Department of Obstetrics and Gynecology, Istanbul Bakirkoy Women and Childrens Hospital, İstanbul, Turkey

Transcription

1 Acta Obstetricia et Gynecologica. 2009; 88: ORIGINAL ARTICLE Which type of mid-urethral sling procedure should be chosen for treatment of stress urinary incontinance with intrinsic sphincter deficiency? Tension-free vaginal tape or transobturator tape KEMAL GÜNGÖRDÜK, IBRAHIM CELEBI, CEMAL ARK, OZGU CELIKKOL & GOKHAN YILDIRIM Department of Obstetrics and Gynecology, Istanbul Bakirkoy Women and Childrens Hospital, İstanbul, Turkey Abstract Objective. To compare tension-free vaginal tape (TVT) and transobturator tape (TOT) for surgical treatment of stress urinary incontinence (SUI) with intrinsic sphincter deficiency. Design. Retrospective study. Setting. Gynecology department, Bakirkoy Women and Childrens Hospital, Istanbul. Sample. Three hundred women urodynamically diagnosed with stress incontinence with intrinsic sphincter deficiency underwent synthetic mid-urethral sling procedures (TVT180, TOT 120). Methods. Before the operation, a complete medical history was taken and a gynecologic examination was performed. Subjects with detrusor overactivity or previous sling surgery were excluded. Clinical checkups were conducted at 3, 6, and 12 months, and then annually. Main outcome measures. Intraoperative complications, postoperative complications, and subjective cure rates. Results. There were no significant differences in demographics between the TVT and TOT groups: mean age, parity, body mass index, menopausal status, and hormone replacement therapy. At a mean follow-up of (range 1246) months, the overall cure rates were 78.3% for TVT and 52.5% TOT (pb0.0001). The risk of treatment failure in women who received TOT was 4.9 times higher than in women who underwent TVT. There were no significant differences in perioperative and postoperative complication rates between the two groups. Conclusion. TVTappears to be the preferable surgical option for the treatment of SUI with intrinsic sphincter deficiency. Key words: Tension-free vaginal tape, transobturator tape, intrinsic sphincter deficiency, stress urinary incontinence Introduction Stress urinary incontinence (SUI) is the complaint of involuntary leakage of urine on effort or exertion, or on sneezing or coughing. This bothersome symptom is experienced by a significant number of women and has a dramatic effect on quality of life. The reported prevalence of SUI is variable, but several studies suggest that it may be as high as one in four adult women (1). SUI can develop through two mechanisms: hypermobility or significant displacement of the urethra and bladder neck during exertion and intrinsic sphincter deficiency. These conditions can co-exist in women (1). Many different surgical procedures (colposuspension, traditional slings, and injectables) are commonly used, but these procedures are associated with significant morbidity and resource use or low success rates (2,3). Tension-free vaginal tape (TVT) is a standard minimally invasive procedure used to treat urinary stress incontinence since 1995 when it was first described by Ulmsten (4). Because it is a simple technique with a good outcome, the TVT procedure is becoming more popular. However, there are rare but significant intraoperative complications which may result in considerable morbidity, such as bladder perforation, bowel, and major vascular injuries (58). Consistent with the spirit of improving procedural safety, recent modifications in the method of placement of the tension-free mid-urethral sling have taken place. To avoid blind passage of introducers into the retropubic space, a unique approach using the obturator foramina has been developed. Correspondence: Kemal Güngördük, Kartaltepe Mah. Bıtısıkbaglarorta Sok., No: 13/5 Bakırköy, İstanbul, Türkey. maidenkemal@yahoo.com (Received 5 March 2009; accepted 6 May 2009) ISSN print/issn online # 2009 Informa UK Ltd. (Informa Healthcare, Taylor & Francis AS) DOI: /

2 Treatment of stress urinary incontinance with intrinsic sphincter deficiency 921 In 2001, Delorme described the transobturator tape (TOT) mid-urethral sling (9). Like the TVT, this is a minimally invasive mid-urethral sling using a synthetic tape, but it is placed using a transobturator approach rather than a retropubic one. The transobturator technique has been advocated because it avoids this retropubic passage and, at least in theory, should reduce the risk of bladder, bowel, and iliac vessel injury. Also it has been shown to have similar efficacy and safety to TVT in retrospective series and meta-analyses (10,11). In intrinsic sphincter deficiency, the urethral closure mechanism is considered to function poorly, possibly due to aging, previous surgery, or a neurological etiology. Clinically, women with intrinsic sphincter deficiency have more severe incontinence and a lower surgical success rate than women with stress incontinence and normal urethral function (12). Until now, there have been few studies to compare the treatment outcomes of TVT and TOT procedures of women with intrinsic sphincter deficiency. However, all of these studies describe short-term outcomes (13,14). In this study, we report our four-year experince of TVT and TOT technique for treating women with intrinsic sphincter deficiency. Material and methods The study was retrospectively conducted on 300 patients diagnosed with SUI and with intrinsic sphincter deficiency and who underwent incontinence surgery (TVT 180; TOT 120) from January 2005 to January The ethics committee approved the study. Inclusion criteria included women with SUI who had unsuccessful conservative therapy and, on urodynamic assessment, a diagnosis of intrinsic sphincter deficiency with no contraindications to vaginal surgery. All the women signed informed consent. Exclusion criteria included detrusor overactivity, symptoms of overactive bladder, urinary retention, previous anti-incontinence surgery, neurologic bladder, women with anticoagulant or antipsychotic treatment, and pregnant women. Women with a moderate degree of pelvic organ prolapse were included. All participants were assessed with standard history taking, physical examination including evaluation of the presence of pelvic organ prolapse (using pelvic organ prolapse-quantification staging system), cotton swab test (Q-Tip test), stress test (cough provocation), urinalysis, urine culture, and urodynamic evaluations. A standard questionnaire included age, parity, body mass index, underlying co-morbidity, previous hysterectomy and anti-incontinence surgery history, menopausal, and hormone replacement status. SUI was diagnosed according to the result of urodynamic tests, i.e. involuntary loss of urine when the intravesical pressure exceeds intraurethral pressure in the absence of detrusor contraction. Urodynamic studies (Dantec-5000, Copenhagen, Denmark) included uroflowmetry, multichannel cystometry, Valsalva leak-point pressure, and urethral pressure profilometry. Valsalva leak-point pressures were determined with bladder volumes of 200 ml and 7-Fr catheter. Urethral pressure profilometry was performed with a 7-Fr catheter fitted with a transducer (intra-abdominal pressure was measured transvaginally). The diagnosis of intrinsic sphincter deficiency was based on the measurements of the resting maximum urethral pressure profile and/or the abdominal leakpoint pressure with Valsalva maneuver and/or cough. Intrinsic sphincter deficiency was defined as Valsalva leak-point pressure less than 60 cm H 2 O or maximal urethral closure pressure less than 20 cm H 2 O (14). The TVT procedures were performed in accordance with the technique by Ulmsten (15). Under general anesthesia, the patient was positioned in the dorsal lithotomy position. The sites of the suprapubic stab incisions were located along the superior rim of the pubic bone, two fingerbreadths lateral to the midline, each 0.51 cm in length. The bladder was drained with a Foley catheter and a 1.5 midline incision was made at the mid-urethra. Metzenbaum scissors were used to dissect under the vaginal epithelium laterally to create a periurethral spaces to the inferior pubic ramus. Once the periurethral spaces were ready, a special prolene tape (Ethicon Inc, Sommerville, New Jersey, USA) covered by a plastic sheath was introduced using a two-component needle instrument. The tip of this needle first perforates the urogenital diaphragm, and is then moved upwards within the retropubic space (keeping the tip close to the pubic bone). After perforation of the rectus sheath, a small 1 cm incision is made over the needle point in the skin just above the superior rim of the pubic bone. Cystoscopy (70-degree lens) with the needle in place was preformed to rule out bladder penetration. This procedure is then repeated on the other side with the other needle, ensuring that the skin incisions are B5 cm apart. The tape is therefore placed in a U-form shape around the midurethra. During this step, a Metzenbaum scissors are placed between the urethra and the tape to prevent an increase in the tension of the tape. The vaginal incision was closed with absorbable suture. The remaining sling mesh was cut off at the abdominal skin. The Foley catheter was then replaced.

