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Voiding DisordersNCT04184752

Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele

An observational study of Voiding Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. Read more about this study

Who is it for?
Ages 20 to 85 years, women only
Conditions the study is for
Voiding Disorders
What is being tested?
Urodynamic study
How many people
602 participants
Where
1 siteTaiwan
Study dates
1 Apr 1996to 30 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All women with symptoms of voiding dysfunction and without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed.

Who may be able to join

  • Women with symptoms of voiding dysfunction.

Who cannot join

  • Cystocele
  • Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Urodynamically Age-specific Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Voiding Dysfunction Without Cystocele

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. However, urodynamic/videourodynamic studies are invasive. The investigators are interested in whether there were specific symptoms or measurements that can be used for initial differential diagnosis between DU and BOO. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the clinical and urodynamic differences between the DU, BOO and non-DU/BOO groups.

Read the detailed description

Between April 1996 and September 2018, all women with symptoms of voiding dysfunction 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 (Qmax), voided volume, post-void residual volume (PVR) and detrusor pressure at a maximum flow rate (PdetQmax) were excluded from this study. Besides, women with cystocele were also excluded. The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%. Those women without DU or BOO were allocated to the non-DU/BOO group.

STATA software was used for statistical analysis. ANOVA test with Bonferroni correction or chi-square test was used for statistical analysis as appropriate. Linear regression analysis with age adjustment was used to assess the adjusted effect of variables. P < 0.05 was considered as statistical significant.

Being tested
Urodynamic study
Keywords
Bladder outlet obstruction, Detrusor underactivity, Voiding dysfunction
Medical subject headings
Urinary Bladder Neck Obstruction, Urinary Bladder, Underactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urodynamic studyDiagnostic test

    Also called Pad test

    The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position [14]. A 20-minute pad test for each woman was also performed [15, 16]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS [3]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.

Study groups in NCT04184752
Study groupRoleWhat they receive
Detrusor underactivityThe DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. BVE = voided volume / (voided volume+ PVR) x 100%.
Receives: Diagnostic Test: Urodynamic study
Bladder outlet obstructionThe BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s.
Receives: Diagnostic Test: Urodynamic study
Non-DU/BOO groupThose women without DU or BOO were allocated to the non-DU/BOO group.
Receives: Diagnostic Test: Urodynamic study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Detrusor underactivity or Bladder outlet obstruction

    The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%.

    Measured: Between April 1996 and September 2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start1 Apr 1996
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04184752
Sponsor's protocol ID
201907011RINC
Status last verified
Aug 2019
First submitted
28 Nov 2019
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make IPD available to other researchers.

Publications

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

    PubMed 19937315

  • 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

  • Karmakar D, Sharma JB. Current concepts in voiding dysfunction and dysfunctional voiding: A review from a urogynaecologist's perspective. J Midlife Health. 2014 Jul;5(3):104-10. doi: 10.4103/0976-7800.141185.

    PubMed 25316994

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Voiding Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Detrusor underactivity or Bladder outlet obstruction (time frame: Between April 1996 and September 2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04184752, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.

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