BJOG Exchange
required to improve the adoption of safe embryo transfer policy. We believe public and professional discussions at forums such as the Blue Journal Club are catalysts to encourage better practice for women undergoing ARTs. References 1 Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE, et al. Global Obstetrics Network (GONet) collaboration. Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG 2015;122:27–37. 2 Harris J, Kearley K, Heneghan C, Meats E, Roberts N, Perera R, et al. Are journal clubs effective in supporting evidence-based decision making? A systematic review. BEME Guide No. 16. Med Teach 2011;33:9–23. 3 Chambers GM, Wang YA, Chapman MG, Hoang VP, Sullivan EA, Abdalla HI, et al. What can we learn from a decade of promoting safe embryo transfer practices? A comparative analysis of policies and outcomes in the UK and Australia, 2001–2010. Hum Reprod 2013;28:1679–86. 4 Human Fertilisation and Embryology Authority (HFEA). National Data 2013. Finsbury Tower, London: HFEA. [www.hfea.gov.uk/9461. html]. 17 December 2014. Accessed 22 February 2015.
Elaine Leunga & Dimitrios Siassakosb a
Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK bSchool of Clinical Sciences, University of Bristol, The Chilterns, Southmead Hospital, Bristol, UK
Accepted 3 March 2015. DOI: 10.1111/1471-0528.13403
Re: Does preoperative urodynamics improve outcomes for women undergoing surgery for stress urinary incontinence? A systematic review and meta-analysis
Sir, We read with interest the systematic review about preoperative urodynamics;1 however, we are skeptical regarding the conclusions. There are two important mistakes. (1) It is not correct that patients with voiding
dysfunction were excluded: 11.9 and 16.0% had voiding dysfunction preoperatively in the VALUE and VUSIS–II studies, respectively! (2) The statement: ‘uroflowmetry is an essential component of office evaluation’ is not supported by the data, as uroflowmetry was not part of the office evaluation in the randomised controlled trials (RCTs)! Despite the results of the RCTs, we think that uroflowmetry should be performed in all patients, and that invasive urodynamics (UDS) should only be performed on indication. The results of the RCTs can’t be generalised because of the following methodological flaws in the studies: 1 Invasive UDS was not really applied to the decision-making. In the VALUE study, 93% of the patients in both groups (with or without invasive UDS) had surgical treatment; in the VUSIS-II study, 95 and 92% of the patients in both groups, respectively, had surgical treatment. You cannot test the value of invasive UDS if you don’t use it in your decision-making, which has been acknowledged by the authors of the VALUE study.2 2 In 20 cases modifications (more or less obstructive) were planed based on UDS; however, the modification was only performed in seven cases in the VALUE study. You cannot blame invasive UDS if you don’t follow the findings. 3 The principles of ‘good urodynamic practice’ (GUP) were not followed.3 GUP implies a urodynamic ‘question’ followed by an ‘answer’, and subsequently acting accordingly. In the included studies invasive UDS was performed in all patients, without a strategy for interpretation. GUP also implies the reproduction of the patient’s symptoms while precise measurements are performed. In the VUSIS–II study, stress incontinence (SI) couldn’t be demonstrated in threequarters of the included patients. What can be concluded is that the doctors involved didn’t manage to use invasive UDS in their decision-making,
ª 2015 Royal College of Obstetricians and Gynaecologists
and consequently couldn’t demonstrate any effect! This result cannot be extrapolated to other doctors who believe in UDS and base their choice of treatment on UDS. Urinary incontinence symptoms are unreliable as to the underlying dysfunction, and thus women with mixed symptoms (even pure SI) may present underlying pure detrusor overactivity or different combinations of SI with or without detrusor overactivity, and with or without voiding dysfunction. The fact that detrusor overactivity or voiding dysfunction reduces the outcome of surgery is supported by the findings of the included studies, thus in the VALUE study fewer women with voiding dysfunction meet the primary outcome of surgery (62.1%), compared with those without voiding dysfunction (78.3%; P = 0.064), whereas in the VUSIS-II study bothersome postoperative incontinence was present in 32% with detrusor overactivity, compared with 17% without detrusor overactivity. The patients should know this before a decision about surgery is taken. The VALUE/VUSIS-II studies may lead clinicians to believe that a standard midurethral sling will always be a successful treatment in women with postvoid residual volume < 150 ml, which is not necessarily true. The RCTs were not designed to answer this question. We need RCTs to find which treatment is best for those with SI combined with either detrusor overactivity or voiding dysfunction. & References 1 Rachaneni S, Latthe P. Does preoperative urodynamics improve outcomes for women undergoing surgery for stress urinary incontinence? A systematic review and metaanalysis BJOG 2015;122:8–16. 2 Sirls LT, Richter HE, Litman HJ, Kenton K, Lemack GE, Lukascz ES, et al. Re: the effect of urodynamic testing on clinical diagnosis, treatment plan and outcomes in women undergoing stress urinary incontinence surgery. J Urol 2013;189:204–9. 3 Sch€ afer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, et al. Good
1147
BJOG Exchange
urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn 2002;21:261–74.
