Single-Center Retrospective Study of the Technique, Safety, and 12-Month Efficacy of the MiniArc Single-Incision Sling: A New Minimally Invasive Procedure for Treatment of Female SUI R.D. MOORE, D.O., F.A.C.O.G., F.A.C.S. DIRECTOR, ADVANCED PELVIC SURGERY CO-DIRECTOR, UROGYNECOLOGY ATLANTA UROGYNECOLOGY ASSOCIATES ATLANTA, GA G.K. MITCHELL, M.D., F.A.C.O.G. STAFF PHYSICIAN ATLANTA UROGYNECOLOGY ASSOCIATES ATLANTA, GA J.R. MIKLOS, M.D., F.A.C.O.G., F.A.C.S. DIRECTOR, UROGYNECOLOGY ATLANTA UROGYNECOLOGY ASSOCIATES ATLANTA, GA ABSTRACT This study was conducted to report on the technique, safety, and early efficacy of a single-incision minisling to treat female stress urinary incontinence (SUI). Women suffering from SUI were offered a singleincision approach to place a suburethral polypropylene mesh tape in a position similar to that of a transobturator sling without passage of needles through the groin. Retrospective data was collected on 61 patients that received the new MiniArc single-incision sling at a single center in the United States. Patient selection and concomitant procedures were determined by the senior authors at the center, and the senior authors were the primary surgeons in all cases. Procedures were completed under general, regional, or MAC anesthesia as determined by the surgeon. Average operative time for the sling procedure alone was short and the average blood loss was 29 cc. There were no intraoperative complications. There was one postoperative adverse event secondary to urinary retention that was resolved by loosening of the sling under local anesthesia in an office setting. The overall cure rate at 12 months determined by physician and patient assessment in 58/61 patients was 91.4%. No patients suffered pain or dyspareunia secondary to the sling, and no erosions or extrusions were reported. In this initial study, the MiniArc single-incision sling appears to be a safe approach to treat female SUI, and the early clinical results are encouraging. - 1 -
Single-Center Retrospective Study of the Technique, Safety, and 12-Month Efficacy of the MiniArc Single-Incision Sling MOORE, MITCHELL, MIKLOS Stress urinary incontinence (SUI) is estimated to affect between 4% and 35% of adult women worldwide, and can lead to deterioration in the quality of life of those affected. 1 Over the years, various surgical treatments have been shown to be effective in treating SUI, including colposuspension (Burch, MMK) and traditional pubovaginal sling procedures using various materials and various methods of securing the sling in place. The introduction of tension-free vaginal tape (TVT; Gynecare, Johnson & Johnson, Sommerville, NJ) in 1996 revolutionized the treatment of SUI with a minimally invasive procedure that could be completed under local anesthesia in an outpatient setting. 2 The TVT procedure and subsequent similar tension-free sling products such as the SPARC procedure (American Medical Systems, Minnetonka, MN) have been shown to have excellent cure rates and have provided women with less invasive options for treatment; however, even with these minimally invasive techniques surgical complications still arise. 3 The blind retropubic needle approach used with these techniques has been associated with a variety of intra- and postoperative complications, including bladder perforation, pain, voiding dysfunction, and de novo urge symptoms. Other rare but potentially serious injuries to the urethra, bowel, or arteries and nerves in the retropubic space as a INTRODUCTION well as mortalities attributed to either major vascular or bowel injury have also been reported. 4 Initially described by Delorme in 2001, the transobturator approach for tension-free sling placement (TOT) was developed in an attempt to reduce the potential for complications associated with the retropubic access route inherent to the prior tape procedures. 5 Since its introduction, the transobturator approach has increased in popularity because of the ease of the approach and the safety advantages inherent in avoiding the blind retropubic needle passage. The TOT sling has also been shown to be an effective minimally invasive procedure for SUI; studies to date have shown similar cure rates and fewer complications when compared with the retropubic approach. 