Synthetic Suburethral Slings Research Articles

MP-04.14: The efficacy of trans-section of synthetic sub-urethral sling tape for treatment of obstructive voiding symptoms following transobturator sling surgery after 3 years' follow up

The objective of this study is to evaluate outcome of trans-section of sub-urethral sling in treating obstructive voiding symptoms following transobturator sling surgery and to evaluate recurrence rate of stress urinary incontinence (SUI) and degree of voiding dysfunction after minimal 3-year follow-up.

Short‐term clinical and quality‐of‐life outcomes in women treated by the TVT‐Secur procedure

The TVT-Secur (Ethicon, Somerville, NJ, USA) is a minimally invasive suburethral synthetic sling used in the treatment of female stress urinary incontinence. It claims to cause less postoperative pain and to enable performing in an office setting. However, this may be at the expense of a significant learning curve and a higher early failure rate. To assess objectively the success rate of the TVT-Secur procedure in the 'U' configuration at six months. Secondary outcomes focussed on subjective success rates, complications, patient satisfaction and quality-of-life (QOL). A prospective observational study was undertaken at two tertiary referral urogynaecology centres. A cohort of 42 consecutive patients with urodynamic stress incontinence who underwent the TVT-Secur procedure in the 'U' configuration between November 2006 and August 2007 were followed up for six months. Three standardised QOL questionnaires were completed preoperatively and at six months. A urogenital history, visual analogue score (VAS) for patient satisfaction, uroflow and urinary stress test were performed at six months. Recruitment was ceased prematurely because of a high number of early failures. Objective and subjective success rates at six months were 58.3% and 51.3% respectively. Complications included urinary tract infections, voiding difficulty, groin discomfort, haematoma, vaginal pain, tape erosion and intra-operative dislodgement of tape. Prevalence of de novo urge incontinence was 10.3%. Only symptom-specific QOL scores improved and only 48.6% indicated a high level satisfaction (VAS > or = 80%) with TVT-Secur. On the basis of this limited study, we are hesitant to recommend the 'U' configuration of the TVT-Secur over its more established counterparts, the TVT and TVT-O.

Minimally Invasive Synthetic Suburethral Sling Operations for Stress Urinary Incontinence in Women

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Efficacy of Synthetic Suburethral Slings in Female Urinary Stress Incontinence with Overactive Bladder

Objectives: The aim of the present study was to investigate the efficacy of synthetic suburethral slings in female stress urinary incontinence (SUI) patients with overactive bladder (OAB).Methods: From May 2002 to April 2005, a total of 295 women with SUI underwent suburethral sling procedure. Of the 295 women, only those who were followed up for at least 12 months were included in the study, yielding 236 patients. The patients were divided into three groups: pure SUI; SUI with OAB dry; and SUI with OAB wet. Telephone questionnaires by were used to evaluate the postoperative improvement of SUI and storage symptoms.Results: There were significant differences in preoperative symptom score, quality of life (QoL) score, and preoperative voided volume among the three groups. There were no significant differences among the three groups in terms of the cure rate for the stress component (group 1, 88.6%; group 2, 86.2%; group 3, 86.7%; P = 0.943). Eighty percent of group 1 patients improved in frequency, but two patients (2.3%) complained of de novo urgency. In group 2, 81.5 and 82.7% improved in frequency and urgency, respectively, but one patient (1.7%) complained of de novo urge incontinence. In group 3, 76.9 and 84.4% improved in frequency and urge incontinence, respectively.Conclusion: Suburethral slings are simple, safe and highly effective in treating SUI with OAB.

