nerve preservation has less impact on urinary continence in RPP. However, in our series nerve preservation may have been performed in too small a subset of patients using only a unilateral approach to demonstrate a significant effect. Since the initiation of this study the use of bilaterally nerve sparing RPP at our institution has become much more widely endorsed, and the longitudinal assessment of these patients may provide an answer in the future. The observation made in this study that age is an important predictor of time to regain continence, concurred with the findings of Wei et al.14 While the pathophysiology of this observation remains poorly understood, the association of age and continence has been documented in previous RPP studies.17 There are likely several age related factors that affect urethral and detrusor function including decreased urethral coaptation, increased detrusor instability and delayed wound healing. To our knowledge longitudinal assessments of HRQOL scores have only been reported in RRP cases. In a large study that included 247 RRP patients, 56% and 71% recovered baseline urinary function and bother scores, respectively.8 Average time to recover these scores was approximately 7 to 8 months. In our study recovery of urinary domain related quality of life scores were analyzed using the same methodology introduced by Litwin et al5, 8 in reference to patient individual baseline scores. We found that 66% and 82% of RPP cases recovered baseline urinary function and bother scores, respectively, after an average of 6 to 7 months. Among the urinary domain subscales the urinary incontinence score was the slowest to recover and normalized in approximately 60% of patients by 1 year. Our results may further be compared to those of a cross-sectional survey of patients who
Median Mos to Baseline 6.3 3.1 6.7 6.3 6.5 3.8 6.7
underwent RRP and completed the EPIC questionnaire a median of 30 months after surgery.18 This study reported an average urinary incontinence subscale score of 79 points on a scale of 0 to 100 compared to 93 points for age matched controls without prostate cancer. While the results of our study based on only 92 patients are subject to selection bias and cannot be compared directly, it does appear that the urinary incontinence scores in RPP cases, calculated at 83 points at 12 months are roughly equivalent if not higher, and may improve further with longer followup. Meanwhile, the large proportion of patients that recovered urinary continence and baseline HRQOL scores suggests that our data are mature and permits valuable insights into the time course of recovery after RPP. Previous studies have suggested associations of urinary domain related QOL with race, relationship status, education and income, yet failed to demonstrate statistically significant correlations.8 In this study postoperative XRT was the only variable that correlated with delayed recovery of urinary irritation/obstruction scores as well as urinary summary scores, yet not function or incontinence. These findings are plausible since XRT is known to cause radiation cystitis and irritative voiding symptoms.18, 19 However, given the small subset of patients on which the results are based, future confirmatory studies will be necessary to assess the impact of postoperative XRT on urinary domain related QOL. CONCLUSIONS
This study outlines the recovery of urinary continence within 12 months after RPP based on validated patient selfassessment tools, and suggests that a majority of patients regain urinary continence early depending on the definition of continence applied. Additionally, most recovery of urinary domain related QOL occurred within the first 6 months. While postoperative XRT adversely affected the recovery of urinary domain related quality of life, advanced patient age and number of medical comorbidities delayed time to recovery of urinary continence. Future longitudinal studies with more extended followup should assist in identifying further the impact of these variables. Katie Snider maintained the HRQOL database. REFERENCES
