- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613311
Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele
August 1, 2018 updated by: National Taiwan University Hospital
Prevalence Rates of Evident, Occult and no Demonstrated Urodynamic Stress Incontinence and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Prevalence rates of urodynamic urinary incontinence (USI) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation, especially for occult USI.
Misdiagnosis of occult USI before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair.
Thus, the aim of this study was to elucidate the above findings and between-group associations.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed.
ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis.
USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction.
The recruited patients with cystocele were classified into three groups (i.e.,evident USI, occult USI and no demonstrated USI) according to pad weight results before and after prolapse reduction.
Study Type
Observational
Enrollment (Actual)
480
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with cystocele more than stage II
Description
Inclusion Criteria:
- Age >20y/o
- Cystocele > stage II
- Complete urodynamic study
Exclusion Criteria:
- Pregnancy
- Urinary tract infection
- Previous pelvic reconstruction surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Evident urodynamic stress incontinence(USI)
Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed.
USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction.
|
Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile
|
Occult USI
Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed.
USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction after prolapse reduction by vaginal gauze.
|
Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile
|
ND USI
Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed.
No USI was noted in this group.
|
Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evident USI
Time Frame: Between November 2011 and January 2017
|
USI note before reduction of prolapse
|
Between November 2011 and January 2017
|
Occult USI
Time Frame: Between November 2011 and January 2017
|
USI note after reduction of prolapse
|
Between November 2011 and January 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2011
Primary Completion (Actual)
January 31, 2017
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
July 18, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (Actual)
August 3, 2018
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201805048RIN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share IPD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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