Tape Fixation: An Important Surgical Step to Improve Success Rate of Anti-Incontinence Surgery

Tomasz Rechberger, Konrad Futyma,* Katarzyna Jankiewicz, Aneta Adamiak, Micha Bogusiewicz, Aleksandra Bartuzi, Pawe Miota, Pawe Skorupski and Jacek Tomaszewski
From the Second Department of Gynecology, Medical University of Lublin, Lublin, Poland

Abbreviations and Acronyms ISD intrinsic sphincter deciency ITT intent to treat IVS-04M intravaginal monolament sling MUS PVR SUI TVT mid urethral sling post-void residual urine stress urinary incontinence tension-free vaginal tape

Submitted for publication October 27, 2010. Study received local ethics committee approval. Supported by KBN Grant N407 309433. To view the accompanying video, please see the online version of this article (Volume 186, Number 1) at www.jurology.com. * Correspondence: ul. Jaczewskiego 8, 20-954 Lublin, Poland (telephone: 48 81 7244268; FAX: 48 81 7244849; e-mail: futymakonrad@mp.pl).

Purpose: Mid urethral slings are effective surgical treatment for stress urinary incontinence. However, 5% to 20% of patients still experience surgical failure with clinically signicant recurrent or persistent stress urinary incontinence. Since a subset of these failures may be caused by improper tape position, we elucidated whether additional paraurethral xation of a tape to prevent displacement during tensioning could improve the transobturator sling outcome. Materials and Methods: The study was done in 463 patients with stress urinary incontinence who were randomly allocated to treatment with a standard transobturator intravaginal monolament sling procedure (232) or to an intravaginal transobturator monolament sling with additional 2-point tape xation (231). Another 2 absorbable sutures parallel to the urethra were added to x the tape and prevent displacement during tape tensioning. Outcome was assessed by a cough test and a 1-hour pad test at 12 months. Results: Clinical efcacy of the procedure with xation was signicantly higher with 195 women (95.12%) cured or improved compared to the 199 (88.73%) cured or improved with the standard sling (chi-square 5.71, p 0.0169). There was no increase in intraoperative or postoperative complications. Also, among patients with intrinsic sphincter deciency we noted a signicantly better outcome in the xation group than in the control group, that is 39 of 41 patients (95.1%) cured or improved vs 31 of 42 (73.8%) (chi-square 10.65, p 0.0011). Conclusions: Tape xation signicantly increases the clinical efcacy of the transobturator sling, especially in patients with intrinsic sphincter deciency. Key Words: urethra; urinary incontinence, stress; suburethral slings; prostheses and implants; Poland IN 1995 Petros and Ulmsten introduced a new surgical technique based on integral theory called TVT, which revolutionized female SUI surgery due to its simplicity and high effectiveness.1 A short learning curve accompanied by high clinical efcacy are the underlying features of its current clinical usefulness and popularity.2,3 The attractiveness of this method for patients and physi0022-5347/11/1861-0180/0 THE JOURNAL OF UROLOGY 2011 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION

cians led to several modications of the original retropubic TVT procedure.4,5 In 2001 Delorme described the transobturator route for mid urethral tape placement, which further simplied surgery by avoiding the intrapelvic and retropubic passage of the needle, resulting in a markedly decreased complication rate.6 Despite the high success rate of the MUS (average 80% to 95%) a subset of
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patients remains refractory to this treatment. Several risk factors for tape failure are recognized, of which commonly cited factors are obesity, ISD, aging, previous anti-incontinence surgery, concurrent prolapse surgery, hypoestrogenism, preoperative anticholinergic use, neurological disorders and comorbidities typical of elderly individuals, such as hypertension, diabetes and dementia.79 Recently, poor surgical technique and tape placement too close to the bladder neck were noted as risk factors for mid urethral tape failure. Considering sling functionality, tape placement under the mid urethra seems to be essential for a favorable outcome regardless of the type of operation (retropubic or transobturator). The main mechanism of retropubic sling action relies on urethral angulation on a fulcrum created by the tape. For the transobturator sling, in which urethral angulation occurs in 24% to 50% of cured patients, continence is restored mainly as a result of urethral encroachment by the tape.10 Thus, from the theoretical point of view placing a tape under the middle section of the urethra is essential for surgery to be effective. Kociszewski et al noted that when a TVT was positioned between the 50th and 80th percentile of urethral length, as measured from the bladder neck, the cure rate exceeded 90% while a location outside this zone was associated with treatment failure in 36% of patients.11 Correspondingly the position of a transobturator tape under the proximal half of the urethra increases the failure risk 6-fold.10 In more than 70% of patients with recurrent SUI after receiving an MUS who were treated at our department the tape was located under the proximal part of the urethra.12 Although it is unclear whether the inappropriate tape position resulted from incorrect surgical technique, pelvic anatomical variability or tape slippage in the postoperative period, there is no doubt that appropriate placement of the tape under the mid urethra enables the highest success rate to be achieved. Since there is currently no denitive intraoperative method to ensure that the tape is positioned correctly, general principles should be kept in mind while performing the sling procedure, such as a short vaginal skin incision, proper preparation of the paraurethral space, creation of an adequate angle between the tape arms and tension-free placement. However, even when all of these surgical tips are strictly followed, unintended poor tape positioning is responsible for some MUS surgical failures. Thus, we elucidated whether additional periurethral tape xation to ensure its proper position would inuence the success rate of transobturator sling surgery.

MATERIALS AND METHODS

Consolidated Standards of Reporting Trials criteria were followed for the description of this trial,13 which was approved by the local ethics committee with a further appendix describing the new xation technique. We have used intravaginal slings to treat SUI since 1999. A total of 1,927 women underwent the MUS operation as of December 2009, of whom 705 received a retropubic sling and 1,222 received a transobturator sling.14 The current study was done in 463 patients from January 2007 to May 2009. Figure 1 shows participant ow through each stage of the trial. Women with genuine SUI, which was diagnosed based on gynecologic examination and urodynamics, were classied to undergo surgical treatment. All patients provided informed consent and fullled study inclusion criteria. Table 1 shows demographic data. Patients were randomly allocated to 2 groups in a 1:1 ratio, including group 1232 treated with the standard transobturator IVS-04M procedure and group 2231 treated with the transobturator IVS-04M procedure with additional 2-point tape xating sutures to prevent tape displacement (g. 2). Only monolament tapes were used. The number of patients with ISD, dened as Valsalva leak point pressure less than 60 cm H2O during urodynamics, did not differ signicantly between the treatment arms, that is 42 of 213 (19.7%) received an IVS-04M and 41 of 205 (20.0%) received an IVS-04M with xation (chi-square 0.1, p 0.75). SUI surgery was done according to instructions in the intravaginal sling obturator manual (Covidien). As a modication, 2 additional polyglactin No. 1 sutures were placed parallel to the urethra 0.5 cm laterally on each side of the mid urethra, and between 1.0 and 1.5 cm from the external urethral meatus. These 2 sutures

Figure 1. Participant ow through each stage of trial

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Table 1. Demographic parameters of all patients and those with ISD IVS-04 Overall: No. pts Mean SD age Mean SD parity Mean SD body mass index (kg/m2) ISD: No. pts Mean SD age Mean SD parity Mean SD body mass index (kg/m2) 213 55.8 2.6 28.9 IVS-04 205 54.8 2.6 28.2 Fixation p Value

