Tension-free Midurethral Sling Research Articles

The distribution of different surgical types for female stress urinary incontinence among patients’ age, surgeons’ specialties and hospital accreditations in Taiwan: a descriptive 10-year nationwide study

This study aims to identify the changing trends of different surgical types for female stress urinary incontinence (SUI) and the distribution amongst various providers' characteristics. A total of 17,532 women who had undergone surgery for SUI during 1996-2005 were identified from the National Health Insurance Research Database for analysis. Retropubic urethropexy (RPU) was the most common surgical type (43%), followed by tension-free mid-urethral sling (MUS; 24%), and traditional pubovaginal sling (15%). MUS had an annual growth rate of 20.5%, whilst traditional pubovaginal sling was reduced by 11.3% annually after 2002. RPU was the most common procedure by both gynecologists and urologists. Gynecologists performed more Kelly plications, whereas urologists performed more traditional pubovaginal sling. MUS was more commonly performed in medical centers than in regional and local hospitals. There has been a notable growth and changing trend in various surgical types for female SUI in Taiwan.

Complication Rates of Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing Tension-Free Midurethral Tapes to Other Surgical Procedures and Different Devices

Complication Rates of Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing Tension-Free Midurethral Tapes to Other Surgical Procedures and Different Devices

Safety and efficacy of transobturator tension-free midurethral sling for surgical management of stress urinary incontinence in women

Dear Editor, The article by Barry et al. [1] is a nicely conducted multicenter randomized study from Australia, which further establishes the efficacy of transobturator approach (TO) of tension-free midurethral slings in the management of stress urinary incontinence (SUI), comparable to suprapubic tension-free vaginal tape (TVT-SP) at least in short term (objective and subjective success rates; 82.8 vs 78%, p= 0.51, and 84.2 vs 85.4%, p=0.66, respectively). It also establishes the safety advantage of this approach over the suprapubic counterpart with regards to bladder perforation (0 vs 8.5%, p<0.05), blood loss (49 vs 64 ml, p<0.05), and operative time (14.6 vs 18.5 min, p<0.001). However, while one can be assured of utilizing this approach with impunity in most of the cases of SUI, there are certain important issues to be addressed in a given individual case before embarking onto any approach for a successful outcome. Since the successful inception of pubovaginal sling more than a century ago, a lot of research has been undertaken towards improving the understanding of continence mechanisms in women. The focus has shifted from the bladder neck to the midurethra; DeLancey’s hammock hypothesis emphasized the importance of pubourethral ligaments in maintaining the continence, and lately Petros and Ulmstein proposed the “midurethra theory” elucidating the role of weakening of pubococcygeus muscle in addition of the former [2]. These theories have led to the development of TVTs placed at midurethral level by suprapubic, transobturator, or prepubic routes. The former has been proven to be highly efficacious over long term (85–92% success rate), which is equivalent to pubovaginal sling and superior to colposuspension, both in primary as well as in recurrent SUI [3]. Various single-armed clinical studies and randomized controlled trials have proven the efficacy, although short term, of transobturator tape procedure as well, with the added advantage of lower incidence of side effects, e.g., bladder perforation, postoperative voiding dysfunction, and early return to work. Despite the shift of the focus from bladder neck to midurethra, intrinsic sphincter deficiency (ISD) remains one of the important pathophysiological mechanisms underlying SUI, and some degree of ISD is present in most of the patients. Significant ISD is found in only a small percentage of patients and is usually associated with highgrade incontinence. There is still no consensus on the urodynamic definition of ISD and measures like maximal urethral closure pressure (MUCP) less than 20–30 cmH2O and Valsalva leak point pressure (VLPP) <60 cmH2O have been used for definition. There is only moderate correlation between the two parameters, and they are described to represent weakness at different levels: MUCP at midurethra and VLPP at bladder neck. Studies on TVT-SP have failed to demonstrate a significant effect of either of the parameters on the surgical results; however, a combination of both, along with absence of a significant hypermobility, has shown to be predictive of poor results [4]. Int Urogynecol J (2008) 19:893–894 DOI 10.1007/s00192-007-0485-7

Editorial Comment on: Complication Rates of Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Comparing Tension-Free Midurethral Tapes to Other Surgical Procedures and Different Devices

Objectives: To evaluate the complication rates of tension-free midurethral slings compared with other surgical treatments for stress urinary incontinence, including other tension-free midurethral slings. Methods: A systematic review of the literature using MEDLINE, EMBASE, and Web of Science was performed in January 2007. Meta-analysis was conducted by using the Review Manager software 4.2. Results: Our search identified 33 randomized controlled trials reporting data on complication rates. Our meta-analysis showed that complication rates were similar after tension-free vaginal tape (TVT) and Burch colposuspension, with the exclusion of bladder perforation, which was more common after TVT (p = 0.0001), and reoperation rate, which was significantly higher after Burch colposuspension (p = 0.02). TVT and pubovaginal sling were followed by similar complication rates. With regards to the comparisons among retropubic tapes, TVT and intravaginal slingplasty had similar complication rates, whereas suprapubic arc sling (SPARC) was complicated by higher rates of voiding lower urinary tract symptoms (LUTS) (p = 0.02) and reoperations (p = 0.04). Comparing retropubic and transobturator tapes, the occurrence of bladder perforations (p = 0.007), pelvic haematoma (p = 0.03), and storage LUTS (p = 0.01) was significantly less common in patients treated by transobturator tapes. Conclusions: Tension-free slings were followed by lower risk of reoperation compared with Burch colposuspension, whereas pubovaginal sling and tension-free midurethral slings had similar complication rates. With regards to different tension-free tapes, voiding LUTS and reoperations were more common after SPARC, whereas bladder perforations, pelvic haematoma, and storage LUTS were less common after transobturator tapes. The quality of many evaluated studies was limited.

Editorial Common on: Tension-Free Midurethral Slings in the Treatment of Female Stress Urinary Incontinence: A Systematic Review and Meta-analysis of Randomized Controlled Trials of Effectiveness

In the last decade numerous trials have attempted to assess the clinical effectiveness of new devices for the treatment of stress urinary incontinence (SUI). The main issue for urologists and gynaecologists lies in making sense of a huge range of disparate literature spread over many journals and several years, generated with different brand names and generally performed in different settings. Often some trials comparing more medical devices report uncertain or even conflicting results of their net effect on continence. In a good systematic review, Novara et al provide a rational assessment, which takes great care to analyse all relevant studies and assess the quality of design and conduct in each one [1]. The authors tried to combine the findings of each study in an unbiased manner and to provide a quantitative estimate of net benefit aggregated overall, with the aim of presenting a balanced, impartial summary of existing clinical evidence. This meta-analysis has several benefits and some flaws, which deserve attention. Benefits. Many small or medium-sized trials have tried to compare the efficacy of different midurethral slings (MUSs) without pre-study power calculation or with a low power. They tend to be inconclusive and have a low external validity in answering questions about the clinical efficacy of MUSs. Statisticians advise clinicians to discount such low-power studies when making clinical decisions, claiming that low-power trials are unethical [2]. On the other hand, the so-called underpowered trials might be acceptable because they could ultimately be combined in a metaanalysis [3]. Novara et al seem to support this view and deserve praise for eliminating some selection [52] Abrams P, Andersson KE, Brubaker L, et al. Recommendations for clinical research. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence, 3rd International Consultation on Incontinence. Plymouth, United Kingdom: Health Publications; 2005. p. 1624–6.

Surgical Considerations for Recurrent Stress Urinary Incontinence after the Midurethral Sling Procedure: Redo Midurethral Sling and Shortening of the Tape

Purpose: There are no clear-cut guidelines of how to treat patients who have failed after a tension-free midurethral sling (MUS) procedure. We describe our experience with repeat MUS procedures and transvaginal shortening of the previously implanted tape for those patients with an initially failed MUS procedure. Materials and Methods: We reviewed the medical records of the patients who failed with their initial MUS procedure and then had a second operation. Of the 20 women, 14 patients had repeat MUS and another 6 patients underwent shortening of the implanted tape. Repeated MUS was done by either the retropubic or transobturator pathway. Shortening of the tape was done with a metal hemoclip to shorten the previously implanted tape. The preoperative characteristics and the intraoperative and postoperative data were assessed by reviewing the operative notes, medical records and office notes. Results: The mean interval between the first and repeat procedures was 8.4 months (range: 1-48). The mean follow up time after the second operation was 29.9 months (range: 7-70). Seven patients underwent repeat MUS instead of tape shortening because the implanted tape had migrated or severe adhesions were noted on the intraoperative findings. Ten (71.4%) of 14 patients who underwent repeat MUS achieved full continence, while 4 patients (28.6%) had significant improvement. Of the patients with tape shortening, 4 (66.6%) achieved full continence, one (16.7%) improved and one (16.7%) was failed. Conclusions: Based on our limited experience, a repeat MUS sling procedure or tension revision of the tape might be an effective treatment for the patients with failed MUS. (Korean J Urol 2007;48:527-535)

