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Video: Postoperative RT for patients at high-risk of recurrence after RP: does timing matter?

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Postoperative radiation therapy for patients at high-risk of recurrence after radical prostatectomy: does timing matter?

Charles C. Hsu*†, Alan T. Paciorek‡, Matthew R. Cooperberg‡, Mack Roach III*, I-Chow J. Hsu* and Peter R. Carroll‡

 

*Department of Radiation Oncology, Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, †Department of Radiation Oncology, College of Medicine, University of Arizona, Tucson, AZ, and ‡Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA

 

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OBJECTIVE

To evaluate among radical prostatectomy (RP) patients at high-risk of recurrence whether the timing of postoperative radiation therapy (RT) (adjuvant, early salvage with detectable post-RP prostate-specific antigen [PSA], or ‘late’ salvage with a PSA level of >1.0 ng/mL) is significantly associated with overall survival (OS), prostate-cancer specific survival or metastasis-free survival, in a longitudinal cohort.

PATIENTS AND METHODS

Of 6 176 RP patients in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), 305 patients with high-risk pathological features (margin positivity, Gleason score 8–10, or pT3–4) who underwent postoperative RT were examined, either in the adjuvant (≤6 months after RP with undetectable PSA levels, 76 patients) or salvage setting (>6 months after RP or pre-RT PSA level of >0.1 ng/mL, 229 patients). Early (PSA level of ≤1.0 ng/mL, 180 patients) or late salvage RT (PSA level >1.0 ng/mL, 49 patients) was based on post-RP, pre-RT PSA level. Multivariable Cox regression examined associations with all-cause mortality and prostate cancer-specific mortality and/or metastases (PCSMM).

RESULTS

After a median of 74 months after RP, 65 men had died (with 37 events of PCSMM). Adjuvant and salvage RT patients had comparable high-risk features. Compared with adjuvant, salvage RT (early or late) had an increased association with all-cause mortality (hazard ratio [HR] 2.7, P = 0.018) and with PCSMM (HR 4.0, P = 0.015). PCSMM-free survival differed by further stratification of timing, with 10-year estimates of 88%, 84%, and 71% for adjuvant, early salvage, and late salvage RT, respectively (P = 0.026). For PCSMM-free survival and OS, compared with adjuvant RT, late salvage RT had statistically significantly increased risk; however, early salvage RT did not.

CONCLUSION

This analysis suggests that patients who underwent early salvage RT with PSA levels of <1.0 ng/mL may have comparable metastasis-free survival and OS compared with adjuvant RT; however, late salvage RT with a PSA level of >1.0 ng/mL is associated with worse clinical outcomes.

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Article of the Week: Increase of Framingham CVD risk score is associated with severity of LUTS

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Giorgio Russo, discussing his paper. 

If you only have time to read one article this week, it should be this one.

Increase of Framingham cardiovascular disease risk score is associated with severity of lower urinary tract symptoms

Giorgio I. Russo, Tommaso Castelli, Salvatore Privitera, Eugenia Fragala, Vincenzo Favilla, Giulio Reale, Daniele Urzı, Sandro La Vignera*, Rosita A. Condorelli*, Aldo E. Calogero*, Sebastiano Cimino and Giuseppe Morgia

 

Department of Urology, and *Department of Medical and Paediatric Sciences, Section of Endocrinology, Andrology and Internal Medicine, University of Catania, Catania, Italy

 

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OBJECTIVE

To determine the relationship between lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and 10-year risk of cardiovascular disease (CVD) assessed by the Framingham CVD risk score in a cohort of patients without previous episodes of stroke and/or acute myocardial infarction.

PATIENTS AND METHODS

From September 2010 to September 2014, 336 consecutive patients with BPH-related LUTS were prospectively enrolled. The general 10-year Framingham CVD risk score, expressed as percentage and assessing the risk of atherosclerotic CVD events, was calculated for each patient. Individuals with low risk had ≤10% CVD risk at 10 years, with intermediate risk 10–20% and with high risk ≥20%. Logistic regression analyses were used to identify variables for predicting a Framingham CVD risk score of ≥10% and moderate–severe LUTS (International Prostate Symptom Score [IPSS] ≥8), adjusted for confounding factors.

