Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Bianchi-Ferraro, Ana Maria H. M.; Bella, Zsuzsanna Ilona Katalin de Jármy Di; Castro, Rodrigo Aquino; Bortolini, Maria Augusta Tezelli; Sartori, Marair Grácio Ferreira; Girão, Manoel Joâo Batista Castello

doi:10.1007/s00192-012-1998-2

Cited by 26 publications

(10 citation statements)

References 26 publications

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“…The single-incision sling (TVT-Secur, Gynecare TVT Secur System, Ethicon Inc., Somerville, New Jersey, US) was inserted using the "U" insertion technique. 10 The manufacturer discontinued the commercialization of the TVT-S in 2012. 11 Three-dimensional US imaging and a clinical evaluation were performed between April 2013 and June 2014.…”

Section: Methodsmentioning

confidence: 99%

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up

Rodrigues

Bianchi-Ferraro

Zucchi

et al. 2017

Rev Bras Ginecol Obstet

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Objective Using three-dimensional ultrasound (3D-US), we aimed to compare the tape position and the angle formed by the sling arms in different techniques of mid-urethral sling insertion for the surgical treatment of stress urinary incontinence, three years after surgery. In addition, we examined the correlations between the US findings and the clinical late postoperative results. Methods A prospective cross-sectional cohort study of 170 patients who underwent a sling procedure between May 2009 and December 2011 was performed. The final sample, with US images of sufficient quality, included 26 retropubic slings (tension-free vaginal tape, TVT), 42 transobturator slings (tension-free vaginal tape-obturator, TVT-O), and 37 single-incision slings (tension-free vaginal tape-Secur, TVT-S). The images (at rest, during the Valsalva maneuver, and during pelvic floor contraction) were analyzed offline by 2 different observers blinded against the surgical and urinary continence status. Group comparisons were performed using the Student t-test, the chi-squared and the Kruskal-Wallis tests, and analyses of variance with Tukey multiple comparisons. Results Differences among the groups were found in the mean angle of the tape arms (TVT = 119.94°, TVT-O = 141.93°, TVT-S = 121.06°; p < 0.001) and in the distance between the bladder neck and the tape at rest (TVT = 1.65 cm, TVT-O = 1.93 cm, TVT-S = 1.95 cm; p = 0.010). The global objective cure rate was of 87.8% (TVT = 88.5%, TVT-O = 90.5%, TVT-S = 83.8%; p = 0.701). The overall subjective cure rate was of 83.8% (TVT = 88.5%, TVT-O = 88.5% and TVT-S = 78.4%; p = 0.514). The slings were located in the mid-urethra in 85.7% of the patients (TVT = 100%, TVT-O = 73.8%, TVT-S = 89.2%; p = 0.001), with a more distal location associated with obesity (distal: 66.7% obese; mid-urethra: 34% obese; p = 0.003). Urgency-related symptoms were observed in 23.8% of the patients (TVT = 30.8%, TVT-O = 21.4%, TVT-S = 21.6%; p = 0.630). Conclusions The angle formed by the arms of the sling tape was more obtuse for the transobturator slings compared with the angles for the retropubic or single-incision slings. Retropubic slings were more frequently located in the mid-urethra compared with the other slings, regardless of obesity. However, the analyzed sonographic measures did not correlate with the urinary symptoms three years after the surgery.

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Section: Methodsmentioning

confidence: 99%

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up

Rodrigues

Bianchi-Ferraro

Zucchi

et al. 2017

Rev Bras Ginecol Obstet

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“…9 Pain Pain is the most poorly studied complication of SMUS surgery; we found only a few studies that included prospective data collection and/or validated questionnaires assessing pain. 30,79,90,95,152,168,174,229,254 Some investigators used postoperative questionnaires that contained pain questions, but most relied on patients' recall or chart review. 39 In addition, many different descriptors of pain have been reported including vaginal, pelvic, groin, thigh, leg, suprapubic and lower abdominal pain, dyspareunia and "pain, patient self-report. "…”

Section: Reviewsmentioning

confidence: 99%

“…9,110,143 In studies of effectiveness and safety, pain was mostly divided into perioperative pain and pain lasting more than 6 weeks. Perioperative pain has been reported in up to 33% of patients, 252 occurring more frequently after implantation of TOT slings than RP slings, 331 and chronic pain (of any definition) has been reported in 0-31% of patients (REFS 17,18,20,30,39,47,48,53,58,59,(61)(62)(63)66,69,70,73,76,79,82,(89)(90)(91)95,98,99,140,152,155,159,164,167,168,(171)(172)(173)(174)177,(180)(181)(182)185,208,…”

Section: Reviewsmentioning

confidence: 99%

Safety considerations for synthetic sling surgery

et al. 2015

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Implantation of a synthetic midurethral sling (SMUS) is the most commonly performed anti-incontinence operation in women worldwide. The effectiveness of the SMUS is comparable to that of the historical gold standards--autologous fascial slings and the Burch colposuspension. Much controversy, however, has evolved regarding the safety of this type of sling. Overall, the quality of the studies with respect to assessing risks of SMUS-associated complications is currently poor. The most common risks in patients with SMUS include urethral obstruction requiring surgery (2.3% of patients with SMUS), vaginal, bladder and/or urethral erosion requiring surgery (1.8%) and refractory chronic pain (4.1%); these data likely represent the minimum risks. In addition, the failure rate of SMUS implantation surgery is probably at least 5% in patients with stress urinary incontinence (SUI). Furthermore, at least one-third of patients undergoing sling excision surgery develop recurrent SUI. Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after SMUS implantation surgery is ≥15%.

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“…Stage 5 -RCTs, n =19 [78][79][80][81][82][83][84][85][86][87][88][89][90][91][92][93][94][95][96] Nineteen papers described results from 15 RCTs (Appendix A). These more rigorous studies started to appear in 2010, although the RCTs were small (the largest study recruited 285 subjects [85]).…”

Section: Stage 3 -Public Acceptance and Third-party Endorsement No Pmentioning

confidence: 99%

“…It is not possible to comment on the role of Ethicon in sponsoring RCTs, because the published reports seldom mention funding sources. Only four of the RCTs identified in this review were registered in ClinicalTrials.gov: of those, Gynecare was mentioned as a collaborator for only one [91,96].…”

Section: Stage 3 -Public Acceptance and Third-party Endorsement No Pmentioning

confidence: 99%

The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model

Ross

Robert

Ducey

2015

Health Policy and Technology

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Objective: In 1981 McKinlay described "Seven Stages in the Career of a Medical Innovation". We wished to examine whether the model fits a modern device life cycle, and to comment on device manufacturers' influence on the life cycle. We chose to study the complete life cycle of TVT Secur, a mesh kit for surgical treatment of stress urinary incontinence in women, from its marketing in 2006 to device discontinuation for commercial reasons in March 2013. Methods: A PubMed review was undertaken to identify all published literature related to TVT Secur from 2006 to November 2014. Each publication was classified according to McKinlay's seven stages.Results: Eighty-three relevant publications from 22 countries were identified: 4 promising reports, 1 professional adoption, 0 third-party endorsement, 34 standard procedure, 19 randomised controlled trials (RCTs) from 2010 and mainly describing comparisons with other TVT family members), 0 professional denunciation of RCT findings, and 4 erosion and discreditation. Conclusions:McKinlay's seven stages model was useful to describe TVT Secur's truncated life cycle. TVT Secur, fully approved and licensed according to all jurisdictional requirements, generated many descriptive cohort studies but more rigorous RCT evidence appeared only half way through its life cycle. Device discontinuation meant that the stage of erosion and discreditation described by McKinlay occurred after TVT Secur was no longer available.

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Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial

Abstract: TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.

Cited by 26 publications

References 26 publications

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up

Pelvic Floor 3D Ultrasound of Women with a TVT, TVT-O, or TVT-S for Stress Urinary Incontinence at the Three-year Follow-up

Safety considerations for synthetic sling surgery

The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model

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