Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe CystoceleNCT03613324
BOO and DU and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
An observational study of Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele
- What is being tested?
- Pad test
- How many people
- 455 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with more than stage II cystocele
Who may be able to join
- Age > 20y/o
- Cystocele > stage II
- Complete pad test and urodynamic study
Who cannot join
- Pregnancy
- Urinary tract infection
- Had received pelvic reconstruction surgery
About this study
Official title: Prevalence Rates of Bladder Outlet Obstruction and Detrusor Underactivity and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
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.
- Being tested
- Pad test
- Keywords
- Cystocele, Bladder outlet obstruction, Detrusor underactivity, Urodynamic study
- Medical subject headings
- Urinary Bladder Neck Obstruction, Cystocele, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pad testDiagnostic test
Also called Urodynamic study
20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Pad test |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOO
Bladder outlet obstruction: Qmax was <12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.
Measured: November 2011 to January 2017
DU
Detrusor underactivity: <12 mL/s and PdetQmax was <10 cmH2O
Measured: November 2011 to January 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jan 2011
- Primary completion30 Nov 2017
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe CystoceleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613324
- Sponsor's protocol ID
- 201805025RINB
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Rates of Bladder Outlet Obstruction and Detrusor Underactivity and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
- ClinicalTrials.gov ID
- NCT03613324
- Acronym / sponsor ID
- 201805025RINB
- Keywords
- Cystocele, Bladder outlet obstruction, Detrusor underactivity, Urodynamic study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bladder outlet obstruction (BOO) | – | Diagnostic Test: Pad testBetween 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. |
| Detrusor underactivity (DU) | – | Diagnostic Test: Pad testBetween 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. |
| ND BOO/DU | – | Diagnostic Test: Pad testBetween 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with more than stage II cystocele
Key inclusion criteria (3 listed)
- Age > 20y/o
- Cystocele > stage II
- Complete pad test and urodynamic study
Key exclusion criteria (3 listed)
- Pregnancy
- Urinary tract infection
- Had received pelvic reconstruction surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pad testAlso: Urodynamic study20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry. | Diagnostic test | Bladder outlet obstruction (BOO), Detrusor underactivity (DU), ND BOO/DU |
Primary outcome
BOO
Time frame: November 2011 to January 2017
Bladder outlet obstruction: Qmax was <12 mL/s and PdetQmax was ≥25 cmH2O with sustained detrusor contraction during voiding cystometry.
DU
Time frame: November 2011 to January 2017
Detrusor underactivity: <12 mL/s and PdetQmax was <10 cmH2O
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No. No plan to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Outlet Obstruction and Detrusor Underactivity in Women With Severe Cystocele, run by National Taiwan University Hospital.
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 3 inclusion and 3 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
BOO (time frame: November 2011 to January 2017). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2018.