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Keywords:

  • natural history;
  • predictive factor;
  • prostate cancer;
  • prostatectomy;
  • urinary incontinence

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

Objectives:  To evaluate the clinical prognosis of incontinence and to determine the predictors for further recovery of urinary continence in patients not achieving urinary continence within 1 year after radical prostatectomy.

Methods:  A total of 708 patients were evaluated regarding urinary continence status at 1 year after surgery from a prospectively maintained radical prostatectomy database. Of these, 73 (10.3%) did not recover urinary continence within 1 year after surgery. For these patients, incontinence status and the number of pads for urinary control were assessed serially.

Results:  In 708 patients, factors associated with the recovery of urinary continence within 1 year after radical prostatectomy were membranous urethral length, prostatic apex shape and patient age. Among 73 patients with urinary incontinence, 41 (56.2%) achieved urinary continence with a mean time of 15.4 months subsequent to the first year after radical prostatectomy (baseline). A younger age at surgery (P = 0.027) and one pad being required (vs≥2 pads) at baseline (P = 0.046) were identified as independent factors for achievement of urinary continence within a further 2 years. Only the number of pads was a significant factor for further recovery of urinary continence in the longer follow up (hazard ratio 0.36, P = 0.029).

Conclusion:  Compared with factors related to the prostate or membranous urethra, patient age and severity of incontinence at 1 year after radical prostatectomy are more strongly related to the recovery of urinary continence later than 1 year after surgery. These findings might help to decide whether a definite treatment is required for persistent incontinence beyond 1 year after radical prostatectomy.


Abbreviations & Acronyms
BMI =

body mass index

CI =

confidence interval

HR =

hazard ratio

NVB =

neurovascular bundle

OR =

odds ratio

PSA =

prostate-specific antigen

RP =

radical prostatectomy

UC =

urinary continence

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

RP is excellent for the long-term control of prostate cancer.1 However, it has been associated with complications or sequelae, such as urinary incontinence and erectile dysfunction; these complications are a significant concern to physicians and their patients.2,3 UC is usually achieved within 1 year after surgery; however, approximately 10% of patients fail to recover UC within this period, after which they tend to seek definitive treatment for incontinence.2 This is because additional improvement of incontinence has been found to be minimal beyond 1 year after surgery.4 Therefore, 1 year after surgery is considered to be the appropriate time for evaluation and proceeding with definitive, surgical treatment for persistent incontinence, even though there are no standardized guidelines on this issue.5

As for the recovery of UC beyond 1 year after surgery, several longitudinal surveys have well demonstrated that clinical improvement in urinary control can occur later than this point in time in some patients.2,6–8 However, as these studies analyzed the urinary function or time-dependent changes of all the patients who had undergone RP, rather than just those who did not achieve UC within 1 year after surgery, these findings might not sufficiently reflect the prognosis of urinary outcome in patients who do not recover UC within 1 year after RP. In addition, the study periods of the studies documenting various clinical and surgical factors potentially related to the achievement of UC were limited to the first year after surgery,9–14 and there is a paucity of literature on the predictive factors for the further recovery of UC subsequent to the first year after surgery.15–17 Also, the literature on this issue dealt with the total patients who had undergone RP,15–17 rather than those who did not achieve UC within 1 year after surgery.

Information on this issue might assist with the provision of appropriate counseling and the planning of treatment strategies for patients with persistent incontinence beyond 1 year after RP. We tried to evaluate the clinical prognosis of incontinence and identify factors for the further recovery of UC after 1 year of surgery in patients who had not achieved UC by 1 year.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

Study population

Between January 2004 and July 2008, 798 consecutive men underwent RP for clinically localized or locally advanced prostate cancer at Seoul National University Bundang Hospital, Seongnam, Korea. All clinical data with regard to demographic characteristics, surgical procedure, pathological results, surgical complications18 and follow-up blood tests were prospectively collected in a computerized database. The detailed variables obtained from the database were as follows: age at surgery, body mass index, PSA, membranous urethral length (measured by preoperative magnetic resonance imaging),19 prostatic apex shape (categorized into four different types according to the shape of the prostatic apex on the midsagittal plane of the magnetic resonance imaging scans),20 Charlson comorbidity score,21 methods of surgical approach (open retropubic vs pure laparoscopic or robot-assisted), neurovascular bundle sparing (non-sparing vs unilateral/bilateral sparing), operative time, specimen volume, tumor volume percent, pathological Gleason score and pathological T stage.

In our institution, robot-assisted RP have been carried out since late 2007. Therefore, 139 (17.4%) patients underwent robot-assisted surgery during the study period. We did not carry out procedures for bladder neck preservation or puboprostatic ligament sparing22 on a routine basis, and few cases of restoration of the Denonvilliers musculofascial plate23 were carried out during the study period. Follow up of the patients consisted of physical examination, urinalysis, PSA examination, digital rectal examination and the completion of validated questionnaires assessing the status of urinary or erectile function (if required), and was carried out every 3 months for the first 1 or 2 years, every 6 months in the next 3 or 4 years, and yearly thereafter. The institutional review board approved the study protocol.

The achievement of UC was defined as wearing no pads or an occasional security pad. “Wearing an occasional security pad” referred to patients occasionally wearing a pad for protection, because they were concerned about possible incontinence even though they had no actual leakage. In contrast, those who wore a security pad because of slight leakage were classified as patients who used one pad daily. Incontinence status and the number of pads required per day for urinary control were assessed serially by patient interview and validated questionnaires regarding voiding status carried out by a research assistant. Of all the patients investigated, 775 completed at least 1 year of follow-up visits after surgery; of these, we excluded 19 who had received pelvic irradiation before achievement of UC, 10 who were incontinent before surgery or might have had a neurogenic bladder, and 38 about whom there was no information regarding time to the achievement of UC. Thus, a total of 708 patients were evaluated regarding their continence status at 1 year after RP. In these patients, a total of 73 (10.3%) patients did not achieve UC within 1 year after RP and underwent further follow-up studies with regard to incontinence status for at least 2 years. If suspected, the presence of anastomotic stricture was investigated with cystourethroscopy. Generally, urodynamic evaluation was recommended to all the patients in order to elucidate an accurate cause for their incontinence; however, the decision to carry out a urodynamic study was made at the physician and patient's discretion. All the patients were instructed to carry out daily pelvic floor muscle exercises. During the follow up, we also discussed a male sling or artificial urinary sphincter surgery with the patients, and censored patients from the follow up if they had received such anti-incontinence surgery.

Statistical analyses

Time to UC and percentage of continent patients from the baseline (at 1 year after RP) at each follow up were calculated using Kaplan–Meier curve estimates and compared using log–rank statistics. Logistic regression analyses were carried out to identify the factors related to achievement of UC within a further 2-year period from the baseline among the variables obtained from the database. In addition, the number of pads required per day, which reflected the severity of incontinence at the baseline, was added to the logistic regression. Finally, Cox proportional hazards analysis was carried out to determine the independent predictive factors of further recovery of UC for the whole follow-up period.

The spss software package version 19.0 (IBM, Somers, NY, USA) was used, and a two-tailed P-value <0.05 was determined to show statistical significance.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

In 708 patients evaluated at 1 year after RP, factors associated with the recovery of UC within 1 year after surgery were membranous urethral length (OR 1.94, P = 0.041) and prostatic apex shape (P = 0.035), as well as patient age at surgery (OR 0.89, P = 0.028) based on multivariate logistic regression analysis. A total of 73 (10.3%) patients did not recover UC within 1 year after RP. Table 1 shows the clinicopathological characteristics of these patients. All these patients were continent before surgery. Surgeries were carried out by a total of four surgeons, and a neurovascular bundle sparing procedure, either unilateral or bilateral, was carried out in 31 patients. At 1 year after RP (baseline), 94.5% of these patients were using two or fewer pads per day on a regular basis for urinary control; one patient was using six pads daily. During the follow up, 18 patients underwent urodynamic studies, and these showed urodynamic stress incontinence. Four (22.2%) of the 18 patients were found to have detrusor overactivity; however, urodynamic stress incontinence also accompanied detrusor overactivity in these patients. The mean duration of patient follow up from the baseline was 41.6 months.

