Most cited article - PubMed ID 19181436
Initial experience with a short, tension-free vaginal tape (the tension-free vaginal tape secur system)
INTRODUCTION: Single-incision miduretral slings (SIMS) were withdrawn from the market in many countries due to lower efficacy. In some countries they are still in use, preferred primarily because it is possible to perform the procedure under local anesthesia. Based on our previous clinical experience we postulated that local anesthesia decreased primary anchor fixation in the obturator complex. The aim of the study is to assess how local infiltration anesthesia influences anchor fixation of the tape in porcine obturator complex. METHODS: The experiment was designed to determine the maximum force necessary to extract an implant anchor from a porcine obturator complex. The implant was extracted at a constant speed and data sampling frequency, and the data on displacement of the testing system, achieved force and time were recorded. The implant arms were divided into groups on the right and left sides. In the first group, the anchored arms were used for two implantations - primary and secondary without infiltration anesthesia - and in the second group they were used in the same way, using infiltration anesthesia. RESULTS: A total of 40 implanted anchors were tested in the experiment, totaling ten single-incision slings (each anchor was implanted twice). An average of 8.28 N (Newton) (SD 6.73, min. 2.11, max. 30.34 N) is required to remove the implant anchor from the obturator complex without infiltration by local anesthesia. An average force of 4.40 N (SD 2.99 min. 1.2, max. 9.48) is required to remove the anchor from the obturator complex after infiltration. Local anesthesia reduces anchor fixation in the obturator complex by 47%. CONCLUSIONS: The local infiltrative anesthesia decreases anchor fixation in the porcine obturator complex.
- Keywords
- Midurethral sling (MUS), Obturator complex, Single-incision midurethral sling (SIMS), Stress urinary incontinence, Trans-obturator tape,
- Publication type
- Journal Article MeSH
INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the length of adjustable single-incision midurethral tape (SIMS; Ajust), which is needed to fix this tape to the obturator membrane. From these data, we can deduce the optimal length of the SIMS. METHODS: For this study, we employed the intra-operative data of patients included in a single-center randomized trial comparing the efficacy of Tension free vaginal tape obturator (TVT-O) and Ajust. The length of the Ajust tape was calculated using the formula: total length of the tape minus the length of the stylet used for the tape lock, minus the length of the lock minus the width of the two anchors. The length of the obturator tape was calculated using the formula: total tape length minus the snipped parts of the tape. The correlation coefficient of the tape length to basic biometric parameters, such as height, weight, and body mass index, was calculated. RESULTS: For this study, data from 50 women from each group, TVT-O and Ajust, were used. The mean length of the Ajust tape inside the body is 11.6 cm (SD 0.9), with a minimum length of 9.6 cm and a maximum length of 14.6 cm. The mean length of TVT-O tape inside the body is 20.3 cm (SD 2.1), with a minimum of 14.8 cm and a maximum length of 24.5 cm. CONCLUSIONS: This study demonstrates that to achieve continence it is necessary to use different lengths of single-incision tape. Inappropriate SIMS length could cause failure related to the tape itself and not to the TVT technique.
- Keywords
- Ajust, Single-incision midurethral sling, Stress urinary incontinence, Surgical treatment, TVT-O,
- MeSH
- Surgical Wound MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Urinary Incontinence, Stress surgery MeSH
- Suburethral Slings * MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
INTRODUCTION AND HYPOTHESIS: The aim of the study was to describe fixation of the TVT ABBREVO and establish whether the tape penetrates through obturator muscles and membrane (obturator complex) into the adductor region and, if so, how far it penetrates. METHODS: Eight formalin-embalmed female cadavers were used to simulate TVT ABBREVO surgery (totalling 16 insertions). Following tape insertion, dissection was performed and ends of the tape were identified. In cases of penetration, the length of tape penetrating into the adductor region was measured. RESULTS: Of the 16 cases, the tape ended in the obturator membrane in eight, in the internal obturator muscle in one, and penetrated through the obturator membrane into the external obturator muscle in five, where it remained. In two cases, it penetrated through the obturator internus muscle, obturator membrane and obturator externus muscle into the group of thigh adductors; one penetration was by 3 mm and the second by 10 mm. No contact with the obturator nerve or its branches was noted in any case. CONCLUSIONS: No TVT contact with the obturator nerve was noted; tape penetrated into the adductor region in two of the 16 cases.
- Keywords
- Anatomy, Cadaver study, Complications, Sling fixation, TVT ABBREVO, Urogynecology,
- MeSH
- Gynecologic Surgical Procedures instrumentation MeSH
- Muscle, Skeletal * MeSH
- Humans MeSH
- Suburethral Slings * MeSH
- Check Tag
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI). METHODS: This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire--Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented. RESULTS: One hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02). CONCLUSIONS: Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.
- MeSH
- Gynecologic Surgical Procedures methods MeSH
- Cough MeSH
- Middle Aged MeSH
- Humans MeSH
- Longitudinal Studies MeSH
- Follow-Up Studies MeSH
- Treatment Failure MeSH
- Surveys and Questionnaires MeSH
- Aged MeSH
- Urinary Incontinence, Stress surgery MeSH
- Suburethral Slings * MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH