Randomized Clinical Trial Comparing Suprapubic Arch Sling (SPARC) and Tension-Free Vaginal Tape (TVT): One-Year Results

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1 European Urology European Urology 47 (2005) Randomized Clinical Trial Comparing Suprapubic Arch Sling () and Tension-Free Vaginal Tape (): One-Year Results Sero Andonian, Tony Chen, Benoit St-Denis, Jacques Corcos* Division of Urology, Department of Surgery, Sir Mortimer B. Davis-Jewish General Hospital, McGill University, 3755 Côte Ste-Catherine, Suite E208, Montreal, Quebec, Canada, H3T 1E2 Accepted 28 December 2004 Available online 13 January 2005 Abstract Purpose: Suprapubic Arch sling () has been initially presented as being comparable to Tension-free Vaginal Tape () without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year. Materials and methods: 84 women presenting with Stress Urinary Incontinence (SUI) were randomly assigned to or as a minimally invasive mid-urethral sling procedure. All patients were re-evaluated at 1, 6, and 12 months. Symptom assessment, Incontinence Impact Questionnaire (IIQ), physical examination, Uro-Dynamic Studies (UDS) and 1-hour pad test were repeated at 1-year follow-up. Results: 41 patients were randomized to and 43 to. The two groups had similar baseline characteristics. Both procedures resulted in similar peri-operative complications: bladder perforation (24% vs. 23%), median estimated blood loss (0 50 ml), median hospital stay (1-night), post-operative analgesia, and persistent urinary retention necessitating tape resection (2 patients in each group). There were three other complications in the group: tape erosion, infected pelvic hematoma, and urinary tract infection. At 12 months, there was no statistically significant difference between and, in terms of objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p 0.1; 12% difference, 95% CI: 25.4% to 1.4%) and subjective cure rates as determined by IIQ scores ( vs ; p = 0.46). Conclusions: At 1-year follow-up, there is no statistically significant difference between and. Longer follow-up is needed to confirm these results. # 2005 Elsevier B.V. All rights reserved. Keywords: Stress urinary incontinence; Tension-free vaginal tape; Suprapubic arch sling; Efficacy trial; Randomized clinical trial 1. Introduction It is estimated that 10.6% of adult women suffer from varying degrees of Stress Urinary Incontinence(SUI)[1]. In addition to the social implications, this condition costs $11.2 billion annually in the USA [2]. A variety of * Corresponding author. Tel x5166; Fax: address: jcorcos@uro.jgh.mcgill.ca, (J. Corcos). retropubic and transvaginal surgical techniques have been developed to restore support to the urethral sphincteric apparatus. However, there is no consensus about the best procedure [3]. Furthermore, morbidity and convalescence issues have stimulated a search for less invasive procedures. In 1996, Ulmsten developed Tension-free Vaginal Tape (), a minimally-invasive procedure based on the hammock hypothesis of DeLancey [4,5]. Asnewproceduresare introduced,the initialresults focus on success. Ulmsten, in his sentinel paper, claimed /$ see front matter # 2005 Elsevier B.V. All rights reserved. doi: /j.eururo

2 538 S. Andonian et al. / European Urology 47 (2005) a high success rate of 85% with no complications [5]. This led to a dramatic increase in the number of procedures performed [6 9]. Recent retrospective data indicate that is not without complications [8,10]. Therefore, modifications of the original procedure have been developed. Suprapubic Arch sling () is one such modification, where needles are driven from the suprapubic region to the vagina, in the opposite direction to needles. The procedure is proposed to reduce the intra-operative complications of, such as bladder perforation and retropubic bleeding, since the needles follow the curvature of the symphysis pubis, and theoretically avoiding important adjacent structures. has been presented as being comparable to without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year. 2. Materials and methods 2.1. Endpoints of the study The 1-hour pad test was chosen upon the recommendations of the International Continence Society. Weight gain of up to 2 g may result from weighing errors, sweating or vaginal discharge, whereas a loss of <1 g is within experimental error and the patient is considered continent [29]. Therefore, in this trial, 1-hour pad test of 2 g was considered as an objective cure, and this was the primary endpoint of the study. As a secondary endpoint, we have used the Incontinence Impact Questionnaire (IIQ) of Shumaker, where a score of less than 50 would be representative of good Quality of Life (QoL), between 50 and 70 would be moderate QoL, and greater than 70 would be indicative of poor QoL [11,12,28]. Furthermore, IIQ has been tested in our population with moderate test-retest reliability and good internal consistency [12]. Therefore, the Shumaker IIQ was used to determine subjective cure rates as a secondary endpoint in this trial Sample size determinations and statistical analysis Since the primary endpoint of the trial was objective cure rate as defined by the 1-hour pad test of 2 g, the success rate of 90% for was used. It was decided that 30% difference in success rate between the two procedures would be clinically significant. Therefore, to detect 30% difference, with an alpha value of 0.05 and power of 80%, at least 38 subjects in each group is required. This number is increased to 42 per group to account for 10% dropout during the follow-up period. Sample size determination was performed using PS software version by Dupont and Plummer [31]. Data were analyzed using the SAS software, version 7. Student s t-test and ANOVAwere used for continuous variables. Chi square and Fisher exact tests were used for proportions. Two-sided p values were calculated Inclusion and exclusion criteria This prospective, randomized clinical trial was performed at a single institution (Jewish General Hospital). Women were eligible for the trial if they had Urodynamic Stress Incontinence (USI) with or without pelvic organ prolapse. All pre-operative parameters were recorded by a single experienced female urologist (JC). Detailed history was obtained with patient age, menopausal status, parity, co-morbid medical conditions, previous incontinence or pelvic surgery, number of pads per day, hormone replacement therapy, and incontinence history, including incontinence grade and quality of life assessment with IIQ [11,12]. On physical examination, in addition to the Blaivas type of incontinence, estimated by the degree of bladder neck and urethral mobility, the presence of rectocele, enterocele, cystocele and pelvic organ prolapse was assessed [30]. Multichannel urodynamic study (UDS) of each patient included: flowmetry, post-void residual, cystometogram, leak point pressure and 1-hour pad test. These were done to make sure that all patients had stable bladder function and good flow rates without clinically significant post-void residual. Women with previous failed anti-incontinence surgeries or bulking agents treatments were also eligible for the study. Women with mixed urinary incontinence were not excluded as far as their cystometrogram showed normal capacity, compliance and no uninhibited contractions. Women with obstructive, unstable bladder functions, or neurogenic bladders were excluded from the study. Urinary tract infection was temporary exclusion criteria Randomization and follow-up Patients were blinded to the procedure and had envelope randomization immediately prior to the start of the surgery. Peri-operative information was obtained from pre-printed operative reports filled by the surgeon immediately post-operatively. This included type of anesthesia, operative time (incision to closure), estimated blood loss (0 50 ml, ml, and >250 ml), and bladder perforation (one or both sides). In addition, information from anesthesia and nursing reports were also used. Post-operatively, all patients were re-evaluated by symptom assessment and physical examination at 1, 6 and 12 months. Furthermore, at 12 months, all patients, except 1 patient who had died of an unrelated cause, completed the IIQ and underwent UDS and the 1-hour pad test by a dedicated UDS nurse (BS), who was blinded to the procedure Surgical techniques The procedure was carried out as described by Ulmsten, with the exception of the type of anesthesia [5]. sets are manufactured by Gynecare, a division of Ethicon, Inc. (Sommerville, NJ, USA). sets are manufactured by American Medical Systems, Inc. (Minnetonka, MN, USA). Both techniques have been previously described [5,10]. Anterior and posterior colporrhaphy, and vaginal hysterectomy were performed simultaneously in symptomatic women with pelvic organ prolapse. A 16F Foley catheter was left in situ until complete patient recovery from anesthesia. Patients were invited to urinate before leaving the hospital, and a bladder scan ensured that postvoid residual was <150 ml. In cases of higher residual volumes, an indwelling urethral catheter was re-inserted and the patient was followed at the clinic within 48 hours for a voiding trial and measurement of post-void residual. 3. Results Out of 93 eligible women with SUI, only 84 agreed to participate and gave informed consent for this study that took place from April 2001 till December Nine patients declined to participate in the study

3 S. Andonian et al. / European Urology 47 (2005) Table 1 Distribution of patients according to grade and type of SUI Table 4 One-year efficacy results Patients Mean age (95% CI) 62.6 ( ) 60.4 ( ) Grade 1 4 (9.7%) 4 (9.3%) 2 26 (63.4%) 27 (62.8%) 3 11 (26.8%) 12 (27.9%) Type I 1 (2.4%) 1 (2.3%) IIa 27 (65.9%) 22 (51.2%) IIb 6 (14.6%) 9 (20.9%) III 7 (17.1%) 11 (25.6%) 1-hr Pad test (g) (95% CI) 30.9 ( ) 29.3 ( ) Pre-op IIQ (95% CI) 65.5 ( ) 61.3 ( ) because they could not comply with the follow-up schedule due to travel plans during the winter months. Forty-one patients were randomized into the group, and 43 into the group. Both groups had similar baseline characteristics with regard to age, grade and type of SUI, IIQ mean scores and pad tests (Table 1). Eighty-three and seventy-two percent of patients received spinal anesthesia in the and groups, respectively (Table 2). In addition, no statistical significant difference was found in the mean operative (OR) time between the 2 groups. Both groups had similar peri-operative complications. There was no statistically significant difference in bladder perforation rate (10 in each group), median estimated blood loss (0 50 ml), post-operative analgesia during hospital stay, and median hospital stay (1 night) (Table 3). Immediate post-operative Table 2 Type of anesthesia and operative duration Anesthesia Local 1 (2.4%) 2 (4.7%) Spinal 34 (83%) 31 (72%) General 6 (15%) 10 (23%) OR time (95% CI) 32.3 min ( ) 35.6 min ( ) Table 3 Peri-operative complications Bladder perforation 10 (24%) 10 (23%) Median blood loss (ml) (range) 50 (0 250) 50 (0 250) Patients with >250 ml blood loss 4 (10%) 3 (7%) Analgesia 14 (34%) 22 (51%) Median hospital stay (range) 1 night (0 7) 1 night (0 3) Complete retention 2 (4.9%) 4 (9.3%) Patients cured (1-hour pad test 2 g) 34/41 (83%) 40/42 (95%) Post-op IIQ (95% CI) 49.9 ( ) 45.3 ( ) complete retention was seen in 2 and 4 patients. This was not statistically significant (p = 0.36). Two patients in each group required reoperation to loosen the tape after 3 days. The other two resumed spontaneous complete voiding within 48 hours of the operation. There were three other complications in patients: (1) tape erosion into the vagina requiring partial tape removal,(2) infected pelvic hematoma necessitating intravenous antibiotics and percutaneous drainage, and (3) fever on post-operative day 1 necessitating empiric therapy with broad-spectrum antibiotics for 1 week. Unrelated to the incontinence surgery, a patient died of myocardial infarction at 12 months. Therefore, the denominator for cure was reduced to 42 in the group. All 41 patients in the group completed the follow-up at 1 year. At 12 months, and had similar objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p 0.1) (12% difference, 95% CI: 25.4% to 1.4%). Furthermore, there was no statistical difference in the subjective cure rates as determined by post-operative mean IIQ scores ( vs , p = 0.46) (mean difference of 4.6; 95% CI: 7.5 to 16.7) (Table 4). 4. Discussion has been presented as being comparable to without published trials. This is the first randomized prospective trial comparing with. As there was no statistical difference between the 2 arms of the trial in terms of pre-operative characteristics, patient randomization was successful. In the present study, the majority of patients (83% of and 72% of ) had regional anesthesia for the procedure. This is in contrast to the original description by Ulmsten who performed under local anesthesia with IV sedation. However, Ulmsten s paper was criticized by the journal editors for the high doses of sedation used during the procedure [5]. Therefore, in our experience, regional low spinal anesthesia both reduces operative time and is better tolerated by patients. Even though regional anesthesia impairs the ability to cough effectively, a recent randomized trial comparing local and regional anesthesia for