Gunnar Lose & Niels Klarskov Department of Obstetrics & Gynaecology, Herlev Hospital, Herlev, Denmark Accepted 3 March 2015. DOI: 10.1111/1471-0528.13457
Authors’ reply
Sir, We read with great interest the letter from Gunnar Lose and Niels Klarskov. They seem to have misunderstood our study question on the role of preoperative urodynamics in improving outcomes in surgical treatment of women with stress urinary incontinence (SUI). They appear to be looking for an answer to a completely different study question, described in their own words as ‘We need RCTs to find which treatment is best for those with SI combined with either detrusor overactivity or voiding dysfunction’, and this was outside the remit of our systematic review. In our systematic review we specified that our conclusion is applicable to women undergoing primary SUI surgery with isolated SUI, or stress-predominant mixed urinary incontinence, who have a normal bladder capacity and post-void residual urine (PVR). Their second error seems to be the inclusion of the VUSIS–II study in their letter. The VUSIS–II study is designed to answer a different question to that of our systematic review. Its objective is ‘To estimate whether a strategy of immediate surgery was non-inferior to
1148
a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI)’.1 Although 11.9% of participants in the VALUE study were found to have voiding dysfunction following urodynamics after inclusion into the study, this change in preoperative diagnosis did not result in different outcomes of success or complication rates of the surgical treatments.2 We disagree with their comment on uroflowmetry, as two of the randomised controlled trials (RCTs) in our systematic review have incorporated uroflowmetry as a part of their evaluation.3,4 In the VALUE study, although 93% of study participants in both the study groups underwent surgical treatment, invasive urodynamics (UDS) seem to have influenced the choice of the surgical treatment. After urodynamic testing 12 patients for whom a retropubic midurethral sling was planned received a transobturator midurethral sling, and the converse happened for six women. So UDS diagnosis was used in decisionmaking on the selection of the type of midurethral sling.2 The question on principles of good urodynamic practice has already been answered by the author of the VUSIS I and VUSIS II studies, Van Leijsen et al., during a previous correspondence to the editor in response to a letter to from Gunnar Lose and Niels Klarskov.5 We agree with their comment that the RCTs included in our systematic review were not designed to answer the question whether a standard midurethral sling will always be a successful treatment in
women with PVR < 150 ml. We would like to reiterate that the objective of our systematic review was to assess whether the performance of urodynamics altered the outcomes of cure or complications in women undergoing surgery with isolated SUI or stress-predominant mixed UI symptoms. References 1 van Leijsen SA, Kluivers KB, Mol BW, Hout J, Milani AL, Roovers JP, et al. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol 2013;121:999–1008. 2 Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med 2012;366:1987–97. 3 Romero MJ, Ortiz GMA, Gomez P. Does pressure flow study improve the outcome of surgery in women with SUI? Eur Urol 2010;9 (Suppl 9):228. 4 Hilton P, Armstrong N, Brennand C, Howel D, Shen J, Bryant A, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women. Health Technol Assess 2015;19:1–274. 5 van Leijsen SA, Kluivers KB, Heesakkers JP, Vierhout ME. Utility of urodynamics before surgery for stress urinary incontinence: response to editorial by Lose and Klarskov. Int Urogynecol J 2014;25:999.