1. Stanford, J. L., Feng, Z., Hamilton, A. S., Gilliland, F. D., Stephenson, R. A., Eley, J. W. et al: Urinary and sexual function after radical prostatectomy for clinically localized prostate
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URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
cancer: the Prostate Cancer Outcomes Study. JAMA, 283: 354, 2000 Begg, C. B., Riedel, E. R., Bach, P. B., Kattan, M. W., Schrag, D., Warren, J. L. et al: Variations in morbidity after radical prostatectomy. N Engl J Med, 346: 1138, 2002 Litwin, M. S., Lubeck, D. P., Henning, J. M. and Carroll, P. R.: Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database. J Urol, 159: 1988, 1998 Gray, M., Petroni, G. R. and Theodorescu, D.: Urinary function after radical prostatectomy: a comparison of the retropubic and perineal approaches. Urology, 53: 881, 1999 Litwin, M. S., McGuigan, K. A., Shpall, A. I. and Dhanani, N.: Recovery of health related quality of life in the year after radical prostatectomy: early experience. J Urol, 161: 515, 1999 Kielb, S., Dunn, R. L., Rashid, M. G., Murray, S., Sanda, M. G., Montie, J. E. et al: Assessment of early continence recovery after radical prostatectomy: patient reported symptoms and impairment. J Urol, 166: 958, 2001 Penson, D. F. and Litwin, M. S.: Quality of life after treatment for PCa. Contemp Urol, 35: 44, 2000 Litwin, M. S., Melmed, G. Y. and Nakazon, T.: Life after radical prostatectomy: a longitudinal study. J Urol, 166: 587, 2001 Wei, J. T., Dunn, R. L., Litwin, M. S., Sandler, H. M. and Sanda, M. G.: Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology, 56: 899, 2000 Thrasher, J. B. and Paulson, D. F.: Reappraisal of radical perineal prostatectomy. Eur Urol, 22: 1, 1992
11. Guyatt, G. H., Bombardier, C. and Tugwell, P. X.: Measuring disease-specific quality of life in clinical trials. CMAJ, 134: 889, 1986 12. Weldon, V. E.: Technique of modern radical perineal prostatectomy. Urology, 60: 689, 2002 13. Ruiz-Deya, G., Davis, R., Srivastav, S. K., Wise, A. M. and Thomas, R.: Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome. J Urol, 166: 581, 2001 14. Wei, J. T., Dunn, R. L., Marcovich, R., Montie, J. E. and Sanda, M. G.: Prospective assessment of patient reported urinary continence after radical prostatectomy. J Urol, 164: 744, 2000 15. Talcott, J. A., Rieker, P., Propert, K. J., Clark, J. A., Wishnow, K. I., Loughlin, K. et al: Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy. J Natl Cancer Inst, 89: 1117, 1997 16. Kaye, K. W., Creed, K. E., Wilson, G. J., D’Antuono, M. and Dawkins, H. J.: Urinary continence after radical retropubic prostatectomy. Analysis and synthesis of contributing factors: a unified concept. Br J Urol, 80: 444, 1997 17. Weldon, V. E., Tavel, F. R. and Neuwirth, H.: Continence, potency and morbidity after radical perineal prostatectomy. J Urol, 158: 1470, 1997 18. Wei, J. T., Dunn, R. L., Sandler, H. M., McLaughlin, P. W., Montie, J. E., Litwin, M. S. et al: Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer. J Clin Oncol, 20: 557, 2002 19. Penson, D. F.: Quality of life following prostate cancer treatments. Curr Urol Rep, 1: 71, 2000
Vol. 170, 2374 –2378, December 2003 Printed in U.S.A.
DOI: 10.1097/01.ju.0000097240.99415.a7
URINARY CONTINENCE AND QUALITY OF LIFE IN THE FIRST YEAR AFTER RADICAL PERINEAL PROSTATECTOMY MATTHEW D. YOUNG, ALON Z. WEIZER, ARI D. SILVERSTEIN, ALFONSO CRISCI, DAVID M. ALBALA,* JOHANNES VIEWEG, DAVID F. PAULSON AND PHILIPP DAHM†,‡ From the Division of Urology, Department of Surgery, Duke University Medical Center, Durham, North Carolina
ABSTRACT