The Bone Anchor Suburethral Synthetic Sling for Iatrogenic Male Incontinence: Critical Evaluation at a Mean 3-Year Followup

We retrospectively report objective and subjective outcomes in 40 male patients who underwent bone anchored suburethral synthetic sling positioning for stress urinary incontinence due to intrinsic sphincter deficiency. Patients with stress urinary incontinence due to radical retropubic prostatectomy (32), robot assisted laparoscopic prostatectomy (3) and transurethral prostate resection (5) underwent bone anchored suburethral synthetic sling positioning between December 2002 and December 2007. Mean followup was 35.2 months (range 2 to 62). Previous anti-incontinence procedures, radiotherapy and transurethral procedures due to urethral stricture were performed in 5, 11 and 5 patients, respectively. Before and after surgery patients were evaluated by physical examination, urethral cystoscopy, urodynamics, a 1-hour pad test and a quality of life questionnaire. Patients were stratified into 3 groups, including group 1-cured (dry with a pad weight of 0 to 1 gm), group 2-improved (mild to moderate incontinence with a pad weight of 2 to 50 gm) and group 3-failed (patient condition unchanged with a pad weight of greater than 50 gm). At the final followup visit 22 (55%), 5 (12.5%) and 13 patients (32.5%) were cured, improved and failed, respectively. Mean pad weight significantly decreased to 51.3 gm in 54% of cases, while the mean total questionnaire score significantly increased to 72.9 in 65% and abdominal leak point pressure significantly increased to 92.5 cm H(2)O in 52%. Statistical analysis showed a significant association between preoperative radiotherapy and treatment failure (85% of patients). Complications were perineal pain in 73% of cases, detrusor overactivity in 5% and sling infection in 15%. The bone anchored suburethral synthetic sling is a simple and attractive procedure that can produce immediate good results with low morbidity, especially when strictly selected patients are treated. Radiotherapy remains a strong predictor of failure.

Prise en charge des complications érosives après mise en place d’une bandelette sous-urétrale

To describe the management of patients with an erosive complication after tension free vaginal tape. To establish a diagnostic approach, describe the results on symptoms and continence after a conservative surgery. Retrospective descriptive study of 38 patients supported for complications after suburethral synthetic sling. We have diagnosed 12 erosions vaginal and five bladder erosions. Patients have been treated from a recovery surgery according to a conservative approach (partial resection or endoscopic section). Of the 12 patients with a vaginal erosion, 10 expressed symptoms in relation with their erosion. After partial resection, eight patients (80% of patients with symptomatic erosion) did not have more complain. Of these, 50% were continent, the other with mostly a slight recurrence accessible to a second suburethral sling. First endoscopic section was a minimally invasive option for bladder erosion. However, an only cystoscopic approach seemed to be not sufficient to cut the sling as far as possible. After section, two patients have been treated from a laparotomy with bladder dissection, one for immediate outcome unsatisfactory, the other for reccurent symptoms. The results for continence were excellent as the suburethral portion was not resected. Our study showed the importance of regular clinical surveillance, feasibility and the relative success of this conservative approach. The technical feasability and the increasing number of patients must not forget to respect good indication and rigorous technique. These complications invite us to moderate our indications especially for young patients.

The use of synthetic sub-urethral slings in the treatment of female stress urinary incontinence

We set out to review the existing literature regarding the use of synthetic suburethral sling products for the treatment of female stress urinary incontinence. Products currently implanted are examined and scrutinized, and evidence regarding their efficacy and complication rates is noted. Additionally, specifics of presently utilized synthetic materials, including construction method and biocompatibility, are explored and directly correlated to currently marketed products. This investigation was undertaken with the use of the Medline database. Studies pertaining to synthetic or surgical mesh, as well as each specific suburethral sling product, are included. Our findings and ultimately our recommendations stem from the preponderance of evidence supporting the continued use of knitted, macroporous polypropelene mesh slings. Several existing marketed products detailed in the study fit this description. Specific reference is made to recent reports of vaginal erosions and deep space infections related to several specific products. A cautionary note is also made regarding the implantation of transobturator sling products currently marketed without the necessary pre-market testing, potentially placing the public at risk. From the currently available literature on biomaterials, it seems clear that knitted macroporous polypropylene is the material of choice for suburethral implantation. With respect to the means and techniques by which these mesh materials are suburethrally implanted, the surgeon's choice often dictates which method is used, but recent experience has demonstrated that the transobturator approach can be equally as effective as the traditional tension-free vaginal tape, with less-associated morbidity. Ongoing randomized controlled trials will further clarify and distinguish between methods.

Why pelvic floor surgeons should utilize ultrasound imaging

Why pelvic floor surgeons should utilize ultrasound imaging

Safety of a New Transobturator Suburethral Synthetic Sling (TVT-O) Procedure During the Training Phase

ObjectiveThe TVT-O (Ethicon, Somerville, NJ) is a new transobturator suburethral synthetic sling used in the treatment of female stress urinary incontinence (SUI). This study aimed to evaluate the complication rates and procedural times associated with performing this procedure during a period of transition from the retropubic tension-free vaginal tape (TVT) procedure to the transobturator TVT-O procedure. MethodsWe performed a retrospective analysis of the first 50 patients to undergo the TVT-O procedure in one gynaecologist’s practice. All patients had SUI or mixed urinary incontinence. Operative times and intraoperative and perioperative complications were recorded. At the two-week and six- to eight-week postoperative reviews, a urogenital history and examination were performed. ResultsThe only complications encountered were two cases (4%) of urinary tract infection and one case (2%) of superficial wound infection. There were no cases of postoperative voiding difficulty, hemorrhage, hematoma, persistent groin pain, or vascular or visceral injuries. The mean procedural time was 21 minutes. ConclusionThese preliminary results indicate that the TVT-O procedure is a safe treatment for female SUI even during the training phase. In light of the safety and the ease of transition to this technique, this finding is encouraging for surgeons who are making the transition from other surgical procedures for female SUI to the transobturator TVT-O.

Various surgical approaches to treat voiding dysfunction following anti-incontinence surgery

The aims of this study are to report the efficacy of retropubic urethrolysis, vaginal urethrolysis, and cutting of synthetic suburethral slings in treating postoperative voiding dysfunction that occurs after anti-incontinence surgery and to report the recurrence rate of stress urinary incontinence (SUI). All patients from January 1996 to October 2003 who presented with voiding dysfunction following an anti-incontinence procedure and who subsequently underwent either retropubic urethrolysis, vaginal urethrolysis, or synthetic suburethral sling takedown were included in the study. Pre- and postoperative irritative symptoms (urinary frequency or urgency), obstructive symptoms (hesitancy, voiding difficulty, and incomplete emptying), and stress urinary incontinence symptoms were obtained in a standardized fashion. The Incontinence Impact Questionnaire and Urogenital Distres Invetory quality of life (QOL) questionnaires were also obtained to objectify these symptoms. Other objective postoperative analysis included simple uroflowmetry, measurement of postvoid residual (PVR), and simple or subtracted cystometry. Forty-four patients were included in the study (suburethral sling takedown = 14, vaginal urethrolysis = 20, and retropubic urethrolysis = 10), 77% of whom had objective follow-up. Preoperatively, 31 patients (70.5%) had irritative symptoms, 41 (93.2%) had obstructive symptoms, and 6 (13.6%) had symptoms of stress urinary incontinence (SUI), while postoperatively, these symptoms were found in 30 (68.2%), 11 (25.0%), and 18 (40.9%), respectively. Postoperatively, 6 patients (17.6%) had a PVR > 100 cc, 5 patients (14.7%) had a bladder contractions, and 16 patients (47.1%) demonstrated the sign or diagnosis of (SUI). Additionally, there was a statistically significant improvement in both QOL questionnaires. Various surgical approaches may be used to treat voiding dysfunction following an anti-incontinence procedure. Following a vaginal or retropubic urethrolysis or takedown of a synthetic suburethral sling, obstructive symptoms are likely to improve, irritative symptoms may remain unchanged, and almost half will develop recurrence of SUI.

Biomechanics and biocompatibility of synthetic suburethral slings

Aim of study: The aim of our work was to find the correlation between biomechanical properties of synthetic suburethral slings and tissue reaction after implantation of them.

Minimally invasive synthetic suburethral slings: emerging complications

The tension-free vaginal tape (TVT) and related suburethral mesh devices have revolutionised the management of urinary stress incontinence worldwide and the available evidence suggests that they are as effective as existing continence procedures. They have been marketed as minimally invasive procedures with low complication rates. Evidence concerning the safety and efficacy of these new products, which include transobturator devices, is gradually emerging, but not before the widespread adoption of these techniques for first-line treatment of stress incontinence. This review explores current evidence of emerging complications associated with these techniques.

