BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

NCT03613324 | Completed

• 1 other identifier: 201805025RINB
• Study Type: observational
• Target: 455
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prevalence rates of bladder outlet obstruction (BOO) and detrusor underactivity (DU) and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Conditions

Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele

Keywords

Cystocele; Bladder outlet obstruction; Detrusor underactivity; Urodynamic study

Outcome Measures

Primary Outcomes (2)

• BOO

  Bladder outlet obstruction: Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

  November 2011 to January 2017

• DU

  Detrusor underactivity: \<12 mL/s and PdetQmax was \<10 cmH2O

  November 2011 to January 2017

Study Arms (3)

Bladder outlet obstruction (BOO)

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Woman were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

Diagnostic Test: Pad test

Detrusor underactivity (DU)

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O during voiding cystometry.

Diagnostic Test: Pad test

ND BOO/DU

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20 min pad testing and urodynamic studies in a medical center were reviewed. This group revealed no demonstrated bladder outlet obstruction nor detrusor underactivity.

Diagnostic Test: Pad test

Interventions

Pad test DIAGNOSTIC_TEST

20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.

Also known as: Urodynamic study

Bladder outlet obstruction (BOO); Detrusor underactivity (DU); ND BOO/DU

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 more than stage II cystocele

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Urinary tract infection
• Had received pelvic reconstruction surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Cystocele; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations; 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: January 1, 2011
• Primary Completion: November 30, 2017
• Study Completion: May 31, 2018
• Last Updated: August 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share