Tension-free Tape Research Articles

Review of transobturator and retropubic tape procedures for stress urinary incontinence

Recently, various types of tension free vaginal tapes via retropubic and transobturator route (inside-out technique; outside-in technique) have been adopted for treatment of stress urinary incontinence. The aim of this review is to assess the recent evidence on effectiveness and complications of these tapes in stress urinary incontinence. There was no significant difference found between tension free vaginal tapes and colposuspension for the cure of stress urinary incontinence at 5 years in a multicentre randomized controlled trial. Vault and posterior vaginal wall prolapse were commoner after colposuspension. A recent systematic review and meta-analysis reported that subjective cure for inside-out technique (five randomized controlled trials) and outside-in technique (six randomized controlled trials) at 2-12 months was no better when compared with tension free vaginal tapes (odds ratio: 0.85; 95% confidence interval: 0.60-1.21). Bladder injuries (odds ratio: 0.12; 95% confidence interval: 0.05-0.33) and voiding difficulties (odds ratio: 0.55; 95% confidence interval: 0.31-0.98) were less common, whereas groin/thigh pain (odds ratio: 8.28; 95% confidence interval: 2.7-25.4) and vaginal injuries or mesh erosion (odds ratio: 1.96; 95% confidence interval: 0.87-4.39) were more common in transobturator tapes. Sexual function was overall improved; the pain being more with outside-in technique than inside-out technique route. The tension free tapes are effective in treating stress urinary incontinence; evidence for superiority of transobturator over retropubic tapes is currently limited.

Einfluss von Persönlichkeit auf die Lebensqualität nach einer Harninkontinenzoperation: Ergebnisse nach spannungsfreier transobturatorischen Tape-Implantation (TOT)

We evaluated the two-year follow-up results for tension-free obturator tape operations by comparing patients before (n = 64) and after (n = 204) the procedure, using the King's Health Questionnaire and the Giesen test. A psychometric analysis of the two groups showed an improved quality of life (with particular focus on the social impact, day-to-day activities, stress due to incontinence, sleep disturbance and general health). The success of the operation could not be explained by personality factors. Subjective cure rates of 79.9 % together with an improved ability to form social contacts demonstrated the success rate of the innovative TOT method.

Sexual function in women following the transvaginal tension-free tape procedure for incontinence

Objective: To assess the impact of the tension-free vaginal tape (TVT) procedure on the sexual function of women who underwent this treatment for stress urinary incontinence (SUI). Method: The Lemack questionnaire was mailed to 135 women treated for SUI only, with no concomitant pelvic organ prolapse repair. Results: Of the 82 returned questionnaires (60.7%), 66 (80.5%) could be included in the analysis. Compared with preoperative responses, there were no significant postoperative changes regarding frequency of sexual intercourse, satisfaction with sexual intercourse, or personal importance of having an active sexual life. Although there was a significant postsurgical decrease in urinary coital incontinence ( P = 0.02) and 12 women (25.5%) reported improved satisfaction from intercourse, 11 women (23.4%) complained of a worsening. Conclusion: These results suggest that TVT for SUI does not significantly affect sexual function in women. Additional prospective studies are warranted to verify these preliminary findings and compare the impact of the TVT with that of other anti-incontinence procedures.

Comparison of the Efficacy and Vaginal Erosion Rate between Monofilament and Multifilament Polypropylene Tapes for Treating Urinary Incontinence

Purpose: We compared the efficacy and vaginal erosion rates between a polypropylene multifilament tape (anterior intravaginal slingplasty; IVS) and a polypropylene monofilament tape (tension free vaginal tape; TVT) as surgical implants for suburethral, tension-free tape for the treatment of stress urinary incontinence (SUI). Materials and Methods: We retrospectively reviewed the women (n=272) who underwent an anterior IVS (n=142) or a TVT (n=130) procedure for managing SUI, between January 2004 and December 2005 at Cheil General Hospital. Only 216 patients (the anterior IVS group: 112, the TVT group: 104) with a follow-up of at least 24 months were included in this study. Preoperatively, each patient received a history review, a physical examination, a voiding diary, a pad test, uroflowmetry and determination of the postvoid residual urine. Follow-up evaluations were performed at 1 month, 3 months and annually after the operation. Results: The two groups were similar for their preoperative characteristics. There was no significant difference between the 2 groups in terms of the cure rate: cure (89.29% vs. 89.42%, respectively, p=0.974), improvement (6.25% vs. 7.69%, respectively, p=0.677), and failure (4.46% vs. 2.89%, respectively, p=0.539) for the anterior IVS and TVT groups, respectively. Nine women developed vaginal erosion, and this occurred significantly more in the anterior IVS group than the TVT group (7.14% vs. 0.96%, respectively, p=0.036). Conclusions: Anterior IVS and TVT appear to be equally effective for the surgical treatment of female SUI. However the number of women who were diagnosed with vaginal erosion was significantly higher in the anterior IVS group than in the TVT group. It is possible that the multifilamentous nature of the anterior IVS tape might contribute to vaginal erosion. (Korean J Urol 2008;49:844-849) 󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏󰠏

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

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.

Case report: Osteomyelitis following a transobturator sling (TVT‐O)

The estimated prevalence of urinary incontinence (UI) among women in Europe is 35%, of whom 70% have stress (stress urinary incontinence [SUI]) or mixed UI.1 Tensionfree tape procedures have become widespread for treatment of SUI. The technique, which is effective, is nonetheless associated with a risk of complications.2 The complications of the tension-free vaginal tape (TVT) are related to the retropubic access route and include tape erosion, bowel injury, bladder injury and vascular injury, including haematoma.3 As an alternative procedure to the retropubic slings, the transobturator approach to apply the sling has been adopted. This access route limits the potential risks of bladder lesions and does not traverse the pelvic/abdominal cavities. The first method of transobturator suburethral suspension was described by Delorme4 presented as an outside–in technique (i.e. passing the insertion device from lateral to medial through the obturator foramen to emerge in a vaginal incision) (TOT ; Medical Mentor Systems, Leiden, the Netherlands). In 2003, the transobturator route had been used with and inside–out technique reported by de Leval5 (i.e. beginning at a vaginal incision and passing the insertion device laterally through the obturator foramen) (TVT-O ; Ethicol, Somerville, NJ, USA). This is the first case report of a patient presenting with osteomyelitis following a TVT-O procedure.

POS-01.133: Clinical trial of tension-free transobturator suburethral tape (inside-out TVT-O) procedure for the treatment of stress urinary incontinence

POS-01.133: Clinical trial of tension-free transobturator suburethral tape (inside-out TVT-O) procedure for the treatment of stress urinary incontinence

MP-07.16: Seven year follow-up of the tendinous vaginal support: a minimally invasive approach for stress urinary incontinence

Despite the good cure rate reported with TVT, major complications such as, bowel and major blood vessels injuries have been described. To avoid these complications, transobturator approach was developed. The continence rate of this procedure has been similar to those obtained with transvaginal retropubic approach.The study presents the long term follow up of the tendinous urethral support (TUS), an anatomical approach for treating female stress urinary incontinence that consists in placing a mid-urethral tension-free tape anchored to the tendinous arc bilaterally.

Transvaginal vs transobturator approach for synthetic sling placement in patients with stress urinary incontinence

We present comparative short-term experience with the transvaginal (TVT) and the transobturator (TVT-O) approaches for the treatment of stress urinary incontinence (SUI). We studied 315 women with SUI, treated with a tension-free tape placement. The TVT approach was applied in 265 women, while 50 women were treated by the TVT-O approach. The mean operation time was 25 and 17 min in the TVT and TVT-O group, respectively (p<0.001). In the TVT group, continence rates were 87% after 1 year, while in the TVT-O group, the continence rate was 94%. Postoperative pain was reported in 14.4 and 28% of the TVT and TVT-O patients, respectively (p=0.02). Complications such as bladder perforation, retropubic hematoma, and urinary retention took place only in the TVT group. Urinary tract infections were recorded in 20 and 8% of the TVT and TVT-O patients, respectively (p=0.04), while vaginal erosion took place in 1.5 and 2% and de novo urgency in 14 and 8%. Both approaches show high rates of cure at the first postoperative year, while complications are less with the TVT-O procedure.

Cirugía de la incontinencia urinaria femenina en régimen de cirugía mayor ambulatoria: Estudio de impacto presupuestario

The surgical procedures for the insertion of tension free vaginal tapes in the treatment of female stress urinary incontinence (SUI) are simple and can be done as outpatient operations. The aim of this study was to perform a budget study comparing TVT in an outpatient basis with transobturator tape (TOT) with hospital admission.Retrospective analysis of the medical records of 23 patients undergoing surgery for SUI between October 2004 and October 2005. 13 patients were treated by TVT in an outpatient basis (group 1, Department of Urology), 10 patients were treated by TOT with hospital admission (Group 2, Department of Gynaecology). Cost analysis was carried out by the construction of a Marcov model, incorporating the time sequence of the treatment, including adverse events and results. Variables considered for the analysis: number of visits, preoperative tests, operative time, tape cost, hospital stay, unpredicted visits in the first postoperative month at the outpatient clinics or emergency room, and hospital readmissions. Statistical analysis was performed with the G-Stat software. Student's t test was used to compare quantitative variables.11/13 patients (84.6%) in group 1 completed the day-surgery protocol. Mean surgical time was 61.7 min. (SD 16.2; 35-100) and 61.6 min. (SD 8.3; 50-73) for groups I and 2 respectively. Two cases in group 1 had perioperative complications (15.4%); no patient in group 2 had perioperative complications. Mean hospital stay was 1.3 days for group 1 (SD 0.85; 1-4) and 2.9 days for group 2 (SD 0.31; 2-3). Three patients in group 1 (23%) and 2 in group 2 (20%) presented postoperative complications. Mean cost per process was 4740 EUR for group 1 and 7099 EUR for group 2.SUI correction by tension free tapes as day surgery is a valid option which saves a substantial amount of resources.

