Overactive BladderPhase 4RESORT part 2NCT02667470
Reproducibility Study of OABSS and Its Response to Treatment
A Phase 4 study testing Solifenacin in people with Overactive Bladder, run by Astellas Pharma Inc at 1 site in Thailand.
Trial summary
The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to May 2013
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At screening visit (Week -2):
- Symptoms of OAB ≥ 3 months
- Number of urgency episodes in last 3 days ≥ 3
- Based on the 3-day micturition diary prior to Visit 1 (Week 0):
- Number of micturition per day ≥ 8
- Number of urgency episodes in 3 days ≥ 3
Who cannot join
- At screening visit (Week -2):
- Stress is the predominant factor as determined by the investigator
- Indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Treatment for OAB was started, quitted or changed in 4 weeks
- Diabetic neuropathy
- At Visit 1 (Week 0):
- Patient who did not complete the 3-day micturition diary according to the instruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin
- Keywords
- Solifenacin, Overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Also called Vesicare
Oral
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin | Experimental | Not described Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OABSS scores from prior to treatment and after treatment
Measured: Prior to treatment and after treatment (up to 12 weeks)
Secondary outcomes (9)
Correlation of change between OABSS scores and number of micturitions per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of incontinence episodes per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of urgency episodes per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of nocturia episodes per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of total voided volume per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of pads per day
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score
Measured: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score
Measured: Prior to treatment and after treatment (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667470
- Sponsor's protocol ID
- ATH-002
- Acronym
- RESORT part 2
- Status last verified
- Jan 2016
- First submitted
- 26 Jan 2016
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT02667470
- Acronym / sponsor ID
- RESORT part 2 / ATH-002
- Conditions
- Overactive Bladder
- Keywords
- Solifenacin, Overactive bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 29 Jan 2016 (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 objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solifenacin | Experimental | Drug: Solifenacin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At screening visit (Week -2):
- Based on the 3-day micturition diary prior to Visit 1 (Week 0):
Key exclusion criteria (8 listed)
- At screening visit (Week -2):
- At Visit 1 (Week 0):
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 |
|---|---|---|
| SolifenacinAlso: VesicareOral | Drug | Solifenacin |
Primary outcome
Change in OABSS scores from prior to treatment and after treatment
Time frame: Prior to treatment and after treatment (up to 12 weeks)
9 secondary outcomes
Correlation of change between OABSS scores and number of micturitions per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of incontinence episodes per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of urgency episodes per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of nocturia episodes per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of total voided volume per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of pads per day
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score
Time frame: Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score
Time frame: Prior to treatment and after treatment (up to 12 weeks)
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 29 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin in people with Overactive Bladder, run by Astellas Pharma Inc at 1 site in Thailand.
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 6 inclusion and 8 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 29 Jan 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in OABSS scores from prior to treatment and after treatment (time frame: Prior to treatment and after treatment (up to 12 weeks)). 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 29 Jan 2016.