Purpose: We attempt to characterize the return of urinary continence and urinary domain related quality of life objectively after radical perineal prostatectomy (RPP). Materials and Methods: A total of 92 RPP candidates were prospectively enrolled in a quality of life (QOL) survey using a validated assessment tool and evaluated before surgery, and then after surgery at 1 month and subsequent 3-month intervals. The time to regain continence based on 3 different definitions and the time to recover baseline urinary domain related QOL was calculated. Results: Median time to regain continence after RPP ranged from 3.0 to 3.3 months depending on the definition of continence. Median time for patients to regain continence depending on age (younger than 55, 55 to 64 and older than 64) and medical comorbidities (none, 1 and 2 or more) varied between 1.4 ⫾ 0.3, 3.0 ⫾ 0.9 and 3.3 ⫾ 0.4 months, respectively (p ⫽ 0.028), and 1.4 ⫾ 0.2, 3.3 ⫾ 0.2 and 3.5 ⫾ 2.6 months, respectively (p ⫽ 0.009). Twelve months after RPP 84%, 66% and 82% of patients regained individual baseline urinary summary, function and bother scores, respectively. Postoperative radiation (XRT) represented the only independent predictor of the time to recover baseline urinary domain summary scores in a multivariate analysis (p ⫽ 0.042) with a median delay in the XRT (10 patients) and nonXRT group (82 patients) of 8.0 and 6.7 months, respectively. Conclusions: Based on self-reported questionnaire data, a majority of patients regain urinary continence and urinary domain related QOL within 12 months after RPP. The time course of recovery from radical prostatectomy represents an important outcome criterion that should be shared with patients considering treatment options. KEY WORDS: urinary incontinence, prostatectomy, quality of life
Urinary incontinence represents one of the principal sources of postoperative morbidity to patients undergoing radical prostatectomy for localized prostate cancer. As such, it has been an area of extensive clinical research with a variety of reported results in terms of prevalence and severity.1, 2 Much of the variability has been ascribed to the methodology used to assess continence, which was often quite variable and subject to bias. Previous investigators have suggested that patients may seek to minimize adverse outcomes when discussing them with the surgeon.3, 4 Thus, more recent investigations have used validated instruments that are self-administered to characterize urinary function more comprehensively and minimize potential bias5, 6 as well as address related quality of life (QOL) issues.7, 8 Since radical retropubic prostatectomy (RRP) is the approach used in the majority of radical prostatectomies, continence after radical perineal prostatectomy (RPP) has not been studied as extensively. In this report we attempt to characterize the return of urinary continence after RPP objectively in a prospective evaluation of urinary continence and urinary domain related QOL using a validated patient administered instrument.
MATERIALS AND METHODS
Between January 2001 and February 2002, 96 consecutive patients undergoing RPP as primary treatment for clinically organ confined prostate cancer agreed to participate in a prospective study of urinary function, bother and urinary domain related QOL. Of these, 92 patients (95.8%) completed the preoperative questionnaire and at least 2 postoperative questionnaires with a minimum followup of 6 months, and were included in the analysis. The Expanded Prostate Cancer Index Composite (EPIC), a validated QOL instrument,9 was administered to the patients before surgery, at 1 month after surgery and at subsequent 3-month intervals up to 1 year after surgery. The questionnaires were mailed to the patients from an independent third party and entered into a dedicated database. Patients who did not return the preaddressed envelope received up to a total of 3 followup phone calls as a reminder. Demographic and clinical patient variables assessed at baseline included patient age, ethnicity, relationship status, educational background, household income, employment status, past medical history, preoperative prostate specific antigen (PSA) serum level (ng/ml) and baseline urinary continence. RPP was performed with a standardized surgical technique10 by 1 of 3 attending surgeons, either with bilateral sacrifice or unilateral preservation of the neurovascular bundles. Postoperative variables included prostate size, Gleason score and pathological tumor stage. In addition, it was recorded whether patients received postoperative radiation therapy (XRT) for early biochemical failure during followup and/or adverse pathological features.
Accepted for publication June 27, 2003. * Financial interest and/or other relationship with Applied Medical, Thermatrix, Merck, Lilly-ICOS and Ethicon. † Recipient of the American Foundation for Urological Research Award. ‡ Corresponding author: Duke University Medical Center, Box 2626, Durham, North Carolina 27710 (telephone: 919-684-9949; FAX: 919-681-7414; e-mail: [email protected]). 2374
URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
Statistical data analysis was performed using commercially available software. Three different definitions of urinary continence based on patient responses to different questionnaire items were selected to reflect the range of incontinence severity. Definitions 1, 2 and 3 were based on the respective answers to the questions “Do you have a problem with dripping or leaking urine?”, “Over the last 4 weeks how often have you leaked urine?” and “How many pads or adult diapers per day did you usually use to control leakage over the last 4 weeks?” According to these definitions and the questionnaire responses, individual patient continence status was determined at baseline as well as at each interval after surgery. Time to regain continence after surgery was measured in months and represented the interval for a patient to respond with “very small” or “none” to item 1, “once a day” or “less than once a day” to item 2 and “one pad” or “no pad” to item 3. EPIC questionnaire responses were used to calculate average urinary function, bother, continence and irritation/ obstruction subscale scores, as well as urinary domain summary health related quality of life (HRQOL) scores. These were tabulated at various intervals as means ⫾ SD on 0 to 100 scales to facilitate comparison with previous studies.8 Higher scores represented better HRQOL. All other means were reported ⫾ SEM. Baseline pretreatment HRQOL scores obtained from each patient allowed patients to serve as their own controls. For the longitudinal followup analysis patients were considered to have returned to baseline when their HRQOL scores returned to within 10 points of preoperative score. These 10 point windows were used based on earlier studies suggesting that 0.3 to 0.5 SD represents a clinically meaningful change.8, 11 Kaplan-Meier analysis and comparison with the log rank test were used for univariate analysis of time to regain continence and time to regain individual baseline HRQOL scores. For this part of the analysis a patient was considered to have returned to baseline only when the followup score actually returned to at least the actual pretreatment score.8 Preoperative, intraoperative and postoperative variables were analyzed. The Cox proportional hazards regression model was used to determine predictors of time to regain continence as well as regain actual HRQOL scores, and p ⬍ 0.05 was considered statistically significant. RESULTS
Demographic and clinical characteristics of the patient population are summarized in tables 1 and 2. Mean patient age was 60.2 ⫾ 0.8 years (range 43 to 78). Baseline levels of urinary
TABLE 1. Distribution of case variables Variable Preop PSA (ng/ml): 0–4.0 4.1–10.0 10.1–20.0 Greater than 20.0 Prostatectomy specimen size (cc): Less than 35 35 or Greater Nerve sparing RPP: No Yes Prostatectomy Gleason score: 4–6 7 8–10 Pathological tumor stage: pT2 pT3 Postop radiation: No Yes
No. Pts (%) 16 (17.4) 58 (63.0) 11 (12.0) 7 (7.6) 49 (53.3) 43 (46.7) 72 (78.3) 20 (21.7) 40 (43.5) 37 (40.2) 15 (16.3) 54 (58.7) 38 (41.3) 82 (89.1) 10 (10.9)
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TABLE 2. Demographic and clinical characteristics of 92 patients at baseline No. Pts (%) Age: Younger than 55 55–64 Older than 64 Ethnicity: Black White Other Annual household income: Less than $10,000 $10,001–$30,000 $30,001–$100,000 Greater than $100,000 Education: High school diploma or less Some college training after high school College degree Graduate or professional degree Marital or relationship status: Married or living with spouse or partner Unmarried or not in significant relationship Working full or part-time Comorbidity reported: Diabetes Cardiovascular disease Respiratory disease Gastrointestinal disease Renal disease Major depression Cigarette smoking Alcohol abuse No. reported comorbidities: 0 1 2 or Greater