11.3 1.1 6.7

9.8 1.2 3.8

0.4 0.76 0.2

41 63.3 2.9 28.9

11.0 1.1 4.8

42 60.1 2.8 28.3

6.4 1.0 3.2

0.75 0.71 0.67 0.5

xed the tape close to the urethral wall and prevented tape displacement during nal tape adjustment. Placing these 2 additional polyglactin sutures required approximately 1 minute. The tape was then adjusted by pulling its ends so that it was positioned at beneath the urethra without tension, so that a Kelly clamp could be inserted between urethra and tape. After vaginal skin closure the nal tape adjustment was made by pulling the ends of the tape, which caused a 1.0 cm backward movement of the urethra. Due to the xating sutures the urethra was not compressed. This simple modication does not markedly increase operative time or cost. Study followup visits were scheduled 1, 6 and 12 months postoperatively. The 1 and 6-month visits were scheduled to assess the healing process, ie tape erosion and urinary retention, and subjective efcacy. During these visits we did not perform the 1-hour pad test. The other reason for these visits was to monitor our patients to minimize the dropout rate. The nal efcacy of the 2 procedures was assessed objectively 12 months postoperatively by a cough test with the patient supine and standing with a comfortably full bladder, and by a standard 1-hour pad test. The pad test was performed as described previously.15 All women were given preweighed pads to be worn instead of the pads that they wore, if any. All were instructed to drink 500 ml plain water during 15 minutes. The following

30 minutes included walking and in the last 15 minutes the women were instructed to perform the standard International Continence Society provocation exercises16 in the examination room. The pad was then reweighed using a 0.1 gm sensitive 510-33 weight scale (Kern). All patients were instructed not to empty the bladder during the 1-hour period unless absolutely necessary. A pad gain of greater than 1 gm was considered a positive pad test. Patients were considered completely cured if they were free of all subjective SUI symptoms, and cough tests and a pad test were negative. The operation was considered as a failure if the patient still reported urine leakage during increases in intra-abdominal pressure, or cough tests or the pad test was positive. In the improved group the cough test was negative but patients still reported occasional urinary leakage or the pad test was negative but the increase in pad weight was less than 1 gm but not zero. Patients who did not attend the 12-month followup visit were interviewed by telephone and the Incontinence Severity Index questionnaire was used to assess treatment efcacy.17 It categorizes urinary incontinence, if any, into slight, moderate, severe and very severe. By the Incontinence Severity Index improvement was considered if the patient experienced only slight incontinence. Of the 45 patients who did not attend this visit 38 were interviewed by telephone. Of these patients 14 with IVS-04 answered the telephone, including 3 with failure, and 24 with IVS-04 plus xation answered the telephone, including 4 with failure. Four of us (KF, KJ, AB and PM) were involved in followup while blinded to the patient procedure. Statistical analysis was done with Statistica, version 8.0 (StatSoft) using the chi-square and t tests, as appropriate. All statistical tests were 2-sided with p 0.05 considered statistically signicant. Our calculations showed that the study groups should have at least 180 patients, assuming 75% power to calculate the clinical efcacy for the 2 procedures.18

RESULTS
At 12-month followup 418 patients were available for clinical evaluation, including 213 with IVS-04 and 205 with IVS-04 plus xation. Clinical effectiveness was estimated objectively by cough and pad tests. We noted a statistically signicant difference in clinical efcacy between these 2 procedures (table 2).
Table 2. Subjective and objective cure rates in study groups No. No Fixation Subjective cure Result: Cured/improved Failed Lost to followup Result: Cured/improved Failed Lost to followup 0.03 172/28 27 5 Objective cure 161/28 24 19 195/20 14 2 No. Fixation p Value

0.08 (ITT) 0.017

Figure 2. Tape xation with 2 polyglactin (Vicryl) sutures

175/20 10 26

0.4 (ITT)

