Tape Erosion Research Articles

A safe and simple solution for intravesical tension‐free vaginal tape erosion: removal by standard transurethral resection

To report our experience with the successful removal of visible tension-free vaginal tape (TVT) by standard transurethral electroresection, as intravesical tape erosion after TVT is a rare complication, and removal can be challenging, with few cases reported. Five patients presenting with TVT erosion into the bladder were treated at our institutions from December 2004 to July 2007; all had standard transurethral electroresection. Their records were reviewed retrospectively to retrieve data on presenting symptoms, diagnostic tests, surgical procedures and outcomes. The median (range) interval between the TVT procedure and the onset of symptoms was 17 (1-32) months. The predominant symptoms were painful micturition, recurrent urinary tract infection (UTI), urgency and urge incontinence. There were no complications during surgery. The storage symptoms and UTI resolved completely after removing the eroded mesh in all but one patient. Cystoscopy at 1 month after surgery showed complete healing of the bladder mucosa. Although TVT erosion into the bladder is rare, persistent symptoms, particularly recurrent UTIs, must raise some suspicion for this condition. Standard transurethral electroresection seems to be a safe, simple, minimally invasive and successful treatment option for TVT removal.

Anterior Colporrhaphy Plus Inside-out Tension-free Vaginal Tape for Associated Stress Urinary Incontinence and Cystocele

Study Objective To reveal the efficacy and feasibility of concomitant anterior colporrhaphy and tension-free vaginal tape-obturator to treat stress urinary incontinence (SUI) and concomitant cystocele. Design Controlled trial without randomization (Canadian Task Force classification II-1). Setting University hospitals in Rome, Italy. Patients Fifty consecutive patients with SUI associated with symptomatic cystocele were enrolled into the study. Exclusion criteria were: uterine prolapse greater than or equal to 1, rectocele greater than or equal to 1, overactive bladder, overactive bladder symptoms, intrinsic urethral sphincter deficiency, urinary retention, previous anti-incontinence and/or prolapse surgery, neurologic bladder, psychiatric disease, body mass index greater than 30, and elevated intraabdominal pressure. The preoperative evaluation consisted of: complete history, physical examination, 3-day voiding diary, and urodynamic testing. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF) was used to subjectively quantify the patient perception of SUI symptom severity. Interventions All patients underwent an ultralateral anterior colporrhaphy plus tension-free vaginal tape-obturator. Measurements and Main Results In all, 43 (91%) and 46 (92%) patients were objectively cured for cystocele and SUI, respectively. The median operating time, blood loss, and hospitalization were 43 minutes (range 35–56), 64 mL (range 40–148), and 1 day (range 1–2), respectively. Overall early postoperative complication rate was 16%, although all were minor. Only 1 patient, at 12-month follow-up, developed tape erosion that required surgical removal. The ICIQ-UI SF questionnaire scores were 13.4 ± 6.8 and 3.5 ± 3.2 (p <.01) between preoperative and 12-month follow-up, respectively. Conclusion Concomitant tension-free vaginal tape-obturator plus ultralateral anterior colporrhaphy are feasible and safe procedures for the treatment of SUI and with associated cystocele with a high success rate and low intraoperative and postoperative complications rate.

Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence

The aim of this study was to evaluate the long-term effectiveness and safety of the tension-free vaginal tape (TVT) procedure. In a Nordic three-center prospective observational cohort study, 90 women with primary stress incontinence had a TVT operation performed in local anesthesia. Assessment included a 24-h pad test, a stress test, physical examination, and a visual analog scale for assessing the degree of bother. Patient's global impression of cure was obtained, and condition specific quality of life questionnaires were used. Seventy-seven percent of the initial cohort of 90 women and 89% of those alive and capable of cooperating were assessed 11.5 years after the TVT operation. Ninety percent of the women had both a negative stress test and a negative pad test being objectively cured. Subjective cure by patients global impression was found in 77%, 20% being improved and only 3% regarded the operation as a failure. No late-onset adverse effects of the operation were found, and no case of tape erosion was seen. The TVT procedure is safe and effective for more than 10 years.

