- Email: [email protected]
Elephants Can Remember
EUROPEAN UROLOGY 58 (2010) 678–680
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial and Reply from Authors Referring to the article published on pp. 671–677 of this issue
Elephants Can Remember Elisabetta Costantini *, Massimo Lazzeri Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia, Italy
Surgery for stress urinary incontinence (SUI) has changed dramatically in the past two decades. Since Ulmsten and Petros originally described the tension-free vaginal tape (TVT) procedure for female SUI in 1995, the midurethral tape has become widespread in clinical practice, and many other techniques, materials, and approaches have been proposed. The number of procedures appears to be on the increase, with a remarkable shift in the relative numbers of different devices. Safety and efficacy were confirmed over time [1–5]. Rigorous scientific assessment of the outcome of surgery for urinary incontinence provides us with an idea of what we are achieving in this field of non–life-threatening disease. Surgeons can benchmark their practice and identify cost-effective treatments, which are crucially needed in our budget-restricted health care systems. Moreover, when we provide the right information, patients can make informed decisions in light of demonstrated risks and benefits. The remarkable gain in life expectancy in developed countries, with more marked increases in Japan and some European countries like Spain and Italy, stands out as one of the most important achievements of the last century. If the present yearly growth in life expectancy continues through the 21st century, most babies born in the year 2000 or afterwards in countries with long-lived residents will celebrate their 100th birthdays This scenario is the result of projections, but we do not have to look to the future to see the challenges of an ageing population: The oldest old group (>85 yr of age) has over the past decades been the most rapidly expanding segment of the population in developed countries, and today we are treating the female baby boomers who are not willing to fade into the sunset of their golden years. Consequently, we will operate on more and more people who live longer, and our results need to be durable over time.
All of us who are engaged in the treatment of urinary incontinence use outcome measures such as urodynamics, pad tests, bladder diaries, symptom questionnaires, symptom-bother questionnaires, quality-of-life (QoL) instruments, and measures of satisfaction. Probably none of these is the ideal instrument [6–8]. In fact, any outcome measure should be reliable, valid, responsive to change over time, and interpretable within clinical practice, but that is not yet sufficient. Extending follow-up becomes essential if we are to know—not just wonder—how our surgery holds up over time. Long-term follow-up is the main factor affecting the validity of interstudy comparisons of the efficacy and safety of treatment for SUI. We would like to praise Zullo and co-workers [9], who compared the use of TVT and transobturator TVT (TVT-O) over a 5-yr follow-up and concluded that results are similar with both techniques (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively). Complication rates were low (16.1% and 17.2%, respectively, for TVT-O and TVT), even after 5 yr. Interestingly, the authors also reported that the development of complications such as dyspareunia or incontinence during intercourse may lessen patient satisfaction, even in dry patients. Thus, we have to go back to the patient’s perspective and expectations. Independent of incontinence status, other factors may change the outcome’s perception. For example, the patient’s age, general health, or comorbidities may worsen QoL and affect the outcome of incontinence surgery even if not directly related to it. In the first edition of the International Consultation on Incontinence, members and delegates reached the consensus that short-term surgical follow-up should be considered as being up to 3 mo, medium term from 3 to 12 mo, and long term over 12 mo [10]. There are occasions when short-term trial follow up and the early presentation of outcomes may
DOI of original article: 10.1016/j.eururo.2010.08.004 * Corresponding author. Department of Medical-Surgical Specialties and Public Health, Urology and Andrology Section, Ospedale S. Maria della Misericordia, Loc. S. Andrea delle Fratte, Perugia 06100, Italy. Tel. +39 0755784416; Fax: +39 0755784416. E-mail address: [email protected] (E. Costantini). 0302-2838/$ – see back matter # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 58 (2010) 678–680
be not only appropriate but indeed mandatory. Such is the case of the paper by Brubaker et al on abdominal sacrocolpopexy with or without Burch colposuspension to reduce SUI in women with pelvic organ prolapse (POP) [11]. The study was designed to answer the question of whether a prophylactic anti-SUI procedure reduced the chances of postoperative SUI in women without preoperative SUI symptoms. The investigators initially planned to enrol a total of 480 women to identify a 10% difference in stress incontinence in the two groups. However, after the first interim planned analysis of 50% of women who had reached the 3-mo end point after surgery, the trial was terminated, because 20.9% in the Burch group demonstrated evidence of SUI versus 39.7% in the control group. In this case, a shortterm follow-up was sufficient; when significant differences in efficacy or safety outcomes become apparent before the end of a study, it may be ethically unacceptable to continue randomisation. In a recent review on long-term studies of pelvic floor dysfunction, Hilton found that in 127 papers published in the past 25 years on incontinence or POP that included the phrase ‘‘long term’’ in their title or abstract, follow-up periods ranged from 1 to 14 yr, with a mean of 59.5 mo in those investigating surgical treatments [12]. Although we argued for more long-term, high-quality studies and for the definition of long term to be changed to imply outcome at 5 yr or more, we concede that difficulties arise when undertaking and interpreting long-term studies. Extended follow-up periods could be subject to recall bias and increase measurement error, especially when investigating changes in QoL or other subjective measures. Patients’ recollections of the experience during the reference period are what matters most, and any response process—even for current status—relies on cognitive processing and memory. In Elephants Can Remember, one of Agatha Christie’s last novels, she recalls a story about an Indian tailor who stuck a needle into an elephant’s tusk. The next time the elephant came past he splashed a great mouthful of water all over the tailor, although he had not seen the tailor for several years. The elephant had not forgotten. Thus, when we want to extend subjective long-term follow-up, what is the most challenging issue? We need to focus on people with memories like elephants. Conflicts of interest: The authors have nothing to disclose.
679
References [1] Lee K-S, Choo M-S, Doo CK, et al. The long term (5-years) objective TVT success rate does not depend on predictive factors at multivariate analysis: a multicentre retrospective study. Eur Urol 2008; 53:176–83. [2] Waltregny D, Gaspar Y, Reul O, Hamida W, Bonnet P, de Leval J. TVT-O for the treatment of female stress urinary incontinence: results of a prospective study after a 3-year minimum follow-up. Eur Urol 2008; 53:401–10. [3] Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol 2007;52: 663–79. [4] Novara G, Galfano A, Boscolo-Berto R, et al. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol 2008;53:288–309. [5] Novara G, Artibani W, Barber MD, et al. Updated systematic review and meta-analysis of the comparative data on colposuspension, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010;58:218–38. [6] Costantini E, Lazzeri M, Bini V, Giannantoni A, Mearini L, Porena M. Sensitivity and specificity of one-hour pad test as a predictive value for female urinary incontinence. Urol Int 2008;81:153–9. [7] Costantini E, Lazzeri M, Bini V, Del Zingaro M, Kocjiancic E, Porena M. The incontinence impact questionnaire: results in an Italian female population stratified by educational status. Urol Int 2009;83:187–92. [8] Costantini E, Lazzeri M, Giannantoni A, et al. Preoperative Valsalva leak point pressure may not predict outcome of mid-urethral slings. Analysis from a randomized controlled trial of retropubic versus transobturator mid-urethral slings. Int Braz J Urol 2008;34:73–81. [9] Angioli R, Plotti F, Muzii L, et al. Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial. Eur Urol 2010;58:671–7. [10] Jonas JG, Stanton U, Lose G. Research methodology in incontinence. In: Abrams P, Khoury S, Wein A, editors. Incontinence: WHO–UICC International Consultation on Incontinence. ed. 1 Plymouth, UK: Health Publication; 1999. [11] Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006;354:1557–66. [12] Hilton P. Long-term follow-up studies in pelvic floor dysfunction: the Holy Grail or a realistic aim? BJOG 2008;115:135–43.
doi:10.1016/j.eururo.2010.08.033
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial and Reply from Authors Referring to the article published on pp. 671–677 of this issue
Elephants Can Remember Elisabetta Costantini *, Massimo Lazzeri Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia, Italy
Surgery for stress urinary incontinence (SUI) has changed dramatically in the past two decades. Since Ulmsten and Petros originally described the tension-free vaginal tape (TVT) procedure for female SUI in 1995, the midurethral tape has become widespread in clinical practice, and many other techniques, materials, and approaches have been proposed. The number of procedures appears to be on the increase, with a remarkable shift in the relative numbers of different devices. Safety and efficacy were confirmed over time [1–5]. Rigorous scientific assessment of the outcome of surgery for urinary incontinence provides us with an idea of what we are achieving in this field of non–life-threatening disease. Surgeons can benchmark their practice and identify cost-effective treatments, which are crucially needed in our budget-restricted health care systems. Moreover, when we provide the right information, patients can make informed decisions in light of demonstrated risks and benefits. The remarkable gain in life expectancy in developed countries, with more marked increases in Japan and some European countries like Spain and Italy, stands out as one of the most important achievements of the last century. If the present yearly growth in life expectancy continues through the 21st century, most babies born in the year 2000 or afterwards in countries with long-lived residents will celebrate their 100th birthdays This scenario is the result of projections, but we do not have to look to the future to see the challenges of an ageing population: The oldest old group (>85 yr of age) has over the past decades been the most rapidly expanding segment of the population in developed countries, and today we are treating the female baby boomers who are not willing to fade into the sunset of their golden years. Consequently, we will operate on more and more people who live longer, and our results need to be durable over time.
All of us who are engaged in the treatment of urinary incontinence use outcome measures such as urodynamics, pad tests, bladder diaries, symptom questionnaires, symptom-bother questionnaires, quality-of-life (QoL) instruments, and measures of satisfaction. Probably none of these is the ideal instrument [6–8]. In fact, any outcome measure should be reliable, valid, responsive to change over time, and interpretable within clinical practice, but that is not yet sufficient. Extending follow-up becomes essential if we are to know—not just wonder—how our surgery holds up over time. Long-term follow-up is the main factor affecting the validity of interstudy comparisons of the efficacy and safety of treatment for SUI. We would like to praise Zullo and co-workers [9], who compared the use of TVT and transobturator TVT (TVT-O) over a 5-yr follow-up and concluded that results are similar with both techniques (72.9% and 71% of patients objectively cured after TVT-O and TVT, respectively). Complication rates were low (16.1% and 17.2%, respectively, for TVT-O and TVT), even after 5 yr. Interestingly, the authors also reported that the development of complications such as dyspareunia or incontinence during intercourse may lessen patient satisfaction, even in dry patients. Thus, we have to go back to the patient’s perspective and expectations. Independent of incontinence status, other factors may change the outcome’s perception. For example, the patient’s age, general health, or comorbidities may worsen QoL and affect the outcome of incontinence surgery even if not directly related to it. In the first edition of the International Consultation on Incontinence, members and delegates reached the consensus that short-term surgical follow-up should be considered as being up to 3 mo, medium term from 3 to 12 mo, and long term over 12 mo [10]. There are occasions when short-term trial follow up and the early presentation of outcomes may
DOI of original article: 10.1016/j.eururo.2010.08.004 * Corresponding author. Department of Medical-Surgical Specialties and Public Health, Urology and Andrology Section, Ospedale S. Maria della Misericordia, Loc. S. Andrea delle Fratte, Perugia 06100, Italy. Tel. +39 0755784416; Fax: +39 0755784416. E-mail address: [email protected] (E. Costantini). 0302-2838/$ – see back matter # 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 58 (2010) 678–680
be not only appropriate but indeed mandatory. Such is the case of the paper by Brubaker et al on abdominal sacrocolpopexy with or without Burch colposuspension to reduce SUI in women with pelvic organ prolapse (POP) [11]. The study was designed to answer the question of whether a prophylactic anti-SUI procedure reduced the chances of postoperative SUI in women without preoperative SUI symptoms. The investigators initially planned to enrol a total of 480 women to identify a 10% difference in stress incontinence in the two groups. However, after the first interim planned analysis of 50% of women who had reached the 3-mo end point after surgery, the trial was terminated, because 20.9% in the Burch group demonstrated evidence of SUI versus 39.7% in the control group. In this case, a shortterm follow-up was sufficient; when significant differences in efficacy or safety outcomes become apparent before the end of a study, it may be ethically unacceptable to continue randomisation. In a recent review on long-term studies of pelvic floor dysfunction, Hilton found that in 127 papers published in the past 25 years on incontinence or POP that included the phrase ‘‘long term’’ in their title or abstract, follow-up periods ranged from 1 to 14 yr, with a mean of 59.5 mo in those investigating surgical treatments [12]. Although we argued for more long-term, high-quality studies and for the definition of long term to be changed to imply outcome at 5 yr or more, we concede that difficulties arise when undertaking and interpreting long-term studies. Extended follow-up periods could be subject to recall bias and increase measurement error, especially when investigating changes in QoL or other subjective measures. Patients’ recollections of the experience during the reference period are what matters most, and any response process—even for current status—relies on cognitive processing and memory. In Elephants Can Remember, one of Agatha Christie’s last novels, she recalls a story about an Indian tailor who stuck a needle into an elephant’s tusk. The next time the elephant came past he splashed a great mouthful of water all over the tailor, although he had not seen the tailor for several years. The elephant had not forgotten. Thus, when we want to extend subjective long-term follow-up, what is the most challenging issue? We need to focus on people with memories like elephants. Conflicts of interest: The authors have nothing to disclose.
679
References [1] Lee K-S, Choo M-S, Doo CK, et al. The long term (5-years) objective TVT success rate does not depend on predictive factors at multivariate analysis: a multicentre retrospective study. Eur Urol 2008; 53:176–83. [2] Waltregny D, Gaspar Y, Reul O, Hamida W, Bonnet P, de Leval J. TVT-O for the treatment of female stress urinary incontinence: results of a prospective study after a 3-year minimum follow-up. Eur Urol 2008; 53:401–10. [3] Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W. Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol 2007;52: 663–79. [4] Novara G, Galfano A, Boscolo-Berto R, et al. Complication rates of tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials comparing tension-free midurethral tapes to other surgical procedures and different devices. Eur Urol 2008;53:288–309. [5] Novara G, Artibani W, Barber MD, et al. Updated systematic review and meta-analysis of the comparative data on colposuspension, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol 2010;58:218–38. [6] Costantini E, Lazzeri M, Bini V, Giannantoni A, Mearini L, Porena M. Sensitivity and specificity of one-hour pad test as a predictive value for female urinary incontinence. Urol Int 2008;81:153–9. [7] Costantini E, Lazzeri M, Bini V, Del Zingaro M, Kocjiancic E, Porena M. The incontinence impact questionnaire: results in an Italian female population stratified by educational status. Urol Int 2009;83:187–92. [8] Costantini E, Lazzeri M, Giannantoni A, et al. Preoperative Valsalva leak point pressure may not predict outcome of mid-urethral slings. Analysis from a randomized controlled trial of retropubic versus transobturator mid-urethral slings. Int Braz J Urol 2008;34:73–81. [9] Angioli R, Plotti F, Muzii L, et al. Tension-free vaginal tape versus transobturator suburethral tape: five-year follow-up results of a prospective, randomised trial. Eur Urol 2010;58:671–7. [10] Jonas JG, Stanton U, Lose G. Research methodology in incontinence. In: Abrams P, Khoury S, Wein A, editors. Incontinence: WHO–UICC International Consultation on Incontinence. ed. 1 Plymouth, UK: Health Publication; 1999. [11] Brubaker L, Cundiff GW, Fine P, et al. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med 2006;354:1557–66. [12] Hilton P. Long-term follow-up studies in pelvic floor dysfunction: the Holy Grail or a realistic aim? BJOG 2008;115:135–43.
doi:10.1016/j.eururo.2010.08.033