Trial reportInternational urogynecology journal2016
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.
Trial report in International urogynecology journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Single-incision sling operations for urinary incontinence in women.The Cochrane database of systematic reviews · 2023Pooled it
- Adjustable slings versus other surgical methods in female stress urinary incontinence: a systematic review and meta-analysis.International urogynecology journal · 2023Pooled it
- Pooled it
- De novo overactive bladder following midurethral sling procedures: a systematic review of the literature and meta-analysis.International urogynecology journal · 2017Pooled it
- Single-incision mini-slings versus standard synthetic mid-urethral slings for surgical treatment of stress urinary incontinence in women: The SIMS RCT.Health technology assessment (Winchester, England) · 2022Trial
- What is the optimal length for single-incision tape?International urogynecology journal · 2019Trial
- Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial.International urogynecology journal · 2019Trial
- A randomized comparison of a single-incision needleless (Contasure-needleless®) mini-sling versus an inside-out transobturator (Contasure-KIM®) mid-urethral sling in women with stress urinary incontinence: 24-month follow-up results.International urogynecology journal · 2018Trial
- Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling.International urogynecology journal · 2017Trial
- Electrotherapy Plus Photobiostimulation for the Treatment of Mild Pelvic Organ Prolapse and Stress Urinary Incontinence.Journal of clinical medicine · 2026Article
- Instruments Used for the Assessment of SUI Severity in Urogynecologic Surgical Trials: A Scoping Review.International urogynecology journal · 2024Article
- Could infiltration anesthesia decrease anchor-fixation quality of midurethral slings in the obturator complex?International urogynecology journal · 2023Article
- Medium-term safety outcomes in patients undergoing tension free vaginal tape obturator for stress urinary incontinence in Murcia, Spain. Historical cohortRevista colombiana de obstetricia y ginecologia · 2021Article
- Management of mid-urethral tape complications: a retrospective study.Journal of obstetrics and gynaecology of India · 2020Article
- Are the same tapes really the same? Ultrasound study of laser-cut and mechanically cut TVT-O post-operative behavior.International urogynecology journal · 2018Article
- Ambulatory MiniArc Precise Sling under Local Anesthesia for Stress Urinary Incontinence: Feasibility and Outcome.Gynecology and minimally invasive therapyArticle
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThe 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.
methodsThis single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O).
resultsThe mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse.
conclusionsAfter 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.
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Registered trials
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