Maturitas 77 (2014) 239–242
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Review
New surgical approaches for urinary incontinence in women Vladimir Revicky a,∗ , Douglas G. Tincello b a b
Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK Department of Cancer Studies & Molecular Medicine, University of Leicester Royal Infirmary Leicester LE2 7LX, UK
a r t i c l e
i n f o
Article history: Received 15 December 2013 Accepted 22 December 2013 Keywords: Urinary incontinence Tension-free vaginal tape TVT
a b s t r a c t Urinary incontinence (UI) is highly prevalent and common complaint. A large proportion of women with UI can be correctly diagnosed by their symptoms alone. First line of treatment should follow conservative route in a form of pelvic floor muscle training for stress UI and bladder training for the urgency UI. If conservative management is ineffective, medical and surgical treatment is the next considered. For the treatment of over-active bladder and urgency UI, intra-vesical injections of botulinum toxin A, utilising a flexible or rigid cystoscope has become an established treatment. An alternative to the use of onaBoNTA is sacral nerve stimulation (SNS). Vaginal tapes/slings procedures have become treatment of choice for stress UI. Different approaches of introduction of vaginal tape can be used, including retropubic ‘bottom-up’ (TVT), and transobturator ‘inside-out’ (TVT-O), or ‘outside-in’ (TOT). TVT and TVT-O/TOT seem comparable although there are differences in complications (bladder injury with TVT vs. leg pain with TVT-O/TOT). Recently single incision approaches have been introduced whereby the vaginal tape is inserted via a single vaginal incision. Based on current evidence, single incision slings are not recommended. Individual clinicians should decide which to use based on expertise and experience, nevertheless, bladder injuries are probably less of an issue than leg pain. © 2014 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2. 3.
4. 5.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Conservative management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Medical management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3. Surgical management of urge incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4. Surgical procedures for stress urinary incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Further research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competing interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provenance and peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Introduction The International Continence Society defines urinary incontinence (UI) as the complaint of any involuntary leakage of urine
∗ Corresponding author. Tel.: +44 116 258 6881. E-mail addresses: [email protected], [email protected] (V. Revicky). 0378-5122/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.maturitas.2013.12.008
239 240 240 240 240 240 240 241 241 241 241 241 241 241
[1]. UI may occur as a result of a number of abnormalities of function of the lower urinary tract. Involuntary urine leakage on effort or exertion or on sneezing or coughing is defined as stress urinary incontinence (SUI) while involuntary urine leakage accompanied or immediately preceded by urgency, which is a sudden compelling desire to urinate that is difficult to defer is referred to as urge UI (UUI) [1]. Mixed UI is involuntary urine leakage associated with both urgency and exertion, effort, sneezing or coughing [1]. Some patients complain of urinary frequency, urgency and
240
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
nocturia without leaking. This is termed overactive bladder (OAB) and is often, but not always associated with underlying detrusor overactivity (DO). Urinary incontinence is highly prevalent and common complaint. Some reports estimated that UI may be affecting up to 25% of women [2]. Almost half of these women have SUI, 11% have urge UI and 36% have mixed UI [2]. UI can be very distressing and socially disruptive, women with UI, 60% avoid going away from home, 50% feel odd or different from others, 45% avoid public transport and 50% report avoiding sexual activity through fear of incontinence [3]. There are limited data regarding cost of treating UI, but, data from the Leicestershire MRC Incontinence Study estimated the annual cost to the NHS at £536 m [4]. 2. Management A large proportion of women with UI can be correctly diagnosed by their symptoms alone [5]. With addition of gynaecological examination, dip-stick test of urine and the use of a bladder diary, these women can be triaged straight away for conservative management of SUI or UUI. Bladder diaries provide evidence of filling and voiding over a number of days and can provide information about urinary frequency, urgency and nocturia, bladder capacity and total urine output. They also record UI episodes and fluid intake. Urodynamic testing has been done routinely for all patients before treatment, but in the last five years this practice has been increasingly questioned. Invasive urinary testing or urodynamic testing is a measurement of intra-vesical pressure using multichannel cystometry. This involves the measurement of both bladder and intra-abdominal pressures by catheters inserted into the bladder and the rectum or vagina. The aim is to replicate the woman’s symptoms by filling the bladder and observing pressures changes or leakage caused by provocation tests. Recently published trials were trying to answer the question of the value of the urodynamic testing prior surgical intervention, however, it is still unclear if urodynamic testing affects the outcome of the treatment of UI [6–9]. 