Table 1. Clinicopathological characteristics of patients who did not achieve urinary continence within 1 year after radical prostatectomy
VariableNumber or meanPercentage or range
  1. †In three patients, computed tomography scan was obtained rather than magnetic resonance imaging before surgery. ‡Three patients received adjuvant hormone therapy before achievement of urinary continence and four patients received salvage hormone or radiation therapy after achievement of urinary continence.

No. patients73 
Age (years)68.548–76
BMI (kg/m2)24.218.7–30.1
PSA (ng/mL)11.51.2–35.8
Membranous urethral length, mm (70 cases)12.56.0–19.0
Prostatic apex shape (70 cases)  
 Type I1216.4
 Type II2534.2
 Type III1520.5
 Type IV1824.7
Charlson comorbidity score  
 03953.4
 12635.6
 279.6
 311.4
Clinical stage  
 T14967.1
 T21926.1
 T356.8
Surgical approach  
 Open retropubic5068.5
 Pure laparoscopic1013.7
Robot-assisted1317.8
NVB sparing (unilateral or bilateral)3142.5
Lymphadenectomy5372.6
Operative time (min)185.595–470
Specimen volume (mL)44.520–98
Tumor volume (%)13.61–98
Pathological Gleason score  
 ≤62635.6
 74054.8
 ≥879.6
Pathological stage  
 T2N05778.1
 T3aN01115.0
 T3bN034.1
 T4N011.4
 N111.4
Positive surgical margin2027.4
Modified Clavien classification  
 Grade I56.8
 Grade II2331.5
 Grade III11.4
Adjuvant/salvage therapy79.6
No. pads required at baseline (per day)  
 14865.7
 22128.8
 334.1
 ≥411.4
Follow up from the baseline (month)41.625–79

Figure 1a shows the actuarial probability curve of the achievement of UC in these patients. A total of 41 (56.2%) patients achieved UC, with a mean time to continence of 15.4 months from the baseline; 21 (51.2%) achieved UC within 2–12 months, 14 (34.1%) within 13–24 months and six (14.7%) over 25 months from the baseline. The last patient to achieve UC did so 50 months from the baseline. Five patients were censored from the follow up as they received either a male sling (3 cases) or artificial urinary sphincter surgery (2 cases) 10–27 months from the baseline, and the number of pads required at the baseline was one for one patient, two for three patients and three for one patient, respectively, among these patients. Of the 73 patients who did not recover UC within 1 year after RP, 27 were reported to be incontinent at their last follow up; 17 had been followed up for 25–36 months, four for 37–48 months and six for longer than 48 months from the baseline. In these patients, the mean number of pads required at the time of the last follow-up visit was 1.6 per day.

image

Figure 1. Kaplan–Meier curve estimates of time to urinary continence in patients who did not achieve urinary continence within 1 year after radical prostatectomy. (a) Overall estimate in the whole patients. A dotted line represents mean time to urinary continence in patients who achieved urinary continence during the follow up. (b) Subgroup estimate according to the number of pads required per day at 1 year after radical prostatectomy. (c) Subgroup estimate according to prostatic apex shape. (d) Subgroup estimate according to patient age at surgery. Age groups were stratified as three groups by equal distributions. Time to recovery of urinary continence among the groups was compared using log–rank statistics. (b) Number of pads used at 1-year visit of RP: inline image, 1 pad (n = 48); inline image, ≥2 pads (n = 25); P = 0.009. (c) Prostatic apex shape: inline image, Type I (n = 12); inline image, Type II (n = 25); inline image, Type III (n = 15); inline image, Type IV (n = 18); P = 0.091. (d) Patient age: inline image, ≤67 years (n = 28); inline image, 68–70 years (n = 21); inline image, ≥71 years (n = 24); P = 0.614.