RESULTS

As category of Framingham CVD risk score increased, we observed higher IPSS (18.0 vs 18.50 vs 19.0; P < 0.05), high IPSS–voiding (6.0 vs 9.0 vs 9.5; P < 0.05) and worse sexual function. Prostate volume significantly increased in those with intermediate- vs low-risk scores (54.5 vs 44.1 mL; P < 0.05). Multivariate logistic regression analysis showed that intermediate- [odds ratio (OR) 8.65; P < 0.01) and high-risk scores (OR 1.79; P < 0.05) were independently associated with moderate–severe LUTS. At age-adjusted logistic regression analysis, moderate–severe LUTS was independently associated with Framingham CVD risk score of ≥10% (OR 5.91; P < 0.05).

  • cardiovascular disease
CONCLUSION

Our cross-sectional study in a cohort of patients with LUTS–BPH showed an increase of more than five-fold of having a Framingham CVD risk score of ≥10% in men with moderate–severe LUTS.

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Editorial: LUTS – an independent risk factor for CVD

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Russo et al. [1] have identified LUTS as an independent risk factor for cardiovascular disease (CVD). The more severe the LUTS the more the CVD risk increased. LUTS in men is caused by a group of disorders, e.g. the metabolic syndrome and central obesity, which have similar risk factors to those that cause CVD [2]. Furthermore, LUTS is associated with erectile dysfunction (ED), which is well established as being linked to silent or symptomatic CVD [3]. The question arises as to whether the age of the patient rather than the LUTS is the cause for the CVD, in other words, is the LUTS merely a bystander or coincidental problem?

The evidence, however, is accumulating that LUTS is independent of age and a risk factor for CVD [2]. A multi-disciplinary consensus looked at ED and LUTS emphasising the importance of co-diagnosis with awareness of cardiovascular risk factors being present in patients with LUTS, ED, or LUTS and ED, and reviewed the literature on the underlying pathophysiology [2].

The link between ED and LUTS was brought home by the Multinational Survey of the Aging Male (MSAM) study. Many large epidemiological studies using well-powered multivariate analyses consistently provide overwhelming evidence of a link between ED and LUTS [4].

The pathogenic mechanisms underlying the relationships between ED and LUTS have been the subject of several recent reviews [5]. The underlying mechanisms include: the alteration of the nitric oxide-cyclic guanosine monophosphate pathway, enhancement of Rho-kinase (ROCK) signalling, autonomic hyperactivity, and pelvic atherosclerosis, secondary to endothelial dysfunction [6]. Additional contributing factors may include chronic inflammation and sex steroid ratio imbalance, all of which contribute to increased CVD risk.

LUTS, with or without ED, should trigger a search for cardiovascular risk factors and metabolic problems. In 2008, the International Journal of Impotence Research published a symposium entitled ‘Cardiac Sexology: Can we save a patient’s life and his love life?’. The recognition that urologists have an important role in the early identification of cardiovascular risk should encourage urologists to work closely with cardiologists [3].

Certainly the degree of risk recorded by Russo et al. [1] is substantially greater than one would expect from age alone. Possible mechanisms include the co-existence of inflammatory activity manifest by a raised C-reactive protein (CRP), which is commonly found in association with more severe LUTS and in turn, increased CVD risk [7]. Similarly chronic sleep disturbance, especially nocturia, is common in both LUTS and CVD, as is depression [2].

Endothelial dysfunction, which is recognised to be the major vascular risk for CVD, also occurs in LUTS that is chronic or severe usually affecting the prostate gland or bladder. There are, therefore, strong links between LUTS, ED and CVD a common denominator being increased adrenergic tone. Patients with LUTS should be asked about alternative symptoms, including ED, and screened for cardiovascular risk even if they have no cardiac symptoms. LUTS may not be as strong a risk factor as ED for CVD, but it appears to be an independent marker for increased risk, which should not be ignored. Men are reluctant to volunteer their concerns, so it is important that healthcare professionals ask the appropriate questions.

