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Year : 2012  |  Volume : 28  |  Issue : 1  |  Page : 111-112
 

Less pain is no gain: Is minimal invasive tension-free vaginal tape-Secur effective in the treatment of women with stress urinary incontinence?


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Date of Web Publication12-Apr-2012

Correspondence Address:
Arun Chawla
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How to cite this article:
Chawla A. Less pain is no gain: Is minimal invasive tension-free vaginal tape-Secur effective in the treatment of women with stress urinary incontinence?. Indian J Urol 2012;28:111-2

How to cite this URL:
Chawla A. Less pain is no gain: Is minimal invasive tension-free vaginal tape-Secur effective in the treatment of women with stress urinary incontinence?. Indian J Urol [serial online] 2012 [cited 2019 Oct 18];28:111-2. Available from: http://www.indianjurol.com/text.asp?2012/28/1/111/94972

Hinoul P, Vervest HA, den Boon J, Venema PL, Lakeman MM, Milani AL, et al. A Randomized, Controlled Trial Comparing an Innovative Single Incision Sling With an Established Transobturator Sling to Treat Female Stress Urinary Incontinence. J Urol 2011;185:1356-62.



   Summary Top


There has been significant evolution in the treatment of stress urinary incontinence (SUI). Prior to the mid-urethral tapes, options of transvaginal needle suspension, Burch colposuspension, and the autologous facial slings were available. A minimally invasive sling using polypropylene tension-free vaginal tape (TVT) was introduced in 1996. Since then, several attempts have been made to make this procedure even less invasive. The first major adjustment, the trans-obturator approach, appears to have good long-term results, with comparative trials showing fairly equivalent efficacy between the retropubic and transobturator approaches. The most recent modification is a transvaginal single-incision sling using polypropylene tape.

Hinoul and colleagues in a multi-institutional study, prospectively compared the efficacy of the Gynecare TVT™ Obturator (TVT-O) sling with single-incision Gynecare TVT Secur™ sling in 194 randomly assigned patients. The authors excluded patients with a prior failed repair for SUI, prolapse of stage II or more, and those requiring concomitant surgery, from their study. The primary outcome was defined as 12-month objective SUI cure rate, determined using a standing cough stress test at a bladder volume of 300 mL or a volume greater than 70% of the maximum bladder capacity based on the patient's bladder diary. Secondary outcome measures included subjective evaluation of voiding and SUI, visual analog scale (VAS) pain scores, and quality-of-life outcomes using the Dutch version of the Urogenital Distress Inventory (UDI). In this study, authors found that objective SUI cure rates were higher with TVT-O at both 6 and 12 months. At 6 months, SUI was identified in 24.4% of TVT Secur patients compared with none of the TVT-O patients (P < 0.0001) and at 12 months, SUI was identified in 16.4% of TVT Secur patients compared with 2.4% of TVT-O patients (P = 0.002). A similar observation was seen with subjective SUI outcomes at 24 months, with 24% of TVT Secur patients complaining of SUI vs 8.3% of TVT-O patients. De-novo urgency and/or urge incontinence at 12 months were noted in 23% of TVT Secur patients and 16.7% of TVT-O patients, which was not statistically significant. Anticholinergic treatment was given for 12 TVT Secur and 14 TVT-O patients during the first 12 months after surgery. A significantly greater improvement in the urinary incontinence subscale of the UDI was noted in TVT-O patients compared with TVT Secur patients. The authors observed less pain with TVT Secur, with patients having a lower VAS pain score the first 2 weeks after surgery (but not thereafter), and less need for analgesics the first 5 days after surgery (but not thereafter). Mesh exposures were noted in 7 of 96 TVT Secur patients, all of which required surgical closure as compared to one in TVT-O group, in which mesh exposure resolved with local estrogen therapy. In TVT-O group, 92% were available for follow-up at 12 months compared with 65% only in the TVT Secur arm. At the end of one year, 8 patients in TVT Secur group had retreatment with another procedure (type not specified) and 6 patients of TVT Secur arm awaiting next procedure for unresolved SUI. Two patients in the TVT-O arm underwent tape release for persistent voiding symptoms.


