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: TVT-O production has been modified to laser cutting from mechanical cutting. We compared the behavior of laser and mechanically cut tension-free vaginal tape-obturator (TVT-O) using ultrasound at various time points after surgery. METHODS: This is a retrospective analysis of clinical and ultrasound data from two previously reported randomized controlled trials with TVT-O. Behavior of mechanically cut TVT-O implanted in January 2007 to November 2009 and laser-cut TVT-O implanted in May 2010 to May 2012 was assessed by ultrasound at day 1, the 2nd week, the 3rd month, and the 1st and 2nd years post-operatively. Bladder neck and tape margins positions were described by coordinates in the orthogonal system calculated from polar coordinates. Tape mobility was measured as a change in the upper and lower tape margin position from rest to maximal Valsalva. Comparison of 2-year subjective and objective surgery outcomes was also performed. RESULTS: In total, 68 mechanically cut and 50 laser-cut TVT-Os were implanted. Follow-up data were available from 49 and 45 women respectively. No differences in any baseline characteristics or bladder neck mobility were observed. Significantly lower tape mobility was observed on day 1 and week 2 after mechanically cut TVT-O, although subsequent mobility was comparable to laser-cut TVT-O. The subjective and objective surgery outcomes were comparable. CONCLUSIONS: Although without clinical significance, early postoperative behavior of the mechanically cut and laser-cut TVT-O tapes differs. The less stiff, mechanically-cut TVT-O loosens within 2 weeks of implantation, whereas the stiffer, laser-cut TVT-O keeps its tension.

• Keywords
• TVT-O, Tape elongation properties, Tape mobility, Tape stiffness, Ultrasound,
• MeSH
• Surgical Tape * MeSH
• Gynecologic Surgical Procedures instrumentation   methods   MeSH
• Humans MeSH
• Urinary Bladder MeSH
• Postoperative Period MeSH
• Retrospective Studies MeSH
• Urinary Incontinence, Stress surgery   MeSH
• Suburethral Slings * MeSH
• Ultrasonography * MeSH
• Urologic Surgical Procedures methods   MeSH
• Treatment Outcome 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 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.

• Keywords
• Ajust™, Single incision midurethral sling, Stress urinary incontinence, Surgical treatment, TVT-O,
• MeSH
• Time Factors MeSH
• Adult MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Pain, Postoperative MeSH
• Preoperative Care MeSH
• Surveys and Questionnaires MeSH
• Aged MeSH
• Urinary Incontinence, Stress surgery   MeSH
• Suburethral Slings * MeSH
• Urologic Surgical Procedures methods   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• 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 objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI). METHODS: A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient's life quality. RESULTS: Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n = 48) and SIS groups (n = 45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6 ± 1.8 vs 3.1 ± 2.1, p < 0.001) and 12 h postoperatively (3.8 ± 1.7 vs 2.1 ± 1.7, p < 0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p = 0.399) or patient-reported success rates (91.3 % vs 93.2 %; p = 0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life. CONCLUSIONS: The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.

• Keywords
• Efficacy, Mid-urethral sling, Patient-reported outcomes, Randomized controlled trial, Single-incision sling, Stress urinary incontinence,
• MeSH
• Operative Time MeSH
• Patient Reported Outcome Measures MeSH
• Blood Loss, Surgical MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Follow-Up Studies MeSH
• Pain, Postoperative etiology   MeSH
• Prospective Studies MeSH
• Aged MeSH
• Urinary Incontinence, Stress surgery   MeSH
• Suburethral Slings * adverse effects   MeSH
• Groin MeSH
• Urinary Incontinence, Urge etiology   MeSH
• Urologic Surgical Procedures adverse effects   methods   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
• Comparative Study MeSH

INTRODUCTION AND HYPOTHESIS: The objective was to describe the fixation site of the anchor of the Ajust mid-urethral minisling. METHODS: This cadaveric study was based on a group of 11 formalin-embalmed bodies with legs positioned in 30° flexion and 30° abduction, and a group of five fresh-frozen bodies with legs positioned as normal during the procedure. The groups were later compared. The fixation site was dissected and described. The distance to the obturator bundle was considered as the primary safety parameter. To compare the groups of fresh-frozen bodies and formalin-embalmed bodies, the Student's t test and Mann-Whitney test were used. RESULTS: In the group of formalin-embalmed bodies the mean distance from the anchoring device to the obturator nerve was 4.23 cm. In 19 cases out of 22 the anchor was within the complex of the obturator membrane and obturator muscles. In the group of fresh frozen bodies the mean distance to the obturator nerve was 3.15 cm. In 9 cases out of 10 the anchor was in the complex of the obturator membrane and obturator muscles. CONCLUSION: The distance from the anchor to the obturator nerve was more than 2 cm in all cases. Correct placement in the obturator membrane was achieved in 65.6 % of cases. In 87.5 % of cases the anchor was placed within the complex of obturator membrane and obturator muscles.

• MeSH
• Embalming MeSH
• Dissection MeSH
• Prosthesis Implantation methods   MeSH
• Cryopreservation MeSH
• Humans MeSH
• Cadaver MeSH
• Obturator Nerve anatomy & histology   MeSH
• Pelvis anatomy & histology   MeSH
• Patient Positioning MeSH
• Prosthesis Retention * MeSH
• Suburethral Slings * MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH