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CompletedNCT04981080Updated Jul 28, 2021

DU and BOO in Women With and Without Symptoms of VD

An observational study in Detrusor Underactivity and Bladder Outlet Obstruction, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,886
Ages
20 Years to 85 Years
Sex
Female
01

Study summary

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity or bladder outlet obstruction. However, the prevalence of detrusor underactivity and bladder outlet obstruction remained obscure. Thus, the aim of this study was to elucidate the prevalence of detrusor underactivity and bladder outlet obstruction in women with and without symptoms of voiding dysfunction.

Read the detailed description

Between February 2005 and December 2020, all women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of maximum flow rate, voided volume, post-void residual volume and detrusor pressure at maximum flow rate were excluded from this study. Detrusor underactivity was defined when the detrusor pressure at maximum flow rate was less than 20 cmH2O, the maximum flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %. Bladder outlet obstruction was defined when the the detrusor pressure at maximum flow rate was not less than 40 cmH2O, and the maximum flow rate was less than 12 mL/s. Those women without detrusor interactivity or bladder outlet obstruction were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression test were used for statistical analysis as appropriate. A p \< 0.05 was considered as statistically significant.

02

Conditions studied

  • Detrusor Underactivity
  • Bladder Outlet Obstruction

Keywords

  • detrusor underactivity
  • bladder outlet obstruction
  • voiding dysfunction
03

In context

Urinary Bladder, Underactive

31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.

Browse Urinary Bladder, Underactive 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 to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation

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

  • Women with lower urinary tract symptoms
  • Complete urodynamic study

Exclusion criteria

Exclusion Criteria:

  • Advanced cystocele
  • After surgery for cystocele repair
  • Chronic infection
  • Incomplete data
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,886 participants (actual)
Patient registry
No

Groups and cohorts

  • Symptom of voiding dysfunction

    Women with lower urinary tract symptoms including voiding symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed

    Diagnostic Test: Urodynamic study

  • No symptom of voiding dysfunction

    Women with lower urinary tract symptoms but without cystocele or voiding symptoms who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed

    Diagnostic Test: Urodynamic study

Interventions

  • Diagnostic testUrodynamic study

    The urodynamic assessment, including noninstrumented uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and urethral pressure profilometry, was performed with the patient in a sitting position according to the recommendations by the International Continence Society.

06

What researchers measure

Primary outcomes

  1. Detrusor underactivity

    The detrusor pressure when maximal flow rate was less than 20 cmH2O, the maximal flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %

    Time frame: February 2005 and December 2020

  2. Bladder outlet obstruction

    The detrusor pressure when maximal flow rate was not less than 40 cmH2O, and the maximal flow rate was less than 12 mL/s

    Time frame: February 2005 and December 2020

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

References and documents

Publications

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. PubMed 19941278 ↗
  • Choi YS, Kim JC, Lee KS, Seo JT, Kim HJ, Yoo TK, Lee JB, Choo MS, Lee JG, Lee JY. Analysis of female voiding dysfunction: a prospective, multi-center study. Int Urol Nephrol. 2013 Aug;45(4):989-94. doi: 10.1007/s11255-013-0475-2. Epub 2013 May 31. PubMed 23722818 ↗
  • Retraction: Current Concepts in Voiding Dysfunction and Dysfunctional Voiding: A Review from a Urogynaecologist's Perspective. J Midlife Health. 2018 Jan-Mar;9(1):50. doi: 10.4103/0976-7800.227258. PubMed 29628732 ↗
  • Robinson D, Staskin D, Laterza RM, Koelbl H. Defining female voiding dysfunction: ICI-RS 2011. Neurourol Urodyn. 2012 Mar;31(3):313-6. doi: 10.1002/nau.22213. Epub 2012 Mar 13. PubMed 22415792 ↗
  • Hsiao SM, Lin HH, Kuo HC. Videourodynamic Studies of Women with Voiding Dysfunction. Sci Rep. 2017 Jul 28;7(1):6845. doi: 10.1038/s41598-017-07163-2. PubMed 28754926 ↗
  • Lukacz ES, DuHamel E, Menefee SA, Luber KM. Elevated postvoid residual in women with pelvic floor disorders: prevalence and associated risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):397-400. doi: 10.1007/s00192-006-0164-0. Epub 2006 Jun 28. PubMed 16804634 ↗
  • Milleman M, Langenstroer P, Guralnick ML. Post-void residual urine volume in women with overactive bladder symptoms. J Urol. 2004 Nov;172(5 Pt 1):1911-4. doi: 10.1097/01.ju.0000140502.34334.75. PubMed 15540753 ↗

Individual participant data

Plan to share: No — Individual participant data is available under reasonable request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2005 to primary completion in Dec 2020, 190 months.

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

Registered
Jul 20, 2021
First posted
Jul 28, 2021
StartActual
Feb 1, 2005
Primary completionActual
Dec 31, 2020
CompletionActual
Dec 31, 2020
Last update
Jul 28, 2021
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 Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04981080
Responsible party
Sponsor
First posted
Jul 28, 2021
Start date
Feb 1, 2005
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jul 28, 2021

Study contacts

Ho-Hsiung Lin, PhD
principal investigator · National Taiwan University Hospital

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 2021. You cannot join it, but the record below documents what was studied.

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