3. Treatment 3.1. Conservative management Pelvic floor muscle training is effective in reducing stress UI symptoms, with subjective cure rate from 16 to 56% [10]. A Cochrane systematic review demonstrated that women were about 17 times more likely to report cure than controls (RR 16.8, 95% CI 2.4–119.0) [10]. A further Cochrane review of published studies demonstrated the effectiveness of bladder training in reducing urgency or mixed UI symptoms (RR 17, 95% CI 1.13–256) [11,12]. Percutaneous posterior tibial nerve stimulation (PTNS) delivers neurostimulation to the S2–S4 roots of the sacral nerve plexus via the posterior tibial nerve, and can be offered as a treatment for UUI or OAB symptoms. Two randomised trials showed a clinical effectiveness of PTNS [13,14]. However, the evidence was not adequate to compare PTNS with medical therapy and further, PTNS was unlikely to be a cost-effective alternative to medical treatment [7]. 3.2. Medical management If conservative treatment is ineffective, medical and surgical treatments are considered. Antimuscarinic drugs are used to treat OAB. They block muscarinic receptors in the bladder, which reduces bladder muscle contractions and affects bladder sensation, reducing urinary urgency and the related symptoms of urgency incontinence, frequency and nocturia.
Available preparations include oxybutynin, tolterodine, tropsium, propiverine and solifenacin. Recent recommendation on the use of these drugs has been published by the UK National Institute of Clinical Excellence [7]. 3.3. Surgical management of urge incontinence For the treatment of OAB and UUI (whether confirmed by urodynamic testing or not), intra-vesical injections of onabotulinum toxin A (onaBoNTA) utilising a flexible or rigid cystoscope have become an established second-line treatment in the last five years. There are several preparation of onaBoNTA available, although the vast majority of published research is with the preparation onabotulinum toxin A, marketed by Allergan as BOTOX® . Several randomised trials have been published, including three large studies. Tincello et al. recruited 240 women with proven detrusor overactivity [15]. 122 women received 200 U of onaBoNTA and 118 received placebo, and showed 2.5-fold decrease in urgency episodes and 4-fold decrease of leakage episodes at six months in comparison to placebo. There was a 3-fold increased risk of urinary infection and 4-fold increase in the incidence of voiding difficulties (16%) after treatment. Three more recent studies examined the efficacy of lower doses of onaBoNTA to treat OAB (i.e. without urodynamic confirmation [16–18]). Denys et al. [16] treated 99 patients to receive placebo, or 50, 100, or 150 U of BOTOX and followed them up for 6 months. At three months, 50% or more improvement in urgency and urge incontinence was seen in 65% and 55% of patients after 100 or 150 U. Continence was achieved in 55% and 50% at three months. Only three patients had high residual volumes, and there was a dose response in residual volume with 100 and 150 U. 50 U was not different from placebo in all outcomes. Nitti et al. [17] randomised 550 patients with OAB and at least three incontinence episodes per day to receive 100 U or placebo. At 12 weeks, the active group showed significantly fewer incontinence episodes and 23% patients become continent. Urinary retention occurred in 5%. Chapple et al. [18] randomised 548 patients refractory to oral medication to receive 100 U or placebo and reported essentially identical data. onaBoNTA has recently been granted a licence for the treatment of OAB in most European countries and the USA. An alternative to the use of onaBoNTA is a sacral nerve stimulation (SNS). The principle of neurostimulation is that electrical stimulation of the sacral reflex pathway will inhibit the reflex behaviour of the bladder and reduce detrusor overactivity. Sacral nerve root stimulators have been developed to provide chronic stimulation directly to the S3 nerve roots. SNS is an invasive twostage procedure, with significant cost and a need to change the pulse generator every 7 years. With use of SNS, 52% of patients were dry at 18 months and a further 24% reported at least 50% reduction in leakage episodes [19]. 3.4. Surgical procedures for stress urinary incontinence There are many procedures described for the treatment of stress urinary incontinence. All continence procedures aim to provide a tension-free support to the mid-urethra or bladder-neck, to prevent downward displacement during coughing or straining. Mid-urethral tapes are inserted via a small sub-urethral vaginal incision and small incisions in the supra-pubic or groin area, depending on the type of tape used. The retropubic tension-free vaginal tape (TVT) was first introduced into clinical practice in 1996 by Ulmsten et al. [20]. Prior to this, the majority of continence procedures had been performed by an abdominal route, using the Burch colposuspension. However, the effectiveness of retropubic mid-urethral tape procedures is similar to the effectiveness of open colposuspension [21].
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
As a result of the minimal access approach, the patient’s hospital stay and morbidity are very much reduced. Different approaches of introduction of the vaginal tape can be used, including retropubic ‘bottom-up’ (TVT), when the vaginal tape is introduced through vagina, underneath and around both sides of the mid-part of the urethra, retropubically in a ‘U’ shape and exited via skin incisions in the supra-pubic area, and transobturator ‘inside-out’ (TVT-O), when vaginal tape is introduced through vagina, underneath of the mid-part of the urethra, through both obturator foramens and exited via groin incisions, or ‘outside-in’ (TOT), when the tape in introduced in the opposite direction to TVTO. These approaches were introduced due to perceived problems with bladder injuries, however, few comparative data were available at that time. Numerous uncontrolled studies have published outcomes on retropubic and transobturator tapes but there are few randomised studies. A systematic review of the literature identified eleven randomised controlled trials (RCT) containing 1261 women [22]. Meta-analysis of these compared TVT with TVT-O and TOT procedures and demonstrated that subjective cure rates at 2–12 months were the same for all procedures [22], and further, showed that bladder injuries were eight times more common and voiding difficulties were twice as common after TVT in comparison to TVTO or TOT [22]. Nevertheless, the incidence of groin or thigh pain was eight times more common and vaginal mesh erosion was twice as common after TVT-O or TOT [22]. This systematic review supported previous findings of randomised controlled trial (RCT) which compared TVT and TVT-O procedure and demonstrated the same cure rates but showed a high incidence of leg pain following TVTO (26.4% vs. 1.7%, p = 0.0001) [23]. Another study compared TVT-O with TOT and reported cure rates with no statistically difference between both procedures [24]. Recently single incision approaches have been introduced whereby the synthetic tape is inserted via a single vaginal incision. One retrospective, one prospective observational study and one RCT investigated the single incision procedures, which were compared with either TVT or TVT-O. None of the trials showed any clinical benefit of the single incision procedures in comparison with TVT or TVT-O and clearly demonstrated a significantly higher rate of persistent stress UI at 6 weeks (OR 9.49, 95% CI 2.8–32.6) and 6 months (OR 8.14, 95% CI 2.7–24.7), and stress UI at 6 months (OR 7.58, 95% CI 2.7–24.7) with single incision procedures in comparison with TVT [25–27]. The reason for the development of single incision approaches was to assess whether it would be associated with less risk of injury and faster recovery, but the evidence does not support this [25–27]. 4. Conclusion For the treatment of OAB and urgency UI, intra-vesical injections of onabotulinum toxin A utilising a flexible or rigid cystoscope have become an established treatment. An alternative is sacral nerve stimulation. Vaginal tape procedures have become the treatment of choice for stress UI. Based on current evidence, single incision tapes are not recommended. TVT and TVT-O/TOT seem comparable although there are differences in complications (bladder injury with TVT vs. leg pain with TVT-O/TOT). Individual clinicians should decide which to use based on expertise and experience, although, bladder injuries are probably less of an issue than leg pain. Bladder injuries almost invariably heal after short-term bladder draining with no sequelae, whereas leg pain can be chronic and quite debilitating. 5. Further research Currently, we have long term data for efficacy and safety of TVT procedures [28], but, long term data for TVT-O/TOT and single
241
incisions procedures are still lacking. Another controversy surrounds the use of urodynamic testing prior to surgical treatment for UI. Although two RCTs were trying to address this uncertainty [7,8], it is still unclear if urodynamic testing affects the outcome of the treatment for UI [6]. While the data for the effectiveness of onaBoNTA are compelling, there are fewer data on long-term outcomes. Limited data suggest repeat treatment is equally effective, but we do not yet know whether this is true indefinitely, nor what proportion of patients will require lifelong treatment. The short- and long-term cost effectiveness of onaBoNTA treatment is unknown. Contributors Dr Vladimir Revicky and Professor Douglas G. Tincello have written paper, reviewed literature, reviewed paper. Competing interest The authors declare no conflict of interest. Funding The authors have received no funding for this article. Provenance and peer review Commissioned and externally peer reviewed. References [1] Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002;21(2):167–78. [2] Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT Study. Journal of Clinical Epidemiology 2000;53(11):1150–7. [3] Norton PA, MacDonald LD, Sedgwick PM, et al. Distress and delay associated with urinary incontinence, frequency, and urgency in women. British Medical Journal 1988;297(6657):1187–9. [4] Perry S, Shaw C, Assassa P, et al. An epidemiological study to establish the prevalence of urinary symptoms and felt need in the community: the Leicestershire MRC Incontinence Study. Leicestershire MRC Incontinence Study Team. Journal of Public Health Medicine 2000;22(3):427–34. [5] Martin JL, Williams KS, Abrahams KR, et al. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technology Assessment 2006;10(6):1–132. [6] Murdoch M, McColl EM, Howel D, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing. Trials 2011;12:169. [7] National Institute for Health and Care Excellence. Urinary incontinence in women: the management of urinary incontinence in women. London: National Institute for Health and Care Excellence; 2013. CG171. [8] Nager CW, Brubaker L, Litman HJ, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. New England Journal of Medicine 2012;366:1987–97. [9] Van Leijsen SA, Kluivers KB, Mol BW, et al. Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourology and Urodynamics 2012;31:1118–23. [10] Dumoulin C, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women (Cochrane review). Cochrane Database of Systematic Reviews 2010;25(1):CD005654. [11] Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults (Cochrane review). Cochrane Database of Systematic Reviews 2009;1:CD001308. [12] Fantl JA, Wyman JF, McClish DK, et al. Efficacy of bladder training in older women with urinary inontinence. Journal of the American Medical Association 1991;265(5):609–13. [13] Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. Journal of Urology 2010;184:2001–6.
242
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
[14] Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. Journal of Urology 2010;183:1438–43. [15] Tincello DG, Kenyon S, Abrams KR, et al. Botulinum toxin A versus placebo for refractory detrusor overactivity in women: a randomised blinded placebo-controlled trial of 240 women (the RELAX study). European Urology 2012;62(3):49–68. [16] Denys P, Le NL, Ghout I, et al. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. European Urology 2012;61:520–9. [17] Nitti VW, Dmochowski R, Herschorn S, et al. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. Journal of Urology 2013;189:2186–93. [18] Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. European Urology 2013;64: 249–56. [19] Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. Journal of Urology 1999;162(2):352–7. [20] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. International Urogynecology Journal and Pelvic Floor Dysfunction 1996;7(2):81–5.
[21] Ward K, Hilton P, UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG: An International Journal of Obstetrics & Gynaecology 2008;115:226–33. [22] Latthe P, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG: An International Journal of Obstetrics & Gynaecology 2007;114:522–31. [23] Teo R, Moran P, Mayne C, Tincello D. Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women. Journal of Urology 2011;185(4):1350–5. [24] Abdel-fattah M, Ramsay I, Pringle S, et al. Randomised prospective singleblinded study comparing ‘inside-out’ versus ‘outside-in’ transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG: An International Journal of Obstetrics & Gynaecology 2010;117:870–8. [25] Kennelly MJ, Moore R, Nguyen JN, Lukban J, Siegel S. Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. International Urogynecology Journal 2012;23:1285–91. [26] Bernasconi F, Napolitano V, Natale F, Leone V, Lijoi D, Cervigni M. TVT SECUR System: final results of a prospective, observational, multicentric study. International Urogynecology Journal 2012;23:93–8. [27] Basu M, Duckett J. A randomised trial of a retropubic tension-free vaginal tape versus a mini-sling for stress incontinence. BJOG: An International Journal of Obstetrics & Gynaecology 2010;117(6):730–5. [28] Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstetrics & Gynecology 2004;104(6):1259–62.
Contents lists available at ScienceDirect
Maturitas journal homepage: www.elsevier.com/locate/maturitas
Review
New surgical approaches for urinary incontinence in women Vladimir Revicky a,∗ , Douglas G. Tincello b a b
Leicester General Hospital, Gwendolen Road, Leicester LE5 4PW, UK Department of Cancer Studies & Molecular Medicine, University of Leicester Royal Infirmary Leicester LE2 7LX, UK
a r t i c l e
i n f o
Article history: Received 15 December 2013 Accepted 22 December 2013 Keywords: Urinary incontinence Tension-free vaginal tape TVT
a b s t r a c t Urinary incontinence (UI) is highly prevalent and common complaint. A large proportion of women with UI can be correctly diagnosed by their symptoms alone. First line of treatment should follow conservative route in a form of pelvic floor muscle training for stress UI and bladder training for the urgency UI. If conservative management is ineffective, medical and surgical treatment is the next considered. For the treatment of over-active bladder and urgency UI, intra-vesical injections of botulinum toxin A, utilising a flexible or rigid cystoscope has become an established treatment. An alternative to the use of onaBoNTA is sacral nerve stimulation (SNS). Vaginal tapes/slings procedures have become treatment of choice for stress UI. Different approaches of introduction of vaginal tape can be used, including retropubic ‘bottom-up’ (TVT), and transobturator ‘inside-out’ (TVT-O), or ‘outside-in’ (TOT). TVT and TVT-O/TOT seem comparable although there are differences in complications (bladder injury with TVT vs. leg pain with TVT-O/TOT). Recently single incision approaches have been introduced whereby the vaginal tape is inserted via a single vaginal incision. Based on current evidence, single incision slings are not recommended. Individual clinicians should decide which to use based on expertise and experience, nevertheless, bladder injuries are probably less of an issue than leg pain. © 2014 Elsevier Ireland Ltd. All rights reserved.
Contents 1. 2. 3.
4. 5.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1. Conservative management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2. Medical management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3. Surgical management of urge incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.4. Surgical procedures for stress urinary incontinence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Further research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Competing interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Provenance and peer review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1. Introduction The International Continence Society defines urinary incontinence (UI) as the complaint of any involuntary leakage of urine
∗ Corresponding author. Tel.: +44 116 258 6881. E-mail addresses: [email protected], [email protected] (V. Revicky). 0378-5122/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.maturitas.2013.12.008
239 240 240 240 240 240 240 241 241 241 241 241 241 241
[1]. UI may occur as a result of a number of abnormalities of function of the lower urinary tract. Involuntary urine leakage on effort or exertion or on sneezing or coughing is defined as stress urinary incontinence (SUI) while involuntary urine leakage accompanied or immediately preceded by urgency, which is a sudden compelling desire to urinate that is difficult to defer is referred to as urge UI (UUI) [1]. Mixed UI is involuntary urine leakage associated with both urgency and exertion, effort, sneezing or coughing [1]. Some patients complain of urinary frequency, urgency and
240
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
nocturia without leaking. This is termed overactive bladder (OAB) and is often, but not always associated with underlying detrusor overactivity (DO). Urinary incontinence is highly prevalent and common complaint. Some reports estimated that UI may be affecting up to 25% of women [2]. Almost half of these women have SUI, 11% have urge UI and 36% have mixed UI [2]. UI can be very distressing and socially disruptive, women with UI, 60% avoid going away from home, 50% feel odd or different from others, 45% avoid public transport and 50% report avoiding sexual activity through fear of incontinence [3]. There are limited data regarding cost of treating UI, but, data from the Leicestershire MRC Incontinence Study estimated the annual cost to the NHS at £536 m [4]. 2. Management A large proportion of women with UI can be correctly diagnosed by their symptoms alone [5]. With addition of gynaecological examination, dip-stick test of urine and the use of a bladder diary, these women can be triaged straight away for conservative management of SUI or UUI. Bladder diaries provide evidence of filling and voiding over a number of days and can provide information about urinary frequency, urgency and nocturia, bladder capacity and total urine output. They also record UI episodes and fluid intake. Urodynamic testing has been done routinely for all patients before treatment, but in the last five years this practice has been increasingly questioned. Invasive urinary testing or urodynamic testing is a measurement of intra-vesical pressure using multichannel cystometry. This involves the measurement of both bladder and intra-abdominal pressures by catheters inserted into the bladder and the rectum or vagina. The aim is to replicate the woman’s symptoms by filling the bladder and observing pressures changes or leakage caused by provocation tests. Recently published trials were trying to answer the question of the value of the urodynamic testing prior surgical intervention, however, it is still unclear if urodynamic testing affects the outcome of the treatment of UI [6–9]. 3. Treatment 3.1. Conservative management Pelvic floor muscle training is effective in reducing stress UI symptoms, with subjective cure rate from 16 to 56% [10]. A Cochrane systematic review demonstrated that women were about 17 times more likely to report cure than controls (RR 16.8, 95% CI 2.4–119.0) [10]. A further Cochrane review of published studies demonstrated the effectiveness of bladder training in reducing urgency or mixed UI symptoms (RR 17, 95% CI 1.13–256) [11,12]. Percutaneous posterior tibial nerve stimulation (PTNS) delivers neurostimulation to the S2–S4 roots of the sacral nerve plexus via the posterior tibial nerve, and can be offered as a treatment for UUI or OAB symptoms. Two randomised trials showed a clinical effectiveness of PTNS [13,14]. However, the evidence was not adequate to compare PTNS with medical therapy and further, PTNS was unlikely to be a cost-effective alternative to medical treatment [7]. 3.2. Medical management If conservative treatment is ineffective, medical and surgical treatments are considered. Antimuscarinic drugs are used to treat OAB. They block muscarinic receptors in the bladder, which reduces bladder muscle contractions and affects bladder sensation, reducing urinary urgency and the related symptoms of urgency incontinence, frequency and nocturia.
Available preparations include oxybutynin, tolterodine, tropsium, propiverine and solifenacin. Recent recommendation on the use of these drugs has been published by the UK National Institute of Clinical Excellence [7]. 3.3. Surgical management of urge incontinence For the treatment of OAB and UUI (whether confirmed by urodynamic testing or not), intra-vesical injections of onabotulinum toxin A (onaBoNTA) utilising a flexible or rigid cystoscope have become an established second-line treatment in the last five years. There are several preparation of onaBoNTA available, although the vast majority of published research is with the preparation onabotulinum toxin A, marketed by Allergan as BOTOX® . Several randomised trials have been published, including three large studies. Tincello et al. recruited 240 women with proven detrusor overactivity [15]. 122 women received 200 U of onaBoNTA and 118 received placebo, and showed 2.5-fold decrease in urgency episodes and 4-fold decrease of leakage episodes at six months in comparison to placebo. There was a 3-fold increased risk of urinary infection and 4-fold increase in the incidence of voiding difficulties (16%) after treatment. Three more recent studies examined the efficacy of lower doses of onaBoNTA to treat OAB (i.e. without urodynamic confirmation [16–18]). Denys et al. [16] treated 99 patients to receive placebo, or 50, 100, or 150 U of BOTOX and followed them up for 6 months. At three months, 50% or more improvement in urgency and urge incontinence was seen in 65% and 55% of patients after 100 or 150 U. Continence was achieved in 55% and 50% at three months. Only three patients had high residual volumes, and there was a dose response in residual volume with 100 and 150 U. 50 U was not different from placebo in all outcomes. Nitti et al. [17] randomised 550 patients with OAB and at least three incontinence episodes per day to receive 100 U or placebo. At 12 weeks, the active group showed significantly fewer incontinence episodes and 23% patients become continent. Urinary retention occurred in 5%. Chapple et al. [18] randomised 548 patients refractory to oral medication to receive 100 U or placebo and reported essentially identical data. onaBoNTA has recently been granted a licence for the treatment of OAB in most European countries and the USA. An alternative to the use of onaBoNTA is a sacral nerve stimulation (SNS). The principle of neurostimulation is that electrical stimulation of the sacral reflex pathway will inhibit the reflex behaviour of the bladder and reduce detrusor overactivity. Sacral nerve root stimulators have been developed to provide chronic stimulation directly to the S3 nerve roots. SNS is an invasive twostage procedure, with significant cost and a need to change the pulse generator every 7 years. With use of SNS, 52% of patients were dry at 18 months and a further 24% reported at least 50% reduction in leakage episodes [19]. 3.4. Surgical procedures for stress urinary incontinence There are many procedures described for the treatment of stress urinary incontinence. All continence procedures aim to provide a tension-free support to the mid-urethra or bladder-neck, to prevent downward displacement during coughing or straining. Mid-urethral tapes are inserted via a small sub-urethral vaginal incision and small incisions in the supra-pubic or groin area, depending on the type of tape used. The retropubic tension-free vaginal tape (TVT) was first introduced into clinical practice in 1996 by Ulmsten et al. [20]. Prior to this, the majority of continence procedures had been performed by an abdominal route, using the Burch colposuspension. However, the effectiveness of retropubic mid-urethral tape procedures is similar to the effectiveness of open colposuspension [21].
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
As a result of the minimal access approach, the patient’s hospital stay and morbidity are very much reduced. Different approaches of introduction of the vaginal tape can be used, including retropubic ‘bottom-up’ (TVT), when the vaginal tape is introduced through vagina, underneath and around both sides of the mid-part of the urethra, retropubically in a ‘U’ shape and exited via skin incisions in the supra-pubic area, and transobturator ‘inside-out’ (TVT-O), when vaginal tape is introduced through vagina, underneath of the mid-part of the urethra, through both obturator foramens and exited via groin incisions, or ‘outside-in’ (TOT), when the tape in introduced in the opposite direction to TVTO. These approaches were introduced due to perceived problems with bladder injuries, however, few comparative data were available at that time. Numerous uncontrolled studies have published outcomes on retropubic and transobturator tapes but there are few randomised studies. A systematic review of the literature identified eleven randomised controlled trials (RCT) containing 1261 women [22]. Meta-analysis of these compared TVT with TVT-O and TOT procedures and demonstrated that subjective cure rates at 2–12 months were the same for all procedures [22], and further, showed that bladder injuries were eight times more common and voiding difficulties were twice as common after TVT in comparison to TVTO or TOT [22]. Nevertheless, the incidence of groin or thigh pain was eight times more common and vaginal mesh erosion was twice as common after TVT-O or TOT [22]. This systematic review supported previous findings of randomised controlled trial (RCT) which compared TVT and TVT-O procedure and demonstrated the same cure rates but showed a high incidence of leg pain following TVTO (26.4% vs. 1.7%, p = 0.0001) [23]. Another study compared TVT-O with TOT and reported cure rates with no statistically difference between both procedures [24]. Recently single incision approaches have been introduced whereby the synthetic tape is inserted via a single vaginal incision. One retrospective, one prospective observational study and one RCT investigated the single incision procedures, which were compared with either TVT or TVT-O. None of the trials showed any clinical benefit of the single incision procedures in comparison with TVT or TVT-O and clearly demonstrated a significantly higher rate of persistent stress UI at 6 weeks (OR 9.49, 95% CI 2.8–32.6) and 6 months (OR 8.14, 95% CI 2.7–24.7), and stress UI at 6 months (OR 7.58, 95% CI 2.7–24.7) with single incision procedures in comparison with TVT [25–27]. The reason for the development of single incision approaches was to assess whether it would be associated with less risk of injury and faster recovery, but the evidence does not support this [25–27]. 4. Conclusion For the treatment of OAB and urgency UI, intra-vesical injections of onabotulinum toxin A utilising a flexible or rigid cystoscope have become an established treatment. An alternative is sacral nerve stimulation. Vaginal tape procedures have become the treatment of choice for stress UI. Based on current evidence, single incision tapes are not recommended. TVT and TVT-O/TOT seem comparable although there are differences in complications (bladder injury with TVT vs. leg pain with TVT-O/TOT). Individual clinicians should decide which to use based on expertise and experience, although, bladder injuries are probably less of an issue than leg pain. Bladder injuries almost invariably heal after short-term bladder draining with no sequelae, whereas leg pain can be chronic and quite debilitating. 5. Further research Currently, we have long term data for efficacy and safety of TVT procedures [28], but, long term data for TVT-O/TOT and single
241
incisions procedures are still lacking. Another controversy surrounds the use of urodynamic testing prior to surgical treatment for UI. Although two RCTs were trying to address this uncertainty [7,8], it is still unclear if urodynamic testing affects the outcome of the treatment for UI [6]. While the data for the effectiveness of onaBoNTA are compelling, there are fewer data on long-term outcomes. Limited data suggest repeat treatment is equally effective, but we do not yet know whether this is true indefinitely, nor what proportion of patients will require lifelong treatment. The short- and long-term cost effectiveness of onaBoNTA treatment is unknown. Contributors Dr Vladimir Revicky and Professor Douglas G. Tincello have written paper, reviewed literature, reviewed paper. Competing interest The authors declare no conflict of interest. Funding The authors have received no funding for this article. Provenance