BJOG Exchange
under each table, including baseline values. A better comparison of outcome, both objective and subjective, would have been to compare the change from baseline value in both arms, rather than comparing values at follow-up.2 The lack of a significant difference in resorting to surgery, despite the higher recurrence rate with anterior colporrhaphy, may reflect the duration of follow-up. A longer follow-up would be useful in this respect. These points need to be borne in mind when looking at the results of this trial. This is particularly pertinent in any future re-look at the use of mesh coating for prolapse surgery. Notwithstanding the withdrawal of several mesh products from the market, as a result of complications and litigation cost, the high recurrence rate with anterior colporrhaphy is like to maintain interest in the use of mesh for surgery. & References 1 Rudnicki M, Laurikainen E, Rogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG 2014;121: 102–11. 2 Ward K, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67–70.
SIMF Ismail Department of Obstetrics and Gynaecology, Royal Sussex County Hospital, Brighton, UK Accepted 16 February 2014. DOI: 10.1111/1471-0528.12830
Authors’ reply Sir, We read with great interest the remarks regarding our randomised controlled trial comparing anterior colporrhaphy with repair using collagen-coated transvaginal mesh for anterior vaginal wall prolapse. We agree with the authors that comparing a synthetic mesh with a
1448
coated synthetic mesh would be the most interesting, as indicated in the ‘Commentary’ published in association with our manuscript. However, our study was planned 6 years ago and, at that time, only few data were available evaluating the usefulness of synthetic mesh.1 Furthermore, most studies at that time included few patients or were of poor quality. In particular, the recurrence rate was poorly defined. At the initiation of the study, we therefore still think that comparison of a conventional operation with a new one is the optimal condition to gather new information. Limitation of the age to 55 years was decided during protocol finalisation due to the ethical problem of implantation of synthetic material in younger patients with a primary cystocele, as the longterm complications were not well known. Furthermore, as noted, all patients received local estrogen therapy in the hope that the vaginal mucosa would be in the same condition in all women. We agree with the observation that normality of continuous data should be evaluated before use. Most authors use the Kolmogorov–Sminov or Shapiro– Wilk test to evaluate whether data fit a normal distribution, but these tests have limitations.2 Therefore, we used non-parametric tests such as the Mann–Whitney U-test or Wilcoxon sign-rank test, which do not assume normality of the data. We agree that changes from baseline are interesting. We have recently looked into these data trying to compare change in anatomic status with change in symptom and Quality of Life (QoL) scores. The data will be published as soon as possible. Long-term follow-up is always of interest and therefore we invited all centres to follow patients up to 3 years. These data will be completed during spring and presented as well. The phenomenon that many patients
do not require a new operation despite objective recurrence is fascinating and needs further clarification. This also calls for an examination of the huge difference between objective and subjective cure rate. Do we have the right instruments to measure prolapse or should we develop new tools to achieve a more accurate description of the association between the patient’s perspective and the objective outcome? It is obvious that we still need treatment options in patients with recurrent prolapse. So far, however, only synthetic mesh has demonstrated superiority compared with conventional methods regarding the objective outcome. We do not believe that the use of mesh is hazardous and we still think that its use is justified in certain patients. & References 1 Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn 2008;27:3–12. 2 Asghar Ghasemi A, Saleh Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012;10:486–9.
M Rudnicki,a E Laurikainen,b R Pogosean,c I Kinne,d U Jakobssene & P Telemanf a
Department of Obstetrics and Gynaecology, Odense University Hospital, Odense, Denmark b Department of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland c Department of Obstetrics and Gynaecology, Lindk€oping Hospital, Lindk€obing, Sweden d Department of Obstetrics and Gynaecology, Ahus University Hospital, Ahus, Norway e Center for Primary Healthcare Research, Faculty of Medicine, Lund University, Lund, Sweden fDepartment of Obstetrics and Gynaecology, University Hospital Lund, Lund, Sweden Accepted 15 March 2014. DOI: 10.1111/1471-0528.12831
ª 2014 Royal College of Obstetricians and Gynaecologists
under each table, including baseline values. A better comparison of outcome, both objective and subjective, would have been to compare the change from baseline value in both arms, rather than comparing values at follow-up.2 The lack of a significant difference in resorting to surgery, despite the higher recurrence rate with anterior colporrhaphy, may reflect the duration of follow-up. A longer follow-up would be useful in this respect. These points need to be borne in mind when looking at the results of this trial. This is particularly pertinent in any future re-look at the use of mesh coating for prolapse surgery. Notwithstanding the withdrawal of several mesh products from the market, as a result of complications and litigation cost, the high recurrence rate with anterior colporrhaphy is like to maintain interest in the use of mesh for surgery. & References 1 Rudnicki M, Laurikainen E, Rogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG 2014;121: 102–11. 2 Ward K, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67–70.
SIMF Ismail Department of Obstetrics and Gynaecology, Royal Sussex County Hospital, Brighton, UK Accepted 16 February 2014. DOI: 10.1111/1471-0528.12830
Authors’ reply Sir, We read with great interest the remarks regarding our randomised controlled trial comparing anterior colporrhaphy with repair using collagen-coated transvaginal mesh for anterior vaginal wall prolapse. We agree with the authors that comparing a synthetic mesh with a
1448
coated synthetic mesh would be the most interesting, as indicated in the ‘Commentary’ published in association with our manuscript. However, our study was planned 6 years ago and, at that time, only few data were available evaluating the usefulness of synthetic mesh.1 Furthermore, most studies at that time included few patients or were of poor quality. In particular, the recurrence rate was poorly defined. At the initiation of the study, we therefore still think that comparison of a conventional operation with a new one is the optimal condition to gather new information. Limitation of the age to 55 years was decided during protocol finalisation due to the ethical problem of implantation of synthetic material in younger patients with a primary cystocele, as the longterm complications were not well known. Furthermore, as noted, all patients received local estrogen therapy in the hope that the vaginal mucosa would be in the same condition in all women. We agree with the observation that normality of continuous data should be evaluated before use. Most authors use the Kolmogorov–Sminov or Shapiro– Wilk test to evaluate whether data fit a normal distribution, but these tests have limitations.2 Therefore, we used non-parametric tests such as the Mann–Whitney U-test or Wilcoxon sign-rank test, which do not assume normality of the data. We agree that changes from baseline are interesting. We have recently looked into these data trying to compare change in anatomic status with change in symptom and Quality of Life (QoL) scores. The data will be published as soon as possible. Long-term follow-up is always of interest and therefore we invited all centres to follow patients up to 3 years. These data will be completed during spring and presented as well. The phenomenon that many patients
do not require a new operation despite objective recurrence is fascinating and needs further clarification. This also calls for an examination of the huge difference between objective and subjective cure rate. Do we have the right instruments to measure prolapse or should we develop new tools to achieve a more accurate description of the association between the patient’s perspective and the objective outcome? It is obvious that we still need treatment options in patients with recurrent prolapse. So far, however, only synthetic mesh has demonstrated superiority compared with conventional methods regarding the objective outcome. We do not believe that the use of mesh is hazardous and we still think that its use is justified in certain patients. & References 1 Maher C, Baessler K, Glazener CM, Adams EJ, Hagen S. Surgical management of pelvic organ prolapse in women: a short version Cochrane review. Neurourol Urodyn 2008;27:3–12. 2 Asghar Ghasemi A, Saleh Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012;10:486–9.
M Rudnicki,a E Laurikainen,b R Pogosean,c I Kinne,d U Jakobssene & P Telemanf a
Department of Obstetrics and Gynaecology, Odense University Hospital, Odense, Denmark b Department of Obstetrics and Gynaecology, Turku University Hospital, Turku, Finland c Department of Obstetrics and Gynaecology, Lindk€oping Hospital, Lindk€obing, Sweden d Department of Obstetrics and Gynaecology, Ahus University Hospital, Ahus, Norway e Center for Primary Healthcare Research, Faculty of Medicine, Lund University, Lund, Sweden fDepartment of Obstetrics and Gynaecology, University Hospital Lund, Lund, Sweden Accepted 15 March 2014. DOI: 10.1111/1471-0528.12831
ª 2014 Royal College of Obstetricians and Gynaecologists
