Nejvíce citovaný článek - PubMed ID 23749242
Fixation of the Ajust minisling based upon cadaveric study
INTRODUCTION: Single-incision miduretral slings (SIMS) were withdrawn from the market in many countries due to lower efficacy.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.
- Klíčová slova
- Midurethral sling (MUS), Obturator complex, Single-incision midurethral sling (SIMS), Stress urinary incontinence, Trans-obturator tape,
- Publikační typ
- časopisecké články 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.
- Klíčová slova
- Ajust, Single-incision midurethral sling, Stress urinary incontinence, Surgical treatment, TVT-O,
- MeSH
- chirurgická rána MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- stresová inkontinence moči chirurgie MeSH
- suburetrální pásky * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. METHODS: This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). RESULTS: The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse. CONCLUSIONS: After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.
- Klíčová slova
- Ajust™, Single incision midurethral sling, Stress urinary incontinence, Surgical treatment, TVT-O,
- MeSH
- časové faktory MeSH
- dospělí MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- pooperační bolest MeSH
- předoperační péče MeSH
- průzkumy a dotazníky MeSH
- senioři MeSH
- stresová inkontinence moči chirurgie MeSH
- suburetrální pásky * MeSH
- urologické chirurgické výkony metody MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH