Lower Urinary Tract DysfunctionNCT01884753
Correlations of 3D Urethral and Paraurethral Sonographic Findings With Urodynamic Studies, Lower Urinary Tract Symptoms & Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms.
An observational study of Lower Urinary Tract Dysfunction and Overactive Bladder Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Dysfunction, Overactive Bladder Syndrome
- How many people
- 279 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Feb 2014to 30 Jun 2021
- How long will I take part?
- 12 Weeks
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with lower urinary tract symptoms
Who may be able to join
- Women with lower urinary tract symptoms
- Not less than 20 years-old
Who cannot join
- Patients with a history of stroke.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored.
Read the detailed description
Female lower urinary tract dysfunction includes stress urinary incontinence, overactive bladder syndrome and voiding dysfunction. There are a lot of bladder studies, such as researches of bladder wall thickness and bladder volume. However, there were few studies of urethra for female patients with lower urinary tract symptoms (LUTS), especially for storage disorder. Thus, the main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. The investigators hope to identify important LUTS sonographic biomarkers that can be used by primary physicians as a tool for assess female LUTS, and thus decreasing the need of further invasive urodynamic studies.
Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction (assessed by female sexual function index) can be explored.
In addition, women who receive antimuscarinics treatment will receive follow-up 4D imaging and request to complete questionnaire 12 weeks later.
- Keywords
- lower urinary tract symptoms, overactive bladder syndrome, antimuscarinic drug, three-dimensional power Doppler ultrasound, sexual dysfunction
- Medical subject headings
- Lower Urinary Tract Symptoms, Sexual Dysfunction, Physiological
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 |
|---|---|---|
| Adult women with lower urinary tract symptoms | Adult women (not less than 20 year-old) with lower urinary tract symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts
We will get the associations of urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts, and the above results will be compared to that of the asymptomatic control group.
Measured: 1 day
Secondary outcomes (1)
Urethral/pelvic blood flow perfusion pattern after antimuscarinics
We will compare the urethral/pelvic blood flow perfusion pattern between the baseline and 12 weeks' antimuscarinic treatment (solifenacin 5 mg SR qd or tolerodine 4 mg ER qd) in women with overactive bladder syndrome.
Measured: 12 weeeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start2 Feb 2014
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract DysfunctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
- Investigators
- Sheng-Mou Hsiao, MD, Principal investigator, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884753
- Sponsor's protocol ID
- 102021-F
- Status last verified
- Aug 2021
- First submitted
- 19 Jun 2013
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations of 3D Urethral and Paraurethral Sonographic Findings With Urodynamic Studies, Lower Urinary Tract Symptoms & Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms.
- ClinicalTrials.gov ID
- NCT01884753
- Acronym / sponsor ID
- 102021-F
- Keywords
- lower urinary tract symptoms, overactive bladder syndrome, antimuscarinic drug, three-dimensional power Doppler ultrasound, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 2 Feb 2014 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Jun 2013 (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 main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction can be explored.
Detailed description
Female lower urinary tract dysfunction includes stress urinary incontinence, overactive bladder syndrome and voiding dysfunction. There are a lot of bladder studies, such as researches of bladder wall thickness and bladder volume. However, there were few studies of urethra for female patients with lower urinary tract symptoms (LUTS), especially for storage disorder. Thus, the main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D ultrasound examinations, and to correlate the sonographic findings with urodynamic variables, pad weights and LUTS. The investigators hope to identify important LUTS sonographic biomarkers that can be used by primary physicians as a tool for assess female LUTS, and thus decreasing the need of further invasive urodynamic studies.
Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction (assessed by female sexual function index) can be explored.
In addition, women who receive antimuscarinics treatment will receive follow-up 4D imaging and request to complete questionnaire 12 weeks later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult women with lower urinary tract symptoms | – | –Adult women (not less than 20 year-old) with lower urinary tract symptoms |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with lower urinary tract symptoms
Key inclusion criteria (2 listed)
- Women with lower urinary tract symptoms
- Not less than 20 years-old
Key exclusion criteria (1 listed)
- Patients with a history of stroke.
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
Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts
Time frame: 1 day
We will get the associations of urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts, and the above results will be compared to that of the asymptomatic control group.
1 secondary outcome
Urethral/pelvic blood flow perfusion pattern after antimuscarinics
Time frame: 12 weeeks
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 13 Sep 2023.
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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.
Sheng-Mou Hsiao, MD principal investigator
Department of Obstetrics & Gynecology, Far Eastern Memorial 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 Lower Urinary Tract Dysfunction and Overactive Bladder Syndrome, run by Far Eastern Memorial 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: finished, as of the sponsor's last update on 13 Sep 2023. 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?
Urethral/pelvic blood flow perfusion pattern between subgroups of women with lower urinary tracts (time frame: 1 day). 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 13 Sep 2023.