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Table 2 shows the factors related to achievement of UC within a further 2 years from the baseline. In the multivariate analysis, younger patients or those who only required one pad at the baseline were significantly more likely to achieve UC within a further 2 years from the baseline. Table 3 shows the factors predictive of the further recovery of UC during the whole follow-up period. In the univariate analysis, number of pads required at the baseline was a significant factor for the further recovery of UC; PSA and prostatic apex shape were marginally not significant to this effect. However, only the number of pads was an independent predictive factor in the multivariate analysis of the whole follow-up period. Different surgical approaches, such as the open retropubic, pure laparoscopic or robot-assisted approach, showed no differences in their effect on the achievement of UC within a further 2-year period from the baseline or on further recovery of UC during the whole follow-up period.

Table 2. Logistic regression analysis of the factors related to achievement of urinary continence within a further 2 years from the baseline
VariableUnivariateMultivariate
OR (95% CI) P-valueOR (95% CI) P-value
  • Variables with statistical significance in multivariate logistic regression analysis.

Age (years)0.90 (0.79–1.01)0.0720.77 (0.60–0.97)0.027
BMI (kg/m2)1.13 (0.93–1.38)0.218  
PSA (ng/mL)1.05 (0.99–1.12)0.1231.00 (0.90–1.10)0.922
Membranous urethral length (mm)0.87 (0.71–1.08)0.202  
Prostatic apex shape 0.157 0.082
 Type II vs I0.46 (0.10–2.12) 0.17 (0.01–2.47) 
 Type III vs I0.76 (0.15–3.86) 0.33 (0.02–5.03) 
 Type IV vs I2.67 (0.45–15.60) 6.94 (0.42–33.22) 
Charlson comorbidity score 0.550  
 1 vs 00.56 (0.19–1.63)   
 ≥2 vs 00.67 (0.14–3.12)   
Surgical approach 0.200 0.344
Pure laparoscopic vs open retropubic0.50 (0.12–2.14) 3.41 (0.05–56.89) 
Robot-assisted vs open retropubic0.32 (0.08–1.21) 0.28 (0.04–2.02) 
NVB sparing (unilateral or bilateral)1.00 (0.37–2.71)1.000  
Operative time (min)1.00 (0.99–1.00)0.331  
Specimen volume (mL)1.03 (0.99–1.06)0.1161.04 (0.98–1.10)0.170
Tumor volume (%)0.99 (0.97–1.01)0.546  
Pathological Gleason score (≥7 vs≤6)0.68 (0.25–1.82)0.438  
Pathological T stage (≥T3 vs T2)1.25 (0.35–4.44)0.730  
No. pads required at baseline (≥2 vs 1/day)0.39 (0.13–1.13)0.0820.15 (0.02–0.89)0.046
Table 3. Cox proportional hazards analysis of factors predictive of the further recovery of urinary continence during the whole follow-up period
VariableUnivariateMultivariate
HR (95% CI) P-valueHR (95% CI) P-value
  • Variable with statistical significance in Cox proportional hazards analysis.

Age (years)0.95 (0.88–1.02)0.1570.95 (0.87–1.04)0.249
BMI (kg/m2)1.05 (0.93–1.18)0.462  
PSA (ng/mL)1.02 (1.00–1.05)0.0861.01 (0.97–1.05)0.701
Membranous urethral length (mm)0.99 (0.87–1.12)0.815  
Prostatic apex shape 0.096 0.112
 Type II vs I0.74 (0.29–1.92) 0.80 (0.27–2.40) 
 Type III vs I0.82 (0.30–2.25) 0.98 (0.27–3.55) 
 Type IV vs I1.61 (0.64–4.06) 2.44 (0.82–7.26) 
Charlson comorbidity score 0.797  
 1 vs 00.79 (0.40–1.59)   
 ≥2 vs 01.01 (0.38–2.65)   
Surgical approach 0.178 0.592
Pure laparoscopic vs open retropubic0.50 (0.18–1.43) 1.26 (0.14–11.80) 
Robot-assisted vs open retropubic0.46 (0.16–1.31) 0.53 (0.16–1.82) 
NVB sparing (unilateral or bilateral)1.06 (0.57–1.98)0.855  
Operative time (min)1.00 (1.00–1.00)0.353  
Specimen volume (mL)1.01 (0.99–1.03)0.295  
Tumor volume (%)0.98 (0.96–1.01)0.253  
Pathological Gleason score (≥7 vs≤6)0.82 (0.43–1.54)0.528  
Pathological T stage (≥T3 vs T2)0.99 (0.46–2.15)0.982  
No. pads required at baseline (≥2 vs 1/day)0.38 (0.17–0.82)0.0140.36 (0.14–0.90)0.029

Figure 1b–d shows the Kaplan–Meier curve estimates of time to the recovery of UC in the subgroups stratified by number of pads required at the baseline, prostatic apex shape and age at surgery. In particular, no patients using two or more pads at the baseline achieved UC beyond 20 months from the baseline (Fig. 1b).

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

Our finding that the recovery of UC can occur later than 1 year after RP is not new, as it has been shown in several longitudinal surveys documenting the natural history of urinary control after surgery.2,6–8 However, by focusing on patients who had not achieved recovery of UC within 1 year after surgery, we have elucidated more clearly the clinical prognosis of incontinence and have shown predictive factors for the further recovery of UC in these patients.

In our contemporary series of patients who underwent RP, 10.3% failed to recover UC within 1 year after surgery, which is comparable with the percentages in previous studies.6,15,24 During the further 41.6-month follow-up period, 56.2% of these patients achieved UC, with a mean time to UC of 15.4 months. Most recovery in these patients occurred within a further 2-year follow-up period; therefore, we tried to identify factors related to the achievement of UC within this period. Younger patients and those who required only one pad at the baseline were significantly more likely to recover UC within a further 2 years from the baseline. However, only the number of pads was associated with further recovery of UC after this point. Actually, no patients using two or more pads at the baseline achieved UC later than 20 months from the baseline (Fig. 1b). Although these factors might have been recognized as being possibly associated with the recovery of UC after RP, few studies have explored these in the setting of the further recovery of UC beyond 1 year after RP. To the best of our knowledge, the present study was the first to evaluate predictors for the further recovery of UC in the patients who did not achieve UC within 1 year after RP.

Interestingly, patient age at surgery was not a statistically significant factor predicting further recovery of UC during the whole follow-up period, even though it was associated with the recovery of UC within 2 years from the baseline. In general, patient age at surgery has been consistently found to be an independent predictor for early recovery of UC (within 1 year). Additionally, in some studies, long-term recovery (later than 1 year after surgery) was dependent on patient age in an analysis of all the patients who underwent RP.15–17 In the present study, however, four of the six patients who recovered UC later than 2 years from the baseline belonged to the oldest group after the patents were divided into three age groups of equal distribution (Fig. 1d). This is the most likely reason for the loss of significance of patient age as a predictive factor for the further recovery of UC in the longer follow up. More studies are required to confirm the effect of patient age on the long-term recovery of UC in patients who do not achieve UC within 1 year after RP.