Anterior vaginal wall reconstruction: anterior colporrhaphy reinforced with tension free vaginal tape underneath bladder base

To assess the effectiveness of the polypropylene tape in preventing cystocele recurrence. Fifty Caucasian women aged 50-77 years (mean age 66.6 years), with stage II-IV pelvic organ prolapse, enrolled into the study. Vaginal reconstructive surgery included an anterior colporrhaphy on all patients, posterior colpoperineorrhaphy on 28 patients and hysterectomy on 36 patients. Patients were divided into a study group of 28 women and a control group of 22 women. As reinforcement to the anterior colporrhaphy procedure, in the study group a polypropylene tape (TVT-O) was placed underneath the bladder base and fixed with polyglactin sutures. Postoperative follow-up was carried out every 4 months (total 48 months). The assessment of the anatomic result included both clinical evaluation of the operated sites and perineal sonography. The mean postoperative distance of the bladder base to the inferior edge of the symphysis pubis was 1.5 cm (range: 1.0-2.2 cm) in the study group and 2.8 cm (range: 2.0-3.8) in the control group. Postoperatively, there were two cases of stress incontinence and two cases of urge incontinence, one in each group. No case of tape erosion was noted, no dyspareunia and no recurrent cystocele in the study group. Four cases of recurrent cystocele (20%) were reported in the control group. While the preliminary results of our study are encouraging, larger series of patients and longer follow-up are required to verify the effectiveness of the aforementioned modification.

Clinical study on tension-free vaginal tape and tension-free vaginal tape obturator for surgical treatment of severe stress urinary incontinence

To investigate the clinical efficacy and improvement of patients' quality of life in tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) for surgical treatment of severe female stress urinary incontinence. This study was a randomized, single-blinded, controlled trial. Patients were randomized by a computer-generated randomization schedule with allocation to either TVT or TVT-O procedure. TVT procedure was performed in 35 cases and TVT-O in 34 cases. None had received surgery for urinary incontinence or was in pregnancy. Transvaginal hysterectomy and prolapse reparation were done simultaneously in some of the patients. All patients were requested to complete the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) as part of their pre- and postoperative assessment. All patients were evaluable and the mean follow-up was 14.5 months. The mean operative time was (18 +/- 5) min in the TVT-O group, significantly shorter than in the TVT group (27 +/- 5) min (P < 0.01). The two groups did not differ significantly in perioperative blood loss, postoperative complications (including tape erosion, pain in thigh or behind pubis), postvoid residual volume, hospital stays or expenses (all P > 0.05). Sixty patients were successfully treated for stress urinary incontinence (88.6% and 85.3% for TVT and TVT-O groups, respectively). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P < 0.01), except in subscale measuring symptoms of voiding dysfunction (P > 0.05). Both techniques appear to be equally effective in the surgical treatment of severe stress urinary incontinence in a short term review. Significant improvements could also be seen in patients' quality of life. However, TVT-O has a shorter operative time. No evidence of increasing risk of urethral obstruction after the operation could be found. Long term follow-ups are necessary to evaluate outcomes of different types of surgery for stress urinary incontinence.

Trans‐obturator suburethral tape for female stress incontinence: a cohort of 254 women with 1‐year to 2‐year follow‐up

A clinical cohort study of 254 women undergoing trans-obturator surgery for stress urinary incontinence was conducted to assess the efficacy of the trans-obturator suburethral tape (TOT) after a follow-up of 1 year (251 evaluable patients) and 2 years (62 patients). Seventy-five patients had previous gynaecologic surgery. Overall cure and improvement rates were 82% at 6 and 12 months, and 90% at 24 months. The most favourable results were obtained in patients with occult incontinence and urethral hypermobility. The relative risk (RR) for failure in patients with a history of gynaecologic surgery was 3.3 (95% CI: 1.1-14.7). There were 8 cases of bladder perforation (3.1%) during the learning phase with the TOT procedure, 20 of urinary retention (7.9%) - in 1 patient the tape was released after 12 days of insertion - and 3 of tape erosion (1.2%). Results are encouraging but should be substantiated on a larger series over a longer follow-up.

Tension‐free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5‐year follow up

To compare the long-term outcomes of tension-free vaginal tape (TVT) and colposuspension as primary treatment for stress incontinence. Multicentre randomised controlled trial. Secondary and tertiary care gynaecology, urology and urogynaecology departments in 14 centres in the UK and Eire. Women with urodynamically confirmed stress incontinence and who had previously failed to respond to conservative treatment were invited to participate. Three hundred and forty-four women were randomised; 175 to TVT and 169 to colposuspension. This paper reports the 5-year outcomes. The primary outcome at 5 years was a 1-hour perineal pad test; other outcomes included clinical examination, Short Form-36 (SF-36) health status and Bristol Female Lower Urinary Tract Symptoms (BFLUTS) questionnaires. A negative 1-hour pad test was recorded in 58/72 (81%) women in the TVT group and 44/49 (90%) in the colposuspension group (P = 0.21, Fisher's exact test) at 5 years. There was an increase in enterocoele and rectocele in the colposuspension group; three late tape complications were seen in the TVT group. This study did not detect a significant difference between TVT and colposuspension for the cure of stress incontinence at 5 years. The effect of both procedures on cure of incontinence and improvement in quality of life is maintained in the long term. Vault and posterior vaginal wall prolapse are seen more commonly after colposuspension. Tape erosion may occur several years after surgery.

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.

The multifilament polypropylene tape erosion trouble: tape structure vs surgical technique. Which one is the cause?

This study was designed to clarify whether the structure of multifilament tape or the surgical technique is associated with vaginal erosions. Patients were randomized into two groups: in group 1, formed from the patients who were operated with the technique "setting the tape loosely leaving a scissor tip gap between the tape and the urethra," and in group 2, formed from the patients who were operated with the technique "setting the tape actually touched the urethra and covering the tape by the adjacent pubocervicovaginal fascia with the aid of a suture." After 4-year follow-up, it was found that the erosion rate was very high in group 1 (13.6%). We conclude that the high erosion rate seen in multifilament tapes is associated with the surgical technique that is used, not the structure of the multifilament tape.

MP-07.05: The usefulness of transurethral resection for the treatment of intravesical tape erosion with bladder stone following tension-free vaginal tape (TVT) procedure

Intravesical tape erosion with stone formation following tension-free vaginal tape(TVT) procedure is rare, but bothersome complication. A variety of approaches, such as transurethral, laparoscopic or open surgery, were performed for the management of this complication. We report a novel technique of transurethral resection(TUR) of intravesical tape.

Groin abscess secondary to trans obturator tape erosion: Case report and literature review

To report a case of groin abscess secondary to trans obturator tape erosion and review the literature on the incidence, predisposing factors, symptoms and management of tape erosion. The clinical history, operative details, postoperative symptoms, findings and management of this case are reported. A thorough literature review of midurethral tape erosions and, in particular, transobturator tape erosions was performed. A 46-year-old woman with urodynamic stress incontinence underwent trans obturator tape insertion. Eight weeks later she developed vaginal discharge and was subsequently diagnosed with a left lateral vaginal wall tape erosion. The eroded section was excised under general anaesthetic. Two weeks later she presented with a large right sided groin abscess which required incision, drainage and debridement of necrotic areas of gracillis and adductor muscles. Short term results following trans obturator tape insertion report excellent efficacy rates (90-96% after 1 year), however there is a lack of long term data on safety and efficacy. Current literature on transobturator tape erosion is scanty and reported rates range from 1.9-7% depending on the tape inserted. Tape erosion commonly presents with vaginal discharge, bleeding or dyspareunia and several methods of management have been reported including conservative management, excision of the eroded section or removal of the entire tape. Groin abscess following tape erosion is a serious complication resulting in further surgery and months of morbidity for the woman. Prompt management of tape erosion is essential to minimise such complications and more data is required on the long term efficacy and safety of transobturator tapes.