Suneetha Rachanenia & Pallavi Lattheb a
School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK bBirmingham Women’s Hospital, Birmingham, UK
Accepted 14 April 2014. DOI: 10.1111/1471-0528.13458
ª 2015 Royal College of Obstetricians and Gynaecologists
required to improve the adoption of safe embryo transfer policy. We believe public and professional discussions at forums such as the Blue Journal Club are catalysts to encourage better practice for women undergoing ARTs. References 1 Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE, et al. Global Obstetrics Network (GONet) collaboration. Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG 2015;122:27–37. 2 Harris J, Kearley K, Heneghan C, Meats E, Roberts N, Perera R, et al. Are journal clubs effective in supporting evidence-based decision making? A systematic review. BEME Guide No. 16. Med Teach 2011;33:9–23. 3 Chambers GM, Wang YA, Chapman MG, Hoang VP, Sullivan EA, Abdalla HI, et al. What can we learn from a decade of promoting safe embryo transfer practices? A comparative analysis of policies and outcomes in the UK and Australia, 2001–2010. Hum Reprod 2013;28:1679–86. 4 Human Fertilisation and Embryology Authority (HFEA). National Data 2013. Finsbury Tower, London: HFEA. [www.hfea.gov.uk/9461. html]. 17 December 2014. Accessed 22 February 2015.
Elaine Leunga & Dimitrios Siassakosb a
Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK bSchool of Clinical Sciences, University of Bristol, The Chilterns, Southmead Hospital, Bristol, UK
Accepted 3 March 2015. DOI: 10.1111/1471-0528.13403
Re: Does preoperative urodynamics improve outcomes for women undergoing surgery for stress urinary incontinence? A systematic review and meta-analysis
Sir, We read with interest the systematic review about preoperative urodynamics;1 however, we are skeptical regarding the conclusions. There are two important mistakes. (1) It is not correct that patients with voiding
dysfunction were excluded: 11.9 and 16.0% had voiding dysfunction preoperatively in the VALUE and VUSIS–II studies, respectively! (2) The statement: ‘uroflowmetry is an essential component of office evaluation’ is not supported by the data, as uroflowmetry was not part of the office evaluation in the randomised controlled trials (RCTs)! Despite the results of the RCTs, we think that uroflowmetry should be performed in all patients, and that invasive urodynamics (UDS) should only be performed on indication. The results of the RCTs can’t be generalised because of the following methodological flaws in the studies: 1 Invasive UDS was not really applied to the decision-making. In the VALUE study, 93% of the patients in both groups (with or without invasive UDS) had surgical treatment; in the VUSIS-II study, 95 and 92% of the patients in both groups, respectively, had surgical treatment. You cannot test the value of invasive UDS if you don’t use it in your decision-making, which has been acknowledged by the authors of the VALUE study.2 2 In 20 cases modifications (more or less obstructive) were planed based on UDS; however, the modification was only performed in seven cases in the VALUE study. You cannot blame invasive UDS if you don’t follow the findings. 3 The principles of ‘good urodynamic practice’ (GUP) were not followed.3 GUP implies a urodynamic ‘question’ followed by an ‘answer’, and subsequently acting accordingly. In the included studies invasive UDS was performed in all patients, without a strategy for interpretation. GUP also implies the reproduction of the patient’s symptoms while precise measurements are performed. In the VUSIS–II study, stress incontinence (SI) couldn’t be demonstrated in threequarters of the included patients. What can be concluded is that the doctors involved didn’t manage to use invasive UDS in their decision-making,
ª 2015 Royal College of Obstetricians and Gynaecologists
and consequently couldn’t demonstrate any effect! This result cannot be extrapolated to other doctors who believe in UDS and base their choice of treatment on UDS. Urinary incontinence symptoms are unreliable as to the underlying dysfunction, and thus women with mixed symptoms (even pure SI) may present underlying pure detrusor overactivity or different combinations of SI with or without detrusor overactivity, and with or without voiding dysfunction. The fact that detrusor overactivity or voiding dysfunction reduces the outcome of surgery is supported by the findings of the included studies, thus in the VALUE study fewer women with voiding dysfunction meet the primary outcome of surgery (62.1%), compared with those without voiding dysfunction (78.3%; P = 0.064), whereas in the VUSIS-II study bothersome postoperative incontinence was present in 32% with detrusor overactivity, compared with 17% without detrusor overactivity. The patients should know this before a decision about surgery is taken. The VALUE/VUSIS-II studies may lead clinicians to believe that a standard midurethral sling will always be a successful treatment in women with postvoid residual volume < 150 ml, which is not necessarily true. The RCTs were not designed to answer this question. We need RCTs to find which treatment is best for those with SI combined with either detrusor overactivity or voiding dysfunction. & References 1 Rachaneni S, Latthe P. Does preoperative urodynamics improve outcomes for women undergoing surgery for stress urinary incontinence? A systematic review and metaanalysis BJOG 2015;122:8–16. 2 Sirls LT, Richter HE, Litman HJ, Kenton K, Lemack GE, Lukascz ES, et al. Re: the effect of urodynamic testing on clinical diagnosis, treatment plan and outcomes in women undergoing stress urinary incontinence surgery. J Urol 2013;189:204–9. 3 Sch€ afer W, Abrams P, Liao L, Mattiasson A, Pesce F, Spangberg A, et al. Good
1147
BJOG Exchange
urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn 2002;21:261–74.
Gunnar Lose & Niels Klarskov Department of Obstetrics & Gynaecology, Herlev Hospital, Herlev, Denmark Accepted 3 March 2015. DOI: 10.1111/1471-0528.13457
Authors’ reply
Sir, We read with great interest the letter from Gunnar Lose and Niels Klarskov. They seem to have misunderstood our study question on the role of preoperative urodynamics in improving outcomes in surgical treatment of women with stress urinary incontinence (SUI). They appear to be looking for an answer to a completely different study question, described in their own words as ‘We need RCTs to find which treatment is best for those with SI combined with either detrusor overactivity or voiding dysfunction’, and this was outside the remit of our systematic review. In our systematic review we specified that our conclusion is applicable to women undergoing primary SUI surgery with isolated SUI, or stress-predominant mixed urinary incontinence, who have a normal bladder capacity and post-void residual urine (PVR). Their second error seems to be the inclusion of the VUSIS–II study in their letter. The VUSIS–II study is designed to answer a different question to that of our systematic review. Its objective is ‘To estimate whether a strategy of immediate surgery was non-inferior to
1148
a strategy based on discordant urodynamic findings followed by individually tailored therapy in women with stress urinary incontinence (SUI)’.1 Although 11.9% of participants in the VALUE study were found to have voiding dysfunction following urodynamics after inclusion into the study, this change in preoperative diagnosis did not result in different outcomes of success or complication rates of the surgical treatments.2 We disagree with their comment on uroflowmetry, as two of the randomised controlled trials (RCTs) in our systematic review have incorporated uroflowmetry as a part of their evaluation.3,4 In the VALUE study, although 93% of study participants in both the study groups underwent surgical treatment, invasive urodynamics (UDS) seem to have influenced the choice of the surgical treatment. After urodynamic testing 12 patients for whom a retropubic midurethral sling was planned received a transobturator midurethral sling, and the converse happened for six women. So UDS diagnosis was used in decisionmaking on the selection of the type of midurethral sling.2 The question on principles of good urodynamic practice has already been answered by the author of the VUSIS I and VUSIS II studies, Van Leijsen et al., during a previous correspondence to the editor in response to a letter to from Gunnar Lose and Niels Klarskov.5 We agree with their comment that the RCTs included in our systematic review were not designed to answer the question whether a standard midurethral sling will always be a successful treatment in
women with PVR < 150 ml. We would like to reiterate that the objective of our systematic review was to assess whether the performance of urodynamics altered the outcomes of cure or complications in women undergoing surgery with isolated SUI or stress-predominant mixed UI symptoms. References 1 van Leijsen SA, Kluivers KB, Mol BW, Hout J, Milani AL, Roovers JP, et al. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol 2013;121:999–1008. 2 Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med 2012;366:1987–97. 3 Romero MJ, Ortiz GMA, Gomez P. Does pressure flow study improve the outcome of surgery in women with SUI? Eur Urol 2010;9 (Suppl 9):228. 4 Hilton P, Armstrong N, Brennand C, Howel D, Shen J, Bryant A, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women. Health Technol Assess 2015;19:1–274. 5 van Leijsen SA, Kluivers KB, Heesakkers JP, Vierhout ME. Utility of urodynamics before surgery for stress urinary incontinence: response to editorial by Lose and Klarskov. Int Urogynecol J 2014;25:999.
Suneetha Rachanenia & Pallavi Lattheb a
School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK bBirmingham Women’s Hospital, Birmingham, UK
Accepted 14 April 2014. DOI: 10.1111/1471-0528.13458
ª 2015 Royal College of Obstetricians and Gynaecologists
