Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
1 other identifier
observational
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2019
CompletedStudy Start
First participant enrolled
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 16, 2020
September 1, 2020
1.7 years
May 3, 2019
September 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Microbiome
change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative
Six weeks
Secondary Outcomes (1)
Prevalence of overactive bladder symptoms
Six weeks
Study Arms (1)
MUS Cohort
This cohort will undergo midurethral sling placement.
Interventions
Eligibility Criteria
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.
You may qualify if:
- Age \> 18 years old
- Planning to undergo retropubic midurethral sling placement
You may not qualify if:
- Prior surgery for stress urinary incontinence
- Untreated pelvic organ prolapse \> Stage II based on POP-Q assessment
- Concomitant surgery for prolapse
- Current use of anticholinergic medications
- Use of systemic or vaginal antibiotics in the last 2 months
- Active urinary tract infection
- History of recurrent UTI
- Pregnancy
- History of pelvic radiation or bladder cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Collins Medical Trustcollaborator
Study Sites (2)
Legacy Good Samaritan Hospital
Portland, Oregon, 97210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 8, 2019
Study Start
May 3, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share