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Graham Jackson, Mike G. Kirby* and Ray Rosen†

 

St. Thomas’ Hospital, London, UK, *The Prostate Centre, London, UK and †New England Research Institutes, Inc. (NERI), Waterto wn, MA, USA

 

References

 

1 Russo GI, Castelli T, Privitera S et al. Increase of Framingham cardiovascular disease risk score is associated with severity of lower urinary tract symptoms. BJU Int 2015; 116:791–6

 

2 Kirby M, Chapple C, Jackson G et al. Erectile dysfunction and lower urinary tract symptoms: a consensus on the importance of co-diagnosis. Int J Clin Pract 2013; 67: 606–18

 

3 Nehra A, Jackson G, Miner M et al. The Princeton III consensus for the management of erectile dysfunction and cardiovascular disease. Mayo Clin Proc 2012; 87: 766–78

 

4 Rosen R, Altwein J, Boyle P et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol 2003; 44: 637–49

 

5 Gacci M, Eardley I, Giuliano F et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2011; 60: 809–25

 

6 Kohler TS, McVary KT. The relationship between erectile dysfunction and lower urinary tract symptoms and the role of phosphodiesterase type 5 inhibitors. Eur Urol 2009; 55: 38–48

 

7 Vlachopoulos C, Ioakeimidis N, Stefanadis C. Biomarkers, erectiledysfunction, and cardiovascular risk prediction: the latest of an evolving concept. Asian J Androl 2015; 17: 17–20

 

Video: The severity of LUTS is associated with an increase of Framingham CVD risk score

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Increase of Framingham cardiovascular disease risk score is associated with severity of lower urinary tract symptoms

Giorgio I. Russo, Tommaso Castelli, Salvatore Privitera, Eugenia Fragala, Vincenzo Favilla, Giulio Reale, Daniele Urzı, Sandro La Vignera*, Rosita A. Condorelli*, Aldo E. Calogero*, Sebastiano Cimino and Giuseppe Morgia

 

Department of Urology, and *Department of Medical and Paediatric Sciences, Section of Endocrinology, Andrology and Internal Medicine, University of Catania, Catania, Italy

 

Read the full article
OBJECTIVE

To determine the relationship between lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and 10-year risk of cardiovascular disease (CVD) assessed by the Framingham CVD risk score in a cohort of patients without previous episodes of stroke and/or acute myocardial infarction.

PATIENTS AND METHODS

From September 2010 to September 2014, 336 consecutive patients with BPH-related LUTS were prospectively enrolled. The general 10-year Framingham CVD risk score, expressed as percentage and assessing the risk of atherosclerotic CVD events, was calculated for each patient. Individuals with low risk had ≤10% CVD risk at 10 years, with intermediate risk 10–20% and with high risk ≥20%. Logistic regression analyses were used to identify variables for predicting a Framingham CVD risk score of ≥10% and moderate–severe LUTS (International Prostate Symptom Score [IPSS] ≥8), adjusted for confounding factors.

RESULTS

As category of Framingham CVD risk score increased, we observed higher IPSS (18.0 vs 18.50 vs 19.0; P < 0.05), high IPSS–voiding (6.0 vs 9.0 vs 9.5; P < 0.05) and worse sexual function. Prostate volume significantly increased in those with intermediate- vs low-risk scores (54.5 vs 44.1 mL; P < 0.05). Multivariate logistic regression analysis showed that intermediate- [odds ratio (OR) 8.65; P < 0.01) and high-risk scores (OR 1.79; P < 0.05) were independently associated with moderate–severe LUTS. At age-adjusted logistic regression analysis, moderate–severe LUTS was independently associated with Framingham CVD risk score of ≥10% (OR 5.91; P < 0.05).

