Lower Urinary Tract SymptomsNCT02126618
The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary Incontinence
An observational study of Lower Urinary Tract Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Jun 2016
- 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 lower urinary tract symptoms and underwent urodynamic testing
Who may be able to join
- More than 20-year-old woman who with stress urinary incontinence (SUI).
- We will review the clinical data, urodynamics, pad weight and bladder diary of patients who receiving urodynamic studies and 20-minute pad test in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014.
Who cannot join
- < 20 year old female
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics & Gynecology, National Taiwan University Hospital
Taipei, 100
Ho-Hsiung Lin, MD, PhD, 886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw
Ho-Hsiung Lin, MD, PhD
About this study
The aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.
Read the detailed description
Pad testing is an important method to evaluate the severity of women with stress urinary incontinence (SUI). The investigators had proved the superiority of the infusion of the strong desire amount while using 20-minute pad test for detecting SUI. However, a considerable volume of urine may be produced by natural diuresis during the course of 20-minute pad test with strong-desire amount infusion, and may cause bladder overdistension, more urine leakage and overestimate the severity of SUI. Thus, the aim of this study is to estimate of the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.
The investigators will review the clinical data of patients who receiving urodynamic studies in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014. STATA 11.0 software will be used for statistical analysis.
The investigators will get the mean values of diuresis, and the factors affecting the amount of diuresis. Besides, the investigators can get the influence of diuresis on the accuracy of 20-minute pad test as a role of estimating the severity of SUI. The above data should be important for further refinement of 20-minute pad test.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower urinary tract symptoms, urodynamic studies, diuresis
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women with lower urinary tract symptoms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of natural diuresis during pad testing
The aim of this study is to estimate the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- 3,000 participants (estimated)
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
- NCT02126618
- Sponsor's protocol ID
- 201403054RIND
- Status last verified
- Jul 2015
- First submitted
- 28 Apr 2014
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diuresis During 20-minute Pad Test on the Estimation of the Severity of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02126618
- Acronym / sponsor ID
- 201403054RIND
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Lower urinary tract symptoms, urodynamic studies, diuresis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- 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.
The aim of this study is to estimate the amount of extra urine produced by natural diuresis during 20-minute pad test, and assess the effect of diuresis on the accuracy of using 20-minute pad test to estimate the severity of SUI. Besides, the above results may be used for further refinement of the amount of water infusion used for the 20-minute pad test.
Detailed description
Pad testing is an important method to evaluate the severity of women with stress urinary incontinence (SUI). The investigators had proved the superiority of the infusion of the strong desire amount while using 20-minute pad test for detecting SUI. However, a considerable volume of urine may be produced by natural diuresis during the course of 20-minute pad test with strong-desire amount infusion, and may cause bladder overdistension, more urine leakage and overestimate the severity of SUI. Thus, the aim of this study is to estimate of the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.
The investigators will review the clinical data of patients who receiving urodynamic studies in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014. STATA 11.0 software will be used for statistical analysis.
The investigators will get the mean values of diuresis, and the factors affecting the amount of diuresis. Besides, the investigators can get the influence of diuresis on the accuracy of 20-minute pad test as a role of estimating the severity of SUI. The above data should be important for further refinement of 20-minute pad test.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with lower urinary tract symptoms | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with lower urinary tract symptoms and underwent urodynamic testing
Key inclusion criteria (2 listed)
- More than 20-year-old woman who with stress urinary incontinence (SUI).
- We will review the clinical data, urodynamics, pad weight and bladder diary of patients who receiving urodynamic studies and 20-minute pad test in the Department of Obstetrics \& Gynecology of National Taiwan University Hospital between January 2008 and March 2014.
Key exclusion criteria (1 listed)
- < 20 year old female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimation of natural diuresis during pad testing
Time frame: 7 years
The aim of this study is to estimate the amount of extra urine produced by natural diuresis, and assess its effect on the ability of using pad weight to estimate the severity of SUI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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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.
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 Lower Urinary Tract Symptoms, 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 1 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: status not confirmed, as of the sponsor's last update on 7 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Ho-Hsiung, MD, PhD (886-2-23123456 ext. 71557, hhlin@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of natural diuresis during pad testing (time frame: 7 years). 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 7 Jul 2015.