and peer review Commissioned and externally peer reviewed. References [1] Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourology and Urodynamics 2002;21(2):167–78. [2] Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT Study. Journal of Clinical Epidemiology 2000;53(11):1150–7. [3] Norton PA, MacDonald LD, Sedgwick PM, et al. Distress and delay associated with urinary incontinence, frequency, and urgency in women. British Medical Journal 1988;297(6657):1187–9. [4] Perry S, Shaw C, Assassa P, et al. An epidemiological study to establish the prevalence of urinary symptoms and felt need in the community: the Leicestershire MRC Incontinence Study. Leicestershire MRC Incontinence Study Team. Journal of Public Health Medicine 2000;22(3):427–34. [5] Martin JL, Williams KS, Abrahams KR, et al. Systematic review and evaluation of methods of assessing urinary incontinence. Health Technology Assessment 2006;10(6):1–132. [6] Murdoch M, McColl EM, Howel D, et al. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing. Trials 2011;12:169. [7] National Institute for Health and Care Excellence. Urinary incontinence in women: the management of urinary incontinence in women. London: National Institute for Health and Care Excellence; 2013. CG171. [8] Nager CW, Brubaker L, Litman HJ, et al. A randomized trial of urodynamic testing before stress-incontinence surgery. New England Journal of Medicine 2012;366:1987–97. [9] Van Leijsen SA, Kluivers KB, Mol BW, et al. Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourology and Urodynamics 2012;31:1118–23. [10] Dumoulin C, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women (Cochrane review). Cochrane Database of Systematic Reviews 2010;25(1):CD005654. [11] Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults (Cochrane review). Cochrane Database of Systematic Reviews 2009;1:CD001308. [12] Fantl JA, Wyman JF, McClish DK, et al. Efficacy of bladder training in older women with urinary inontinence. Journal of the American Medical Association 1991;265(5):609–13. [13] Finazzi-Agro E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. Journal of Urology 2010;184:2001–6.
242
V. Revicky, D.G. Tincello / Maturitas 77 (2014) 239–242
[14] Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. Journal of Urology 2010;183:1438–43. [15] Tincello DG, Kenyon S, Abrams KR, et al. Botulinum toxin A versus placebo for refractory detrusor overactivity in women: a randomised blinded placebo-controlled trial of 240 women (the RELAX study). European Urology 2012;62(3):49–68. [16] Denys P, Le NL, Ghout I, et al. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. European Urology 2012;61:520–9. [17] Nitti VW, Dmochowski R, Herschorn S, et al. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. Journal of Urology 2013;189:2186–93. [18] Chapple C, Sievert KD, MacDiarmid S, et al. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. European Urology 2013;64: 249–56. [19] Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. Journal of Urology 1999;162(2):352–7. [20] Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. International Urogynecology Journal and Pelvic Floor Dysfunction 1996;7(2):81–5.
[21] Ward K, Hilton P, UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG: An International Journal of Obstetrics & Gynaecology 2008;115:226–33. [22] Latthe P, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG: An International Journal of Obstetrics & Gynaecology 2007;114:522–31. [23] Teo R, Moran P, Mayne C, Tincello D. Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women. Journal of Urology 2011;185(4):1350–5. [24] Abdel-fattah M, Ramsay I, Pringle S, et al. Randomised prospective singleblinded study comparing ‘inside-out’ versus ‘outside-in’ transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG: An International Journal of Obstetrics & Gynaecology 2010;117:870–8. [25] Kennelly MJ, Moore R, Nguyen JN, Lukban J, Siegel S. Miniarc single-incision sling for treatment of stress urinary incontinence: 2-year clinical outcomes. International Urogynecology Journal 2012;23:1285–91. [26] Bernasconi F, Napolitano V, Natale F, Leone V, Lijoi D, Cervigni M. TVT SECUR System: final results of a prospective, observational, multicentric study. International Urogynecology Journal 2012;23:93–8. [27] Basu M, Duckett J. A randomised trial of a retropubic tension-free vaginal tape versus a mini-sling for stress incontinence. BJOG: An International Journal of Obstetrics & Gynaecology 2010;117(6):730–5. [28] Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstetrics & Gynecology 2004;104(6):1259–62.
![[Urogynecology II: urinary incontinence in men and women: surgical treatment of urinary incontinence and prolapse].](/assets/img/hold.png)