6 15 Anatomically, the transobturator sling lies in a position that more closely mimics the natural position of the pubourethral ligament, and therefore is thought to cause less voiding dysfunction and obstruction than the retropubic sling while still maintaining its effectiveness in the treatment of SUI. Despite the less invasive approach of the TOT sling and its encouraging clinical results, the procedure has not been proven to be risk-free. One of the concerns of the procedure is the development of clinically significant groin pain following the passage of needles and mesh through the transobturator space and the medial groin beneath the adductor longus tendon. 16 21 Although the Figure 1. MinArc mini-sling by American Medical Systems. Note the self-fixating tip at the end of the macroporous polypropylene tape. Once the tip is fixated into the obturator muscle, the needle slides out easily. (Copyright and reproduced with permission from American Medical Systems.) b risk is low, the complication can be debilitating when it does occur; therefore, the search for an even less invasive approach to place a tension-free vaginal tape sling has continued. The logical next step toward a less invasive, mid-urethral, tension-free tape sling is one that is placed through a single vaginal incision without any needle passage through the abdomen or groin. If adequate fixation of the tape in a similar position can be accomplished without needle passage through the abdomen or groin, this should provide safer placement without compromising cure rates. This current chapter is a description of the MiniArc Single- Incision Sling (American Medical Systems) and a single-center retrospective study of the safety and short-term efficacy of this minimally invasive treatment for female SUI. MATERIALS AND METHODS Sixty-one consecutive patients at our urogynecology center in Atlanta, Georgia, underwent placement of the MiniArc single-incision sling for treatment of female SUI from March to November 2007. The two senior authors completed all procedures and both surgeons had previous experience placing the TVT-Secur (Gynecare) mini-sling, which was released in the United States in the fall of 2006. The safety and effectiveness of the procedure in consecutive patients were evaluated by retrospective chart review after their 12-month visit. Patient selection was determined by the individual surgeons, and the only inclusion criteria were the diagnosis of SUI. Concomitant procedures were also completed as deemed necessary by the individual surgeons. SUI was confirmed preoperatively by the surgeons with subjective assessment of patients complaints in addition to cough stress test or complex urodynamics. Our center uses qualityof-life (QOL) questionnaires as part of the routine protocol, including the Urogenital Distress Inventory Short Form (UDI-6) both pre- and postoperatively, therefore this was also included in the analysis. Intra- and postoperative safety parameters or any notations of complications were included in the analysis of records. Postoperative continence was determined subjectively by patient and - 2 -
physician during the follow-up timeframe of 12 months using standard questionnaires and patient interviews. Other parameters evaluated included urinary urge symptoms (taken from the QOL forms), time of catheter use, pain at site of implant, infection, mesh extrusion, sling revisions, or any other sling-related complications noted. SURGICAL SURGICAL PROCEDURE The MiniArc procedure can be completed under local, MAC, or general anesthesia in a hospital, outpatient surgery center, or office setting. A 1.5- cm incision is made in the suburethral region. This incision is identical to the incision made for the Monarc (American Medical Systems) transobturator sling or other similar tension-free vaginal tape slings. The vaginal epithelium is dissected off the underlying suburethral tissues out to the pelvic sidewall, just on the posterior surface of the ischiopubic ramus. This dissection follows the same path of that for the Monarc sling but can be made only just slightly wider than the mesh to avoid full dissection. The tunnel that is created should be wide enough to ensure the mesh lies flat under the urethra and to avoid button holing the vaginal sulcus. The MiniArc sling s self-fixating tip is then attached to the curved blunt needle tip to advance the sling into place (Fig. 1). Once attached, the needle is then placed into the dissected tunnel and directed toward the obturator space at approximately a 45 angle. The final trajectory and position is similar to the hammock type position of the Monarc transobturator sling (Figs. 2, 3, 4). The needle tip is actually directed toward the same position in the groin that the transobturator sling incision would be made. Once the pelvic sidewall is penetrated (i.e., the obturator fascia and obturator internus muscle), the needle is advanced until the midpoint of the sling is at the mid-urethra, or just beyond the mid-urethra. The final position of the sling tip should be in the obturator internus muscle. The needle is then easily removed simply by sliding it back out of the fixating tip. Due to the tip s slip-fit design, the sling does not move during disengagement of the needle from the sling. The other side is then completed in Figure 2. Placement of the MiniArc needle in a bony pelvis. Note the direction of the needle is toward the obturator space, which will place the sling in a hammock position that is the same position of the TOT sling. Figure 3. Final position of the MiniArc mini-sling in a hammock-type position under the urethra. (Copyright and reproduced with permission from American Medical Systems.) Figure 4. Lateral view of the MiniArc sling in position under the mid-urethra with the self-fixating tip in the obturator internus muscle. (Copyright and reproduced with permission from American Medical Systems.) - 3 -
Single-Center Retrospective Study of the Technique, Safety, and 12-Month Efficacy of the MiniArc Single-Incision Sling MOORE, MITCHELL, MIKLOS the needle to the self-fixating tip if the sling must be tightened further. Once the final adjustment is accomplished, the vaginal epithelium is then closed with absorbable sutures. Cystoscopy is left to the discretion of the surgeon. RESULTS RESULTS Figure 5. The TVT-Secur device. (Copyright and reproduced with permission from Gynecare.) an identical fashion. The needle is slowly advanced into the obturator muscle until a tension-free adjustment is completed under the mid-urethra. The design of the self-fixating tip and curved needle provide the surgeon excellent control in advancing the needle to obtain precise, tension-free adjustment under the mid-urethra. It is recommended the sling is placed flat against the urethra using a hemostat or other instrument to help guide appropriate tensioning without overtightening the sling. If the patient is under MAC or local anesthesia, a cough test for adjustment of the sling can be completed. The bladder is filled with 250 cc of fluid prior to placement of the second side of the sling. The second side of the sling is then advanced just into the sidewall and the needle is left engaged with the selffixating tip, and the patient is asked to cough. The needle is then sequentially advanced into the obturator internus muscle until there is no longer any leakage with cough. The sling is also equipped with an optional re-docking feature for adjustment that uses a 2-0 Prolene suture that enables the surgeon to go back to the first side and re-dock Table I Demographic and Urodynamic Data (N = 60) Patient Demographics Average age (years) 58 Range: 25 84 Average weight (lbs) 149.4 Range: 110 240 Average parity 2.64 Range: 0 6 Average leak point pressure Average urethral pressure Urodynamic Parameters 71.36 mmhg 39.61 mmhg Patients with leak point pressure? 65 mmhg 26 (49%) Patients with urethral press? 20 mmhg 6 (10.7%) *Not all patients reported values Patient demographic data can be seen in Table 1. Average patient age was 58 years (range: 26 to 84 years) with an average weight of 149.4 lbs (range: 120 to 240 lbs). Urodynamic parameters are also seen in Table 1. The average leak point pressure (LPP) was 71.36 cm- H 2 O, and the urethral closure pressure (UCP) was 39.6 cm-h 2 O. Forty-nine percent of patients were considered to have intrinsic sphincter deficiency by LPP (less than 65) and 10.7% by UCP (less than 20). All implants occurred in a hospital setting under either general (56%), regional (23%), or MAC (21%) anesthesia with local infiltrate per surgeon discretion. A total of 56 out of 61 patients (92%) had concomitant repairs at the time of sling placement. Average blood loss for the MiniArc procedure alone was estimated to be 29 cc (range: 10 to 99 cc; Table 2). Cystoscopy was completed at the end of the procedure in all cases. There were no intraoperative complications reported, including no incidence of bladder or urethral injury and no incidence of postoperative bleeding or hematoma formation. The average time to return to normal voiding was 2.4 days, with 83% of patients voiding normally by 72 hours (Table 3). Two patients required extended catheterization secondary to bladder injuries during other procedures unrelated to the MiniArc. Only one patient required revision/loosening of the sling for urinary retention, and this was completed in the office at 2 weeks postoperatively. This resolved her voiding dysfunction without sequelae, and at 12 months follow-up she reported no voiding dysfunction and was cured of her SUI. Twelve-month follow-up was completed on 58 of the 61 patients implanted. Three patients were lost to follow-up. Postoperatively, there have been no reports of pain, mesh extrusions, or other sling-related complications. None of the self-fixating tips could be palpated on vaginal exam and - 4 -
Table II MiniArc Procedural Parameters (N = 61) Subjects implanted with MiniArc 61 (100%) Estimated blood loss (ml) Mean ± s.d. 29 ± 16 Range 10 99 Anesthesia type Epidural 14/61 (23%) General 34/61 (56%) MAC with local 13/61 (21%) Concomitant procedures 56/61 (92%) Subjects with MiniArc implant complications 0/61 (0%) *All procedures in hospital setting there were no reports of pain during palpation of the surgical implant site on follow-up exam, including palpation of where the self-fixating tip penetrates the sidewall. There were no reports of dyspareunia that were sling related. No patients required revision or removal of the sling for pain, dyspareunia, infection, or rejection. Using both physician and patient assessment of cure, the overall cure rate was 91.4% (53 of 58 patients considered cured of SUI symptoms). Three patients were outright failures, with no improvements in their symptoms. One of these had a TOT sling that resolved her symptoms, and the other two are considering revision. The other two Table III Average Time to Void patients that were considered failures were both significantly improved of their SUI symptoms and are happy with their results, and do not want revision or further treatment. Urinary urgency and frequency symptoms were significantly present in 52% of patients preoperatively and in only 14% of patients postoperatively (75% resolution of urgency/frequency symptoms). Patient quality of life was also significantly improved after MiniArc sling placement with overall QOL scores (UDI-6) showing statistically significant improvement on the assessment questionnaire total scores. UDI-6 total scores decreased from an average of 41.8 ± 24.9 preoperatively to 11.2 ± 13.8 Time Patients % of Total < 24 hours 29 48% < 48 hours 9 15% < 72 hours 12 20% 96 hours 3 5% 5 days 4 7% 6 days 1 2% 7 days 1 2% 9 days 1 2% ISC 2 wks 1 2% Totals 61 100% postoperatively (p < 0.001). Only 2 out of 57 (3.5%) reported de novo urgency or frequency symptoms on their UDI-6 questionnaire. DISCUSSION DISCUSSION Treatment for female SUI has seen revolutionary changes in the last ten years, with new minimally invasive techniques that have been proven safe and effective. The TVT sling was first developed and then the TOT sling followed, which provided a safer means to place a tension-free mesh tape sling with seemingly equivalent cure rates and lower rates of bladder injury and voiding dysfunction. The TOT has been shown to be an effective minimally invasive procedure for SUI in which retrospective studies have shown cure rates between 85% and 95%, and seemingly have fewer complications compared with the retropubic approach. 6 8 They have gained popularity over the original retropubic TVT procedures because they eliminate the need to blindly pass a needle through the retropubic space and therefore minimize the risk of major vascular, bladder, or bowel injury. In one of the largest worldwide multicenter prospective studies to date, the Monarc TOT sling was shown to have an objective cure rate of 91.8% at 12 months. 9 Prospective randomized trials comparing TOT slings to TVT slings have shown equivalent cure rates and decreased complications with the TOT sling approach. 10 14 Anatomically, the transobturator sling lies in a hammock type position that mimics the pubourethral ligament, and therefore is thought to cause less voiding dysfunction or obstruction, fewer urge symptoms, and less anticholinergic use postoperatively than the retropubic slings, which has been confirmed in comparative studies. 15,16,22 De novo urge symptoms are often associated with surgical procedures for SUI. Published literature to date indicates that de novo urge incontinence was noted in 0.8% to 25.9% of patients undergoing TVT procedures. 4 This wide range was attributed to a variation in the definition of urge symptoms in the various studies. Some surgeons speculate that with the proximity of the TVT sling to the bladder due to the - 5 -
Single-Center Retrospective Study of the Technique, Safety, and 12-Month Efficacy of the MiniArc Single-Incision Sling MOORE, MITCHELL, MIKLOS retropubic passage, the sling may actually penetrate or irritate the bladder detrusor muscle, causing detrusor instability in some cases. The TOT sling is subfascial, avoiding the retropubic space, and lies in a hammock-type position under the urethra, which may be the reason there seems to be less obstruction and voiding dysfunction with this type of approach. However, even though the TOT sling seems to be a safer approach with fewer side-effects than retropubic placement, it is not risk-free as groin pain has been reported in some series, particularly with the inside-to-out transobturator approach. 16 20 In a recent prospective randomized trial comparing the TVT-O ( inside-out ) to the Monarc ( outsidein ) TOT procedure, the TVT-O was found to be significantly more painful and the pain lasted significantly longer compared to the Monarc procedure. 21 The source of the postoperative pain with the inside-out approach was attributed to a less predictable, more lateral needle passage through the groin with a closer exit to the obturator nerve. In attempts to make the procedure even less invasive by eliminating needle passages required through the abdomen or groin, the single-incision MiniArc sling has been developed. This is the next logical step in the progression of minimally invasive sling techniques. The TVT-Secur was the first mini-sling released in late 2006; however, initial results have not been as promising as hoped with cure rates in the range of 69% to 82%. 23 25 This has also been confirmed in studies with longer follow-up as well, and may be secondary to the design of the kit and not the procedure itself. 26,27 Debodinance et al. reported prospectively on 110 patients and found the objective cure rate for the TVT-Secur to be 70.6%, and concluded that the results are not as good as TVT or TVT-O. 27 In the authors early experience with the TVT-Secur device, we found difficulty in releasing the trocar away from the mesh once placed in the sidewall, which at times caused the sling to loosen and altered the initial tensioning placed. This and a greater learning curve have also been reported by others in early reports. 28,29 Additionally, the TVT- Secur is placed with the assistance of a bladed trocar, which is more traumatic and wider than the MiniArc system (Fig. 5). A case report was recently published describing severe hemorrhage from the internal obturator muscle after placement of the TVT-Secur device that required laparotomy and drainage of 1000 cc of blood from the retropubic space and oversew of the bleeding muscle, and was thought to be secondary to this sharp-bladed trocar. 30 The new MiniArc single-incision sling shows very promising early clinical results and is one of the least invasive slings to be released to date. It uses the same mesh that has been proven safe in many clinical studies with the Monarc and SPARC sling procedures and also the same positioning of the mesh tape in a subfascial hammock type position of the TOT approach. However, the system uses a unique polypropylene selffixating tip on the end of the mesh to fixate the tape in place in the obturator muscle and fascia, therefore eliminating the need to pass needles through the groin, obturator space, or medial adductor muscles. Theoretically, this should translate to a decreased risk of groin pain or other groin complications such as infections, a result that was confirmed in this study where no patients complained of any postoperative groin pain attributable to the sling and in which were no reports of any groin infections or complications. The procedure also has the advantage of a smaller, less traumatic delivery system compared to other currently available systems; it is very simple to use and easy to control placement and adjustment/advancement of the sling into the pelvic sidewall, with minimal trauma and bleeding. In an initial U.S. multicenter retrospective study, overall objective and subjective cure rates were in the range of 93% at 12 weeks with minimal complications reported and an average blood loss of 27 cc. 31 The current study confirms these findings and shows that the cure rates are holding up over the first year. The average blood loss in the current study was only 29 cc with no reports of postoperative bleeding or hematomas either vaginally or in the obturator space. Postoperative pain was minimal, with no patient