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 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 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

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

INTRODUCTION AND HYPOTHESIS: To estimate distances from the mid-urethra to the obturator foramina and to explore correlations between pelvic dimensions and body height. METHODS: This is a secondary analysis of a parent case-control study on the mechanisms of stress urinary incontinence. We measured pelvic dimensions on magnetic resonance images of women with (cases, n = 50) and without (controls, n = 50) stress urinary incontinence. RESULTS: The mean distance from mid-urethra to the obturator membrane among cases is 31.8 mm (left) and 32.1 mm (right), with a range from 25.9 to 42.0 mm. There were no significant differences in these distances when comparing left with right, or cases with controls. Weak correlation was found between the urethra-to-obturator foramina distances and heights only in the case subjects. CONCLUSION: There is high variability in the distance from mid-urethra to the obturator foramina. Height should not be used as a predictor of dimensions in the lesser pelvis.

• MeSH
• Equipment Design MeSH
• Body Mass Index MeSH
• Hip anatomy & histology   pathology   MeSH
• Humans MeSH
• Magnetic Resonance Imaging MeSH
• Pelvic Floor anatomy & histology   pathology   MeSH
• Pelvic Bones anatomy & histology   pathology   MeSH
• Urinary Incontinence, Stress pathology   MeSH
• Case-Control Studies MeSH
• Suburethral Slings MeSH
• Body Height MeSH
• Urethra anatomy & histology   pathology   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, N.I.H., Extramural MeSH