Efficacy, safety and hospital costs of tension‐free vaginal tape and pubovaginal sling in the surgical treatment of stress incontinence

The efficacy, safety and hospital costs of the tension-free vaginal tape procedure were compared with the pubovaginal sling operation. A total of 60 women urodynamically diagnosed as having stress or mixed urinary incontinence were operated on using either the tension-free vaginal tape or pubovaginal sling operation in a prospective manner. Preoperative characteristics of the women were not significantly different for the groups. The women were followed for up to 24 months. In the tension-free vaginal tape group, the operation time was shorter, numbers of analgesics postoperatively required were less and hospital charges were less expensive compared to those in the pubovaginal sling operation (P < 0.01). Kaplan-Meier survival analysis showed a marginal significant difference (P = 0.059) in the objective cumulative cure rates at 24 months between the groups receiving the former (70.3%) and latter (48.3%) procedures. Subjective cure rates were not significantly different (P = 0.101). In both groups, an improvement in quality of life was significant and surgical complications were identical. De novo urge incontinence developed in 6% and 10% in the former and latter, respectively. The tension-free tape was significantly superior to the pubovaginal sling in terms of operation time, postoperative pain, and hospital charges, but not in cure rates. A longer follow up with a larger sample size is necessary to draw definite conclusions.

Tension-free obturator tape (Monarc Subfascial Hammock) in patients with or without associated procedures

The aim of the present study was to evaluate the safety and efficacy of the tension-free obturator tape (TOT) procedure in patients having concomitant hysterectomy and/or pelvic reconstructive surgery. A chart review from August 2002 to December 2004 identified 341 consecutive female patients with stress urinary incontinence who had undergone a TOT procedure alone (Monarc only group) or a TOT procedure associated with hysterectomy or other pelvic reconstructive surgery (Monarc + other surgery group). Intraoperatively, three cases of hemorrhage occurred. No transfusions were required. There were no cases of bladder injury or injury to obturator nerves or vessels during needle passage via the transobturator route. Three cases of vaginal erosion were found at 3 months follow-up, but no tape removal was required. Two hundred fifty-four patients (74.5%) were contacted by telephone for a second follow-up (average 17 months, range 6-32) and the validated short forms of the Urogenital Distress Inventory (UDI-6) questionnaire and of the Incontinence Impact Questionnaire (IIQ-7) were administered. Results showed a very good quality of life score (0-7) in 93.3% patients. Globally, only three (1.2%) patients had persistent urine leakage related to physical activity. Severe voiding dysfunction occurred in five (2%) patients. The cure rate, considered as the complete absence of urine leakage (score 0 in questions 2 and 3 of the UDI-6), was 73.7% in the Monarc only group vs 57.4% in the Monarc + other surgery group. Pelvic floor defects, benign uterine disorders, and stress urinary incontinence can be safely treated with transobturator tape, using the Monarc device, and concomitant vaginal procedures.

Managing stress urinary incontinence - a primary care issue

Stress urinary incontinence (SUI) is a common condition in women, caused by anatomical problems related to factors such as age, parity, menopause and obesity. Depending on the clinical findings and on the severity of symptoms, SUI can be managed with conservative methods including pelvic floor exercises, vaginal cones and general lifestyle modification advice; or, it can be treated surgically with procedures such as Burch colposuspension, vaginal slings or tension-free tapes and injection of bulking agents alongside the urethra. SUI is greatly underdiagnosed, because many women are reluctant to consult their doctors about their condition. Department of Health guidelines are placing greater emphasis on primary care management of the condition and Primary Care Trusts (PCTs) to provide consistent, integrated continence care services. The availability of new, non-invasive treatment options, such as duloxetine, are likely to have a positive impact on the future of SUI management.