Is there still a place for the pubovaginal sling at the bladder neck in the era of the midurethral sling?

Perhaps the most significant advance in the modern-day surgical management of stress urinary incontinence is the introduction of the tension-free midurethral sling procedures. Based on a theory of anatomy and function, which emphasizes the importance of the midurethra in maintaining continence during stress, these minimally invasive procedures are being used widely in the surgical treatment of stress urinary incontinence. As surgeons continue to experience excellent early results, a major concern is defining the role of the traditional pubovaginal sling placed at the bladder neck. In addition to the obvious indications to consider a more traditional sling procedure (markedly atrophic vaginal wall or situations that may promote sling erosion), are there other clinical scenarios in which there still is a role for the traditional pubovaginal sling? Several clinical conditions that warrant consideration of a traditional sling procedure are presented in this review. Based on the mechanism of action and clinical data demonstrating decreased efficacy of midurethral sling procedures, we propose that a traditional pubovaginal sling be considered in the following clinical conditions: lack of urethral mobility, mixed urinary incontinence, concomitant urethral reconstruction, and after a failed sling procedure. In the absence of randomized control trials, we present evidence that makes a case for consideration of the traditional sling procedure in these complex clinical conditions.

Synthetic slings: which material, which approach

The success in the use of the tension-free midurethral sling procedures (tension-free vaginal tape, suprapubic arch, transobturator tape) has dramatically altered the approach to the surgical management of stress urinary incontinence in women and marked a resurgence in the use of mesh. We will analyze the characteristics of synthetic meshes and explain the rationale for using monofilament materials with larger pore sizes. Thus, the purpose of this review is to introduce the surgeon to a variety of commercially available mesh materials and the characteristics that make mesh suitable for use as sling grafts. Type I macroporous mesh materials appear most suitable for transvaginal implantation. Utilization of these materials in a minimally invasive retropubic or transobturator approach, promising early and intermediate follow-up data has been achieved. The outcome of these procedures in women with urethral hypermobility and genuine stress incontinence seems clear. No controlled data, however, exist to define the role of these procedures in difficult cases of stress incontinence. Newer generations of minimally invasive slings may offer treatment alternatives in these difficult cases. Minimally invasive slings using Type I mesh materials are safe and effective. 'Hybrid' type slings may offer alternatives in difficult cases of stress urinary incontinence.

Significance of tension in tension-free mid-urethral sling procedures: a preliminary study

We report the results of the release and tape-shortening techniques in polypropylene pubovaginal slings. Of female patients who had undergone mid-urethral sling procedures [tension-free vaginal tape procedure and suburethral polypropylene (SPARC)], in cases in which postoperative retention occurred, the patients were offered release or tape cutting. Women reporting postoperative urinary incontinence underwent a tape-shortening procedure. In these patients, the tape was shortened by the use of clips. Mean follow-up time after the release and/or the shortening operations was 9.9 months (range 6-18). A total of 15 women, ranging from 41 to 75 years old (mean 58.3) were included in this study. Upon the latest follow-up, six women exhibited prolonged urinary retention and subsequently underwent a release procedure (n=5) or a tape-cutting procedure (n=1). After the release procedure, all patients remained continent, but one patient's urinary retention issues were not resolved, and she subsequently underwent a tape-cutting. Both of the patients who underwent the cutting procedure then developed recurrent stress urinary incontinence. The tape-shortening technique was conducted with nine patients. Seven of these patients recovered their continence, and no one patient experienced any urinary retention or other voiding difficulties. Two patients reported only minimal stress leakage and elected to undergo no further interventions. Our findings suggest that tension plays a substantial role in tension-free mid-urethral sling procedures.

