Tension-free Vaginal Tape-obturator Group Research Articles

The fabrication of 3D surface scaffold of collagen/poly (L-lactide-co-caprolactone) with dynamic liquid system and its application in urinary incontinence treatment as a tissue engineered sub-urethral sling: In vitro and in vivo study.

To fabricate a novel nanoyarn biomaterial via a dynamic liquid electrospinning system, and to simultaneously evaluate whether nanoyarn is capable of being applied as a urinary sling for future clinical transfer. Nanoyarn was cultured with adipose-derived stem cells (ADSCs). Cell morphology and function were observed on nanoyarn. Female rats that underwent vagina dilatation (VD) and bilateral ovarian resection (BOR) were used as the urinary incontinence model. After 2 weeks, the cells-sling was fixed to the suburethra. A commercial sling that tension-free vaginal tape-obturator (TVT-O) was used as a control. The urodynamic test for leak point pressure (LPP) and histological tests were used to evaluate the sling's performance in vivo. The nanoyarn possessed beneficial properties and the actin filament from ADSCs, which is very similar to muscle. Rats that underwent VD and BOR maintained a low LPP, whereas the LPP in rats with VD alone recovered to normal levels within 2 weeks. LPP in the nanoyarn group gradually decreased on the three urodynamic tests post-suburethral surgery, however, the cell-laden nanoyarn maintained LPP at normal levels for 8 weeks; the TVT-O group showed a significant increase in LPP at 8 weeks. Cell-laden nanoyarn was infiltrated with more cells, collagen, and vessels than the controls. The nanoyarn showed sufficient efficacy to maintain LPP in urinary incontinence rat model. In addition, it improved cell infiltration, collagen and muscle development compared to TVT-O. Thus, the combination of ADSCs and a nanoyarn scaffold could be a promising tissue-engineered sling for the treatment of urinary incontinence.

Comparison of Ajust sling vs. tension-free vaginal tape-obturator sling in the treatment of female stress urinary incontinence

Objective To compare the efficacy and safety of Ajust sling vs. tension-free vaginal tape-obturator (TVT-O) sling in the treatment of female stress urinary incontinence (SUI). Methods Eighty female patients with SUI of initial treatment were randomized by envelope technique to either Ajust sling or TVT-O sling, and the baseline data, perioperative index, complications and treatment effect were compared between the two groups. Results The operation time was shorter, intraoperative blood loss was less, and postoperative visual analogue scale (VAS) score was better in the Ajust group [(14.7±3.9) min, (14.5±5.7) ml, (2.7±0.8) score] than those in the TVT-O group [(21.8±7.3) min, (20.4±7.9) ml, and (3.8±1.1) score; t=5.426, P=0.000; t=3.830, P=0.000; t=5.115, P=0.000]. The groin pain (2 cases) and the overall complication (5 cases) in the Ajust group were significantly decreased as compared with those in the TVT-O group (10 and 21 cases; χ2=6.275, P=0.012; χ2=14.587, P=0.000). The objective cure rate and the subjective cure rate in the Ajust group were 95.0% and 95.0%, and those were 95.0% and 92.5% in the TVT-O group (P=1.000, P=0.000). The postoperative ICIQ-SF score, I-QOL score, FSFI score in the Ajust group [(1.6±0.9), (95.8±5.6), (29.5±7.9) score] and those in the TVT-O group [(1.5±1.1), (96.5±4.4), (30.3±7.1) score] were significant different from those preoperation [(13.2±2.9), (55.7±10.3), (22.4±6.8) score in the Ajust group; (13.8±2.4), (57.0±7.7), (21.9±7.2) score in the TVT-O group; the Ajuest group: t=24.161, P=0.000; t=21.632, P=0.000; t=4.308, P=0.000; the TVT-O group: t=29.466, P=0.000; t=28.169, P=0.000; t=5.254, P=0.000], but there was no statistically significant difference between the two groups (t=0.445, P=0.658; t=0.622, P=0.536; t=0.476, P=0.635). Conclusion As compared with TVT-O sling, Ajust sling is safe and effect in the treatment of female SUI with less complications. Key words: Stress urinary incontinence; Adjustable single incision mini sling; Tension-free vaginal tape-obturator

Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.

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. 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 18years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). The mean follow-up after surgery was 445days (SD 157.6days) in the TVT-O group and 451.8days (SD 127.6days) in the Ajust group (p = 76.6%). At 1year, 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. 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.

Multicenter Prospective Randomized Study of Single-incision Mini-sling Vs Tension-free Vaginal Tape-obturator in Management of Female Stress Urinary Incontinence: A Minimum of 1-Year Follow-up

To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up. We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%. One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n=69) and the TVT-O group (n= 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P= 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P= 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P= .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P= .658), significant improvement in QOL (P= .190), and sexual function (P= .699) in both groups. Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.

Tension-Free Vaginal Tape-O and -Secur for the Treatment of Stress Urinary Incontinence: A Thirty-Six–Month Follow-Up Single-Blind, Double-Arm, Randomized Study

ObjectiveTo compare the efficacy of the inside-out tension-free vaginal tape–obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure. MethodsA single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design. ResultsSixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates. ConclusionsTVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.

Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women—2-year follow-up

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). 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. 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). Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.

Transobturator vs Single-Incision Suburethral Mini-slings for Treatment of Female Stress Urinary Incontinence: Early Postoperative Pain and 3-Year Follow-up

Study Objective To compare related pain and cure using the transobturator and single-incision suburethral mini-sling anti-incontinence operations. Design Open, prospective, nonrandomized 2-armed study comparing 2 surgical procedures for treatment of female stress urinary incontinence (Canadian Task Force classification II-1). Setting A university and a private hospital. Patients One hundred sixty-two women with stress urinary incontinence underwent either a tension-free vaginal tape–obturator (TVT-O) or a single-incision (TVT-SECUR) suburethral or mid-urethral tape operation. Measurements and Main Results Pain levels were estimated using a visual analog scale, and outcome using the Urinary Distress Inventory and the Incontinence Impact Questionnaire. Postoperative vaginal and thigh pain was transient, lasting for up to 2 weeks, and occurred significantly more frequently in the TVT-O group (32% vs 1% and 32% vs 0%, respectively). Dyspareunia was not self-limited, and occurred more frequently in the TVT-SECUR group (7.9% vs 0%). Cure rates were 86.9% in the TVT-O group and 90.9% in the TVT-SECUR group. Complication rates were similar in the 2 groups. Conclusion Both procedures were effective, with few adverse effects. In sexually inactive patients, the TVT-SECUR procedure may be preferable because thigh and vaginal pain is largely averted with this procedure. Sexually active patients might be better referred for the TVT-O procedure because it was not followed by dyspareunia in our series. Patient choice of surgical method rather than randomization weakened the strength of this study.

Randomized Trial of Tension-Free Vaginal Tape and Tension-Free Vaginal Tape-Obturator for Urodynamic Stress Incontinence in Women

We compared the efficacy and complications of tension-free vaginal tape and tension-free vaginal tape-obturator. Women with pure urodynamic stress incontinence undergoing only primary continence surgery were randomized to tension-free vaginal tape or tension-free vaginal tape-obturator at 2 centers between March 2005 and March 2007. Primary outcome was objective cure rate at 6 months, defined by a 24-hour pad test of less than 5 gm. Secondary outcomes were the subjective cure rate on the Patient Global Impression of Improvement, quality of life on the King's Healthcare Questionnaire and symptom severity scores on the International Consultation on Incontinence Questionnaire. A total of 127 women were recruited. The study was stopped early due to excess leg pain in the tension-free vaginal tape-obturator group. Of the women 66 were randomized to tension-free vaginal tape and 61 were randomized to tension-free vaginal tape-obturator. Analysis was done by intent to treat. The objective and subjective cure rate at 6 months for tension-free vaginal tape vs tension-free vaginal tape-obturator was 69.7% vs 72.1% and 72.7% vs 67.2% (p = 0.76 and 0.49, respectively). Cure rates at 1 year were similar but loss to followup was high. Objective and subjective cure rates at 1 year for tension-free vaginal tape vs tension-free vaginal tape-obturator were 50% vs 41% and 53% vs 42.6% (p = 0.31 and 0.24, respectively). More women complained of leg pain after receiving a tension-free vaginal tape-obturator (26.4% vs 1.7%, p = 0.0001). The incidence of perioperative complications was low and similar between the groups. Time to discharge home and time to normal activity were not significantly different. Short-term cure rates at 6 months were similar. Tension-free vaginal tape-obturator caused more transient leg pain. Each procedure achieved a high cure rate and a low complication rate.

Efficacy and safety of TVT-O and TVT-Secur in the treatment of female stress urinary incontinence: 1-year follow-up

To reduce complications of transobturator tension-free vaginal tape, single-incision devices were introduced in the last years. We here report a comparison between the tension-free vaginal tape-obturator (TVT-O) and the TVT-Secur techniques in terms of efficacy and safety. Eighty-four patients with stress urinary incontinence (SUI) were scheduled to undergo TVT-O or TVT-Secur. Duration of the procedure, subjective estimate of blood loss, intraoperative and postoperative complications, postoperative postvoidal residue (PVR), time to first voiding, and pain level were recorded. Urodynamic tests, PVR, Incontinence Questionnaire Short Form (ICIQ-SF), King's Health Questionnaire, and a urinary diary were performed before and 12 months after procedure. No differences in terms of cure rate were observed between the two groups (81.6% vs. 83.8%). Complication rate in the TVT-Secur group was lower (8.1%) than in the TVT-O group (15.8%), but not significant. Both techniques seem to be effective and safe, with a low incidence of complications in both groups.

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results

This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O: response to comment by Minassian and colleagues

We really appreciate the comments of Dr. Minassian and co-workers on our study regarding the comparison between tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) in the treatment of urodynamic stress incontinence [1] and we hope to answer all the questions and remarks they raised. We did not describe both surgical techniques in the article as they were reproduced exactly as the promoting authors, Prof. Ulmsten [2] and Prof. deLeval [3], suggested, except for using different types of anaesthesia in patients undergoing TVT. Therefore, we believed that a full description of the techniques was unnecessary for most of the readers. The procedure time was different, and we agree that 9 min difference has poor clinical and economic relevance, but this was not one of our outcome measures and probably is related to the fact that cystoscopy was performed only in half of the patients undergoing TVT-O. Unfortunately, the original study protocol shared by all participants included cystoscopy for both procedures; but collecting data for the analysis, we realized that some centres did not perform it in all the patients. Most of the patients, 75 (65%) in TVT group and 70 (60%) in TVT-O group, underwent surgery under locoregional anaesthesia; therefore, patients who received general anaesthesia are a small part of the entire sample: six (5%) and 23 (19%). This difference could be explained by the fact that an intraoperative cough test was performed in 62% of the cases in TVT group compared with 15% in TVT-O group. We remind you that the original procedure included the cough test for TVT but not necessarily for TVT-O. Nevertheless, despite this different behaviour, the success rate was similar between the procedures. Time for surgery was calculated at the beginning of the procedure once the patient was ready to be operated on and timerequiredfor anaesthesia was not taken intoconsideration. On the other hand, we agree that time to perform cystoscopy could be responsible for longer time in TVT group. In the original description of the TVT-O procedure, cystoscopy was not considered mandatory but, nevertheless, we included it in our study protocol. As we said before, despite this, the adherence to the study protocol was not complete, and some surgeons did not perform it as suggested. We believe that there were no bladder or urethral perforations as no patient came back either reporting irritative bladder symptoms or micturition disorders; moreover, at physical examination, no fistula or erosion was observed.

A randomized trial comparing TVT with TVT-O: 12-month results

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

Clinical study on tension-free vaginal tape and tension-free vaginal tape obturator for surgical treatment of severe stress urinary incontinence

To investigate the clinical efficacy and improvement of patients' quality of life in tension-free vaginal tape (TVT) and tension-free vaginal tape obturator (TVT-O) for surgical treatment of severe female stress urinary incontinence. This study was a randomized, single-blinded, controlled trial. Patients were randomized by a computer-generated randomization schedule with allocation to either TVT or TVT-O procedure. TVT procedure was performed in 35 cases and TVT-O in 34 cases. None had received surgery for urinary incontinence or was in pregnancy. Transvaginal hysterectomy and prolapse reparation were done simultaneously in some of the patients. All patients were requested to complete the Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) as part of their pre- and postoperative assessment. All patients were evaluable and the mean follow-up was 14.5 months. The mean operative time was (18 +/- 5) min in the TVT-O group, significantly shorter than in the TVT group (27 +/- 5) min (P < 0.01). The two groups did not differ significantly in perioperative blood loss, postoperative complications (including tape erosion, pain in thigh or behind pubis), postvoid residual volume, hospital stays or expenses (all P > 0.05). Sixty patients were successfully treated for stress urinary incontinence (88.6% and 85.3% for TVT and TVT-O groups, respectively). There were significant improvements in postoperative scores for both the IIQ-7 and the UDI-6 (P < 0.01), except in subscale measuring symptoms of voiding dysfunction (P > 0.05). Both techniques appear to be equally effective in the surgical treatment of severe stress urinary incontinence in a short term review. Significant improvements could also be seen in patients' quality of life. However, TVT-O has a shorter operative time. No evidence of increasing risk of urethral obstruction after the operation could be found. Long term follow-ups are necessary to evaluate outcomes of different types of surgery for stress urinary incontinence.

Incontinence-related quality of life and sexual function following the tension-free vaginal tape versus the “inside–out” tension-free vaginal tape obturator

The objective of this cohort study was to compare morbidity, quality of life, and sexual function in stress-incontinent women treated with tension-free vaginal tape (TVT) versus tension-free vaginal tape obturator (TVT-O) in a group of 329. Preoperative scores of the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) were compared to those from a mailed, postoperative questionnaire. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-12) and three additional questions were also included in the mailing. Of the initial 329 patients, 239 (73%) completed the questionnaire with a mean follow-up of 14.7 months. Complications, return to normal voiding, and operative time were less in the TVT-O group. Postoperative PISQ-12 scores and improvements in the UDI-6 and IIQ-7 were comparable between groups. The TVT-O procedure appears to be as effective in improving incontinence-related quality of life as the TVT. No differences in sexual function were demonstrated between groups.

Monarc vs TVT-O for the treatment of primary stress incontinence: a randomized study

The aim of the study was to compare the efficacy and complications of the Transobturator tape (Monarc) vs the tension-free vaginal tape obturator (TVT-O) in women with urodynamic stress incontinence. A prospective, randomized study was conducted. One-hundred and twenty patients were included in the study, and 114 of them were available at 12 months follow-up. Sixty-one patients were subjected to the TVT-O procedure and 53 to the Monarc procedure. Subjective and objective cure and improvement rate and complications incidence were assessed. The objective cure rate was 87% for the TVT-O procedure and 90% for the Monarc group. The subjective cure rate was 80% for the TVT-O group and 77% for the Monarc group. The improvement was 13 and 11.5% for the TVT-O and Monarc groups, respectively. There was one accidental injury to the urethra with the Monarc technique. The Monarc technique presents success rates and complications comparable to the TVT-O method at 1 year follow-up.