   Comments Top


The placement of synthetic, minimally invasive midurethral tape slings has become the most commonly used procedure to treat patients who experience bothersome SUI. Constant efforts are being made to make this surgery minimally invasive; from the "less invasive" procedures like retropubic TVT to even "lesser invasive" procedures like transobturator TOT. The most recent TVT Secur is a transvaginal single-incision sling using polypropylene tape. The principal idea of TVT Secur was to introduce a midurethral sling from single incision without passing the retropubic space or the obturator foramen. It utilizes a tape of shorter length, which is anchored directly to retropubic fascia (U-type) or Obturator internus muscle (H-type). [1] Minimal dissection, less amount of synthetic material, no exit point contributes to less pain and probably fewer complications. [1] Short term success rates of TVT-Secur have been reported to be low in various studies. [2],[3] Significantly lower short term cure rates has been observed by Andrada et al in his prospective study of 123 patients randomized for TVT and TVT Secur. [4] They reported three major complications with TVT Secur, a) injury to corona mortis, which required immediate surgical re-intervention, b) tape erosion into the urethra in spite of normal per-operative cystoscopy, c) severe urgency and bacteriuria soon after surgery with cystoscopy showing one end of TVT- Secur sling inside the bladder at one side. Because these complications coupled with poor outcomes, further enrollment in their study was stopped after interim analysis. Oliveira in his meta-analysis of sixteen studies of single incision slings and others (4 of them being comparative studies) with minimum of 6 months follow-up, observed that in two comparative studies single incision sling was as effective as a trans-obturator comparator and in other two, single incision slings had worse outcomes. The study concluded that a clear statement in favour of use of single incision slings cannot be made and TVT Secur does not seem appropriate as first line management of women with SUI. [5]

Hinoul et al in their study concludes that TVT Secur is less effective than TVT-O. Though TVT Secur is less invasive, associated with decreased pain and discomfort, tradeoffs include unresolved SUI needing retreatment, more peri-operative blood loss and higher risk of mesh extrusion. The authors analyze various factors contributing to lower successful outcomes with TVT Secur; (a) guideless variable trajectory in TVT Secur, (b) decreased tape length and probably not good fixation, (c) increased tape mobility in postoperative period because of wider dissection and hence more space available for tape to move, (d) decreased tape fixation associated with greater mobility and activity because of less postoperative pain, and (e) experience of surgeon probably not being enough.

Randomized, controlled, multicentric design of prospective fashion adds to the strength of this study. But higher loss of patients in follow-up of TVT Secur forms the main limitation of this study (92% of TVT-O Vs 65% TVT Secur at follow-up of one year). Lower success rates and higher incidence of mesh extrusion in TVT Secur group indicates variable technique and experience amongst the surgeons. Though surgeon had experience before putting TVT Secur in study patients, lack of standardized placement and tensioning technique is probably a limiting factor in these patients. The study is also limited by short term data of only one year. Authors fail to explain about reported higher incidence (though statistically insignificant) of de-novo urgency in TVT Secur than TOT group in their study.

The study suggests in the treatment of SUI, attempts are being made to make the minimal invasive slings to micro-invasive. Lesser pain in TVT Secur does not offer enough gain in terms of efficacy. Newer minimal invasive slings may not match the efficacy of the older ones, and hence lose its significance in options of surgical management. More long term data and identifying the suitable patients ideal for these procedures is needed.

 
   References Top

1.Liapis A, Bakas P, Creatsas G. Comparison of the TVT SECUR System "hammock" and "U" tape positions for management of stress urinary incontinence. Int J Gynaecol Obstet 2010;111:233-6.  Back to cited text no. 1
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2.Cornu JN, Sèbe P, Peyrat L, Ciofu C, Cussenot O, Haab F. Midterm prospective evaluation of TVT-Secur reveals high failure rate. Eur Urol 2010;58:157-61.  Back to cited text no. 2
    
3.Kennelly MJ, Moore R, Nguyen JN, Lukban JC, Siegel S. Prospective evaluation of a single incision sling for stress urinary incontinence. J Urol 2010;184:604-9.   Back to cited text no. 3
[PUBMED]  [FULLTEXT]  
4.Andrada HM, Larsson PG, Teleman P, Etén-Bergqvist C, Persson J. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur. Int Urogynecol J Pelvic Floor Dysfunct 2011;22:781-7.  Back to cited text no. 4
    
5.Oliveira R, Silva C, Dinis P, Cruz F. Suburethral single incision slings in the treatment of female stress urinary incontinence: What is the evidence for using them in 2010? Arch Esp Urol 2011;64:339-46.  Back to cited text no. 5
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