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ITT analysis revealed that surgical procedure with additional xation sutures was not more efcient for SUI treatment. Of patients with ISD a significantly better outcome was observed in the xation group. Since all patients with ISD were evaluated objectively and subjectively, ITT analysis was not needed in this subgroup. In the no xation vs the xation group 31 of 42 vs 39 of 41 patients were cured (p 0.001) and 11 vs 2 experienced failure (ITT p 0.001). No serious complication during surgery, including heavy bleeding, occurred in either study group. In the IVS-04 group an intraoperative bladder injury occurred in 4 women (1.87%) and in the IVS-04 with xation it occurred in 3 (1.46%). In each case the bladder wall was sutured, the sling was placed as planned and a Foley catheter was left for 4 days. We noted no stula or vaginal wall erosion during followup. PVR was routinely assessed on postoperative day 1. The rate of signicant PVR, dened as more than 50 ml urine after micturition, was 3.8% in the IVS-04 group vs 4.0% in the IVS-04 with xation group, which was not statistically signicant. When PVR was greater than 100 ml, reversible inhibitors of acetylcholinesterase were administered until efcient voiding was established, usually at 2 to 3 days. When PVR was greater than 300 ml on postoperative day 1, the tape was slightly pulled down by a Hegar dilator covered by 1% lidocaine gel. In all cases proper voiding resumed within 5 to 6 days.

DISCUSSION
Considering that around 4% of women undergo surgery for SUI in their lifetime, this type of operation represents one of the most common indications for surgery in females.19 In the last 15 years remarkable changes in urogynecologic clinical practice have been observed in surgical treatment for female SUI. Colposuspension and autologous slings have been almost abandoned, mainly in favor of MUS.20 Several systematic reviews have conrmed the high efcacy of MUS, although 5% to 20% of treated patients experience surgical failure with persistent or recurrent incontinence.21 Thus, any improvement in the nal success rate after anti-incontinence surgery is important not only from the clinical but also the economical viewpoint. According to the most recent data on MUS efcacy the treatment success rate is around 80% for retropubic and transobturator slings.2123 Identifying unintended tape misplacement as a risk factor for treatment failure would allow surgeons to modify the approach to improve the outcome in individuals. Female urethral stability is provided by the supportive mechanism composed of the anterior vaginal

wall, endopelvic fascia, and pubovesical and pubourethral ligaments plus their attachments to the arcus tendineus fascia pelvis and levator muscle. Increased intra-abdominal pressure in continent women results in distal urethral closure by forward stretching of the distal vagina by the pubococcygeus muscle and backward stretching of the proximal urethra around a competent pubo-urethral ligament.24 The dysfunctional support allows urethral hypermobility and, as a consequence, urine leakage. Thus, we believe that improper tape positioning is responsible for MUS failure in SUI treatment. The introduction of simple surgical modication during MUS procedure ensures proper tape positioning and eliminates an important risk factor for failure. Several groups analyzed clinical predictors of treatment failure after MUS procedures but few addressed tape positioning as a considerable risk factor. There is no doubt that identifying risk factors for failure could improve the nal outcome of the MUS procedure, especially when a risk factor is easily preventable. By introducing an additional 2 resorbable sutures we can easily prevent tape slippage toward the bladder neck, increasing the probability of success. The strength of our study is that data were collected at a single center, ruling out variations in diagnostic assessment or surgical technique. Also, this study included only patients who did not undergo a concomitant surgical procedures due to prolapse since currently there is no agreement on how such surgery inuences the outcome of an anti-incontinence procedure.8 Since all patients were followed by urogynecologists from the same center, wide variation in interpretation of the outcome was unlikely. A major study limitation was that approximately 10% of patients were lost to followup with cough and pad tests after 12 months and, thus, could not be included in the nal analysis. To clarify this point we performed ITT analysis, which showed no statistical signicance in efcacy between the study groups. However, data obtained by telephone interview with patients who could not attend the 12month followup visit did not support the approach that treatment should be considered to have failed in all. In fact, most of these women remained dry after surgery, although treatment failed in 3 in the IVS-04 group and in 4 in the IVS-04 plus xation group. Therefore, we believe that ITT calculation does not reect the exact results of our study. In conclusion, tape xation is a simple surgical maneuver that seems to improve transobturator sling effectiveness, especially in patients with ISD, and does not markedly increase procedure duration or cost.

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