Trial reportInternational urogynecology journal2013
Lack of effect of concomitant stage II cystocele repair on lower urinary tract symptoms and surgical outcome after tension-free vaginal tape procedure: randomized controlled trial.
Trial report in International urogynecology journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis 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
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set.International urogynecology journal · 2018Pooled it
- The use of midurethral sling in the correction of low-stage cystoceles: a prospective randomized trial.International urogynecology journal · 2024Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
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 lower urinary tract symptom changes and surgical outcome between the tension-free vaginal tape (TVT) procedure with and without concomitant stage II pelvic organ prolapse (cystocele) repair in a randomized clinical trial setting.
methodsPatients with urodynamically proven stress urinary incontinence (SUI) and asymptomatic stage II cystocele were randomly and equally allocated to either a TVT and concomitant cystocele repair group or TVT only group. SUI was corrected with TVT in all cases. The cystocele repair procedure was performed with Gynemesh. Lower urinary tract symptoms and surgical outcome were assessed at postoperative year 1. Lower urinary tract symptoms were assessed with the American Urological Association Symptom Score (AUASS) questionnaire, uroflowmetry, and postvoid residual (PVR).
resultsThe cure rate of TVT only and the concomitant repair group was 87 and 91%, respectively (p > 0.05). Cystocele was cured in all patients in the concomitant repair group. After the operation, the total AUASS were 6.4 and 8.4 in the TVT only group and concomitant repair group, respectively, with no statistical difference. There was no difference in the change in peak flow rate (Qmax) and PVR between the two groups. The prevalence of postoperative mixed incontinence was not different between the two groups.
conclusionsIn patients with stage II cystocele and SUI, there was no difference in the surgical outcome and lower urinary tract symptoms between the TVT sling only group and concomitant repair group. Cystocele repair can be safely omitted in patients with stage II cystocele.
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