22 (23.9) 44 (47.8) 26 (28.3) 12 (13.0) 74 (80.4) 6 (6.6) 3 (3.3) 7 (7.6) 54 (58.7) 23 (25.0) 20 (21.7) 16 (17.4) 28 (30.4) 27 (29.3) 79 (85.9) 12 (13.2) 61 (66.3) 13 (14.1) 2 (2.2) 4 (4.3) 9 (9.8) 5 (5.4) 2 (2.2) 13 (14.1) 4 (4.3) 50 (54.3) 29 (31.5) 12 (13.1)
continence measured by preoperative questionnaire responses differed according to the definition of continence applied. Definition 1 was the most sensitive definition (greater than “very small problem” with dripping or leaking urine) of urinary incontinence reported by 6.5% of patients (6 of 92). According to definitions 2 (“leakage more than once a day”) and 3 (“more than one pad per day”) only 3.3% and 2.2% of patients, respectively, were categorized as incontinent before surgery. Time to regain urinary continence according to definitions 1, 2 and 3 was 3.2 ⫾ 0.1, 3.3 ⫾ 0.4 and 3.0 ⫾ 0.7 months (fig. 1), respectively. After 6 months of followup 34.8% ⫹ 5.0%, 37.4% ⫾ 5.2% and 23.9% ⫾ 4.5% of patients, respectively, remained incontinent. Among the variables listed in tables 1 and 2, patient age (younger than 55, 55 to 64, older than 64) and the number of medical comorbidities (none, 1 and 2 or more) were correlated with the time to regain continence by the 3 different definitions (fig. 2). Median time to regain continence for patients with none, 1 and 2 or more medical comorbidities was 1.4 ⫾ 0.2, 3.3 ⫾ 0.2 and 3.5 ⫾ 2.6 months, respectively. Figure 3 illustrates the effect of age on necessary time to regain urinary continence according to definition 3. Median time to regain continence for patients younger than 55, 55 to 64 and older than 64 years was 1.4 ⫾ 0.3, 3.0 ⫾ 0.9 and 3.3 ⫾ 0.4 months, respectively. PSA was correlated with time to regain continence according to definition 1 only. Meanwhile, none of the other demographic or clinical variables such as preoperative continence status (p ⫽ 0.383), tumor stage (p ⫽ 0.838) or prostate size (p ⫽ 0.890) were correlated with time to regain continence according to definition 3 (or any of the other definitions). A trend toward earlier return of continence was seen in patients undergoing a unilateral nerve sparing (2.9 ⫾ 0.1 months) vs a nonnerve sparing approach (3.2 ⫾ 0.2 months), yet this difference was not significant (p ⫽ 0.329). The difference in median time to regain urinary continence (definition 3) of patients who received or did not receive postoperative XRT (3.4 ⫾ 0.8 vs 3.0 ⫾ 2.2 months)
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URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
FIG. 1. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 92) according to definition 1 (greater than “very small” or “no problem” with urinary leakage), definition 2 (leakage frequency greater than “once per day”) and definition 3 (daily use of greater than “one” or “no” protective pad).
FIG. 3. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 92) according to definition 3 (daily use of greater than “one” or “no” protective pad) comparing patients grouped by age (younger than 55, 55 to 64, older than 64 years) with log rank test (p ⫽ 0.028).
(table 3) yet increasing mean urinary bother scores of 67.6, 74.8, 78.2 and 79.2 points, respectively. A multivariate analysis revealed no significant correlation of patient characteristics with time to regain baseline urinary function, bother or incontinence scores. Meanwhile, XRT after RPP was associated with delayed recovery of the urinary domain summary score (p ⫽ 0.042), as well as for the subscale for irritation/obstruction (p ⫽ 0.037). Urinary domain summary scores for patients who did (10) or did not (82) receive XRT were significantly different after 12 months (74.8 ⫾ 9.0 vs 87.5 ⫾ 1.5, p ⫽ 0.018) yet not at baseline (83.7 ⫾ 4.2 vs 86.5 ⫾ 1.6, p ⫽ 0.561). XRT represented the only independent predictor of time to recover baseline urinary domain summary scores in a multivariate analysis (p ⫽ 0.042) with medians of 8.0 and 6.7 months, respectively. DISCUSSION
FIG. 2. Kaplan-Meier analysis of patient probability of continence after RPP (n ⫽ 91) according to definition 3 (daily use of greater than “one” or “no” protective pad) comparing patients grouped by number of medical comorbidities (none, 1, 2 or more) with log rank test (p ⫽ 0.009).