Morbidity associated with posterior intravaginal slingplasty for uterovaginal and vault prolapse

This study was carried out to evaluate the safety and efficacy of posterior intravaginal slingplasty (IVS) for upper genital prolapse. Gynaecology Department, Benenden Hospital, Kent, UK. An observational study was conducted on 127 women, who underwent posterior IVS using the IVS Tunneller (Tyco HealthCare, USS, Norwalk, CT, USA). The indications for surgery were uterovaginal prolapse in 65% and vault prolapse in 35%. Patient follow-up was at 6 weeks, 6 months, 1 year and annually thereafter. In addition to posterior IVS, hysterectomy was performed in 22 patients, anterior colporrhaphy in 63 patients and transobturator mid-urethral tape insertion in eight patients. The mean operating time was 46 +/- 18.5 min and for posterior IVS alone was 27.4 +/- 10 min, and the mean peri-operative drop in haemoglobin level was 1.4 +/- 0.75 gm/dL. There were no rectal, vesical or ureteric injuries. After a mean follow-up of 14 months (range 2-26 months), upper genital support was maintained in 88%, cystocele formation occurred in 8% and recurrent rectocele was seen in 11%. There was a 17% risk of tape erosion (21/127) and a re-operation rate of 24% (30/127). The risk of tape erosion was related to patient age above 60 years (RR = 1.6, 95% CI 1.02-2.5) and current treatment for diabetes (RR = 4, 95% CI 1.7-9.2). Parity, body mass index, menopausal status, HRT use, hysterectomy and surgeon's experience were not found to influence tape erosion rate. Posterior intravaginal slingplasty is a minimally invasive procedure for upper genital prolapse with an acceptable success rate. However, the operation is associated with high vaginal erosion and re-operation rates.

Comment on Karsenty et al.: Severe soft tissue infection of the thigh after vaginal erosion of transobturator tape for stress urinary incontinence

Dear Editor, In this important paper [1], the authors report on a lifethreatening complication from transobturator tape slings, primarily due to poor biocompatibility of a particular synthetic sling material. In addition to recommending the method of treatment (total removal of the sling), the authors recommend this material should not be used for transobturator slings and that, in view of the serious complications that have resulted from insertion of incompatible biomaterials, more serious evaluation should be formed before clinical use is acceptable. In a similar vein, Deng et al. [2] report their experience dealing with serious complications of suburethral slings and, in addition, perform a literature search as well a review of the FDA database. The authors dealt with a series of 26 patients with bladder and/or urethral erosions. In many cases, diagnosis was delayed because patients were treated with watchful waiting and conservative treatment rather than early cystoscopy. Furthermore, the authors make the case that there is a need for a registry for each type of sling and sling material to have a better understanding of the frequency and complication rate from the procedures and materials. In addition, the authors also note that, in Finland, there is a systematic nationwide training program for performing tension-free vaginal tape (TVT) (not mentioned is that the country also monitors every surgeon’s TVT results, requiring retraining and possible restrictions if the surgeon’s results are not acceptable). Just from these two papers, it is apparent that more needs to be done to protect patients. This comes up at professional meetings time and time again. How many more patients need to be harmed before action is taken? This requires a collaborative effort. Regulatory agencies must evaluate biomaterial compatibility more stringently and vigorously monitor results after approval. Industry must do its part to adequately evaluate biomaterials. Professional medical organizations need to work hand-in-hand with industry and regulators in regard to these matters, and surgeons need to be sure there is proper training and monitoring for patient safety. Enough papers have been written; enough meetings have discussed these issues. It is now time for action, and professional medical organizations need to take the lead.

Late erosions of mid-urethral tapes for stress urinary incontinence—need for long-term follow-up?

