Results and Complications of Tension-Free Vaginal Tape (TVT) for Surgical Treatment of Female Stress Urinary Incontinence

Thirty-one patients with stress urinary incontinence were operated on using tension-free vaginal tape (TVT). All were evaluated preoperatively with urodynamics, pad test and stress test. Conservative treatment was without significant effect. Three months after the operation no patients had stress incontinence but 1 with mixed incontinence experienced deterioration of her urge incontinence and 2 experienced de novo urge incontinence. The de novo urge incontinence was significantly improved and the urodynamic investigation normal after approximately 5 months. One patient with a previous operation with Kelly sutures under the urethra developed a urethrovaginal fistula. Fifteen patients were observed for 1 year. One patient who was continent after 3 months developed slight stress incontinence.     

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.     

A 3-month preclinical trial to assess the performance of a new TVT-like mesh (TVTx) in a sheep model

The objective of this study was to evaluate in a sheep model the performance of a new polypropylene mesh (TVTx), which is intended as a less invasive treatment for female stress urinary incontinence. Eight female sheep were used in this study, each one being implanted with eight TVTx samples. At each time-point (weeks 1, 2, 4, and 12) seven TVTx were pulled out, while one TVTx was carefully dissected for histological investigations. One TVTx and one TVT, moreover, were inserted and immediately pulled out for obtaining the initial pullout forces in all sheep. The initial pullout values of TVT and TVTx were overlapping. The pullout forces of TVTx were >5 N (500 g) and increasing from weeks 1 to 12 (p<0.001). Histology revealed good tissue integration of TVTx in the tissue within 12 weeks after implantation. No abnormal histological findings were observed. This data could support the realization of a clinical trial with the TVTx mesh.     

Tension-free vaginal tape: what it’s made of can matter!

Urinary stress incontinence is a significant health concern affecting millions of women and is due to poor anatomical support of the urethra. Sub-urethral tapes aim to correct this lack of support to achieve continence. The simplicity and success rates of the tension-free vaginal tape (TVT) technique compare favourably with Burch colposuspension. The last 13 years have seen the introduction of new materials and approaches used for sub-urethral tapes to optimise the efficacy and reduce the complications of the procedure. We present a case series using a tape made of siliconised polyester (LIFT, Cousin®). Approximately half of the cases have presented with an array of symptoms suggestive of an intense inflammatory response, which resolved only on removal of the tape. A low yield on microbiological samples was evident. We suggest that the material is as important as the weave in deciding which mesh to use.     

Different sling procedures for stress urinary incontinence: A lesson from 453 patients

Several midurethral sling (MUS) procedures, such as tension-free vaginal tape (TVT), TVT obturator (TVT-O), tension-free vaginal tape SECUR (TVT-S), and pubovaginal sling (PVS), have been used for the treatment of female stress urinary incontinence (SUI); however, which method is best for a particular patient group is not known. This study aimed to identify the best rationale for choosing the optimal MUS procedure for each patient. In total, 453 consecutive female patients with SUI who were treated with MUSs in West China Hospital of Sichuan University from September 2003 to September 2011 were enrolled in this study. All the patients underwent comprehensive pre-, intra-, and postoperative evaluations, including collection of demographic information, pelvic examination, and urodynamic testing, and operation-related complications were recorded. The Incontinence Quality of Life questionnaire was also completed. Under local or general anesthesia, 105 cases were treated with TVT, 243 with TVT-O, 90 with TVT-S, and 15 with PVS. Patients with different profiles in terms of age, symptom duration, concomitant procedures, urodynamic parameters, and pelvic organ prolapse (POP) quantification score were treated successfully; the body mass index did not differ significantly among the various treatment options. The cure and improvement rates were similar among the treatment groups: 97.14% (102/105) in TVT, 100% (243/243) in TVT-O, 98.89% (89/90) in TVT-S, and 100% (15/15) in PVS. Only minor complications were experienced by the patients. In conclusion, each MUS procedure was observed to be safe and effective in different subpopulations of patients, and the results suggest that appropriate patient selection is crucial for the success of each MUS procedure.     

Insights From the Early Experience of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry

The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.     

Case Volume and Outcomes After TAVR With Balloon-Expandable Prostheses: Insights From TVT Registry

Background

Given conflicting findings of previous studies, much remains to be understood regarding a volume-outcomes relationship (VOR) in transcatheter aortic valve replacement (TAVR).

Funneling before and after anti-incontinence surgery—a prognostic indicator? Part 2: tension-free vaginal tape

Does the presence of pre- and postoperative funneling of the proximal urethra affect the outcome of tension-free vaginal tape (TVT)? This prospective study of 191 women with proven primary genuine stress urinary incontinence treated by TVT insertion and assessed by pre- and postoperative introital ultrasound aims to answer that question. At 36-month follow-up, the cure rate was 89.5% (Kaplan–Meier estimator). At 6-month follow-up, 6.3% of the women had urge symptoms and 0.5% de novo urge incontinence. The cure rate in preoperative funneling was 77.5% as opposed to 96.6% in the group without funneling (P<0.0001). The funneling rate significantly decreased from 37.2% preoperatively to 17.3% immediately postoperatively (P<0.0001). The continence rate was 57.5% in persistent postoperative funneling vs 96.2% in the group without postoperative funneling (P<0.0001). The complication rate was not higher in the group with persistent postoperative funneling. The TVT procedure significantly reduces bladder neck funneling. Both preoperative and persistent postoperative funneling are associated with an increased probability of therapeutic failure or recurrence.     

TVT and TVT-Obturator: comparison of two operative procedures

AIM: To compare two anti-incontinence operations: the tension-free vaginal tape (TVT) and the TVT-Obturator for the first two 75-patient groups. METHODS: One surgeon operated on two patient groups with urodynamically proven urinary stress incontinence. The first 75-patient group in 1998 included the first TVT procedures performed according to Ulmsten [Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81-6]. Follow-up lasted for 5-6 years. The second 75-patient group in 2004 included the first TVT-Obturator operations performed according to [De Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur. Urol. 2003;44:724-30]. Follow-up lasted for 6-13 months. RESULTS: The two patient groups were similar from the demographic and therapeutic points of view. The TVT-Obturator procedure required neither bladder catheterization nor intra-operative diagnostic cystoscopy. TVT-related bladder penetration (8.0%), post-operative voiding difficulties (5.0%), intra-operative bleeding (4.0%), post-operative field infection (2.7%), and post-operative pelvic floor relaxation (1.3%) were not noted with the TVT-Obturator. The early therapeutic failure rates were 2.7% for the TVT and 1.3% for the TVT-Obturator, and neither bowel nor urethral injuries were recorded. CONCLUSIONS: The surgeons' learning curves of these two minimally invasive surgical procedures for the treatment of female urinary stress incontinence are comparable. The safety and cost-effectiveness of the TVT are well-established. The TVT-Obturator, a novel mid-urethral sling, was designed to overcome some of the TVT-related operative complications. The TVT-Obturator patients seem to have less intra-operative and post-operative surgical complications than the TVT patients. However, long-term comparative data collection is required prior to drawing solid conclusions concerning the superiority of one of these two operative techniques.