Prevalence Rates of USI, BO, DO and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele

• ClinicalTrials.gov Identifier: NCT03613350
• Recruitment Status: Completed
• First Posted: August 3, 2018
• Last Update Posted: August 3, 2018
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

Brief Summary:

Prevalence rates of urodynamic stress incontinence (USI), bladder oversensitivity (BO) /detrusor overactivity (DO) or both 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.

Condition or disease	Intervention/treatment
Lower Urinary Tract Symptom in Severe Cystocele Women	Diagnostic Test: Pad test

Detailed Description:

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction. BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Those women without USI, BO or DO were allocated into the no demonstrated USI+BO/DO group.

Study Design

• Study Type: Observational
• Actual Enrollment: 480 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Prevalence Rates of Urodynamic Stress Incontinence, Bladder Oversensitivity/Detrusor Overactivity or Both and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
• Actual Study Start Date: November 1, 2011
• Actual Primary Completion Date: January 31, 2017
• Actual Study Completion Date: May 31, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Urodynamic stress incontinence; Urodynamic study incontinence Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.	Diagnostic Test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Name: urodynamic study
USI+BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. USI included evident USI and occult USI, which were classified according to pad weight before and after prolapse reduction.BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.	Diagnostic Test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Name: urodynamic study
BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. BO was defined as <300 mL of the volume at strong desire to void during filling cystometry. Detrusor overactivity was defined as evidence of spontaneous detrusor contractions occurring during bladder filling or an uninhibited detrusor contraction occurring at a cystometric capacity that usually results in voiding.	Diagnostic Test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Name: urodynamic study
No demonstrated USI+BO/DO; Urodynamic study incontinence + bladder oversensitivity / detrusor overactivity Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent 20-minute pad testing and urodynamic studies in a medical center were reviewed. No urodynamic stress incontinence, no bladder oversensitivity nor detrusor overactivity was noted in this group.	Diagnostic Test: Pad test; 20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.; Other Name: urodynamic study

Outcome Measures

Primary Outcome Measures :

1. USI [ Time Frame: Between November 2011 and January 2017 ]
   Urodynamic stress incontinence was noted during examination
2. BO/DO [ Time Frame: Between November 2011 and January 2017 ]
   Bladder oversensitivity/detrusor overactivity was noted during examination

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Women with ≥stage II cystocele.

Criteria

Inclusion Criteria:

1. Age >20y/o
2. Severe cystocele, ie, more than stage 2
3. Complete pad test and urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Had received pelvic reconstruction

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03613350
• Other Study ID Numbers: 201805024RINB
• First Posted: August 3, 2018
• Last Update Posted: August 3, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share IPD

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:

Cystocele; Urodynamic stress incontinence; Detrusor overactivity; Pad test; Urodynamic study

Additional relevant MeSH terms:

Cystocele; Lower Urinary Tract Symptoms; Hernia; Urological Manifestations; Urinary Bladder Diseases; Urologic Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical