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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03942549
• Other study ID #: STUDY00019197
• Status: Active, not recruiting
• Start date: May 3, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Retropubic midurethral sling
Midurethral sling

Locations

Country	Name	City	State
United States	Legacy Good Samaritan Hospital	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Collins Medical Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Microbiome	change in the relative abundance of urinary lactobacillus between baseline, 2 and 6 weeks postoperative	Six weeks
Secondary	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.	Six weeks