3 922 K. Güngördük et al. The TOT (Safyre TM, Promedon) procedures were performed in accordance with the technique by Delorme (9). Under general anesthesia, the patient was positioned in the dorsal lithotomy position. A 15-mm incision was made on the anterior vaginal wall over the mid-urethra. The dissection continued laterally until the index finger came in contact with internal surface of the ischiopubic bone and obturator foramen. A horizontal line was drawn from the level of clitoris to the inguinofemoral sulcus on both sides. A 5-mm vertical incision was made where the line crossed the sulcus. A curved device was introduced from this incision through the superficial aponeurosis and obturator foramen with guidance by the index finger on each side. The silicone arm of the polypropylene mesh was then attached to the tip of the device and the device withdrawn pulling the sling with it. The method was an outside to inside method. The same procedure was performed on the contralateral side. The mesh was placed underneath the urethra without any tension. No cystoscopy was performed during this procedure. All TVT and TOT procedures were performed by the same surgical team. Single-dose antibiotic prophylaxis was used intraoperatively. No additional doses of antibiotics were administered unless an infection or an intraoperative complication (such as bladder perforation) was present. The urinary catheter was removed 1224 hours after surgery. Some patients also underwent various other vaginal reconstructive procedures including vaginal hysterectomy, anterior and posterior colporrhaphy, vaginal vault suspension, and enterocele repair. In these patients urinary catheter was removed 2436 hours after surgery. Perioperative complications, operative time, pain scores, estimated blood loss, febrile morbidity, and length of hospital stay were recorded in all patients. The operative time was calculated from the first incision to the end of wound closure. Blood loss was estimated by summation of the blood volume aspirated and the weight difference of the gauze used before and after surgery. If a blood transfusion was performed, the number of transfused blood was recorded. Pain was evaluated using the Visual Analog Scoring (VAS) system: 0 no pain, 2mild pain, 5moderate pain, 7 severe pain, 10 excruciating (16). In our hospital, VAS is recorded every six hours by the nursing staff. The highest visual analog score on postoperative day 0 and postoperative day 1 was used. Patients were discharged when the residual urine volume was B50 ml and were reevaluated two weeks after the intervention as well as 3, 6, and 12 months postoperatively, and annually thereafter. Postoperative complications such as urinary retention, de novo urgency, dysuria, recurrent infection, and vaginal mesh erosion were recorded at this time. The surgeon performed a clinical examination (sling palpation and vaginal erosion) and a cough stress test. During the cough stess test, patients were placed in the supine position and their bladders filled up to 300 ml. They were asked to cough, and a leakage was considered a positive response. A follow-up urodynamic study was not routinely performed but was done if indicated by urinary symptoms. Treatment outcome was assessed in the aspect of overall complication and cure rates. Cure was defined as an absent subjective complaint of leakage and absent objective leakage on a cough stress test (cure/dry). Short-term voiding dysfunction was defined as incomplete bladder emptying that occurred within the first six weeks after surgery. Prolonged voiding dysfunction was defined as intermittent self-catheterization after six weeks postoperatively. A subset of women with short-term voiding dysfunction underwent urethral dilation in the hope of loosening the tension of the sling. This was performed anywhere from two days to six weeks postoperatively. Patients who continued to require self-catheterization beyond six weeks were ultimately offered a takedown or cutting of the tape with the understanding that they could develop recurrent stress incontinence. De novo urgency was defined as a sudden compelling desire to pass urine, which was difficult to defer and urge incontinence was defined as involuntary leakage accompanied by or immediately preceded by urgency. Statistical analysis was carried out using Med Calc 9.3 program. The data were summarized as the mean9sd or the percentage according to the variables. Chi-squared, Fisher-exact and Student s t-tests, KaplanMeier survival analysis, and Cox proportional hazard regression were applied. Relative risk (RR) with 95% confidence interval (CI) was calculated. A p-value of B0.05 was considered significant. Results We studied 180 patients in the TVT group and 120 patients in the TOT group. No patients were lost at follow-up. Mean follow-up was months (range 1245) in the TVT group and months (range 1346) in the TOT group. There was no significant difference in the preoperative characteristics of patients who underwent TVT or TOT (Table I). Mean operative time and estimated blood

4 Treatment of stress urinary incontinance with intrinsic sphincter deficiency 923 Table I. Patient characteristics for the TVT and TOT groups. TVT (n180) TOT (n120) p-value Age a (year) Parity a Body mass index a (kg/m 2 ) Postmenopausal state 85 (47.2%) 65 (54.2%) 0.28 (n,%) Hormone replacement 40 (47.1%) 28 (43.1%) 0.74 therapy (n,%) Prior hysterectomy (n,%) 12 (6.7%) 7 (5.8%) 0.06 Concomitant prolapse 30 (16.7%) 17 (14.2%) 0.63 surgery (n,%) Vaginal hysterectomy 13 6 Anterior colporrhaphy 3 2 Posterior colporrhaphy 2 1 AnteriorPosterior colporrhaphy 12 8 a Data are expressed as mean9standard deviation. Note: TVT, tension-free vaginal tape; TOT, transobturator tape. loss did not differ significantly between the two groups (Table II). The complication rate was 18.9% in the TVT group and 15.8% in the TOT group (RR 0.8, 95% CI ; p 0.53). No major nerve or vessel injury occurred in both groups but four women (2.2%) in the TVT group incurred bladder injury during surgery, which was managed with an indwelling urinary catheter for 37 days. De novo urgency occurred in eight women (4.4%) in the TVT group and five (4.2%) in the TOT group (RR 1.1, 95% CI ; p1.00). There was no difference in the incidence of short-term voiding problems between the two groups (6.7% in the TVT group and 5.0% in the TOT group; RR 0.7, 95% CI ; p 0.81). In the TVT group, three patients had a voiding problem that lasted longer than six weeks. Of these three patients, one had her TVT released and the other two continued with intermittent self-catheterization for two months. The patient who had the tape released did not have recurrence of stress incontinence. In the TOT group, one patient needed clean intermittent selfcatheterization for two months. There was no significant difference for prolonged voiding dysfunction between groups at each follow-up visit (RR 0.4, 95% CI ; p 0.65). During long-term follow-up, mesh erosions developed in four women (2.2%) who received TVT and in three (2.5%) who received a TOT (RR 2.0, 95% CI ; p 1.00). All patients were diagnosed with vaginal erosion associated with leucorrhea. After conservative treatment with local estrogen applications had failed, the mesh had to be completely removed in two patients who received TVT. Only one had recurrence of their SUI. Twelve months after the operations, the cumulative cure rates of TVT and TOT were 93.9 and Table II. Hospital data and intraoperative and postoperative complications. TVT (n180) TOT (n120) p-value Relative risk (95% CI) Operating time a (m) (range) (1474) (1570) 0.01 Estimated blood loss a (ml) (range) (30230) (30210) 0.62 Postoperative hospital stay a (day) (range) (214) (24) 0.25 Pain (day 0) a (range) (08) (08) 0.59 Pain (day 1) a (range) (05) (04) 0.76 Blood transfusion (n) (%) Operative complications (n) (%) Bladder injury 4 (2.2) 0.15 Bowel injury Ureteral injury Major vesel injury Vaginal perforation Retropubic hematoma Obturatuar hematoma Neurologic injury Postoperative complications (n) (%) Recurrent urinary tract infection 4 (2.2) 2 (1.7) (0.14.1) De novo urgency 8 (4.4) 6 (5.0) (0.33.3) Short-term voiding dysfunction 12 (6.7) 6 (5.0) (0.22.0) Long-term voiding dysfunction 3 (1.7) 1 (0.8) ( ) Mesh erosion 3 (1.7) 4 (3.3%) (0.49.2) a Data are expressed as mean9standard deviation. Note: TVT, tension-free vaginal tape; TOT: transobturator tape.

5 924 K. Güngördük et al. 82.5%, respectively (p 0.002). Cox proportional hazard regression revealed that the risk of treatment failure in women who underwent TVT was different compared to those who received TOT (hazard ratio, 4.926; p0.0003). The four-year cumulative cure rates of TVT and TOT were 78.3 and 52.5%, respectively (RR 3.2, 95% CI ; p B0.0001) (Figure 1). Discussion The goal of treatment for intrinsic sphincteric deficiency is to correct incontinence without creating outlet obstruction. Historically, pubovaginal slings have been the procedure of choice. The cure rates in women undergoing pubovaginal sling procedures for intrinsic sphincter deficiency have been reported to be 5084% (17,18). However, because of complications such as longer convalescence and postoperative voiding dysfunction, pubovaginal slings are not popularly used now, but mid-urethral sling procedures are preferably adopted (1921). In our opinion, the important question is which type of mid-urethral sling procedure to choose. Rezapour et al. reported an absolute cure rate of 74% in a long-term follow-up of 49 patients with intrinsic sphinter deficiency (22). A similar result was observed by Lipias et al., where 37 patients with SUI and low urethral closure pressure underwent TVT. They reported a complete cure rate of 73%, while had 9% a considerable improvement (23). Soulié et al. reported a cure rate of 83%, with 17% reporting significant improvements in a group of 52 women of whom 27 had urodynamically confirmed intrinsic sphincter deficiency (24). Figure 1. Overall cure rates. Note: : tension-free vaginal tape, : transobturator tape. TVT has a higher rate of lower urinary tract injury and voiding dysfunction when compared with TOT (25,26). Is it possible to avoid these complications by using TOT in a patient with intrinsic sphinter deficiency? In 2007, Popovic et al. reported that 61 patients with a low-urethral closure pressure were treated for SUI using the transobturator route. The short-term (612 month) cure rate was 70% (25). But there are four reports suggesting that the transobturator route of tape placement is associated with a lower success rate than the retropubic route in women with a low-pressure urethra (13,14,26,27). Likewise, our study demonstrated that the TVT group had a higher cure rate than the TOT group. We also found that the risk of treatment failure in women who received TOT was 4.9 times higher than in those who had a TVT procedure. Recent studies suggest that cure rates of the TOT procedure are comparable to TVT in the short term (B1 year) in women with non-intrinsic sphincter deficiency (28,29). Why does the TOT procedure have a lower success rate than the TVT procedure in women with a low-pressure urethra? The mechanisms responsible for the effectiveness of the TVT and TOT procedures for urinary incontinence are not clearly understood. The pubourethral ligament, together with the continuity of the endopelvic fascia, anterior vaginal wall, arcus tendineus of the pelvic fascia and levator ani, form the hammock-like structure against which the urethra is compressed to achieve continence (30). Reinforcing the pubourethral ligament, which is believed to be one of the most important features of mid-urethral support, is proposed as a possible mechanism for the success of the mid-urethral procedure (31). Therefore, a possible explanation for the findings of increased urethral closure pressure area and continence area in the TVT procedure is that the tape in the TOT procedure was located in the transverse horizontal position, unlike the tape in the TVT procedure, which having a U-shape suspensory segment and a narrower mean angle under the urethra at rest, provides more circumferential compression of the urethra and more of an increase in urethral pressure. Hsiao et al. compared the postoperative urodynamic changes in patients with urodynamic stres incontinence who underwent TVT or TOT procedures. In this study it was demonstrated that the TVT procedure resulted in a higher cure rate with a significantly increased urethral closure pressure and continence area compared to the TOT procedure 12 months postoperatively (32). We recorded an overall complication rate of 18% (TVT: 34/ %; TOT: 19/ %). Obstructive voiding dysfunction is recognized as

6 Treatment of stress urinary incontinance with intrinsic sphincter deficiency 925 the most common reported complication of TVT sling placement (1750%) (33). This only occurred in 4.8% of TOT patients compared to 10.9% for TVT in the Schierlitz et al. series (12). In our study, short-term voiding dysfunction occurred in 6.7% of the TVT and 5.0% of the TOT group, and longterm voiding dysfunction occurred in 1.7% of the TVT and one woman in the TOT group. De novo urge symptoms have been a problem with the traditional incontinence operation (13). The frequency of de novo urgency in our study in both groups was: 4.4% in the TVT and 4.2% in the TOT group, respectively. Bladder perforation is a relatively common occurrence during sling placement, especially in the TVT procedures (13,14,1921), but occurred in only four patients in the TVT group. A potential limitation of this study is its retrospective nature and different numbers of patients in each group. Despite these limitations; the large sample size, long-term follow-up, similar demographic variables in the study population and performance of surgery in a single institution by the same surgical team which probably increases the validity, mitigate the weaknesses. TVT appears to be the preferable surgical option for the treatment of SUI with intrinsic sphincter deficiency. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. References 1. Atherton MJ, Stanton SL. The tension-free vaginal tape reviewed: an evidence-based review from inception to current status. BJOG. 2005;/112:/ Downs S, Black N. Systematic review of the literature on the effectiveness of surgery for stress incontinence in women. Report no. 21. London: Department of Public Health & Policy Publications, London School of Hygiene & Tropical Medicine; Lapitan MC, Cody DJ. 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7 926 K. Güngördük et al. 24. Soulié M, Cuvillier X, Benaïssa A, Mouly P, Larroque JM, Bernstein J, et al. The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study. Eur Urol. 2001; 39: 70914; discussion Popovic I, de Tayrac R, Demaria F, Foulot H, Poncelet C, Madelenat P. Efficiency of the transobturator suburethral tape in the treatment of 61 patients presenting intrinsic sphincter deficiency [in French]. Gynecol Obstet Fertil. 2007;/35:/ Miller JJ, Botros SM, Akl MN, Aschkenazi SO, Beaumont JL, Goldberg RP, et al. Is transobturator tape as effective as tension-free vaginal tape in patients with borderline maximum urethral closure pressure? Am J Obstet Gynecol. 2006;/195:/ Guerette NL, Bena JF, Davila GW. Transobturator slings for stress incontinence: using urodynamic parameters to predict outcomes. Int Urogynecol J Pelvic Floor Dysfunct. 2008;/19:/ Araco F, Gravante G, Sorge R, Overton J, De Vita D, Sesti F, et al. TVT-O vs TVT: a randomized trial in patients with different degrees of urinary stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008; 19: (Epub January 24, 2008). 29. Marzio AZ, Francesco P, Marco C, Elettra M, Innocenza P, Filippo B, et al. One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial. Eur Urol. 2007;/51:/ DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994;/170:/ Lin LY, Sheu BC, Lin HH. Sequential assessment of urodynamic findings before and after tension-free vaginal tape (TVT) operation for female genuine stress incontinence. Eur Urol. 2004;/45:/ Hsiao SM, Chang TC, Chen CH, Lin HH. Sequential comparisons of postoperative urodynamic changes between retropubic and transobturator midurethral tape procedures. World J Urol. 2008; 26: (Epub June 28, 2008). 33. Albouy B, Sambuis C, Andreou A, Sibert L, Grise P. Can transobturator tape for urinary incontinence cause complete urinary retention? Prog Urol. 2004;14:18991.