4 540 S. Andonian et al. / European Urology 47 (2005) showed that subjective and objective success rates were not significantly different in the 2 groups, but women in the epidural blockade group presented significantly greater evidence of urinary obstruction (time to spontaneous voiding and post-void residual) [13]. Furthermore, general anesthesia has been reported to produce comparable success rates [14 16]. However, the best type of anesthesia for sub-urethral sling procedures remains to be demonstrated. An unexpected finding in our study was the high rate of bladder perforation in 10 patients or 24% in each group. This is higher than our previously-published rate of 5.8% in a retrospective, multi-centre study [17]. A recent review of the literature showed the bladder perforation rate to range from 0.7% to 19% [10,18 21]. Bladder injury in has been reported to be 10.5% [22]. The higher rate in the present trial may be due, in part, to the fact that we eliminated recall bias by immediately recording intraoperative complications, which may not be dictated and available in retrospective studies. In previous studies, 2 risk factors were identified in bladder perforation: a history of previous surgeries for SUI, and the learning curve [10,19,23,24]. Another possible explanation for the high perforation rate might be the use of regional anesthesia. Hydrodissection of perivesical tissues is a feature of local anesthesia and this may decrease the perforation rate. However, this remains to be proven. We agree with the authors Niknejad et al. that bladder perforation, when recognized intraoperatively, is without sequelae [10]. In our practice, patients with bladder perforation, a prolonged indwelling catheter is not indicated. In the present study, 2 patients in each group required re-operation to loosen the tape after 3 days for complete urinary retention. This 4.8% complete retention rate is comparable to previously published rates that ranged from 4 to 10% [6 10,18]. Voiding dysfunction in a prospective study of was 10.5% [22]. Klutke and colleagues have advocated tape release under local anesthesia within hours from the operation to allow mobilization of the tape before it becomes fixed in place [25]. In the present study, there was no difference in median estimated blood loss or the number of patients with greater than 250 ml blood loss. However, 1 patient in the group developed a pelvic hematoma, which later became infected, necessitating drainage and intravenous antibiotics. A recent retrospective study of 140 patients who received for SUI found that 6 of them had retropubic hematomas, with 4 requiring postoperative transfusions. Thus, the authors recommended close overnight observation of patients [26]. In the group, a patient developed tape erosion into the vagina that was treated by tape removal. However, it is also possible to manage these patients conservatively by observing them. This was reported in 4 cases with complete spontaneous epithelialization in 3 months [27]. The objective cure rate of 95% in the group is comparable to previously published reports (70.6% 92%) [10]. Similarly, 83% cure rate in group is comparable to 90.4% reported by Deval et al. [22]. In the present trial, at one-year follow-up, there was no statistically significant difference in the objective cure rates of and as defined by the 1-hour pad test of 2 grams. To quantify subjective cure, we used the IIQ scores. The mean scores of both groups indicated that pre-operatively their QoL was moderately affected (65.5 vs. 61.3), but improved to good levels post-operatively (49.9 vs. 45.3) [28]. Similarly, at one year follow-up, there was no statistically significant difference in the mean IIQ scores ( vs , p = 0.46) (mean difference of 4.6; 95% CI: 7.5 to 16.7). The authors plan to follow these patients to assess subjective and objective cure rates at longer follow-ups. 5. Conclusions In conclusion, and do not have statistically significant difference in terms of peri-operative complications, including hospital stay, bladder perforation, operative bleeding, and urinary retention. Furthermore, at 1-year follow-up, they do not have statistically significant difference in terms of subjective and objective cure rates. Longer follow-ups (up to at least 5 years) are needed to determine their long-term differential efficacy. References [1] Corcos J, Shick E. Prevalence of overactive bladder: a Canadian study. Can J Urol 2004;11(3): [2] Overview: Urinary Incontinence in Adults, Clinical Practice Guideline Update., Rockville, MD: Agency for Health Care Policy and Research; htm. [3] Bezerra CA, Bruschini H, Cody DJ. Suburethral sling operations for urinary incontinence in women. Cochrane Database Syst Rev 2003;3:CD [4] DeLancey JOL. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol 1994;170:

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