Tension-free vaginal tape (TVT) procedure has become one of the most common treatments of female urinary stress incontinence. Success rates as high as 81.3% were reported over a follow-up period of 7 years. Erosion of the synthetic mesh is a well-described complication. The mean time for the onset of erosion after sling insertion was 11.2 months. These case reports describe an erosion of a mid-urethral tape after 18 and 28 months, which is uncommon. There is a need for long-term follow-up of patients with TVT.

Bladder erosion of tension-free vaginal tape presented as vesical stone; management and review of literature

The vesical stone formation due to intravesical mesh erosion of tension-free vaginal tape (TVT) is rare. In this report, a case of 48-year-old patient who underwent (TVT) elsewhere is discussed. The patient was presented with vesical stone and persistent stress urinary incontinence. Intravesical stone was detected by non-contrast computed tomography and cystourethroscopy. Stone fragmentation was done by pneumatic lithotripsy and transurethral resection of the mesh was performed. The postoperative control cystoscopy demonstrated complete healing of bladder mucosa.

Mid-term Results and Complications of Posterior Intravaginal Slingplasty for Patients with Uterine and Vaginal Vault Prolapse

Purpose: Only a few reports have been published describing the mid-term results of posterior intravaginal slingplasty (IVS). We analyzed the efficacy and complications of this procedure. Materials and Methods: We analyzed the treatment outcomes of 95 patients who underwent posterior IVS due to uterine (n=59) and vaginal vault (n=36) prolapse. The degrees of prolapse were classified according to pelvic organ prolapse quantification (POPQ) of the International Continence Society (ICS), and posterior IVS was conducted for cases above stage 2. Polypropylene tape was used for all 95 patients. On the postoperative evaluation, stage 0 was regarded as a complete remission, stage 1 as an improvement and above stage 2 as a failure. Results: Among the patients operated on for uterine and vaginal vault prolapse, 48 (81.4%) and 30 (83.3%) patients were cured, and 8 (13.6%) and 6 (16.7%) patientsshowed improvement, and 3 (5.1%) and 0 (0%) patients showed failure, respectively. The mean hospitalization was 3.3 and 3.8 days, the mean operative time was 37.4 and 36.7 minutes, and the mean bleeding volume was 91 and 102ml in the uterine prolapse group and the vaginal vault prolapse group, respectively. The mean follow-up time was 27.3 months (2-40). Identified complications were tape erosion in 9 cases (9.5%), hemorrhage that needed transfusion in 3 cases (3.2%), and recurrent prolapse in 3 cases (3.2%). Conclusions: Posterior IVS proved to be a highly effective therapeutic method for uterine and vaginal vault prolapse, with a low surgical risk and less discomfort to the patients. Tape erosion was a relative frequent complication of this operation. (Korean J Urol 2007;48:971-975)

Fascial patch technique for repair of complicated urethrovaginal fistula

Introduction The operative repair of urethrovaginal fistula due to tension-free vaginal tape (TVT) erosion is a challenging task, and coexisting stress urinary incontinence may complicate the situation even further. We present our technique for the repair of recurrent urethrovaginal fistula combined with stress urinary incontinence, occurring after previous removal of an eroded TVT and failed repair of the fistula. Technical Considerations With the patient in the dorsal lithotomy position, an inverted U-shaped incision was cut in the anterior vaginal wall, and a vaginal flap was developed. The Martius flap from the previous repair was identified and separated from the urethra, thereby disclosing a large fistula hole on the left side of the mid-urethra. Because the periurethral tissues were very friable and attenuated, only one-layer closure of the fistula hole with these tissues was feasible. Therefore, we opted to combine a pubovaginal fascial sling with a fascial patch graft, used to reinforce the fistula site. Through a low transverse abdominal incision, a 15 × 2-cm strip of rectus fascia was harvested. A 2 × 2-cm patch of fascia was excised from the strip and transfixed to the periurethral tissues, covering the sutured fistula site. The Martius flap was repositioned over the flap, and a pubovaginal sling procedure was done. The postoperative course was uneventful, the fistula has healed, and the patient regained full continence. Conclusions This technique can be used in complicated urethrovaginal fistula repair when the surrounding periurethral tissues have been devastated and can be combined with pubovaginal fascial sling placement.