Surgical management of stress urinary incontinence.

This review evaluates the most recent knowledge regarding surgical management of stress urinary incontinence. A comprehensive MEDLINE search was performed, limited to those articles published from 1995 to 2005. In total, 470 articles were reviewed-the most relevant of which were considered, and additional ones were selected by reviewing these studies' bibliographies. Overall, 53 articles were selected and used in this study. Few randomized controlled trials have been performed. The best results of retropubic procedures are seen when the intrinsic urethral sphincter is competent and its effectiveness is sustained in the long term. A laparoscopic approach, although less popular and with a lower short-term cure rate, is an alternative. Sling surgeries can be the first-line treatment for all types of stress urinary incontinence. Autologous grafts are still considered the gold standard, but synthetic materials such as tension-free tape have comparable results with standard open retropubic procedures. Still, long-term cure and complication rates have not yet been elucidated. Using urethral bulking agents is the least invasive approach, applicable in both intrinsic sphincter deficiency and urethral hypermobility. However, it has a poor long-term outcome and necessitates repeat injections. Long-term data suggest that Burch colposuspension and sling procedures produce similar objective cure rates. New synthetic suburethral slings such as tension-free vaginal tape have gained popularity in recent years. Complications of traditional and newer suburethral slings are declining but still occur and often are associated with serious morbidity. New therapies must be studied in randomized clinical trials.

Unrecognized bladder perforation while placing a suburethral synthetic sling: a minimally invasive technique for removing an intravesical sling segment

BJU InternationalVolume 95, Issue 1 p. 187-188 Unrecognized bladder perforation while placing a suburethral synthetic sling: a minimally invasive technique for removing an intravesical sling segment Lewis W. Chan, Lewis W. Chan Department of Urology, Concord Repatriation General Hospital, Sydney, AustraliaSearch for more papers by this authorVincent W. Tse, Vincent W. Tse Department of Urology, Concord Repatriation General Hospital, Sydney, AustraliaSearch for more papers by this author Lewis W. Chan, Lewis W. Chan Department of Urology, Concord Repatriation General Hospital, Sydney, AustraliaSearch for more papers by this authorVincent W. Tse, Vincent W. Tse Department of Urology, Concord Repatriation General Hospital, Sydney, AustraliaSearch for more papers by this author First published: 20 December 2004 https://doi.org/10.1111/j.1464-410X.2005.05275.xCitations: 5 Lewis W. Chan, Department of Urology, Concord Repatriation General Hospital, Hospital Road, Concord, NSW 2139, Australia. e-mail: [email protected] Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article.Citing Literature Volume95, Issue1January 2005Pages 187-188 RelatedInformation

Rising awareness of the complications of synthetic slings

This article will review the current literature on the complications of synthetic suburethral slings used in the treatment of stress urinary incontinence and the management of these complications. Loosely applied mid-urethral synthetic slings are becoming the treatment of choice in the management of stress urinary incontinence. Despite the ease of carrying out these procedures there is still a learning curve and, whilst the current literature shows there has been a significant reduction in the complication rate in recent years with the use of modern synthetic slings, they still occur and can be a significant cause of morbidity. There has been interest in developing better imaging techniques for both establishing early diagnosis and in assisting in the treatment of complications; magnetic resonance imaging of the urethra has been one of the modalities that has been investigated. Further work is needed to predict those who are more likely to develop complications during the placement of suburethral slings; the use of urodynamic procedures has shown equivocal results. Inevitably with more experience the techniques have evolved for the management of complications, such as the treatment of urethral obstruction with transvaginal sling incision. Synthetic materials for slings provide an effective and safe method for treating urinary stress incontinence in women, and have delivered improved efficacy; nevertheless, although the incidence of complications has significantly reduced in recent years, they still represent a significant and not unsubstantial morbidity.

Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects.

Ultrasound imaging is rapidly replacing radiological methods in the investigation of pelvic floor disorders. Transrectal, transvaginal/introital and transperineal/translabial methods are being employed, with the latter probably the most widespread due to ease of use and availability of equipment. Position and mobility of the bladder neck, bladder wall thickness, pelvic floor muscle activity and uterovaginal prolapse can be quantified, and color Doppler may be used to document stress urinary incontinence. Ultrasound imaging has simplified audit activities and enhanced our understanding of the effects of incontinence and prolapse surgery, such as the new synthetic suburethral slings. In recent years, imaging methods have contributed significantly to our understanding of the traumatic effects of childbirth on the pelvic floor. Finally, the assessment of pelvic floor biomechanics may have implications for clinical obstetrics and ultimately for the prevention of delivery-related pelvic floor trauma.

Mechanical properties of urogynecologic implant materials.

Synthetic suburethral slings have recently become popular despite the risk of erosion commonly associated with synthetic implants. Some of these materials seem to have unexpectedly low erosion rates. Based on the hypothesis that erosion is due, in part, to biomechanical properties, we undertook an in vitro study. The biomechanical properties of eight non-resorbable synthetic implant materials, stiffness (slope, N/mm) and peak load (N) were determined from load vs. displacement curves. Open-weave Prolene mesh showed unique biomechanical properties compared to other tested materials. The tension- free vaginal tape had the lowest initial stiffness (0.23 N/mm), i.e. low resistance to deformation at forces below the elastic limit, whereas the stiffest implant tested, a nylon tape, reached 6.83 N/mm. We concluded that the TVT and other wide-weave Prolene tapes have unique biomechanical characteristics. These properties may be at least partly responsible for the apparent clinical success of the implants.

Complications of urethral sling procedures

To review the current literature on complications of suburethral slings used to treat stress urinary incontinence in the female. The surgical treatment of female urinary incontinence has changed considerably since the development of the tension-free vaginal tape procedure, introduced by Ulmsten in 1995. As the follow-up for the first studies is now more than 5 years, the 'long-term' results of the technique can be evaluated. Furthermore, now that the learning phase has been completed and the technique can be considered to be well mastered, it is interesting to review the complications inherent in this technique, their frequency, including those rarer complications that are sometimes associated with severe morbidity, and to consider the ways in which these complications can be prevented or treated. The development of the tension-free vaginal tape procedure has not prevented the development of other types of suburethral sling, but on the contrary, has promoted the development of these alternatives by the use of various sling insertion techniques, and especially various types of materials. There has even been a renewed interest in materials that have been known for a long time (heterologous and autologous materials) in some recent papers, and new synthetic suburethral slings have been proposed with the objectives of combining low morbidity, safety and efficacy. Monofilament polypropylene meshes can be used safely to perform suburethral slings and seems to be the most suitable material in this indication according to the existing literature.

Risk Factors for Rejection of Synthetic Suburethral Slings for Stress Urinary Incontinence

Risk Factors for Rejection of Synthetic Suburethral Slings for Stress Urinary Incontinence

Risk factors for rejection of synthetic suburethral slings for stress urinary incontinence: a case-control study

OBJECTIVE: To identify variables associated with rejection of synthetic, suburethral slings used for female stress urinary incontinence. METHODS: Between 1991 and 1998, gynecologists at our department performed 428 operations for stress urinary incontinence by inserting expanded polytetrafluoroethylene or polyethylene suburethral slings. After suitable exclusions, 386 women followed for at least 24 months after surgery remained for analysis. Of the 386 women, 47 (12.2%) had graft rejection or symptoms associated with rejection within 24 months after surgery, which led to later removal. We compared cases and controls using logistic regression analyses with forward selection to identify independent risk factors and risk markers for rejection. RESULTS: The rejection rate declined sharply during the years 1993–1994 after introduction of routines that included preoperative prophylactic antibiotics active against anaerobes and repeated preoperative treatment of the vagina with chlorhexidine acetate. After adjusting for potentially confounding variables, surgery after 1993, the gynecologist performing the procedure, and adequate antibiotic prophylaxis remained significantly associated with a lower rejection rate. There was no significant association between rejection and sling material, age at surgery, year of surgery (in one year steps), or concomitant prolapse surgery. CONCLUSION: Rejection of suburethral slings might be associated with bacterial contamination of the graft, and the rate was decreased with prophylactic antibiotics a repeated and vaginal disinfection.