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CompletedNCT03613324Updated Aug 3, 2018

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

An observational study in Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele, sponsored by National Taiwan University Hospital. Completed. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
455
Ages
20 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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. Only those with complete data of maximum flow rate (Qmax) and detrusor pressure at maximum flow rate (PdetQmax) were enrolled. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. Woman were defined as having DU when Qmax was \<12 mL/s and PdetQmax was \<10 cmH2O, and were defined as having BOO when Qmax was \<12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.

02

Conditions studied

  • Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele

Keywords

  • Cystocele
  • Bladder outlet obstruction
  • Detrusor underactivity
  • Urodynamic study
03

In context

Urinary Bladder Neck Obstruction

46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.

This study's enrollment of 455 is above the median of 165 across 14 observational studies indexed under Urinary Bladder Neck Obstruction.

Browse Urinary Bladder Neck Obstruction studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with more than stage II cystocele

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 20y/o
  2. Cystocele > stage II
  3. Complete pad test and urodynamic study

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Urinary tract infection
  3. Had received pelvic reconstruction surgery
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
455 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testPad test

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

    Also known as: Urodynamic study

06

What researchers measure

Primary outcomes

  1. BOO

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

    Time frame: November 2011 to January 2017

  2. DU

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

    Time frame: November 2011 to January 2017

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No plan to share IPD

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2011 to primary completion in Nov 2017, 82 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2018
First posted
Aug 3, 2018
StartActual
Jan 1, 2011
Primary completionActual
Nov 30, 2017
CompletionActual
May 31, 2018
Last update
Aug 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03613324
Responsible party
Sponsor
First posted
Aug 3, 2018
Start date
Jan 1, 2011
Primary completion
Nov 30, 2017
Completion
May 31, 2018
Last update
Aug 3, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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