reporting pain with palpation of the sling placement site either sub-urethrally, paraurethrally, or at the insertion site of the self-fixating tip in the sidewall during follow-up exams. One of the concerns with any modification of the tension-free tape sling procedure is short-term fixation until tissue in-growth can occur to fixate the entire sling in position, as this could affect cure rates. If the sling is loosened during release of the placement device or during the immediate postoperative period from patient movement, coughing, straining, and so on prior to tissue in-growth occurring throughout the entire length of the sling, then this may translate to lower cure rates. Fixation with the MiniArc system seems to be excellent and immediate; furthermore, the sling does not move with the release of the placement needle. Once placed, the self-fixating tip seems to secure into the sidewall muscle and tissues very well, and although possible to loosen if necessary in the intra-adjustment of the sling, this can be difficult because of the excellent fixation. This immediate fixation should help hold the sling in place during the healing phase and therefore translate to similar cure rates of TOT slings given its similar position in the pelvis and sidewall musculature. This was preliminarily confirmed clinically in the current study with cure rates in the range of 91.4%, which is consistent with what has been reported to date with the traditional transobturator approach. Of course, this is only a short-term cure rate with small numbers and longerterm, prospective studies are needed; however, our feeling is that if the tape is in the same position as the traditional TOT sling and is fixated well enough to have adequate cure rates at 12 months, then we are optimistic that these cure rates should hold up over longer-term follow-up. The sling should also still offer the same benefits of the hammock-type positioning of the traditional TOT sling, including minimal voiding dysfunction and low rates of urinary retention and sling loosening or release. This was also confirmed in the current study with most patients returning to voiding by Day 3 and only one patient requiring loosening or revision. Overall urge symptoms were also significantly reduced from baseline with 75% of patients reporting significant urge symptoms preoperatively having a resolution of these symptoms postoperatively. De novo urge symptoms were also very minimal, with only 3.5% reporting new significant urge symptoms postoperatively. - 6 -
CONCLUSIONS CONCLUSIONS The MiniArc sling is a new minimally invasive, single-incision sling for treatment of female SUI. The procedure can be performed under local anesthesia with or without a cough test, or under general anesthesia per surgeon discretion. Early clinical results in the current trial show it to be a safe and effective minimally invasive procedure for female SUI with cure rates at 12 months in the range of 91.4%. There were no reports of any postoperative complications such as infection, erosion, hematoma, groin pain, or dyspareunia secondary to the sling. Further investigation with longer-term followup and prospective studies are ongoing and will add to the previous data; however, it does appear in initial studies that the MiniArc sling may offer equivalent efficacy with a less invasive approach than the current procedures being used today and may be the next step in minimally invasive treatment of female SUI. STI REFERENCES REFERENCES 1. 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Morey AF, Medendorp AR, Noller MW, et al. Transobturator versus transabdominal mid urethral slings: a multi-institutional comparison of obstructive voiding complications. J Urol 2006;175:1014-7. 8. Davila GW, Johnson JD, Serels S. Multicenter experience with the Monarc transobturator sling system to treat stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 2006;17(5):460-5. 9. Moore RD, Miklos JR, Cervigni M, et al. Monarc transtobturator sling: combined analysis of 1 year follow-up in 9 countries with 266 patients. Int Urogynecol J Pelvic Floor Dysfunct 2006;17:S203. 10. Daraï E, Frobert JL, Grisard-Anaf M, et al. Functional results after the suburethral sling procedure for urinary stress incontinence: a prospective randomized multicentre study comparing the retropubic and transobturator routes. Eur Urol 2007;51(3):795-801, disc. 801-2. 11. Lee KS, Han DH, Choi YS, et al. 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US Obst Gynecol 2008;3(1):102-5. - 7 -