approached but did not meet statistical significance (p ⫽ 0.052). In a subsequent multivariate analysis only advanced age (definitions 1 and 2) and an increased number of comorbidities (definition 3) were associated with prolonged time to regain urinary continence after RPP. Actual HRQOL scores before surgery, and after 1, 3, 6, 9 and 12 months are reported in table 3. The proportion of patients who returned to preoperative baseline levels within 12 months of followup are reported in table 4. With regard to the urinary summary score, 69.3% and 83.8% of patients returned to within 10 points of individual baseline scores after 6 and 12 months, respectively. The subscale score for urinary continence was the slowest to normalize. A dissociation of patients regaining baseline levels of urinary function and bother was observed, with percentages of 66.2% and 82.4% at 12 months, respectively. The subset of patients who had not regained individual baseline HRQOL scores for urinary function at 3, 6, 9 and 12 months had below average
While recent studies have emphasized the favorable functional results of RPP with continence rates of 93% to 95%,12, 13 a majority of RPP studies have relied on physician based assessments of outcome. However, studies by Litwin et al have raised concerns that urologists may underestimate the severity of patient symptoms and the degree of resulting quality of life impairment.3 Longitudinal studies using validated self-assessment questionnaires have since provided detailed recovery profiles of urinary continence14 and urinary domain related quality of life5, 8 after RRP. To our knowledge comparable data for RPP cases have thus far not been reported. We found that the median time to regain urinary continence and continence rates after 12 months varied according to the definition applied, yet to a lesser extent than in a previous study by Wei et al.14 In that study the first to evaluate the return of continence in a large cohort of patients in a prospective fashion using validated self-assessment tools, median time to regain continence ranged from 2 to 11 months. Urinary continence was achieved by 81% to 98.5% of patients by 24 months after RRP according to the particular definition. Results of these studies emphasize the importance of using strict definitions of continence when discussing outcomes of surgical series. In addition, different thresholds may yield different results. In this study we characterized urinary continence according to definition 1 as “no problem” or “very small problem” with urinary leakage. Had we broadened the definition of continence to include patients with
URINARY CONTINENCE AND QUALITY OF LIFE AFTER RADICAL PERINEAL PROSTATECTOMY
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TABLE 3. Reported HRQOL scores after RPP Physical component summary Mental component summary Urinary function Urinary bother Urinary incontinence Urinary irritation/obstruction Urinary summary score
Baseline 92 Pts
1 Mo 89 Pts
3 Mos 85 Pts
6 Mos 88 Pts
9 Mos 74 Pts
12 Mos 69 Pts
101.6 ⫾ 18.6 102.4 ⫾ 18.0 92.6 ⫾ 11.4 81.6 ⫾ 18.1 91.1 ⫾ 16.6 84.5 ⫾ 15.2 86.2 ⫾ 14.3
77.2 ⫾ 20.8 100.4 ⫾ 21.4 51.2 ⫾ 22.5 58.9 ⫾ 20.7 40.6 ⫾ 28.8 65.9 ⫾ 19.3 55.7 ⫾ 19.9
95.6 ⫾ 20.0 104.0 ⫾ 20.8 69.4 ⫾ 20.2 72.8 ⫾ 19.2 55.4 ⫾ 29.0 82.4 ⫾ 15.4 71.3 ⫾ 18.3
100.4 ⫾ 17.2 106.6 ⫾ 17.4 84.9 ⫾ 17.1 81.9 ⫾ 14.1 78.1 ⫾ 25.1 87.2 ⫾ 11.8 83.2 ⫾ 13.7
101.8 ⫾ 17.0 108.6 ⫾ 15.0 88.0 ⫾ 13.9 84.8 ⫾ 11.8 82.9 ⫾ 21.4 88.9 ⫾ 10.5 86.4 ⫾ 10.8
101.6 ⫾ 18.6 107.2 ⫾ 17.2 87.0 ⫾ 15.4 85.2 ⫾ 16.0 82.7 ⫾ 20.6 88.1 ⫾ 13.2 86.0 ⫾ 14.4
TABLE 4. Patients who regained individual preoperative baseline HRQOL scores within 12 months after RPP % Pts Reaching Baseline
Physical component summary Mental component summary Urinary function Urinary bother Incontinence Irritation/obstruction Urinary summary score
1 Mo
3 Mos
6 Mos
9 Mos
12 Mos
22.5 70.1 10.1 29.2 9.0 39.3 19.1
66.7 75.6 29.4 51.2 18.8 72.9 45.2
80.5 81.2 62.5 70.5 56.8 87.5 69.3
82.4 84.7 74.3 79.5 62.2 85.1 78.1
88.4 80.6 66.2 82.4 58.8 80.9 83.8