CONCLUSION

Our cross-sectional study in a cohort of patients with LUTS–BPH showed an increase of more than five-fold of having a Framingham CVD risk score of ≥10% in men with moderate–severe LUTS.

Read more articles of the week

Article of the Month: Effect of the Interval Between First and Second TUR on Outcomes in NMIBC

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Every Month the Editor-in-Chief selects the Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Ilker Gökce, discussing his paper. 

If you only have time to read one article this week, it should be this one.

Significance of time interval between first and second transurethral resection on recurrence and progression rates in patients with high risk non muscle invasive bladder cancer treated with maintenance intravesical Bacillus Calmette-Guerin

 

Sumer Baltacı, Murat Bozlu*, Asıf Yıldırım†, Mehmet Ilker Gokce, İlker Tinay‡, Guven Aslan§, Cavit Can, Levent Turkeri‡,Ugur Kuyumcuoglu** and Aydın Mungan††

 

Department of Urology, Ankara University School of Medicine, Ankara , *Department of Urology, University of Mersin School of Medicine, Mersin,†Department of Urology, Istanbul Medeniyet University School of Medicine, ‡Department of Urology, Marmara University School of Medicine, Istanbul, §Department of Urology, Dokuz Eylul University School of Medicine Inciralti, Izmir, Department of Urology, Medical Faculty, Eskisehir Osmangazi University, Eskisehir, **Department of Urology, Trakya University School of Medicine, Edirne, and ††Department of Urology, Bulent Ecevit University School of Medicine, Zonguldak, Turkey

 

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OBJECTIVES

To evaluate the effect of the interval between the initial and second transurethral resection (TUR) on the outcome of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) treated with maintenance intravesical Bacillus Calmette-Guérin (BCG) therapy.

PATIENTS AND METHODS

We reviewed the data of patients from 10 centres treated for high-risk NMIBC between 2005 and 2012. Patients without a diagnosis of muscle-invasive cancer on second TUR performed ≤90 days after a complete first TUR, and received at least 1 year of maintenance BCG were included in this study. The interval between first and second TUR in addition to other parameters were recorded. Multivariate logistic regression analysis was used to identify predictors of recurrence and progression.

RESULTS

In all, 242 patients were included. The mean (sd, range) follow-up was 29.4 (22.2, 12–96) months. The 3-year recurrence- and progression-free survival rates of patients who underwent second TUR between 14 and 42 days and 43–90 days were 73.6% vs 46.2% (P < 0.001) and 89.1% vs 79.1% (P = 0.006), respectively. On multivariate analysis, the interval to second TUR was found to be a predictor of both recurrence [odds ratio (OR) 3.598, 95% confidence interval (CI) 1.885–8.137; P = 0.001] and progression (OR 2.144, 95% CI 1.447–5.137; P = 0.003).

CONCLUSIONS

The interval between first and second TUR should be ≤42 days in order to attain lower recurrence and progression rates. To our knowledge, this is the first study demonstrating the effect of the interval between first and second TUR on patient outcomes.

Read more articles of the week

Editorial: Is 42 days the ‘magic number’ for repeat TURBT?

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Gökçe et al. [1] have evaluated a group of 242 patients from 10 centres with high-risk non-muscle-invasive bladder cancer (NMIBC) who underwent repeat resection and subsequent follow-up treatment, including induction and maintenance BCG for at least 1 year. They included patients who had repeat transurethral resection (TUR) within 90 days and excluded anyone who was upstaged to T2 or who did not complete 1 year of maintenance BCG. They divided patients into two groups according to time to second TUR, Group A (14–42 days) and Group B (43–90 days). The groups were similar in terms of patient age and gender, tumour multifocality, presence of carcinoma in situ (CIS), and stage and grade. The only factors on multivariable analysis that were statistically significant predictors of recurrence were grade, associated CIS, and time to second TUR. Only grade and time to second TUR were significant predictors of progression.

