NCT03613350

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

July 1, 2018

Enrollment Period

5.3 years

First QC Date

July 18, 2018

Last Update Submit

August 1, 2018

Conditions

Lower Urinary Tract Symptom in Severe Cystocele Women

Keywords

CystoceleUrodynamic stress incontinenceDetrusor overactivityPad testUrodynamic study

Outcome Measures

Primary Outcomes (2)

  • USI

    Urodynamic stress incontinence was noted during examination

    Between November 2011 and January 2017

  • BO/DO

    Bladder oversensitivity/detrusor overactivity was noted during examination

    Between November 2011 and January 2017

Study Arms (4)

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

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

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

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

Interventions

Pad testDIAGNOSTIC_TEST

20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.

Also known as: urodynamic study
BO/DONo demonstrated USI+BO/DOUSI+BO/DOUrodynamic stress incontinence

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with ≥stage II cystocele.

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Urinary tract infection
  • Had received pelvic reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CystoceleUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsLower Urinary Tract SymptomsUrological ManifestationsSigns 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

No plan to share IPD