“small problems” with urinary leakage, as used by Kielb et al6 the percentage of patients considered incontinent at 6 months after RPP would have been decreased from 34.8% to 19.6%, thereby making our results appear much more favorable. However, we believe that the applied threshold on which we based our analysis of “no problem/very small problem” is more clinically valid. Contrary to previous studies, a nerve sparing approach did not affect time to regain urinary continence.14 To explain the association of urinary continence and nerve preservation Wei et al suggested that a nerve sparing approach aids in preserving the yet poorly characterized motor innervation of the urethral sphincter.14 Since other studies, all based on RRP cases, have also failed to demonstrate an association of a nerve sparing approach and the recovery of urinary continence,15, 16 it is possible that nerve preservation has less impact on urinary continence in RPP. However, in our series nerve preservation may have been performed in too small a subset of patients using only a unilateral approach to demonstrate a significant effect. Since the initiation of this study the use of bilaterally nerve sparing RPP at our institution has become much more widely endorsed, and the longitudinal assessment of these patients may provide an answer in the future. The observation made in this study that age is an important predictor of time to regain continence, concurred with the findings of Wei et al.14 While the pathophysiology of this observation remains poorly understood, the association of age and continence has been documented in previous RPP studies.17 There are likely several age related factors that affect urethral and detrusor function including decreased urethral coaptation, increased detrusor instability and delayed wound healing. To our knowledge longitudinal assessments of HRQOL scores have only been reported in RRP cases. In a large study that included 247 RRP patients, 56% and 71% recovered baseline urinary function and bother scores, respectively.8 Average time to recover these scores was approximately 7 to 8 months. In our study recovery of urinary domain related quality of life scores were analyzed using the same methodology introduced by Litwin et al5, 8 in reference to patient individual baseline scores. We found that 66% and 82% of RPP cases recovered baseline urinary function and bother scores, respectively, after an average of 6 to 7 months. Among the urinary domain subscales the urinary incontinence score was the slowest to recover and normalized in approximately 60% of patients by 1 year. Our results may further be compared to those of a cross-sectional survey of patients who
Median Mos to Baseline 6.3 3.1 6.7 6.3 6.5 3.8 6.7
underwent RRP and completed the EPIC questionnaire a median of 30 months after surgery.18 This study reported an average urinary incontinence subscale score of 79 points on a scale of 0 to 100 compared to 93 points for age matched controls without prostate cancer. While the results of our study based on only 92 patients are subject to selection bias and cannot be compared directly, it does appear that the urinary incontinence scores in RPP cases, calculated at 83 points at 12 months are roughly equivalent if not higher, and may improve further with longer followup. Meanwhile, the large proportion of patients that recovered urinary continence and baseline HRQOL scores suggests that our data are mature and permits valuable insights into the time course of recovery after RPP. Previous studies have suggested associations of urinary domain related QOL with race, relationship status, education and income, yet failed to demonstrate statistically significant correlations.8 In this study postoperative XRT was the only variable that correlated with delayed recovery of urinary irritation/obstruction scores as well as urinary summary scores, yet not function or incontinence. These findings are plausible since XRT is known to cause radiation cystitis and irritative voiding symptoms.18, 19 However, given the small subset of patients on which the results are based, future confirmatory studies will be necessary to assess the impact of postoperative XRT on urinary domain related QOL. CONCLUSIONS
This study outlines the recovery of urinary continence within 12 months after RPP based on validated patient selfassessment tools, and suggests that a majority of patients regain urinary continence early depending on the definition of continence applied. Additionally, most recovery of urinary domain related QOL occurred within the first 6 months. While postoperative XRT adversely affected the recovery of urinary domain related quality of life, advanced patient age and number of medical comorbidities delayed time to recovery of urinary continence. Future longitudinal studies with more extended followup should assist in identifying further the impact of these variables. Katie Snider maintained the HRQOL database. REFERENCES
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