Figures 1 and 2 in the paper show an enormous difference in both recurrence-free survival and progression-free survival according to time to second TUR. For both outcomes, 42 days seemed to be the ‘magic number’, since re-TUR after 42 days was associated with much worse outcome. Patients who had repeat TUR at >42 days had nearly double the rate of both recurrence and progression than those who had repeat TUR within 6 weeks.

This is quite a dramatic result, and it is hard to imagine biologically how such an effect could be explained. Second TUR has two primary objectives, to identify occult muscle-invasive disease, and to remove tumour that was inadvertently left behind at the first resection. Both of these goals have been shown to be important and to result in better outcomes compared with no repeat TUR [2]. However, in this study [1], patients who had repeat TUR at >6 weeks after the initial resection had a progression rate similar to those in prior studies who had no second TUR at all [2]. What could be occurring that would cause a delay of just a few weeks in second TUR to double the risk of subsequent progression of disease?

This is a retrospective study without centralised pathology review, and no information is available about the reasons that patients had repeat TUR at an earlier or later interval, nor about the pathological findings at the repeat TUR. One must be wary that there is significant selection bias involved. There is a hint of this in the fact that the rate of residual tumour at repeat TUR in the two groups is very different (35% vs 53%). Perhaps the later group also had a higher rate of residual invasive components on the repeat resection? Herr et al. [3] have shown that residual T1 disease on repeat TUR is highly predictive of subsequent progression. Or alternatively, perhaps it is the delay in administration of BCG that really results in the worse outcome? Patients with a longer delay to repeat TUR by definition also have at least an equivalent delay in starting BCG.

Although high-risk NMIBC can certainly be aggressive, it seems highly unlikely that a week or two-one way or another in terms of treatment would make such a huge difference in the outcome. However, this is a provocative study that remains to be validated. It will be useful to see if other groups with similar patient populations can duplicate these findings. For the time being, as a routine practice it makes sense to repeat the TUR sooner rather than later whenever possible.

Read the full article
Eila C. Skinner

 

Thomas A. Stamey Research Professor of Urology, Chair, Department of Urology, Stanford University, Stanford, CA, USA

 

References

 

1 Gokce MI, Baltaci S, Bozlu M et al. Significance of the interval between first and second transurethral resection on recurrence and progression rates in patients with high-risk non-muscle-invasive bladder cancer treated with maintenance intravesical Bacillus Calmette-Guerin. BJU Int 2015; 116: 721–6

 

2 Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomized clinical trial. Eur Urol 2010; 58: 185–90

 

3 Herr HW, Donat SM, Dalbagni G. Can restaging transurethral resection of T1 bladder cancer select patients for immediate cystectomy? J Urol 2007; 177: 75

 

Video: Significance of time interval between first and second TUR on recurrence and progression rates in BCG-treated NMIBC

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Significance of time interval between first and second transurethral resection on recurrence and progression rates in patients with high risk non muscle invasive bladder cancer treated with maintenance intravesical Bacillus Calmette-Guerin

 

Sumer Baltacı, Murat Bozlu*, Asıf Yıldırım†, Mehmet Ilker Gokce, İlker Tinay‡, Guven Aslan§, Cavit Can, Levent Turkeri‡,Ugur Kuyumcuoglu** and Aydın Mungan††

 

Department of Urology, Ankara University School of Medicine, Ankara , *Department of Urology, University of Mersin School of Medicine, Mersin,†Department of Urology, Istanbul Medeniyet University School of Medicine, ‡Department of Urology, Marmara University School of Medicine, Istanbul, §Department of Urology, Dokuz Eylul University School of Medicine Inciralti, Izmir, Department of Urology, Medical Faculty, Eskisehir Osmangazi University, Eskisehir, **Department of Urology, Trakya University School of Medicine, Edirne, and ††Department of Urology, Bulent Ecevit University School of Medicine, Zonguldak, Turkey

 

Read the full article
OBJECTIVES

To evaluate the effect of the interval between the initial and second transurethral resection (TUR) on the outcome of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) treated with maintenance intravesical Bacillus Calmette-Guérin (BCG) therapy.

