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

NCT03613311 | Completed

• 1 other identifier: 201805048RIN
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urodynamic Stress Incontinence in Severe Cystocele Women

Keywords

Cystocele; Urodynamic stress incontinence; Pad test; Urodynamic study

Outcome Measures

Primary Outcomes (2)

• Evident USI

  USI note before reduction of prolapse

  Between November 2011 and January 2017

• Occult USI

  USI note after reduction of prolapse

  Between November 2011 and January 2017

Study Arms (3)

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

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

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

Interventions

Urodynamic study DIAGNOSTIC_TEST

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

Evident urodynamic stress incontinence(USI); ND USI; Occult USI

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with cystocele more than stage II

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Urinary tract infection
• Previous pelvic reconstruction surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Cystocele

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 3, 2018
• Study Start: November 1, 2011
• Primary Completion: January 31, 2017
• Study Completion: May 31, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share