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1.  Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up 
The tension-free vaginal tape (TVT) procedure is based on the integral theory that the midurethra has an important role in the continence mechanism. Transobturator vaginal tape (TOT) is the same in concept as TVT but it differs from TVT in that, rather than passing through the retropubic space, sling materials are drawn through the obturator foramina. We prospectively compared TVT with TOT with respect to operation-related morbidity and surgical outcomes at a minimum follow up of 12 months.
Materials and Methods:
A total of 36 women with stress urinary incontinence (SUI) were alternatively assigned to the TVT group (18) or the TOT group. Preoperative evaluation included urodynamic study and I-QOL questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality-of-life questionnaire, long-term complications, and uroflowmetry were evaluated in both groups.
The patient characteristics in both the TVT and TOT group were similar. Mean operating time was significantly shorter in the TOT group likened to the TVT group.
Both the TVT and TOT procedures are minimally invasive and similar in operation-related morbidity. TOT appears to be as effective as TVT, and safer than TVT for the surgical treatment of SUI in women at 12 months follow-up.
PMCID: PMC2779952  PMID: 19881123
Quality of life; stress; transobturator; urinary incontinence; vaginal tape
2.  Meta-analysis of female stress urinary incontinence treatments with adjustable single-incision mini-slings and transobturator tension-free vaginal tape surgeries 
BMC Urology  2015;15:64.
The study on SIMS and SMUS as a whole by Alyaa Mostafa et al showed that after excluding the TVT-S sling, there is no significant difference in patient-reported cure rate and objective cure rate between these two methods. In this paper, we systematically evaluate the relevant data on SIMS-Ajust and TVT-O/TOT and further confirm their safety and effectiveness, providing reliable clinical evidence.
By searching the Medline, Embase, Scopus, and Web of Science databases and the Cochrane Database of Systematic Reviews combined with manual searches, all reports on randomized controlled trials (RCTs) of single-incision mini-sling (SIMS-Ajust) and transobturator tension-free vaginal tape (TVT-O/TOT) surgeries were collected. Using RevMan 5.2 statistical software, the patient-reported cure rate, objective cure rate, operative time, postoperative pain, lower urinary tract injuries, groin pain, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, repeated continence surgery, and other related data on both surgical methods were evaluated.
A total of 154 relevant research reports were retrieved, and five randomized controlled trials were included in this study, involving a total of 678 patients. The meta-analysis results show no significant difference in the patient-reported cure rate and objective cure rate between SIMS-Ajust and TVT-O/TOT [RR = 0.95, 95 % CI (0.87 to 1.04), P > 0.05; RR = 0.97, 95 % CI (0.90–1.05), P > 0.05]. With respect to operation time and groin pain, SIMS-Ajust outperforms TVT-O/TOT [MD = −1.61, 95 % CI (−2.48 to 0.74), P < 0.05; RR = 0.30, 95 % CI (0.11 to 0.85), P < 0.05]. In terms of postoperative pain, lower urinary tract injuries, postoperative voiding difficulties, de novo urgency and/or worsening of preexisting surgery, vaginal tape erosion, and repetition of continence surgery, there is no significant difference between SIMS-Ajust and TVT-O/TOT [RR = 0.50, 95 % CI(0.18–1.43), P > 0.05; RR = 2.82, 95 % CI(0.14–57.76), P > 0.05; RR = 0.64, 95 % CI(0.28–1.45), P > 0.05; RR = 1.06, 95 % CI(0.66–1.71), P > 0.05; RR = 1.04, 95 % CI(0.24–4.45), P > 0.05; RR = 1.64, 95 % CI(0.41–6.61), P > 0.05].
SIMS-Ajust is safe and effective in the treatment of female stress urinary incontinence. Compared with TVT-O/TOT surgery, SIMS-Ajust surgery has the same high objective cure rate and patient-reported cure rate and low incidence of perioperative complications, in addition to its short operative time and low incidence of groin pain. Its long-term efficacy needs further observation.
PMCID: PMC4492097  PMID: 26148987
Single-incision mini-sling; Transobturator tension-free vaginal tape; Female stress urinary incontinence
3.  Efficacy and Safety of the TVT-SECUR® and Impact on Quality of Life in Women with Stress Urinary Incontinence: A 2-Year Follow-Up 
Korean Journal of Urology  2011;52(5):335-339.
As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years.
Materials and Methods
We evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone.
Data from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (p<0.026) and by 32 points at 2 years after TVT-S (p<0.013). Most patients reported significant improvements in quality of life. At the 2-year follow-up, there were no significant complications related to TVT-S.
The results of this study suggest that TVT-S is an efficient and safe procedure for the improvement of both the quality of life of the patients and the SUI itself.
PMCID: PMC3106166  PMID: 21687393
Minimally invasive surgical procedures; Treatment outcome; Urinary stress incontinence
4.  Midurethral Slings for Women with Stress Urinary Incontinence 
Executive Summary
The objective of the current review was to evaluate the safety, efficacy, and cost-effectiveness of midurethral slings compared with traditional surgery.
This assessment was undertaken in order to update and expand upon the health technology & policy assessment of tension-free vaginal tape (TVT, Gynecare Worldwide, a division of Ethicon Inc, a Johnson & Johnson company, Somerville, New Jersey) sling procedure for stress urinary incontinence published by the Medical Advisory Secretariat in February 2004. Since the publication of the 2004 assessment, a number of TVT-like sling alternatives have become available which employ the same basic principles as TVT slings: minimally invasive, midurethral placement, self-fixing, and tension-free. This update will evaluate the efficacy and safety of midurethral slings.
Clinical Need
Normal continence is controlled by the nervous system and involves co-ordination between bladder, urethra, urethral sphincter, and pelvic floor. Incontinence occurs when the relationship among the above components is compromised, either due to physical damage or nerve dysfunction. (1) Stress urinary incontinence is the most common form of urinary incontinence in women. It is characterized by the “complaint of involuntary leakage on effort or exertion, or on sneezing or coughing” when there is increased abdominal pressure without detrusor (bladder wall) contraction. (2) There are 2 factors which define stress urinary incontinence: a weakening in the support of the proximal urethra, causing urethral hyper-mobility and deficiency in the sphincter, causing urethral leakage. Both factors are thought to coexist. (1) Accurate tests are not available to distinguish these 2 types of stress urinary incontinence.
Urinary incontinence is estimated to affect about 250,000 Canadian women and 8 million American women aged 65 and over. (3;4) The prevalence of stress urinary incontinence is very difficult to measure because women with stress urinary incontinence may not tell their health practitioner about their symptoms due to embarrassment associated with stress urinary incontinence. A cross-sectional postal survey of 15,904 adults aged 40 and over who were registered with a local GP in Leicestershire, United Kingdom, revealed that 18% to 34% of respondents had symptoms of SUI. (5) Just over 9% reported symptoms “sometimes,” while almost 3% reported symptoms “most of the time.” Stress urinary incontinence was most common for women in their 50s. A more recent study suggests that 24% of women aged 18 to 44 years and 37% of women aged 45 and over have symptoms of stress urinary incontinence. (6)
Stress urinary incontinence has been associated with a broad range of psychosocial stress and disablement, such as difficulties with activities of daily living, avoidance of social activities, fear of unpleasant odour, and embarrassment. (7) Economic burden may include the cost of pads, drugs, and devices, and the inability to participate in the work force in severe cases.
Midurethral Slings
Suburethral slings differ according to several criteria including placement, approach, method of fixation, and sling material. This review will evaluate slings which fulfill all of the following criteria:
Midurethral placement (as opposed to bladder neck placement)
Self-fixing (no sutures, bone anchors, etc.)
Minimally invasive (using local, epidural, or general anesthesia)
“Tension-free” placement
The different types of midurethral slings available vary according to 3 main parameters:
Implant material, i.e., monofilament, multifilament, elastic, non-elastic, smooth, serrated, etc.,
Delivery instruments, i.e., needles, curved trocars, disposable, reusable, etc.,
Surgical approach
As any one, or any combination of these parameters may vary across the different sling brands, it is difficult to ascribe observed differences in efficacy and safety across slings to any one factor.
Review Strategy
The literature published between January 2000 and February 2006 was searched in the following databases: OVID Medline, In Process and Other Non-Indexed Citations, Embase, Cochrane Database of Systematic Reviews and CENTRAL, INAHTA. The database search was supplemented with a search of relevant Web sites, and a review of the bibliographies of selected papers. The search strategy can be viewed in Appendix 1.
Inclusion Criteria
General population with SUI
Randomized controlled studies, health technology assessments, guidelines
Female subjects
Midurethral, self-fixing, and minimally invasive slings/tapes
English language
The search strategy yielded 391 original citations. Studies were excluded for a variety of reasons, such as using traditional, suburethral slings as opposed to midurethral slings, not including patients with stress urinary incontinence, including males in the study, case reports, and not reporting the outcomes of interest.
There were 13 randomized controlled trials identified that compared midurethral slings to other midurethral slings or traditional surgery. (8-20) (Table 1) Three of the randomized controlled trials (15;17;20) have had subsequent updated articles of longer term results. (21-23) The results of the randomized controlled trials have been stratified into 2 groups: TVT versus colposuspension and comparisons of midurethral slings. No randomized controlled trials were identified that compared a midurethral sling other than TVT to colposuspension.
Summary of Findings
At this time, there does not appear to be one procedure that is more effective than another at curing stress urinary incontinence. TVT appears to have similar cure rates to open colposuspension; and the various midurethral sling types seem to have similar cure rates.
Procedure Time and Length of Hospital Stay
The procedure time and the length of hospital stay for TVT are significantly shorter than the procedure time and length of stay for colposuspension.
The procedure time and length of hospital stay for all midurethral slings appears to be similar.
The most frequently reported complications were bladder perforations, de novo voiding difficulties and device problems.
Quality of Life
Quality of life was not consistently reported in all of the randomized controlled trials. In the studies that reported quality of life there does not appear to be a significant difference in quality of life scores between the sling procedures.
PMCID: PMC3379163  PMID: 23074494
5.  Comparison of Efficacy and Satisfaction between the TVT-SECUR® and MONARC® Procedures for the Treatment of Female Stress Urinary Incontinence 
Korean Journal of Urology  2010;51(11):767-771.
The tension-free vaginal tape SECUR® (TVT-S) is a new, minimally invasive sling procedure for treating female stress urinary incontinence (SUI). However, results of comparisons of the TVT-S with the transobturator tape (TOT) sling are lacking. Therefore, we investigated outcome and satisfaction of the TVT-S procedure compared with the TOT procedure.
Materials and Methods
We included 64 patients with SUI who underwent the TVT-S (n=31) or TOT (MONARC®, n=33) procedure and were followed up for more than 1 year. The preoperative evaluation included history taking, pelvic examination, consecutive 3-day voiding diary, and urodynamic study including Valsalva leak point pressure. Postoperatively, continence status and subjective patient satisfaction were evaluated. Cure was defined as the absence of any episodes of involuntary urine leakage during stressful activities and a stress cough test.
The TVT-S group (71.0%) showed a slightly lower cure rate than did the MONARC group (84.8%); however, there was no significant difference between the 2 groups (p=0.179). Nine of the patients who underwent the TVT-S showed incontinence postoperatively. Among them, the H approach was used in 7 patients and the U approach was done in 2 patients. Following TVT-S and MONARC, the patients' reported satisfaction was 80.6% and 78.8%, respectively. Patient satisfaction did not differ significantly between the two groups (p=0.854).
Our results showed that the TVT-S and MONARC procedures may be comparable in terms of cure rate and patient satisfaction after more than 1 year of follow-up.
PMCID: PMC2991574  PMID: 21165197
Minimally invasive surgical procedures; Treatment outcome; Urinary stress incontinence
6.  Treatment of recurrent stress urinary incontinence in women: comparison of treatment results for different surgical techniques 
There is still no consensus on which surgical technique is the most effective for female recurrent stress urinary incontinence after the initial surgery.
To compare the long-term treatment outcomes of Burch colposuspension operation, transobturator tape implantation (TOT) and tension-free vaginal tape (TVT) procedures performed for female recurrent stress urinary incontinence after the initial surgery.
Material and methods
A retrospective study was performed on 45 women operated on for recurrent stress urinary incontinence after the initial surgery. Depending on the surgical approach, the patients were divided into three groups: group I (n = 19) – Burch colposuspension operation, group II (n = 16) – TOT, and group III (n = 10) – TVT operation was performed. The treatment results were assessed using the UDI-6 (Urogenital Distress Inventory) and IIQ-7 (Incontinence Impact Questionnaire) short form questionnaires. We included one additional question: Is the patient satisfied with the treatment outcome? We classified the urinary continence results after surgery as good when patients were cured or improved, and as bad when the treatment failed.
Good urinary continence results were observed in 84.2% of patients in group I, 93.8% of patients in group II, and 90% of patients in group III. 68.4% of patients in group I, 81.3% of patients in group II, and 90% of patients in group III were satisfied with the treatment outcomes.
Burch colposuspension operation, TOT and TVT procedures performed for the female recurrent stress urinary incontinence treatment are effective and show similar good urinary continence results and similar number of patients satisfied with the treatment outcomes.
PMCID: PMC4105684  PMID: 25097693
surgery; quality of life; urinary incontinence; suburethral sling; treatment outcome
7.  Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial 
BMC Women's Health  2011;11:34.
We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial.
All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature.
This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs.
Trial registration NCT00234754. Registered October 2005.
PMCID: PMC3171308  PMID: 21781314
Urinary incontinence; stress/surgery; suburethral slings; female; treatment outcome; cost-effectiveness; 5 year follow-u
8.  Comparison of Laparoscopic Burch and Tension-Free Vaginal Tape in Treating Stress Urinary Incontinence in Obese Patients 
To compare the efficacy and safety of the tension-free vaginal tape (TVT) and laparoscopic Burch procedures in treating genuine stress urinary incontinence in obese patients.
This was a retrospective evaluation of 91 consecutive cases of TVT alone or TVT combined with other procedures from April 1999 through March 2000 and 51 consecutive cases of the laparoscopic Burch procedure from January 1998 through February 1999. All procedures were performed in a private practice and community hospitals in the midwest. One hundred forty-two women (ages 34 to 79) with stress urinary incontinence documented by clinical examination and preoperative cystometric and urodynamic evaluation were included in the study. They were also divided into 5 groups based on their body mass index (BMI): NL (normal-BMI < 25), OW (overweight-BMI 25 to 29), OBI (obesity I-BMI 30 to 34), OBII (obesity II-BMI 35 to 39), OBIII (obesity III-BMI > 40). In the TVT group, 66% were obese (OBI-21, OBII-17, OBIII-22) versus 36% in the laparoscopic Burch (OBI-13, OBII-5) group.
All TVT patients remain cured or symptoms improved in their genuine stress urinary incontinence, which favorably compares with the laparoscopic Burch procedure after 1 year. Operating time for the TVT portion ranged from 18 to 40 minutes. The laparoscopic Burch procedure in general took over 1 hour. No bladder, bowel, or vascular injuries have occurred in the TVT group. Superficial suprapubic ecchymoses have occurred in the TVT group occasionally but required no intervention. The average length of stay was 1 day; TVT-only patients usually were released on the same day. Ninety percent of patients were voiding normally by postoperative day 7. Most of the patients with continued urinary retention had had combined procedures.
This preliminary study indicates that TVT is a safer, more effective, and easier minimally invasive surgery for genuine stress urinary incontinence regardless of the patients' BMI and favorably compares with the laparoscopic Burch procedure, which requires advanced surgical skills.
PMCID: PMC3043389  PMID: 12002291
Detrusor Instability; Laparoscopy; Marshall-Marchetti-Krantz; Colposuspension; Tension-free vaginal tape; Stress urinary incontinence in obesity; Minimally invasive surgical procedures; Intrinsic sphincter deficiency
9.  Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency 
PLoS ONE  2016;11(5):e0156306.
The aim of this study was to compare the two types of mid-urethral slings for stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD).
This retrospective study included patients who underwent tension-free vaginal tape (TVT) procedure or transobturator tape (TOT) procedure by a single surgeon for SUI with ISD, defined as Valsalva leak point pressure (VLPP) < 60 cmH2O in a urodynamic study. Cases of neurogenic bladder, previous SUI surgery, and concomitant cystocele repair were excluded. The primary outcome was treatment success at 12 months, defined by self-reported absence of symptoms, no leakage episodes recorded, and no retreatment.
Among the 157 women who were included in the final analysis, 105 patients received TVT and 52 patients received TOT. Age, underlying diseases, Stamey grade, cystocele grade, and presence of urge incontinence were not significantly different between the two groups. Urodynamic parameters including maximal urethral closing pressure, detrusor overactivity, VLPP, urethral hypermobility (Q-tip ≥ 30°), were also comparable between the two groups. Success rate was significantly higher in the TVT group than in the TOT group (95.2% vs. 82.7%, p = 0.009). On multivariate analysis, only TOT surgery (OR = 3.922, 95%CI = 1.223–12.582, p = 0.022) was a risk factor for failure following surgical treatment.
TVT is more effective than TOT in treatment of female SUI with ISD.
PMCID: PMC4882043  PMID: 27228092
10.  Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence 
We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI).
Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months.
In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups.
Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O.
PMCID: PMC3797895  PMID: 24143294
Overactive urinary bladder; Stress urinary incontinence
11.  Transobturator tapes are preferable over transvaginal tapes for the management of female stress urinary incontinence: Against 
Midurethral placement of tension-free vaginal tapes with a transvaginal route for stress urinary incontinence achieves higher and better long-term success rates than the transobturator route. Bladder perforations are reported more in transvaginal tape (TVT) but incidences of vaginal erosions, extrusion, and groin pain are exceedingly more in TOT groups. There is no clear evidence that transobturator tape (TOT) is associated with less post-operative voiding problems than TVT. Major complications such as bowel injuries and significant vascular injuries with TVT are rare. TVT has been found to be superior to TOT and preferable in technically demanding conditions such as prior anti-incontinence operation failures, obese women, and very elevated and scarred lateral cul-de sac. TVT is always preferred in severe grades of stress urinary incontinence and with patients of intrinsic sphincter deficiency (ISD) with little or no urethral mobility.
PMCID: PMC2808672  PMID: 19955693
Stress urinary incontinence; transvaginal tape; transobturator tapes
12.  Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial 
BMC Research Notes  2014;7:941.
In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life.
The sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p = 0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change −25 for both groups) but did not differ between groups (p = 0.880).
Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research on new licensed devices in a rapidly changing surgical specialty, and further highlights the need for research before licensing if surgeons and their patients are to be confident in the effectiveness and safety of new surgical devices.
Trial registration NCT00685217, 22 May 2008.
PMCID: PMC4307185  PMID: 25532604
Effectiveness; Randomized controlled trial; Single incision device; Stress urinary incontinence; Surgical treatment
13.  Comparison between three mini-sling surgical procedures and the traditional transobturator vaginal tape technique for female stress urinary incontinence 
Il Giornale di Chirurgia  2014;35(3-4):80-84.
To compare mini-sling and traditional tension-free operations for female stress urinary incontinence.
Study design
A systematic review of articles in the Literature published between 2002 and 2012, was conducted. A Pubmed search was performed. Primary outcomes were subjective and objective cure rates at 12 months comparing the three single-incision mini-slings techniques (TVT-Secur, MiniArc and Monarc systems) with the standard mid-urethral sling procedure TOT (Transobturator Vaginal Tape). Secondary outcomes included peri-operative (vaginal and/or bladder perforation, urine retention, urinary tract infection, bleeding, pain) and post-operative (mesh exposure, de novo urgency, and dyspareunia) complications.
In term of objective cure rate at 12 month after surgery, it is evident that TOT at first, and MiniArc are the most effective procedures. The incidence of post-operative urgency and UTI was lower in TOT technique, while vaginal perforation was described in equal frequency both in TOT and in MiniArc procedures. The advantages of the three above described mini-invasive techniques seem to consist into lower cases of urinary retention, pain and bleeding. Furthermore, bladder perforation and bleeding are not described in the Literature for TVT-Secur and Monarc systems.
Some single-incision slings look promising and as effective as conventional sub-urethral slings at short term evaluation. However, at this moment a clear statement in favor of the widespread use of single-incision slings cannot be made. More studies must define the efficacy of these techniques.
PMCID: PMC4321593  PMID: 24841685
Stress urinary incontinence; Mid-urethral sling; Single-incision mini-sling
14.  Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis 
To assess the efficacy and safety of tension-free vaginal tape (TVT)-Secur for stress urinary incontinence (SUI).
A literature review was performed to identify all published trials of TVT-Secur. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register.
Seventeen publications involving a total of 1,879 patients were used to compare TVT-Secur with tension-free obturator tape (TVT-O) and TVT. We found that TVT-Secur had significant reductions in operative time, visual analog score for pain, and postoperative complications compared with TVT-O. Even though TVT-Secur had a significantly lower subjective cure rate (P<0.00001), lower objective cure rate (P<0.00001), and higher intraoperative complication rate, compared with TVT-O at 1 to 3 years, there was no significant difference between TVT-Secur and TVT-O in the subjective cure rate (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.22–1.08; P=0.08), objective cure rate (OR, 0.49; 95% CI, 0.22–1.09; P=0.08), or complications at 3 to 5 years. Moreover, TVT-Secur had significantly lower subjective and objective cure rates compared with TVT.
This meta-analysis indicates that TVT-Secur did not show an inferior efficacy and safety compared with TVT-O for SUI in 3 to 5 years, even though displaying a clear tread toward a lower efficacy in 1 to 3 years. Considering that the safety is similar, there are no advantages in using TVT-Secur.
PMCID: PMC4703932  PMID: 26739179
Urinary Incontinence, Stress; Suburethral Slings; Randomized Controlled Trial
15.  Tension-free vaginal tape versus lata fascia sling: The importance of transvulvar ultrasound in the assessment of relevant anatomical parameters in treatment of women with stress urinary incontinence 
To describe the relevance of transvulvar ultrasound in the assessment of anatomical differences induced by the lata fascia sling (LFS) and tension-free vaginal tape (TVT) procedures.
Materials and Methods:
Forty women with stress urinary incontinence (SUI), aged 30 to 60 years, have been treated with either LFS (20 patients) or TVT (20 patients). The transvulvar ultrasound of the urethrovesical junction (UVJ) and proximal urethra (PU) has been used as the main investigational tool both pre- and post-operatively. The studied parameters were the vertical (VUVJD) and horizontal (HUVJD) UVJ distances, the pubourethral distance (PUD) and the PU length.
The VUVJD did not vary significantly after the LFS surgery (P=0.10). The PUD became shorter (P=0.001) and the HUVJD became shorter only at rest (P=0.03) after the correction by LFS. The TVT procedure has led to shortening of the VUVJ displacement (P=0.0005) and of the PU length (P=0.02).
The transvulvar ultrasound was of utmost importance in the demonstration that both the LFS and TVT surgical procedures elongate the PU, even though the LFS technique does it more efficiently. The LFS technique focus more on shortening the PUD and the TVT procedure focus more on the correction of the vertical UVJ displacement.
PMCID: PMC2684306  PMID: 19468431
Fascia Lata Sling Procedure; stress urinary incontinence; tension-free vaginal tape; transvulvar or perineal ultrasound; urethrovesical junction mobility and proximal urethra length
16.  Randomized Controlled Study of MONARC® vs. Tension-free Vaginal Tape Obturator (TVT-O®) in the Treatment of Female Urinary Incontinence: Comparison of 3-Year Cure Rates 
Korean Journal of Urology  2012;53(4):258-262.
Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world. However, very few results of randomized clinical trials of transobturator midurethral sling surgery (MONARC vs. TVT-O) for the treatment of female urinary incontinence have been reported. In this study, we compared the 3-year follow-up cure rates of these two procedures.
Materials and Methods
From July 2006 to June 2008, 74 patients who had undergone MONARC (35 patients) or TVT-O (39 patients) were included in the study and were analyzed prospectively. The mean follow-up duration of both groups was 39.2 months. Preoperative and postoperative evaluations included physical examination, uroflowmetry and postvoid residual measurement, involuntary urine loss with physical activity, and urinary symptoms. Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity. The patients' satisfaction after treatment was rated as very satisfied, satisfied, equivocal, and unsatisfied. Very satisfied and satisfied were considered as the satisfied rate.
There were no significant differences in preoperative patient characteristics, postoperative complications, or success rate between the two groups. The cure rate of the MONARC and TVT-O groups was 85.7% and 84.6%, respectively. The patient satisfaction (very satisfied, satisfied) rate of the MONARC and TVT-O groups was 82.8% and 82.1%, respectively.
The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence, with maintenance of high cure rates for 3 years. Longer follow-up is needed to confirm these results.
PMCID: PMC3332137  PMID: 22536469
Urinary incontinence; Suburethral sling; Suburethral slings
17.  Complications associated with transobturator sling procedures: analysis of 233 consecutive cases with a 27 months follow-up 
BMC Women's Health  2009;9:28.
The transobturator tape procedure (TOT) is an effective surgical treatment of female stress urinary incontinence. However data concerning safety are rare, follow-up is often less than two years, and complications are probably underreported. The aim of this study was to describe early and late complications associated with TOT procedures and identify risk factors for erosions.
It was a 27 months follow-up of a cohort of 233 women who underwent TOT with three different types of slings (Aris®, Obtape®, TVT-O®). Follow-up information was available for 225 (96.6%) women.
There were few per operative complications. Forty-eight women (21.3%) reported late complications including de novo or worsening of preexisting urgencies (10.2%), perineal pain (2.2%), de novo dyspareunia (9%), and vaginal erosion (7.6%). The risk of erosion significantly differed between the three types of slings and was 4%, 17% and 0% for Aris®, Obtape® and TVT-O® respectively (P = 0.001). The overall proportion of women satisfied by the procedure was 72.1%. The percentage of women satisfied was significantly lower in women who experienced erosion (29.4%) compared to women who did not (78.4%) (RR 0.14, 95% CI 0.05-0.38, P < 0.001).
Late post operative complications are relatively frequent after TOT and can impair patient's satisfaction. Women should be informed of these potential complications preoperatively and require careful follow-up after the procedure. Choice of the safest sling material is crucial as it is a risk factor for erosion.
PMCID: PMC2760512  PMID: 19781074
18.  Complications Following Outside-in and Inside-out Transobturator-Tape Procedures with Concomitant Gynecologic Operations 
Chonnam Medical Journal  2011;47(3):165-169.
This study was undertaken to compare the complications of outside-in transobturator tape procedures (TOT) and inside-out transobturator tape procedures (TVT-O) with concomitant gynecologic surgery for the treatment of female stress urinary incontinence (SUI). A retrospective review of 206 consecutive patients who underwent either TOT or TVT-O with concomitant gynecologic operations between March 2008 and February 2011 was conducted. The incidence of perioperative complications was compared. For statistical analysis, chi-squared tests were used. There were no reports of intraoperative complications such as vaginal injury or bladder perforation. Postoperative complications were noted in 23 procedures (11.2%). These included 6 cases of urinary retention (2.9%), 2 cases of vulva hematoma (1.0%), 7 cases of urinary tract infection (3.4%), 4 cases of de novo urgency (2.9%), and 4 cases of vaginal erosion (2.9%). There were no significant differences in complication rates between the two groups. Our results suggest that inside-out and outside-in procedures are simple and safe techniques that may have a low rate of complications when used with a concomitant gynecologic operation.
PMCID: PMC3252505  PMID: 22247917
Complications; Urinary stress incontinence; Gynecologic surgical procedures
19.  One-Year Surgical Outcomes and Quality of Life after Minimally Invasive Sling Procedures for the Treatment of Female Stress Urinary Incontinence: TVT SECUR® vs. CureMesh® 
Korean Journal of Urology  2010;51(5):337-343.
We compared the efficacy and safety of two minimally invasive sling procedures used to treat female stress urinary incontinence (SUI), tension-free vaginal tape (TVT) SECUR® and CureMesh®, and assessed the 1-year surgical outcomes.
Materials and Methods
Sixty women with SUI were assigned to undergo either the TVT SECUR (n=38) or CureMesh (n=22) procedures between April 2007 and June 2008. Patients were monitored via outpatient visits at 1 month, 3 months, and 1 year after surgery. The efficacy of these procedures was evaluated by the cough test or by a urodynamic study. At these postoperative visits, the patients also completed several questionnaires, including incontinence quality of life, patient's perception of urgency severity, the scored form of the Bristol Female Lower Urinary Tract Symptoms, visual analog scale, and questions about perceived benefit, satisfaction, and willingness to undergo the same operation again. The objective cure rate was defined as no leakage during the cough test with a full bladder. The subjective cure rate was evaluated by self-assessment of goal achievement performed 1 year postoperatively.
The two groups were similar in preoperative characteristics and urodynamic parameters. The objective cure rates were similar between TVT SECUR and CureMesh (68.4% vs. 77.3%). All respondents reported improvement after surgery. There were no intra-operative complications.
Our results showed that the TVT SECUR and CureMesh procedures are both safe and simple to perform and have no significant differences in efficacy. Comparative studies with long-term follow-up are warranted to determine the true efficacy of these procedures.
PMCID: PMC2873888  PMID: 20495697
Minimally invasive surgical procedures; Stress urinary incontinence; Treatment outcome
20.  Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence 
BMC Women's Health  2009;9:24.
Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.
A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands
Trial registration
Nederlands trial register: NTR 1248
PMCID: PMC2749818  PMID: 19723313
21.  A severe complication of mid-urethral tapes solved by laparoscopic tape removal and ureterocutaneostomy 
Canadian Urological Association Journal  2013;7(9-10):E598-E600.
Mid-urethral tapes are largely used to manage stress urinary incontinence (SUI). In certain cases, however, this procedure results in bothersome complications that lead to complete resection. We present the case of an 85-year-old woman who presented with ongoing suprapubic pain, hematuria, vaginal bleeding and recurrent urinary tract infections. The patient had undergone a tension-free vaginal tape (TVT) procedure in 1999 and a transobturator tape (TOT) placement in 2003 for SUI. Investigations revealed a urethral stone, erosion of both TOT and TVT and an urethra-vaginal fistula. Under local anesthesia the urethral stone was removed endoscopically and the TOT removed via a vaginal approach. Due to her comorbidity, she underwent a laparoscopic intraperitoneal removal of the TVT and a definitive ureterocutaneostomy to relieve her pain, inflammation and incontinence. This is the first ever presented case of erosion of mid-urethral tapes and incontinence treated with a laparoscopic resection of the tape and ureterocutaneostomy as definitive urinary diversion.
PMCID: PMC3776037  PMID: 24069104
22.  How to prevent mesh erosion in transobturator Tension-Free Incontinence Cystocoele Treatment (TICT): a comparative survey 
Il Giornale di Chirurgia  2015;36(1):21-25.
Tension-Free Incontinence Cystocoele Treatment (TICT) was introduced by Leanza-Gasbarro-Caschetto in 2001, on the basis of experimental and clinical investigations to obtain a physiologic mechanism of closure and opening of the urethra in the event of genuine stress urinary incontinence (S.U.I.) and cistocoele. TICT took origin from the previous retropubic tension-free vaginal tape (TVT) based on the integral theory according which mid-urethra has a main role for urinary continence but differs in that the former restores the anatomy and physiology of the entire anterior compartment. Simultaneously Delorme in 2001 spread the TOT (Trans-Obturator Tape) technique, emphasizing the needle passage across the obturator foramen which represents a new and less invasive route in comparison with the retropubic one. Transobturator TICT exploits the advantages of TOT, adding the anatomical repair of bladder prolapse. Introduction of mesh for treatment of pelvic defects gives a lower rate of recurrence, but introduces new complications due to the extraneous materials, among which the most common is represented by mesh erosion. At present the rate of mesh erosion reported is 4.7% in the TOT. Aim of our survey was to verify a technique allowing post-operative erosion prevention.
Patients and methods
230 women with urodynamic stress incontinence and cystocoele after diagnostic phase were allocated to 2 treatment groups (A end B-group), with open alternative method. A-group women underwent transobturator TICT procedure after preparation of anterior compartment by means of a transversal incision taking care to preserve the integrity of the vaginal skin in the site where the mesh would be allocated. Conversely, B-group transobturator TICT was carried out in a classical way, through a longitudinal incision of anterior vaginal skin and suturing after placing the mesh. Each of the two groups was initially constituted by 115 subjects. There were 14 preoperative dropouts among which 6 (115−6=109) in A-group and 8 (115−8=107) in B-group and, after, 16 postoperative dropouts including 7 (109−7=102) in the former and 9 (107−9=98) in the latter. Other pelvic defects were solved during the same operation for a complete repair of pelvic floor.
A-group: subjectively SUI was cured in 87/102 (85.3%) objectively, SUI was cured in 88/102 (86.3%) of patients; cystocoele in 87/102 (85.3%). B-group: subjectively SUI was cured in 86/98 (87.7%) and objectively in 87/98 (88.8%) of patients; cystocoele was solved in 86/98 (87.7%). Between the two groups both anti-incontinence end cystocoele treatment was superimposable (p value > 0.05). Nevertheless regarding mesh erosion, a percentage of 5.1% (5/98) was found among B-group while none among A-group patients where integrity of vaginal skin beneath the mesh was preserved.
Integrity of the vagina beneath the mesh is the right key to prevent ad externum mesh erosion.
PMCID: PMC4396662  PMID: 25827665
Stress urinary incontinence; Cystocele; Mesh erosion
23.  Analysis of 1,000 cases of synthetic midurethral slings used for treatment of female urinary incontinence – a single-center experience 
This study summarized our experience in the treatment of 1,081 women with stress urinary incontinence (SUI) using mid-urethral slings.
Material and methods
The study included 1,081 operated patients. Pure SUI was diagnosed in 77.80% (841) of the patients; another 18.68% (202) had mixed symptoms. The remaining 3.52% (38) suffered from recurrent SUI. Group 1 included the SUI patients treated with TVT. Group 2 – SUI managed with TVT-O. In Group 3, mixed urinary incontinent (MUI) patients were treated with TVT-O.
Retropubic TVT was used in 273 patients (25.25%) and TVT-O in 740 (68.45%). Other slings were used in 68 patients (6.3%). Mean follow-up for the groups was 50.1, 31.1, and 32.6 months respectively. For objective evaluation of cure rate we used the cough stress test. Subjective efficacy was studied via a visual analog scale. The complication rate in each group of the patients was used as a secondary end point. A negative cough test was found in 85.58% of patients in Group 1. For the TVT-O group, the objective cure rate was 84.36%. Intra-operative complications for TVT and TVT-O were not related to age, BMI, or parity. Bladder perforation and pelvic hematoma developed more frequently in the TVT group. There is a higher risk of vaginal perforation for TVT-O. The objective and subjective cure rates for MUI patients were 86.15% and 87.69% respectively.
TVT and TVT-O are equally effective and safe methods of treatment for women suffering from SUI and MUI.
PMCID: PMC3921747  PMID: 24578904
TVT; TVT-O; tension-free tape; stress urinary incontinence
24.  Vaginal Mucosal Flap as a Sling Preservation for the Treatment of Vaginal Exposure of Mesh 
Korean Journal of Urology  2010;51(6):416-419.
Tension-free vaginal tape (TVT) procedures are used for the treatment of stress urinary incontinence in women. The procedures with synthetic materials can have a risk of vaginal erosion. We experienced transobturator suburethral sling (TOT) tape-induced vaginal erosion and report the efficacy of a vaginal mucosal covering technique.
Materials and Methods
A total of 560 female patients diagnosed with stress urinary incontinence underwent TOT procedures at our hospital between January 2005 and August 2009. All patients succeeded in follow-ups, among which 8 patients (mean age: 50.5 years) presented with vaginal exposure of the mesh. A vaginal mucosal covering technique was performed under local anesthesia after administration of antibiotics and vaginal wound dressings for 3-4 days.
Seven of the 8 patients complained of persistent vaginal discharge postoperatively. Two of the 8 patients complained of dyspareunia of their male partners. The one remaining patient was otherwise asymptomatic, but mesh erosion was discovered at the routine follow-up visit. Six of the 8 patients showed complete mucosal covering of the mesh after the operation (mean follow-up period: 16 moths). Vaginal mucosal erosion recurred in 2 patients, and the mesh was then partially removed. One patient had recurrent stress urinary incontinence.
Vaginal mucosal covering as a sling preservation with continued patient continence may be a feasible and effective option for the treatment of vaginal exposure of mesh after TOT tape procedures.
PMCID: PMC2890059  PMID: 20577609
Complications; Suburethral slings; Surgical mesh
25.  AB194. A 12-year retrospective evaluation of TVT and TVT-O in the surgical management of SUI in females and the analysis of influence factors 
Translational Andrology and Urology  2016;5(Suppl 1):AB194.
We evaluate the clinical effect of TVT and TVT-O slings in the surgical management of SUI in women at mostly 12-year follow-ups and the factors that influence it.
In this retrospective analysis, 94 women with stress incontinence treated by TVT (14 cases) or TVT-O (80 cases) were included. Subjective evaluation included ICIQ-SF, KHQ, PGI-I and patient satisfaction, and we recorded the objective data of the procedures. We analyzed whether the age, BMI, disease duration, surgery history, postoperative follow-up duration or other factors were related to the subjective cure rate.
Eight cases of TVT and 59 cases of TVT-O completed the follow-up. Patients were followed up for 1.3–12 years in TVT and 0.2–9.2 years in TVT-O group. The rates of subjectively assessed success were 87.5% and 84.7%, respectively (P=1.00). The total KHQ were (21.93±30.42) and (16.89±25.85) (P=0.55). The operation duration were (59.29±21.02) in TVT group and (29.87±12.04) in TVT-O group (P=0.00). The postoperative days of indwelling catheter were (4.14±1.79) and (3.11±1.51) (P=0.02), and the post-operation hospitalization days were (5.64±2.06) and (5.01±1.77) (P=0.27). The factors above didn’t affect the subjective cure rate.
The patient reported long-term success rate were both high and had no significant differences between the groups. Operation duration and postoperative durations of indwelling catheter of TVT-O was shorter. The factors above didn’t affect the subjective cure rate.
PMCID: PMC4842591
TVT; TVT-O; SUI in women

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