PATIENTS AND METHODS

We reviewed the data of patients from 10 centres treated for high-risk NMIBC between 2005 and 2012. Patients without a diagnosis of muscle-invasive cancer on second TUR performed ≤90 days after a complete first TUR, and received at least 1 year of maintenance BCG were included in this study. The interval between first and second TUR in addition to other parameters were recorded. Multivariate logistic regression analysis was used to identify predictors of recurrence and progression.

RESULTS

In all, 242 patients were included. The mean (sd, range) follow-up was 29.4 (22.2, 12–96) months. The 3-year recurrence- and progression-free survival rates of patients who underwent second TUR between 14 and 42 days and 43–90 days were 73.6% vs 46.2% (P < 0.001) and 89.1% vs 79.1% (P = 0.006), respectively. On multivariate analysis, the interval to second TUR was found to be a predictor of both recurrence [odds ratio (OR) 3.598, 95% confidence interval (CI) 1.885–8.137; P = 0.001] and progression (OR 2.144, 95% CI 1.447–5.137; P = 0.003).

CONCLUSIONS

The interval between first and second TUR should be ≤42 days in order to attain lower recurrence and progression rates. To our knowledge, this is the first study demonstrating the effect of the interval between first and second TUR on patient outcomes.

Read more articles of the week

Article of the Week: Complications following artificial urinary sphincter placement after RP and EBRT

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: A meta-analysis

Anthony S. Bates, Richard M. Martin* and Tim R. Terry

Department of Urology, Leicester General Hospital, University Hospitals of Leicester NHS Trust, Leicester, and *School of Social and Community Medicine, University of Bristol, Bristol, UK

Read the full article
OBJECTIVE

To conduct a systematic review and meta-analysis of artificial urinary sphincter (AUS) placement after radical prostatectomy (RP) and external beam radiotherapy (EBRT).

PATIENTS AND METHODS

There were 1 886 patients available for analysis of surgical revision outcomes and 949 for persistent urinary incontinence (UI) outcomes from 15 and 11 studies, respectively. The mean age (sd) was 66.9 (1.4) years and the number of patients per study was 126.6 (41.7). The mean (sd, range) follow-up was 36.7 (3.9, 18–68) months. A systematic database search was conducted using keywords, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published series of AUS implantations were retrieved, according to the inclusion criteria. The Newcastle–Ottawa Score was used to ascertain the quality of evidence for each study. Surgical results from each case series were extracted. Data were analysed using CMA® statistical software.

RESULTS

AUS revision was higher in RP + EBRT vs RP alone, with a random effects risk ratio of 1.56 (95% confidence interval [CI] 1.02–2.72; P <0.050; I2 = 82.0%) and a risk difference of 16.0% (95% CI 2.05–36.01; P < 0.080). Infection/erosion contributed to the majority of surgical revision risk compared with urethral atrophy (P = 0.020). Persistent UI after implantation was greater in patients treated with EBRT (P <0.001).

CONCLUSIONS

Men receiving RP + EBRT appear at increased risk of infection/erosion and urethral atrophy, resulting in a greater risk of surgical revision compared with RP alone. Persistent UI is more common with RP + EBRT

Read more articles of the week

 

Editorial: Post-prostatectomy incontinence in the irradiated patient: more than just a drop in the ocean

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Improved early detection of prostate cancer has led to an increased incidence of this disease, and an increase in the number of patients undergoing radical prostatectomy (RP). The rate of post-prostatectomy incontinence (PPI) is difficult to determine because of the varying definitions of incontinence, but approximately one in five men require the use of pads in the long term after RP. Incontinence has a significant negative impact on quality of life, and remains many men’s greatest fear, especially for the one in four who present at the age of <65 years. While significant advancements have been made in prostate cancer treatment, strong evidence for the optimum management of PPI remains lacking. Most guidelines are based on grade B or C recommendation and many questions about its surgical management remain unanswered.

