Overactive Bladder SyndromeNCT01819168
Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
An observational study of Overactive Bladder Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Apr 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: We will perform a retrospective study to review the data of bladder diary, urodynamic studies and clinical data of patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital.
Who may be able to join
- patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.
- Conditions
- Overactive Bladder Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder diary
To clarity any difference of reduction in the episodes of nocturia between these two groups.
Measured: 3 months
Secondary outcomes (1)
Frequency and Urgency
To clarity any difference of reduction in the episodes of urinary frequency and urgency between these two groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies 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
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819168
- Sponsor's protocol ID
- 102026-E
- Status last verified
- Feb 2016
- First submitted
- 21 Mar 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimuscarinic Treatment for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing
- ClinicalTrials.gov ID
- NCT01819168
- Acronym / sponsor ID
- 102026-E
- Conditions
- Overactive Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Mar 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 aim of this retrospective study is to analyze if nighttime antimuscarincs may be more effective in treating patients with nocturia.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will perform a retrospective study to review the data of bladder diary, urodynamic studies and clinical data of patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital.
Key inclusion criteria (1 listed)
- patients who underwent tolterodine SR treatment once per day for 12 weeks in Department of Obstetrics \& Gynecology in National Taiwan University Hospital and Far Eastern Memorial Hospital
Key exclusion criteria (1 listed)
- -
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
bladder diary
Time frame: 3 months
To clarity any difference of reduction in the episodes of nocturia between these two groups.
1 secondary outcome
Frequency and Urgency
Time frame: 3 months
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 7 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 1 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 7 Sep 2016. 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?
bladder diary (time frame: 3 months). 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 Sep 2016.