We focused on patients who had not achieved UC within 1 year after RP, because we assumed that the factors that predict recovery of UC would be different according to the time when the achievement of UC is evaluated. In our whole RP series, factors associated with the recovery of UC within 1 year after surgery were membranous urethral length and prostatic apex shape, as well as patient age at surgery. Other studies have also shown membranous urethral length19,25 and variations in the shape of the prostatic apex12 to be independently associated with the recovery of UC within 1 or 2 years, or with early recovery of UC (≤3 months) after surgery. However, these factors did not affect the prognosis of incontinence in patients who had not achieved UC within 1 year after surgery in the present study. Because of this, we suggest that the factors that relate to the prostate or membranous urethra might only affect recovery of UC within 1 or 2 years after RP, whereas factors related to the natural course of urinary function, such as age or severity of incontinence at 1 year after surgery, seem to be more strongly related to the recovery of UC later than 1 or 2 years after surgery. Therefore, considering these different sets of factors might aid physicians in their counseling of patients suffering from persistent incontinence, especially those who are incontinent beyond 1 year after surgery, as well as help to decide whether immediate and definitive treatment is required or whether UC will recover spontaneously with further observation.

With regard to robot-assisted and pure laparoscopic RP, as just 18% and 14% of our patients underwent these surgeries, respectively, we have not ascertained whether robot-assisted and pure laparoscopic surgery are superior to the open retropubic approach in terms of the recovery of UC later than 1 year after surgery. One recent study showed faster recovery of UC in patients who underwent robot-assisted surgery compared with those who underwent open surgery during a follow-up period of up to 2 years.16 At present, as there are little data regarding further improvement in UC beyond 1 or 2 years after surgery in patients who have undergone robot-assisted or pure laparoscopic RP, further studies on this issue with a longer follow-up period are required.

We certainly acknowledge that patients with more severe degrees of incontinence tend to undergo surgery for incontinence during the follow up, thereby possibly introducing an element of selection bias into the study. However, during the follow up, we discussed anti-incontinence surgery with patients, and because male anti-incontinence surgery has not been popular in Korea, just five (6.8%) of our patients had undergone this kind of surgery. Furthermore, the number of pads required at the baseline varied from one to three among the patients who received anti-incontinence surgery. Therefore, the effect of censoring because of anti-incontinence surgery might be minimal in the present study.

Several limitations of the present study deserve mention. First, although there are several methods of quantifying the severity of incontinence, we categorized patients based on the number of pads required per day for urinary control at the baseline. Although this is a quantitative measurement, it still has a subjective aspect. Instead of the number of pads, the pad weight per 24 h seems to be the most accurate measurement,5 and this measurement was also applied to nearly all of our patients; however, the collection rate was not sufficient for analysis. Therefore, we quantified the severity of incontinence with the number of pads used per day. Second, medications, such as antimuscarinics, were not restricted during the evaluation of UC. However, published data have shown that functional impairment of the external urethral sphincter contributes to more than 90% of incontinent cases after RP,26 and just 2% of patients with incontinence complain of urgency incontinence alone.17 Therefore, urinary incontinence symptoms might be ascribed to the impairment of the external urethral sphincter in most of our study cohort. However, because just 18 (24.7%) out of the 73 patients who did not recover UC within 1 year after RP underwent urodynamic studies, we could not ascertain an accurate cause for incontinence in these patients in the present study. Third, we only measured the severity of incontinence quantitatively, but did not examine the qualitative outcomes of urinary status. We used a validated questionnaire during the study period, but the response rate was not high for a statistical analysis. Last, it might be suggested that the number of patients analyzed in the present study was relatively small. In general, however, just 10% of all the patients who undergo RP fail to recover UC within 1 year after the surgery.2 Therefore, we believe that the number of patients in the current study reflects the real-life incidence with regard to UC status after surgery.

The present results suggest the importance of patient age at surgery and severity of incontinence at 1 year after RP rather than the factors related to the prostate or membranous urethra in predicting further recovery of UC later than 1 year after RP. In addition, ultimately, only the severity of incontinence 1 year after surgery was a predictive factor for the further recovery of UC in the longer follow-up period. These findings might provide physicians and patients with practical information that can be used in deciding whether definitive treatment is required for persistent incontinence beyond 1 year after RP.

Acknowledgments

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References

This study has been supported by a grant from Seoul National University Bundang Hospital Research Fund.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgments
  8. Conflict of interest
  9. References
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