Dataset Information

Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

ABSTRACT:

Background

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).

Methods

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.

Results

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.

Conclusion

TVT is more effective than TOT in treatment of female SUI with ISD.

SUBMITTER: Kim HG

PROVIDER: S-EPMC4882043 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Publications

Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

Kim Hyeong Gon HG Park Hyoung Keun HK Paick Sung Hyun SH Choi Woo Suk WS

PloS one 20160526 5

<h4>Background</h4>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).<h4>Methods</h4>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 ...[more]

PMID: 27228092

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Project description:BackgroundWe 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.Methods/designAll 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.DiscussionThis 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 registrationClinicalTrials.gov NCT00234754. Registered October 2005.

Project description:BackgroundIn 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.ResultsThe 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).ConclusionOur 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 registrationClinicalTrials.gov NCT00685217, 22 May 2008.

Project description:Importance: It needs to be clarified whether trans-obturator tape (TOT)-enhanced urethral resistance could impact the voiding function. Objective: Although TOT has been well-recognized for enhancing urethral resistance to restore continence in stress urinary incontinence (SUI) patients, whether the bladder's voiding functions adapt to the TOT-enhanced resistance has not been adequately investigated. This study thereby aimed to investigate whether TOT impacts the bladder's thermodynamic efficacy during the voiding phase. Design: A retrospective analysis of urodynamics performed before and after TOT was assessed. Setting: A tertiary referral hospital in Taiwan. Participants: A total of 26 female SUI patients who underwent urodynamic investigations before and after TOT. Main outcomes and measures: The area enclosed by the pressure-volume loop (Apv), which represents the work performed by the bladder during voiding, in a pressure-volume analysis established by plotting the detrusor pressure versus intra-vesical volume was retrospectively analyzed. Paired Student's t-tests were employed to assess the difference in values before and after the operation. Significance in difference was set at p < 0.05. Results: TOT increased Apv in 20 of 26 (77%) patients and significantly increased the mean Apv compared to the preoperative control (2.17 ± 0.18 and 1.51 ± 0.13 × 103 cmH2O-ml, respectively p < 0.01). TOT also increased the mean urethral resistance (1.03 ± 0.30 vs. 0.29 ± 0.05 cmH2O-sec/ml, p < 0.01) and mean voiding pressure (25.87 ± 1.72 and 19.30 ± 1.98 cmH2O p < 0.01) but did not affect the voided volume and voiding time. Moreover, the TOT-induced Apv increment showed a moderate correlation with the changes in urethral resistance and voiding pressure (both r > 0.5) but no correlation with changes in voided volume or voiding time. It is remarkable that the TOT-induced urethral resistance increment showed a strong correlation with changes in voiding pressure (r > 0.7). Conclusion and Relevance: The bladder enhances thermodynamic efficacy by adapting the voiding mechanism to increased urethral resistance caused by TOT. Further studies with higher case series and longer follow-ups should assess whether this effect could be maintained over time or expire in a functional detrusor decompensation, to define diagnostic criteria that allow therapeutic interventions aimed at its prevention during the follow-up. Clinical Trial Registration: (clinicaltrials.gov), identifier (NCT05255289).

Dataset Information

Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

Background

Methods

Results

Conclusion

Publications

Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

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