Transobturator tape, bladder perforation, and paravaginal defect: a case report

Transobturator midurethral slings (TOT) have been shown to have less risk of vascular and visceral injury than tension-free midurethral slings. Routine cystoscopy has therefore not been felt to be necessary. A case of bladder perforation unrecognized at the time of TOT placement is presented. Findings at sling removal suggested that a clinically nonapparent paravaginal defect may have been instrumental in the injury. Consideration should be given to routine cystoscopy at the time of transobturator sling placement.

Is there still a place for the pubovaginal sling at the bladder neck in the era of the midurethral sling?

Perhaps the most significant advance in the modern-day surgical management of stress urinary incontinence is the introduction of the tension-free midurethral sling procedures. Based on a theory of anatomy and function, which emphasizes the importance of the midurethra in maintaining continence during stress, these minimally invasive procedures are being used widely in the surgical treatment of stress urinary incontinence. As surgeons continue to experience excellent early results, a major concern is defining the role of the traditional pubovaginal sling placed at the bladder neck. In addition to the obvious indications to consider a more traditional sling procedure (markedly atrophic vaginal wall or situations that may promote sling erosion), are there other clinical scenarios in which there still is a role for the traditional pubovaginal sling? Several clinical conditions that warrant consideration of a traditional sling procedure are presented in this review. Based on the mechanism of action and clinical data demonstrating decreased efficacy of midurethral sling procedures, we propose that a traditional pubovaginal sling be considered in the following clinical conditions: lack of urethral mobility, mixed urinary incontinence, concomitant urethral reconstruction, and after a failed sling procedure. In the absence of randomized control trials, we present evidence that makes a case for consideration of the traditional sling procedure in these complex clinical conditions.

Poster 50: Monarc Transobturator Sling for the Treatment of Stress Urinary Incontinence: Interim Results of a U.S. Multicenter, Prospective Study on 112 Patients

OBJECTIVE: This study evaluates a transobturator approach for placement of a tension-free midurethral sling with regard to safety and efficacy for the treatment of stress urinary incontinence (SUI). METHODS: One hundred twelve female subjects were enrolled between July 2003 and May 2004 in an Institutional Review Board-approved prospective, multicenter study and implanted with the Monarc Subfascial Hammock (American Medical Systems, Minnetonka, MN), a tension-free suburethral polypropylene sling. All subjects had confirmed SUI resulting from urethral hypermobility with or without intrinsic sphincter deficiency (ISD). Subjects were excluded if they had previous suburethral sling procedures, uncontrolled detrusor instability, or significant pelvic organ prolapse (extending beyond the hymen). Preoperative objective evaluation included urodynamic testing (UDT), cough-stress test, Q-Tip test, 1-hour pad test, and POP-Q examination. Subjective evaluation included quality-of-life questionnaires (QOL), the UDI-6, and IIQ-7. Procedural and 4- to 8-week postoperative follow-up data were gathered. The preoperative evaluations (minus UDT) were repeated at 6 months postoperatively. Adverse events (AEs) were reported across all evaluations. RESULTS: Mean age was 56.9 years (30–88 yrs) and average time with incontinence was 6 years (<1–40 yrs). Mean preoperative ALPP was 76 cm H2O (0–258 cm). Mean operating time was 19 minutes (5–73 minutes) and mean blood loss was 34 cc (2–250 cc). Forty-four percent subjects had concomitant repairs. Mean time to urinate without a catheter was 13.4 hours (<1–144 hours) for subjects who underwent Monarc only and 16.4 hours (0–96 hours) for subjects with concomitant repairs. Seventy-eight percent subjects treated with Monarc alone went home without a catheter. One intraoperative adverse event was observed—one vaginal skin perforation (repaired with a suture). Of the 108 patients who completed a 4- to 8-week follow-up visit, 98 (90.7%) subjectively reported being completely dry or substantially continent (not requiring protection). Currently, 58 subjects have completed 6-month follow up with an objective cure rate of 87.9% as defined by a negative cough-stress test. Average pad use per day decreased from 2 pads (0–11 pads) preoperatively to one pad (0–6 pads) at 4–8 weeks and 0.2 pads (0–3 pads) at 6 months postoperatively. Improvements in global QOL scores were statistically significant (P<0.001). Thirty (26.8%) subjects reported preoperative urge symptoms; all of whom reported no urge symptoms at 6 months. Twenty-one (18.8%) subjects developed de novo urge; of those, 48% were taking medication at 6 months. Nineteen device-related AEs were reported in 39 (34.8%) subjects. Device-related AEs (from procedural data in 112 patients) include: 3 (2.7%) UTI, 3 (2.7%) mesh extrusion, 2 (1.8%) pain (abdominal, musculoskeletal), and one (0.9%) each urinary retention, bacterial vaginosis, dysuria, incomplete bladder emptying, rectocele, leg numbness (resolved spontaneously with no nerve injury reported), and abscess of groin incision (suture removed, resolved). Treatment failure resulting in revision of the sling occurred in 4 (3.6%) subjects and sling extrusion into the vagina resulted in one (0.9%) revision. CONCLUSION: Preliminary data shows the Monarc transobturator sling procedure to be a safe and effective treatment of SUI with an objective cure rate of 87.9% at 6 months. No urethral, bladder, bowel, or vascular perforations or hematomas were reported in 112 patients. Return to normal voiding was rapid with minimal voiding dysfunction. Long-term follow-up data are necessary; subjects will be followed through 24 months.