Editor's Choice

Editor's Choice

A Randomized, Controlled Trial Comparing Fascia Lata and Synthetic Mesh for Sacral Colpopexy

One hundred women with posthysterectomy vaginal vault prolapse who were scheduled for sacral colpopexy at the University of Louisville Health Sciences Center participated in this double-blind, randomized trial comparing the use of cadaveric fascia lata and polypropylene mesh. The Pelvic Organ Prolapse Quantification system (POP-Q) was used for patient evaluation preoperatively and at 3 months, 6 months, and 1 year postoperatively. Fascial lata was used in 46 patients and polypropylene mesh was used in 54. Eighty-nine women, 44 in the fascia group and 45 in the mesh group, completed the 1-year study period. The 2 groups were similar in social demographics, clinical characteristics, and operative data. Adverse events possibly related to the graft were experienced by 26% of women who received mesh and 15% of women who received fascia (P = .19). Other surgical procedures, in tension-free tape procedures, posterior repairs, and paravaginal repairs were performed frequently and at similar rates in the 2 groups. At the 1-year examination, the rate of objective anatomic failure, as defined by Weber et al, was greater in the women who received fascia (14 of 44; 32%) compared with those who received mesh (4 of 45; 9%) (P = .007). There were 15 instances of POP-Q point Aa (point along the distal anterior vaginal wall) and 3 of POP-Q point Ap (posterior vaginal wall) reaching at least the −1 position. There were no point C (vaginal cuff) failures. The results of the POP-Q evaluations changed over the year of observation. At the end of 12 months, significant differences in between the 2 groups were seen for the mean values of point Aa (P = .02), point C (P = .04), and prolapse stage (P = .03). No differences were seen in total vaginal length, genital hiatus, perineal body, or points Ap or Bp (points along the posterior vaginal wall). When risk factors for surgical failure of sacral colpopexy, other than graft material (age, body mass index, prior prolapse or continence surgery), were subjected to univariate analysis, no significant predictors of failure were seen.

Comparison between monofilament and multifilament polypropylene tapes in urinary incontinence

Objective: We compare the efficacy and late complications between a polypropylene monofilament tape (TVT) and a polypropylene multifilament tape (IVS) in the surgical implant of sub-urethral, tension free tape for the treatment of stress urinary incontinence (SUI). Methods: It is a non-randomised, monocentric retrospective study. Two questionnaires were sent to the patients. The first questionnaire determined the efficacy of the tape and the tolerance of the urinary process. The second questionnaire evaluated discomfort and consequences linked to urinary incontinence and associated urinary troubles. Results: The study included 313 female patients and 256 (82%) responded to the questionnaire (137 TVT, 119 IVS). Patient satisfaction was 88.3% for the TVT tape and 73.5% for the IVS tape ( p < 0.005). The improvement of the quality of life was also higher for the polypropylene monofilament tapes. “De novo” urge incontinence was more common in the TVT group. However, the rates of dysuria and infection of tapes were more common in the IVS group. Conclusion: The type of tape appears to influence efficacy and the emergence of late complications. Our results point at the greater efficacy of the polypropylene monofilament tape.

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.

SUI: Current Management and Unmet Needs

Stress urinary incontinence (SUI) is one common type of incontinence among women. It can have a serious impact on their quality of life. Many women are ashamed to talk about their problem and try to cope with their incontinence themselves. Those women who do seek treatment should initially undergo a basic evaluation to determine the type of incontinence which is present. In case of mild to moderate SUI, conservative treatment can be initiated. This includes lifestyle modifications and pelvic floor muscle training (PFMT). PFMT is effective, provided the patient is trained and able to perform a correct pelvic floor muscle contraction. PFMT is not invasive, but its efficacy depends on long-term compliance. In case of failure of conservative treatment and for women with severe SUI, surgery is today the only solution. There is a wide variety of surgical procedures available, of which the Burch colposuspension is best documented and is still considered the “gold standard”, because of well-known long-term follow-up. The tension-free tape procedures have become very popular the latest years, although more long-term follow-up data (up to 5–10 years) are needed. Only a scarcity of adequately performed randomised, controlled trials (RCTs) is available which evaluated the current treatments available for SUI. There is clearly a need for large, rigorous, prospective RCTs of high quality. Furthermore, there is a need for an efficacious and safe new pharmacological treatment for women with SUI. Duloxetine, a potent and balanced serotonin and noradrenaline reuptake inhibitor, is a promising candidate to fill this gap in the near future.

Stressharninkontinenz der Frau

The integral theory of Petros and Ulmsten has profoundly changed our understanding of the female pelvic floor. Anatomic laxity of the vaginal wall caused by pelvic floor defects induced at different damage zones is frequently not only responsible for stress urinary incontinence but also for pollakisuria, urgency, post-void residual and pelvic pain. A number of minimally invasive techniques have been developed to correct these defects. Applying a tension-free polypropylene tape around the mid-urethra has become an established method to correct the anterior ligaments. The infra-coccygeal sacropexy can achieve dorsal stabilization of the vaginal wall. Currently, polypropylene meshes are increasingly used for repairing supporting pelvic fasciae. The most recommended conservative methods are exercises to strengthen the pelvic floor muscles. Duloxetine increases the rhabdosphincter contractility during the filling phases, but not during voiding, and therefore is a promising drug for clinical use.