Stress Urinary IncontinencePhase 2NCT04512053
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
A Phase 2 study testing TAS-303 18 mg/day in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TAS-303 18 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 4 sitesJapan
- Study dates
- 4 Sep 2020to 22 Dec 2021
- Phase
- Phase 2
- 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
Who may be able to join
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
- The average number of SUI episodes is 1 or more per day
- The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
- The number of "SUI episodes" exceeds the number of "other episodes"
- The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day
Who cannot join
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
- Patient has a serious illness or medical condition
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
A site selected by Taiho Pharmaceutical Co., Ltd.
Aichi
A site selected by Taiho Pharmaceutical Co., Ltd.
Fukuoka
A site selected by Taiho Pharmaceutical Co., Ltd.
Osaka
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo
About this study
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Read the detailed description
The main purpose of this study is to assess the efficacy of TAS-303 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI episode frequency per 24 hours from baseline at week 12.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TAS-303 18 mg/day, Placebo
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-303 18 mg/dayDrug
Oral administration for 12 weeks, once daily
PlaceboDrug
Oral administration for 12 weeks, once daily
| Study group | Role | What they receive |
|---|---|---|
| TAS-303 | Experimental | Not described Receives: Drug: TAS-303 18 mg/day |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in the average SUI episode frequency per 24 hours
Measured: Baseline, week 12
Secondary outcomes (7)
The average urinary incontinence episode frequency per 24 hours
Measured: Baseline, week 4, week 8, week 12
The urinary incontinence volume measured in a 24-hour pad test
Measured: Baseline, week 12
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Measured: Baseline, week 4, week 8, week 12
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
Measured: Baseline, week 4, week 8, week 12
The change in the incontinence quality of life instrument (I QOL) scores
The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome.
Measured: Baseline, week 4, week 8, week 12
The changes in the overactive bladder symptom score (OABSS)
The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome.
Measured: Baseline, week 4, week 8, week 12
Incidence of adverse events and side effects
Measured: Up to 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start4 Sep 2020
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taiho Pharmaceutical Co., Ltd., Study director, Taiho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512053
- Sponsor's protocol ID
- 10060070
- Status last verified
- Feb 2022
- First submitted
- 7 Aug 2020
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical\_trial\_information\_disclosure\_policy/index.html
Publications
Takahashi S, Kato K, Yokoyama O, Takei M, Gotoh M. Efficacy and Safety of TAS-303 in Female Patients With Stress Urinary Incontinence: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. J Urol. 2024 Aug;212(2):267-279. doi: 10.1097/JU.0000000000004024. Epub 2024 Jul 9.
PubMed 38979756
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04512053
- Acronym / sponsor ID
- 10060070
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 13 Aug 2020 (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.
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Detailed description
The main purpose of this study is to assess the efficacy of TAS-303 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI episode frequency per 24 hours from baseline at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS-303 | Experimental | Drug: TAS-303 18 mg/day |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
- The average number of SUI episodes is 1 or more per day
- The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
- The number of "SUI episodes" exceeds the number of "other episodes"
Key exclusion criteria (6 listed)
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
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 |
|---|---|---|
| TAS-303 18 mg/dayOral administration for 12 weeks, once daily | Drug | TAS-303 |
| PlaceboOral administration for 12 weeks, once daily | Drug | Placebo |
Primary outcome
The percent change in the average SUI episode frequency per 24 hours
Time frame: Baseline, week 12
7 secondary outcomes
The average urinary incontinence episode frequency per 24 hours
Time frame: Baseline, week 4, week 8, week 12
The urinary incontinence volume measured in a 24-hour pad test
Time frame: Baseline, week 12
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline, week 4, week 8, week 12
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
Time frame: Baseline, week 4, week 8, week 12
The change in the incontinence quality of life instrument (I QOL) scores
Time frame: Baseline, week 4, week 8, week 12
The changes in the overactive bladder symptom score (OABSS)
Time frame: Baseline, week 4, week 8, week 12
Incidence of adverse events and side effects
Time frame: Up to 13 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 10 Feb 2022.
- Derived from this study: PubMed 38979756Takahashi S, Kato K, Yokoyama O, Takei M, Gotoh M. Efficacy and Safety of TAS-303 in Female Patients With Stress Urinary Incontinence: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. J Urol. 2024 Aug;212(2):267-279. doi: 10.1097/JU.0000000000004024. Epub 2024 Jul 9.
- Individual participant dataSharing planned: Yes. Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018. Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher. See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html
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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.
Taiho Pharmaceutical Co., Ltd. study director
Taiho Pharmaceutical Co., Ltd.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-303 18 mg/day in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 4 sites in Japan.
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 6 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 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The percent change in the average SUI episode frequency per 24 hours (time frame: Baseline, week 12). 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 NCT04512053, which also lists 1 linked publication.
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 10 Feb 2022.