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出境医 / 临床实验 / Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence

Study Description
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.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Device: Retropubic midurethral sling

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
MUS Cohort
This cohort will undergo midurethral sling placement.
 Device: Retropubic midurethral sling
Midurethral sling
Other Name: TVT
Outcome Measures
Primary Outcome Measures :
  1. Urinary Microbiome [ Time Frame: Six weeks ]
    change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative


Secondary Outcome Measures :
  1. Prevalence of overactive bladder symptoms [ Time Frame: Six weeks ]
    Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Planning to undergo retropubic midurethral sling placement

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
United States, Oregon
Legacy Good Samaritan Hospital
Portland, Oregon, United States, 97210
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Collins Medical Trust
Tracking Information
First Submitted Date May 3, 2019
First Posted Date May 8, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date May 3, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2020) 		Urinary Microbiome [ Time Frame: Six weeks ]
change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative
Original Primary Outcome Measures
 (submitted: May 6, 2019)
  • Urinary Microbiome [ Time Frame: Six weeks ]
    change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative
  • Cytokine Profile [ Time Frame: Six weeks ]
    Change in cytokine expression profile of the bladder between baseline, 2, and 6 weeks postoperative
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2019) 		Prevalence of overactive bladder symptoms [ Time Frame: Six weeks ]
Validated symptom questionnaires will be collected at baseline and again at 2 and six weeks postoperatively to assess common symptoms associated with overactive bladder.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
Official Title Changes in the Bladder Micro-environment Following Midurethral Sling Surgery for Stress Urinary Incontinence
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.
Detailed Description

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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Weeks
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Stress Urinary Incontinence
Intervention Device: Retropubic midurethral sling
Midurethral sling
Other Name: TVT
Study Groups/Cohorts MUS Cohort
This cohort will undergo midurethral sling placement.
Intervention: Device: Retropubic midurethral sling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 14, 2020) 		20
Original Estimated Enrollment
 (submitted: May 6, 2019) 		40
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Planning to undergo retropubic midurethral sling placement

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03942549
Other Study ID Numbers STUDY00019197
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ian Fields, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Collins Medical Trust
Investigators Not Provided
PRS Account Oregon Health and Science University
Verification Date September 2020

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