Evidence map›Paper›PMID 31938840›Full record

Trial reportWorld journal of urology2020

Assessment of the effects of autologous muscle-derived cell injections on urethral sphincter morphometry using 3D/4D ultrasound.

Salima Ismail, Mélanie Morin, Le Mai Tu

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Salima IsmailDepartment of Surgery, Division of Urology, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada.ORCID http://orcid.org/0000-0001-9203-5136
Mélanie MorinSchool of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the CHUS, Sherbrooke, QC, Canada.
Le Mai TuDepartment of Surgery, Division of Urology, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre Hospitalier Universitaire de Sherbrooke (CHUS), Sherbrooke, QC, Canada. le.mai.tu@USherbrooke.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe primary objective was to evaluate the effect of autologous muscle-derived cell (AMDC) injections on the urethral sphincter morphometry compared to placebo injections. Secondary aims were to explore the reduction of stress incontinence episode frequency (IEF) and factors associated with the efficacy of AMDC.

methodsThis prospective randomized-controlled study compared the urethral sphincter volumes of participants who had received either an intra-sphincteric injection of 4 cc AMDC in injection media or 4 cc placebo solution, using a transperineal 3D/4D ultrasound at baseline and at 12 months. The reduction of stress IEF on 3-day bladder diary and potential predictors at baseline for response to AMDC were assessed.

resultsFifty-eight participants were included in the study. Compared to baseline, the mean total and external sphincter volumes increased significantly in both groups (respectively, p = 0.001 and p < 0.001 in the AMDC group, p < 0.001 and p = 0.005 in the placebo group) at 12 months. Both groups showed a significant reduction of stress IEF compared to baseline (p = 0.03 and p ≤ 0.001 for AMDC and placebo groups, respectively). There were no between-group differences regarding total and external sphincter volumes and reduction of stress IEF. A longer urethral length (p ≤ 0.001) and a larger external sphincter volume (p ≤ 0.05) were significantly associated with lower stress IEF.

conclusionSignificant increases of sphincter volumes as well as reduction of stress IEF occurred among the AMDC and placebo injection groups with no between-group differences at 12 months. A longer urethral length and a larger external sphincter volume at baseline were identified as potential predictors of AMDC injection response.

Indexed as

AgedAutograftsDouble-Blind MethodHumansImaging, Three-DimensionalInjectionsMaleMiddle AgedMuscle CellsProspective StudiesUltrasonographyUrethraUrinary Incontinence, StressCell therapyMuscle cellsStress urinary incontinenceUltrasonographyUrethra

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.