Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03613311

Collaborator

(none)

480

Enrollment

78.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urodynamic Stress Incontinence in Severe Cystocele Women	Diagnostic Test: Urodynamic study

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 Design

Study Type:

Observational

Actual Enrollment :

480 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Prevalence Rates of Evident, Occult and no Demonstrated Urodynamic Stress Incontinence and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

Actual Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jan 31, 2017

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	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.	Diagnostic Test: Urodynamic study 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.	Diagnostic Test: Urodynamic study 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.	Diagnostic Test: Urodynamic study Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile

Arm

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.

Diagnostic Test: Urodynamic study

Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile

Occult USI

Diagnostic Test: Urodynamic study

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.

Diagnostic Test: Urodynamic study

Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile

Outcome Measures

Primary Outcome Measures

Evident USI [Between November 2011 and January 2017]
USI note before reduction of prolapse
Occult USI [Between November 2011 and January 2017]
USI note after reduction of prolapse

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age >20y/o
Cystocele > stage II
Complete urodynamic study

Exclusion Criteria:

Pregnancy
Urinary tract infection
Previous pelvic reconstruction surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT03613311

Other Study ID Numbers:

201805048RIN

First Posted:

Aug 3, 2018

Last Update Posted:

Aug 3, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Cystocele

Urodynamic stress incontinence

Pad test

Urodynamic study

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Cystocele

Hernia

Study Results

No Results Posted as of Aug 3, 2018