Clinical and quality‐of‐life outcomes in women treated by the TVT‐O procedure

To objectively assess the success rate at 6 months after tension-free vaginal tape obturator (TVT-O) procedure. To assess subjective success rates, complications, patient satisfaction, and quality of life (QOL). A prospective observational study. A tertiary referral urogynaecology practice. A cohort of 100 consecutive women who underwent the TVT-O procedure between March and October 2004. The TVT-O technique was performed as described. Three standardised QOL questionnaires were completed preoperatively at 6 months and 12 months. At 6 months, a urogenital history, visual analogue scale score (VAS) for patient satisfaction, uroflow, and urinary stress test were performed. After 12 months, a urogenital history and patient satisfaction verbal analogue score (VeAS) were obtained by telephone interview. Objective success rate of the TVT-O procedure was measured by negative stress test. Secondary outcomes were subjective success rates at 6 and 12 months, pre- and postoperative comparison of urodynamic parameters, complications, postoperative symptomatology, QOL analysis, and patient satisfaction. Mean follow up was 18.5 months. Objective success rate was 95%. Subjective success rates were 92 and 84% at 6 and 12 months. Complications included recurrent urinary tract infection (six), voiding difficulty (two), persistent groin discomfort (three), haematoma (one), wound infection (one), vaginal tape erosion (one), and urethral irritation (one). Prevalence of de novo urge incontinence was 4.1 and 4.8% at 6 and 12 months. QOL analysis showed significant improvements in QOL scores postoperatively. Visual and verbal analogue scores indicated high patient satisfaction (VAS, VeAS >or= 80%) in 77 and 67% at 6 and 12 months. The TVT-O is a safe and effective treatment for female stress urinary incontinence.

How common are tape erosions? A comparison of two versions of the transobturator tension‐free vaginal tape procedure

To compare two transobturator suburethral tapes (Obtape, Mentor-Porges and TVT-O, Gynaecare, Johnson and Johnson) used in the management of urodynamic stress incontinence (USI), for tape erosion (vaginal/urethral) rates, clinical presentation, management and outcome. We retrospectively studied women who underwent a transobturator suburethral tension-free vaginal tape (TVT) procedure for managing USI in a tertiary referral centre in the West of Scotland over a 36-month period. In our department, the transobturator approach has been the first-choice approach for TVTs since July 2003. Two types of tapes were mainly used, Obtape and TVT-O, and the choice of tape was primarily decided by the surgeons' preference. In all, 316 women had a transobturator tape procedure, of which 96 were associated with another procedure; 112 women had TVT-O using the 'inside-out' technique and 204 had the 'outside-in' technique. Of the latter, 192 had Obtape, four had Obtryx (Boston Scientific) and eight had Monarc (American Medical Systems Inc.) tapes. Sixteen women developed vaginal tape erosion, and significantly more were in the Obtape group than in the TVT-O group (7.29% vs 1.78%, P = 0.038). The patients' age, body mass index, previous vaginal surgery and concomitant vaginal surgery were not significant risk factors for erosions. The time between surgery and diagnosis of erosion was 1-45 weeks, with only one patient being asymptomatic; all others presented with clinical symptoms such as vaginal bleeding, discharge and dyspareunia. Thirteen patients were continent at presentation and 10 of these remained continent after surgical management. In the TVT-O group the erosions were in the lateral vaginal wall, while in the Obtape group the erosions were in the form of central tape extrusion secondary to defective vaginal wall healing. There were significantly more vaginal tape erosions in the Obtape group than in the TVT-O group. No cases of urethral erosions were identified.

Severe soft tissue infection of the thigh after vaginal erosion of transobturator tape for stress urinary incontinence

Since the beginning of use of synthetic midurethral slings, several complications, usually benign, have been reported. Recently, three consecutive cases of severe thigh infection secondary to transobturator insertion of a synthetic tape alarmed us. This is a case report about these three cases and a review of literature about complications of transobturator tapes.