SMALL INTESTINAL SUBMUCOSA TENSION-FREE SLING: POSTOPERATIVE INFLAMMATORY REACTIONS AND ADDITIONAL DATA

The pubovaginal sling using an autologous fascial graft is now generally thought to be the gold standard in treating stress urinary incontinence. There is ongoing debate as to the best alternative sling material and approach. One option is the tension-free mid urethral sling using an 8-ply small intestinal submucosa (SIS) xenograft. Inflammatory reactions have previously been reported in association with this particular procedure.1 Six additional cases are reported herein. A total of 59 patients with stress urinary incontinence underwent surgical treatment between May 2003 and January 2004. Of these patients 18 chose 8-ply SIS. All patients received cephalosporin preoperatively and for 3 days postoperatively. Of these 18 women 6 had postoperative inflammatory reactions.

Urodynamics in the era of tension-free slings: defining the role.

The role of urodynamics in the routine preoperative evaluation of women with stress urinary incontinence is controversial. The introduction of tension-free mid-urethral sling procedures has created a new paradigm in surgical management. The capability of performing these procedures on an ambulatory basis has created more uncertainty about the use of urodynamic testing. The long-term results of these procedures in patients with intrinsic sphincteric deficiency, mixed incontinence, and voiding dysfunction are not clearly known. This article reviews the mechanism of action and results of tension-free slings and proposes a rational role for urodynamic testing in patients considered for these procedures.

Management of Vaginal Erosion of Polypropylene Mesh Slings

The SPARC (American Medical Systems, Minneapolis, Minnesota) polypropylene sling has recently been introduced as an alternative delivery system to TVT (Ethicon, New Brunswick, New Jersey) tension-free vaginal tape for placement of a tension-free mid urethral sling. Erosion must always be considered a risk of synthetic materials. We present 4 cases of vaginal erosion of polypropylene mesh placed with this system and the successful conservative management done. A total of 90 patients received a SPARC polypropylene pubovaginal sling at our institution between October 1, 2001 and October 1, 2002. During followup 3 of our patients and 1 patient with tension-free vaginal tape who was referred from elsewhere presented with vaginal exposure of the mesh. Two patients described persistent vaginal discharge 6 weeks postoperatively, including 1 who complained primarily of partner discomfort during sexual intercourse. Two patients were completely asymptomatic and mesh erosion was discovered at routine physical examination 6 weeks postoperatively. Pelvic examination demonstrated vaginal exposure of the mesh in all cases. Each patient was observed conservatively and 3 months postoperatively all 4 had complete spontaneous epithelialization over the mesh. None had stress incontinence, urgency or urge incontinence, all emptied the bladder to completion and all patients were completely satisfied with the procedure. The recent literature suggests that polypropylene mesh erosion should be treated with complete removal of the sling material. We present 4 cases of vaginal erosion of polypropylene slings that were managed conservatively with observation and resulted in complete spontaneous healing. Sling preservation with continued patient continence and satisfaction is a feasible option in those with vaginal exposure of polypropylene mesh.