Detrusor UnderactivityNCT04981080
DU and BOO in Women With and Without Symptoms of VD
An observational study of Detrusor Underactivity and Bladder Outlet Obstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Detrusor Underactivity, Bladder Outlet Obstruction
- What is being tested?
- Urodynamic study
- How many people
- 1,886 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2005to 31 Dec 2020
- 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: women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation
Who may be able to join
- Women with lower urinary tract symptoms
- Complete urodynamic study
Who cannot join
- Advanced cystocele
- After surgery for cystocele repair
- Chronic infection
- Incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Women With and Without Symptoms of Voiding Dysfunction
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.
- Conditions
- Detrusor Underactivity, Bladder Outlet Obstruction
- Being tested
- Urodynamic study
- Keywords
- detrusor underactivity, bladder outlet obstruction, voiding dysfunction
- Medical subject headings
- Urinary Bladder, Underactive, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic studyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Urodynamic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: February 2005 and December 2020
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
Measured: February 2005 and December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Feb 2005
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Detrusor UnderactivityStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 1,886 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981080
- Sponsor's protocol ID
- 202105082RINA
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is available under reasonable request
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 19941278Choi 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 23722818Retraction: 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 29628732Robinson 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 22415792Hsiao 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 28754926Lukacz 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 16804634Milleman 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Women With and Without Symptoms of Voiding Dysfunction
- ClinicalTrials.gov ID
- NCT04981080
- Acronym / sponsor ID
- 202105082RINA
- Conditions
- Detrusor Underactivity, Bladder Outlet Obstruction
- Keywords
- detrusor underactivity, bladder outlet obstruction, voiding dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,886 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2005 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jul 2021 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom of voiding dysfunction | – | Diagnostic Test: Urodynamic studyWomen 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 |
| No symptom of voiding dysfunction | – | Diagnostic Test: Urodynamic studyWomen 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 |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation
Key inclusion criteria (2 listed)
- Women with lower urinary tract symptoms
- Complete urodynamic study
Key exclusion criteria (4 listed)
- Advanced cystocele
- After surgery for cystocele repair
- Chronic infection
- Incomplete data
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 |
|---|---|---|
| Urodynamic studyThe 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. | Diagnostic test | No symptom of voiding dysfunction, Symptom of voiding dysfunction |
Primary outcome
Detrusor underactivity
Time frame: February 2005 and December 2020
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 %
Bladder outlet obstruction
Time frame: February 2005 and December 2020
The detrusor pressure when maximal flow rate was not less than 40 cmH2O, and the maximal flow rate was less than 12 mL/s
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 28 Jul 2021.
- Results publication: PubMed 19941278Haylen 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.
- Results publication: PubMed 23722818Choi 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.
- Results publication: PubMed 29628732Retraction: 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.
- Results publication: PubMed 22415792Robinson 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.
- Results publication: PubMed 28754926Hsiao 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.
- Results publication: PubMed 16804634Lukacz 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.
- Results publication: PubMed 15540753Milleman 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.
- Individual participant dataSharing planned: No. Individual participant data is available under reasonable request
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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.
Ho-Hsiung Lin, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detrusor Underactivity and Bladder Outlet Obstruction, 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 2 inclusion and 4 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 28 Jul 2021. 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?
Detrusor underactivity (time frame: February 2005 and December 2020). 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?
On the ClinicalTrials.gov record for NCT04981080, 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 28 Jul 2021.