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Tension-free vaginal tape- is there a learning curve?
- Rajesh Varma, Ed Neale (16 July 2002)
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Re: Tension-free vaginal tape- is there a learning curve?
- Paul Hilton, Karen L. Ward (25 July 2002)
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Can the patient choose the type of anaesthetic for Tension Free Vaginal Tape(TVT) procedure?
- Dattakumar P. Kunde, Rajiv Varma , Consultant Gynaecologist, Basildon Hospital, Basildon, Essex and Honorary Senior Lecturer, UCH and Royal Free Hospitals, London. (15 November 2002)
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Patient choice or Hobson's choice?
- Paul Hilton, Tracy Ord, Karen L. Ward (1 December 2002)
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Multicentericity as a pitfall for otherwise carefully planned RCT on surgical techniques
- Bernhard Schuessler Prof. Dr. med (17 November 2003)
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Rajesh Varma, Specialist Registrar Obstetrics and Gynaecology Bedford Hospital, Bedford, UK, MK42 9DJ, Ed Neale
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Few clinical surgical trials can claim almost complete recruitment of the required sample from power calculations, adopt standardised surgical techniques, and undertake systematic evaluation of cure supplemented by assessment of quality of life measures. Ward and Hilton 1 should be commended for incorporating such standards in a well-designed prospective trial, with the added bonus of the intention to perform longer-term follow up. Nevertheless, a striking feature was the relatively high incidence of bladder injury (9%), vaginal perforation (3%) and retropubic haematoma (2%) following tension-free vaginal tape (TVT), even though these were not considered major complications apart from the single case of vascular injury necessitating laparotomy. Although a smaller series, our own TVT audit in over 50 cases reports a less than 4% bladder injury rate with no reported pelvic haematomas or major vascular complications. The trial authors accept these complications are higher than expected from comparable publications, although no further explanation is offered. It is unclear from the data whether this subgroup would be at increased risk of adverse primary and secondary outcome measures compared to the non -complicated cases. Further analysis of this subgroup may have also identified significant predisposing factors such as age, elevated body mass index or previous hysterectomy. Such information would be useful in both preoperative patient counselling and patient selection, as there remains a lack of consensus regarding the preferred criteria and first- line choice surgical procedure for genuine stress incontinence. All new surgical techniques entail a learning curve, and it is significant that the authors stated that participating surgeons had undergone similar training in the procedure but had variable experience before recruitment. Although the study was of limited duration (fifteen months), it would have been interesting to clarify if the safety and efficacy of the vaginal tape procedure underwent a similar temporal variation due to a potential initial learning phase. It is noteworthy that the recent guideline on incontinence from the Royal College of Obstetricians and Gynaecologists states that the extent of local experience with the procedure should form part of the informed consent for any incontinence surgery. 2 Recognising our own advancement up the learning curve, we have successfully progressed from overnight stay to day case management with TVT performed under spinal anaesthetic. As the TVT technique becomes more widely accepted it is possible that future studies will show comparable results to the overseas experience 3,4, justifying its role in stress incontinence. However, there remains a perceived impression that this technique is restricted to subspecialist urgogynaecologists. The success of this multicentre trial could help dispel this myth and encourage gynaecologists from a wider background to undertake appropriate training in this still relatively new technique. Rajesh Varma
Ed Neale
References 1. Ward K, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002; 325-367 2. Incontinence in Women. Study Group. Royal College of Obstetricians and Gynaecologists, London, 2002. 3. Ulmsten U. The basic understanding and clinical results of tension-free vaginal tape for stress urinary incontinence. Urologe A. 2001; 40:269-73. 4. Merlin T, Arnold E, Petros P, MacTaggart P, Tulloch A, Faulkner K, Maddern G. A systematic review of tension-free urethropexy for stress urinary incontinence: intravaginal slingplasty and the tension-free vaginal tape procedures. BJU Int. 2001; 88:871-80 |