The artificial urinary sphincter (AUS) has stood the test of time and has long been considered the ‘gold standard’ treatment for PPI, especially for those with moderate to severe incontinence. The quoted success rates achieved with this device vary from study to study based on the varying definition of ‘dry’. The use of radiotherapy (RT) after prostatectomy is generally considered to have a negative impact on its efficacy and revision rate, although some data have been conflicting. In this month’s BJUI, Bates et al. [1] present a timely and well-structured systematic review and meta-analysis of AUS placement after RP and RT. By analysing pooled results, the authors set out to clarify the effect of RT on AUS efficacy and outcomes. In total, 1886 patients from 15 studies published between 1989 and 2014 were included in the meta-analysis, including 14 studies assessing surgical revision and 11 looking at persistent urinary incontinence. No randomized controlled trials were available for analysis. Retrospective reporting and a lack of standardized postoperative validated assessments were a weakness of individual studies, and efforts to limit the effects of study heterogeneity and risk of bias were made using statistical models. The revision rate after a mean follow-up of 38.4 months was significantly higher in irradiated vs. non-irradiated men (mean 37.3 vs 19.8%; P < 0.007); the risk ratio was 1.56 and number needed to harm was 4 (i.e. one surgical revision for every four AUS devices implanted in irradiated men). Infection/erosion and urethral atrophy accounted for approximately half and one-third of all revisions respectively. Persistent urinary incontinence was also more than twice as likely in irradiated vs non-irradiated men (29.5 vs 12.1%; P = 0.003; risk ratio 2.08, number needed to harm 9).

This study highlights the significant negative impact of RT after RP on functional outcomes and its treatment. This is particularly important considering that approximately one-third of patients will require adjuvant or salvage radiotherapy at some stage after RP. The development of incontinence after RT is primarily attributable to the negative effect of radiation on bladder and urethral tissue. Unlike outcomes with regard to erectile function, the type of primary surgery performed (open vs robotic) does not appear to have any significant impact on PPI [2]. Timing of RT also does not seem to affect function, with similar rates of incontinence reported for early (<6 months after RP) vs late (>6 months after RP) irradiation reported 3 years after RT (24.5 vs 23.3%, respectively; P = 0.79) [3].

New devices, such as the male sling, have increased the options for PPI treatment. Male slings have achieved popularity because of their safety, relative ease of insertion and patients’ strong desire to void naturally without fiddling with pumps. Kumar et al. [4] reported that one in four men who were recommended an AUS as the best option by their surgeon chose a sling; 92% who were offered either also opted against the gold standard AUS. Slings, however, have not fared well in patients with severe incontinence or those who have undergone RT. Pooled analysis of the AdVance® sling reported ‘success’ rates of 56 and 54%, respectively, in these scenarios, compared with a mean overall ‘success’ rate of 75% [5]. Reported success, however, does not equate to being ‘dry’, as reported in many AUS studies, and this lack of uniformity in describing outcomes prevents adequate clarity when comparing different devices. Despite the lower success rate after RT, slings, unlike the AUS, do not appear to have any additional complications in this setting [1, 6], and sling failure does not appear to prejudice subsequent AUS placement [7].

To date, no randomized controlled trial has directly compared efficacy of the newer slings with the AUS. Well-designed trials, with standardized protocols and uniform long-term assessments of outcome, including complications and quality of life, are required to clarify their place in managing PPI. Current randomized controlled trials are evaluating these devices prospectively, and will provide much needed level 1 evidence in this field. The most interesting of these is the MASTER trial (Male synthetic sling vs Artificial urinary Sphincter Trial). This multicentre UK randomized controlled trial is for men with incontinence after prostate surgery for cancer or benign disease [8]. Patients of any age, with any level of incontinence are eligible, and previous RT is not an exclusion criterion. The trial aims to randomize 360 men and will also follow up 360 non-randomized men, and runs until 2019. This trial will help clarify the relative benefits of the devices by incontinence severity. It will also provide some prospective data on the effect of RT on outcomes, although the 2-year follow-up will be too short to evaluate this fully.

The question remains regarding which strategy is the best for post-prostatectomy irradiated patients. Until the results of good quality trials are available, the jury is out. The AUS remains the gold standard in this setting, for now. For patients with mild to moderate incontinence, the sling is an option, and offers some advantages, but offers a lower overall chance of becoming pad free. Patients must be carefully counselled about the risk/benefit of this approach compared with an AUS. Results of the MASTER trial will help better define management of this subgroup. For moderate to severe incontinence, the AUS is the gold standard, albeit with an increased risk of failure and revision. The present meta-analysis arms the clinician with much needed data to quantify the relative risk of complications and adverse outcomes in this setting, and will allow better counselling and management of patient’s expectations.

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Majid Shabbir

Department of Urology, Guy’s Hospital, London, UK

References

1 Bates A, Martin R, Terry T. Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a metaanalysis. BJU Int 2015; 116: 623–33

2 Haglind E, Carlsson S, Stranne J et al. Urinary incontinence and erectile dysfunction after robotic versus open radical prostatectomy: a prospective, controlled, nonrandomised trial. Eur Urol 2015. doi: 10.1016/j.eururo. 2015.02.029. [Epub ahead of print]

3 Sowerby RJ, Gani J, Yim H. Long-term complications in men who have early or late radiotherapy after radical prostatectomy. Can Urol Assoc J 2014; 8: 253–8.

4 Kumar A, Litt ER, Ballert KN, Nitti VW. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence-what do patients choose? J Urol 2009; 181: 1231–5.

5 Van Bruwaene S, Van der Aa F, De Ridder D. Review: the use of sling versus sphincter in post-prostatectomy urinary incontinence. BJU Int 2015; 116: 330–42

6 Zuckerman JM, Tisdale B, McCammon K. AdVance male sling in irradiated patients with stress urinary incontinence. Can J Urol 2011; 18: 6013–7.

7 Lentz AC, Peterson AC, Webster GD. Outcomes following artificial sphincter implantation after prior unsuccessful male sling. J Urol 2012; 187: 2149–53.

8 Abrams P. Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial (MASTER), 2014. Available at: www.controlled-trials.com/ISRCTN49212975/MASTER. Accessed May 2015

 

Video: Complications following AUS placement after RP and radiotherapy

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Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a meta-analysis

Anthony S. Bates1,*, Richard M. Martin2 and Tim R. Terry1

1Department of Urology, Leicester General Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK 2School of Social and Community Medicine, University of Bristol, Bristol, UK

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Objective

To conduct a systematic review and meta-analysis of artificial urinary sphincter (AUS) placement after radical prostatectomy (RP) and external beam radiotherapy (EBRT).

Patients and Methods

There were 1 886 patients available for analysis of surgical revision outcomes and 949 for persistent urinary incontinence (UI) outcomes from 15 and 11 studies, respectively. The mean age (sd) was 66.9 (1.4) years and the number of patients per study was 126.6 (41.7). The mean (sd, range) follow-up was 36.7 (3.9, 18–68) months. A systematic database search was conducted using keywords, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published series of AUS implantations were retrieved, according to the inclusion criteria. The Newcastle–Ottawa Score was used to ascertain the quality of evidence for each study. Surgical results from each case series were extracted. Data were analysed using CMA® statistical software.

Results

AUS revision was higher in RP + EBRT vs RP alone, with a random effects risk ratio of 1.56 (95% confidence interval [CI] 1.02–2.72; P < 0.050; I2 = 82.0%) and a risk difference of 16.0% (95% CI 2.05–36.01; P < 0.080). Infection/erosion contributed to the majority of surgical revision risk compared with urethral atrophy (P = 0.020). Persistent UI after implantation was greater in patients treated with EBRT (P < 0.001).

Conclusions

Men receiving RP + EBRT appear at increased risk of infection/erosion and urethral atrophy, resulting in a greater risk of surgical revision compared with RP alone. Persistent UI is more common with RP + EBRT.

 

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