An observational study in Stress Urinary Incontinence, sponsored by Oregon Health and Science University. Status unknown at 2 sites in United States. Open to female participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Oregon Health and Science University · Observational
This observational cohort study is aimed at determining changes in the cytokine expression profile as well as the urinary and vaginal microbiome of women undergoing midurethral sling placement for the treatment of stress urinary incontinence.
Primary Objectives:
This is a pilot study to evaluate how midurethral sling (MUS) placement for the treatment of stress urinary incontinence (SUI) affects the bladder microenvironment, specifically the local microbial community or "microbiome" of the bladder and the cytokine expression profile. The investigators also aim to correlate any changes in the microbiome or cytokine expression profile with patient-reported urinary symptoms preoperatively and postoperatively.
Specific Aim 1: Assess the change in the urinary and vaginal microbiome (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that the bladder environment will be disturbed by surgery involving the lower urinary tract and will show demonstrable changes in the urinary and vaginal microbiota.
Specific Aim 2: Characterize the cytokine profile of the bladder (preoperatively to postoperatively) in women undergoing MUS placement for the treatment of SUI. The investigators hypothesize that MUS treatment will change the cytokine profile of the bladder and lead to alterations in the expression of pro-inflammatory cytokines.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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The study population will include women over the age of 18 planning to undergo stand-alone midurethral sling placement for treatment of stress urinary incontinence.
Exclusion Criteria:
This cohort will undergo midurethral sling placement.
Device: Retropubic midurethral sling
Midurethral sling
Also known as: TVT
Urinary Microbiome
change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative
Time frame: Six weeks
Prevalence of overactive bladder symptoms
Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder.
Time frame: Six weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University