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Paul Hilton, Consultant Gynaecologist Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP, Karen L. Ward
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We are grateful to Drs Varma and Neale for their comments on our recent article.1 They refer to the high rate of complications recorded within our trial, and in particular to the rate of bladder injury during the Tension-free Vaginal Tape procedure (TVT). We would point out that ours was a multicentre randomised comparative trial involving 39 operating surgeons, of whom 15 were consultants and 24 were supervised trainees. The 14 collaborating centres recruited between 6 and 51 patients, and individual surgeons undertook between 1 and 29 operations (between 1 and 20 TVT procedures). Although all consultants had undergone a similar training in the TVT procedure, they had variable experience of the operation at the time of recruitment; we had intended that this fact, along with the inclusion of units with a range of clinical and academic background, and variable workload, would increase the external validity or generalisability of the results. One would expect that a pragmatic trial of this nature would give results and complication rates at variance with those of smaller personal audit series, although would suggest to Drs Varma and Neale that the rate of bladder injury in their own audit is neither statistically nor clinically significantly different from the rate in our own or other published series.2, 3 The perforations which occurred with TVT within our trial were during the 1st to 13th patient (median 8th) recruited for the procedure at individual centres. In a recent nationwide review of cases from Finland, it is suggested that the weight of complications occur in a surgeons first 15 cases.4 In the senior author’s personal series of 310 TVT’s bladder perforation has occurred in case numbers 65, 68, 144 and 276. However long the ‘learning curve’ might be, the time for complacency at this or any other surgical procedure is never reached. The correspondents raise the important question as to whether the occurrence of bladder perforation increases the risk of adverse primary or secondary outcomes. The issue of sample size was discussed in some detail in our paper, and the numbers involved make subgroup analysis of very limited value. Although we did find variation in cure rates for both TVT and colposuspension between the different centres, we did not find significant differences in results between consultants and trainees, urologists and gynaecologists, university teaching hospitals and district general hospitals, nor between early and late recruits to the trial, and those with and without urinary tract injury.5 Although 11 out of 15 (73%) TVT patients with bladder perforation were cured at 6 months, compared to 104 of 155 (67%) where there was no such complication, a study involving over 4400 cases would be required to answer the question which the correspondents pose, with reasonable power. As we pointed out in our paper, no long term sequelae have yet been reported from recognised bladder perforation at TVT; the same is of course not true for unrecognised operative injury or subsequent erosion into the urinary tract, and reports of such cases are beginning to appear in the literature,6-10 and we are aware of at least 8 such cases within the UK. Drs Varma & Neale suggest that the success of our trial may help dispel the myth that TVT should be restricted in its use to subspecialist urogynaecologists. Whilst we have never personally advocated this limitation, we would look on it as highly regrettable if readers took this to imply that the procedure was appropriate for all surgeons to undertake. We would wholly endorse the recommendations of the recent Royal College of Obstetricians and Gynaecologists study group,11 and would point out in particular the statement: “All surgical procedures should be undertaken only by those with appropriate training and experience to allow them to maintain the highest standards of practice.” Appropriate training for TVT has never been satisfactorily defined, although we would suggest that considerable experience in cystourethroscopy and in retropubic surgery are essential pre-requisites,12 and supervised management of at least 15 cases should be considered desirable. Competing interests: see original paper.1 1. Ward KL, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. British Medical Journal 2002;325:67 (http://bmj.com/cgi/reprint/325/7355/67). 2. Merlin T, Arnold E, Petros P, MacTaggart P, Tulloch A, Faulkner K, et al. A systematic review of tension-free urethropexy for stress urinary incontinence: intravaginal slingplasty and the tension-free vaginal tape procedures. British Journal of Urology International 2001;88(9):871-880. 3. Hinoul P, Rufford J, Cardozo L, Bidmead J, Anders K, Dixon A, et al. TVT: Trouble-free Vaginal Tape? In: International Continence Society (UK section); 2002; Sheffield; 2002. 4. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstetricia et Gynecologica Scandinavica 2002;81(1):72-77. 5. Hilton P. Trials of surgery for stress incontinence - thoughts on the 'Humpty Dumpty principle'. British Journal of Obstetrics & Gynaecology 2002;(in press). 6. Koelbl H, Stoerer S, Seliger G, Wolters M. Transurethral penetration of a tension-free vaginal tape. British Journal of Obstetrics & Gynaecology 2001;108(7):763-5. 7. Haferkamp A, Steiner G, Muller SC, Schumacher S. Urethral erosion of tension-free vaginal tape. Journal of Urology 2002;167:250. 8. Pit MJ. Rare complications of tension-free vaginal tape procedure: late intraurethral displacement and early misplacement of tape. Journal of Urology 2002;167:647. 9. Madjar S, Tchetgen MB, Van Antwerp A, Abdelmalak J, Rackley RR. Urethral erosion of tension-free vaginal tape. Urology 2002;59(4):601. 10. Sweat SD, Itano NB, Clemens JQ, Bushman W, Gruenenfelder J, McGuire EJ, et al. Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol 2002;168(1):144-6. 11. Cardozo L, Maclean A. Incontinence in Women: Proceedings of the 42nd RCOG Study Group: RCOG; 2002. 12. Hilton P. Tension-free Vaginal Tape: the minimalist approach to continence surgery. In: Sturdee D, Oláh K, Keane D, editors. Yearbook of Obstetrics and Gynaecology - Volume 10. London: RCOG Press; 2002. |
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Dattakumar P. Kunde, Locum Consultant in Gynaecology Maidstone Hospital, Hermitage Lane, Maidstone, Kent ME16 9QQ, Rajiv Varma , Consultant Gynaecologist, Basildon Hospital, Basildon, Essex and Honorary Senior Lecturer, UCH and Royal Free Hospitals, London.
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We would like to congratulate Ward and Hilton for excellent design and publication of their study which addresses the important issue of relative efficacy of TVT and Colposuspension for stress urinary incontinence(1). It is noteworthy that in this trial, all but 3 procedures were performed under spinal or local anaesthetic as recommended by Ulmsten et al(2). Their original technique describes the need for demonstrating intraoperative continence by asking the patient to cough after placement of the tape as it is pulled up against the urethra. It is believed that tightening the tape while the patient is asked to cough helps to achieve the optimum tension in the tape that determines the success of the procedure. We have argued against this idea as we believe that a patient who is in supine position, has significant volume of local anaesthetic or saline injected around bladder neck and/or has spinal anaesthesia can not effectively produce the leak pressures mimicking the natural conditions that produce leakage of urine in upright position. Hence, in our opinion the idea of using this as a test of operative success may lead to overtightening of the tape and cause postoperative voiding difficulties. Clearly, this approach needs further evaluation in the context of a research trial. Our own published experience with the first 50 cases of TVT done under general anaesthesia(GA)(3) by a single operator(RV) produced a subjective cure rate comparable to that reported in other series where the procedures were performed under spinal or local anaesthesia.In the study by Ward and Hilton, there were 3 TVT procedures where GA was used. It would be interesting to know the outcome in these cases. The tape achieves continence through a tissue reaction to the tape and it would therefore appear that the tension in the tape is not critical to the success of the procedure.Indeed, in our series of 298 TVT procedures performed till date, all patients had GA. All procedures were performed using the standard surgical technique and the tape was placed very loose under midurethra. Majority of the procedures were day stay procedures(average length of stay of 4.5 hours). Using this technique, we have continued to see a consistent success rate without any rise in complications(Bladder injury rate of < 4%). The National Institute of Clinical Excellence(NICE) is currently conducting an appraisal of tension free vaginal tape in order to formulate guidelines for its use in the treatment of stress urinary incontinence(4). One of its preliminary recommendations includes the option for using local, spinal or general anaesthesia for this procedure. Our observations also indicate that choice of an anaesthetic could be offered to patients undergoing TVT as a single procedure or to those undergoing a major procedure like hysterectomy in combination with TVT. Mr Dattakumar P Kunde MRCOG, Mr Rajiv Varma FRCOG, References: 1. 