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

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:

  1. Age >20y/o
  2. Cystocele > stage II
  3. Complete urodynamic study

Exclusion Criteria:

  1. Pregnancy
  2. Urinary tract infection
  3. 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

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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