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. 2. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anaesthesia for treatment of female urinary incontinence. Int Urogynae J 1996;7:81-86. 3. Kunde D, Varma R. Feasibility of Performing TVT operation for stress urinary incontinence under general anaesthesia. J Obstet Gynaecol 2002; 22(6):663-665. 4. Appraisal Consultation Document: Tension-free vaginal tape for stress urinary incontinence- NICE. http:www.nice.org.uk/article.asp?a=38434. Competing interests: None declared |
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Paul Hilton, Consultant Gynaecologist Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP, Tracy Ord, Karen L. Ward
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We are grateful to Messrs Kunde and Varma for their comments on our recent study, raising the interesting issue of anaesthesia for Tension- free Vaginal Tape (TVT), and the impact this may have on outcome.1 Our trial protocol dictated the use of local anaesthesia with sedation for the TVT arm, as originally described by Ulmsten and colleagues.2 Three cases were carried out under spinal anaesthetic, in breach of protocol, and three were converted to general anaesthesia for reasons specified in our paper. The correspondents seek information regarding the latter group, who were in fact all objectively cured at both 6 months and 2 years; the numbers involved however are clearly too small for sub-analysis to be meaningful. Kunde and Varma advocate patient choice in anaesthesia for TVT. Strangely, however, they make this recommendation based on their own experience of cases, all managed under general anaesthesia. It must seem something of a ‘Hobson’s choice’ for patients if they are told during counselling that their surgeon has carried out almost 300 cases under general anaesthesia and none under sedo-analgesia. One non-randomised 3 and two randomised 4, 5 comparisons of anaesthetic techniques for TVT have now been published. These studies are small, and their results inconsistent, but summation of the cases indicates 18 out of 32 (56%) subjectively cured following surgery under general anaesthesia, with 123 out of 155 (79%) cured following regional block, and 148 out of 172 (86%) following local anaesthesia. Whilst care must be exercised in drawing conclusions from this data, there is at least no clear advantage from general anaesthesia. With the approval of our local research ethics committee, we have recently undertaken a small-scale retrospective postal questionnaire study to ascertain the views of our patients regarding their anaesthesia for TVT. All patients who had undergone TVT without additional surgery, under local anaesthesia with sedation, between January and October 2002 were contacted and asked to complete the questionnaire, several weeks after their discharge from hospital. Of the 36 women contacted, 32 completed the questionnaire. When asked about intra-operative pain, 91% stated they had experienced no or very little pain (scores of 1 or 2 on the Hayward pain scale),6 and none reported severe or the worst pain imaginable (4 or 5 on the Hayward scale). Similarly, in the first seven days following TVT, 78% described themselves as having no or only little pain. Women were also asked to describe how they had felt prior to surgery and currently, in respect of their anaesthesia. Had they been given the choice pre-operatively, 65% said they would have preferred to have a general anaesthetic and/or were anxious about being awake. Following surgery, only one woman still felt she would have preferred a general anaesthetic, with 81% stating they were pleased to avoid general anaesthesia and now felt completely relaxed about their experience of being awake during their procedure. We acknowledge that there may be considerable recall bias in such data, and that patients may report positively about the experience of surgery simply because it is now over. Nevertheless, there seems little doubt that patients’ anxieties about having surgery under local anaesthesia plus sedation are not formed by prior unsatisfactory experience of the technique. Indeed, having undergone the procedure their views regarding local anaesthesia are, with few exceptions, very positive. It seems more likely therefore that patients’ negative preceptions are derived from medical and nursing staff. There is undoubtedly a trend for surgeons in the UK and elsewhere to undertake TVT using regional or general anaesthesia. It is interesting to speculate as to whether this trend is driven by patient choice or surgical conservatism. We wholly endorse the move towards increased patient choice in anaesthetic technique advocated by Kunde and Varma. Nevertheless, we feel that patients can only exercise that choice effectively where surgeons and anaesthetists have experience of all options, and counsel their patients on the basis of the best available data. 1. Ward KL, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. British Medical Journal 2002;325:67-70. 2. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. International Urogynecology Journal & Pelvic Floor Dysfunction 1996;7(2):81-86. 3. Deval B, Jeffrey L, Al Najjar F, Soriano D, Darai E. Determinants of patient dissatisfaction after a Tension-free Vaginal Tape procedures for urinary incontinence. Journal of Urology 2002;167:2093-2097. 4. Wang AC, Chen MC. Randomized comparison of local versus epidural anesthesia for tension-free vaginal tape operation. Journal of Urology 2001;165(4):1177-1180. 5. Adamiak A, Milart P, Skorupski P, Kuchnicka K, Nestorowicz A, Jakowicki J, et al. The efficacy and safety of the tension-free vaginal tape procedure do not depend on the method of analgesia. European Urology 2002;42(1):29-33. 6. Hayward J. Can pain be measured? Nursing 1979(1):32-34. Tracy Ord RN, BSc, Research Nurse Karen L Ward MB, BS, MRCOG, Specialist Registrar and Paul Hilton MD, FRCOG, Consultant Gynaecologist and Subspecialist in Urogynaecology Urogynaecology Unit, Directorate of Women’s Services, Royal Victoria Infirmary Newcastle upon Tyne NE1 4LP, England Tel: +44(0)1912825853 Fax: +44(0)1912275173 Email: paul.hilton@ncl.ac.uk Competing interests: As declared in our original publication.1 |
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Bernhard Schuessler Prof. Dr. med, Head of Department Obstet and Gyn, CH-6000 Luzern 16
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Dear Sir In July 2002 in your journal, Ward and Hilton reported results from a prospective randomised multicentre study on the efficacy of the tension- free vaginal tape (TVT) for primary treatment of female stress urinary incontinence in comparison to abdominal colposuspension (1). Based on several standardised outcome measures the cure rates at six months were interpreted as comparable for both procedures with a potential advantage of the TVT, based on its minimal surgical access and lower postoperative complications. This study was very well received because it is one of the few large randomised controlled studies evaluating new surgical procedures. However, in an editorial three months later these results were criticised based on underpowerment and selection bias due to the fact that a number of women withdrew from the study once they were randomised into the colposuspension group. Furthermore, those women who withdrew had less severe incontinence (2). The authors of this editorial concluded that a more correct interpretation of the study results is that TVT "may be better, worse or the same as colposuspension". The recent release of a further analysis of the study data emphasises that the study is even more flawed. Analysis of outcome by trial centre revealed success rates ranging between 10 to 90 % for TVT and 20 to 92 % for colposuspension (3). This incoherence of the primary data set prevents us to gain any knowledge regarding the success rates of the TVT and colposuspension at all. What it may add, however, is that poor average cure rates of 66 % for TVT and 57 % for colposuspension reported in this study are not related to the procedures themselves but rather to poor performance and technique in some of the study centres. Randomised controlled surgical trials have their own rules. Before starting an RCT on surgical techniques the learning curve needs to be recognized and evaluated using appropriate statistical techniques otherwise waste of time and ressources is inevitable (4). Furthermore, the scientific community and hence patients expectations could be misled by improperly planned studies. Literature 1. 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 2. Maddern GJ, Middleton PF, Grant AM Urinary stress incontinence BMJ 2002;325:389-90 3. Hilton P Trials of surgery for stress incontinence - thoughts on the "Humpty Dumpty principle". Commentary. BrJObstetGynecol 2002;109:1081-1088 4. McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D Randomised trials in surgery: problems and possible solutions BMJ 2002;324:1448-1451 Competing interests: None declared |
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