Stress Urinary IncontinencePhase 2NCT02906683

Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

A Phase 2 study testing TAS-303 in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 to 79 years, women only
Conditions the study is for: Stress Urinary Incontinence
What is being tested?: TAS-303
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 337 participants
Where: 1 siteJapan
Study dates: 20 Oct 2016to 30 Apr 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 79 years
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
Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
Patient is positive in 1-hour pad weight test

Who cannot join

Patient has predominant or primary urge incontinence according to investigator judgment
Patient had a prior surgical SUI treatment
Patient is diagnosed stageII or more of Pelvic Organ Prolapse
Patient has symptoms of Urinary tract infection (UTI)
Patient is positive pregnancy test
Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Taiho Pharmaceutical Co., Ltd selected site
Osaka

Other trials in Japan

About this study

Official title: A Phase IIa 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 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Conditions: Stress Urinary Incontinence
Being tested: TAS-303, 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-303Drug
Oral administration for 8 weeks, once daily.
PlaceboDrug
Oral administration for 8 weeks, once daily.

Study groups in NCT02906683
Study group	Role	What they receive
TAS-303 3mg	Experimental	Not described Receives: Drug: TAS-303
TAS-303 6mg	Experimental	Not described Receives: Drug: TAS-303
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.

Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
Measured: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
Measured: Baseline to Week 8 (8 weeks in treatment period)

Secondary outcomes (13)

Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
Measured: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
Measured: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
Measured: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
Measured: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
Measured: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
Measured: Baseline to Week 8 (8 weeks in treatment period)
Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period
Measured: At Week 8 in the treatment period
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence.
The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better".
The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse".
Measured: Baseline to Week 8 (8 weeks in treatment period)
Any Adverse Events
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Measured: Baseline to Week 8 (8 weeks in treatment period)
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Measured: Baseline to Week 8 (8 weeks in treatment period)
Adverse Drug Reactions
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Measured: Baseline to Week 8 (8 weeks in treatment period)
Serious Adverse Events
Measured: Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration
Measured: Baseline to Week 8 (8 weeks in treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 201630 Apr 2018

First posted20 Sep 2016 (estimated)
Study start20 Oct 2016
Primary completion30 Apr 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02906683
Sponsor's protocol ID: 10060050
Status last verified: May 2024
First submitted: 8 Sep 2016
Last updated: 26 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

All Stress Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence
ClinicalTrials.gov ID: NCT02906683
Acronym / sponsor ID: 10060050
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 337 participants (actual)
Lead sponsor: Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 20 Oct 2016 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 20 Sep 2016 (estimated)
Results: Posted 26 Sep 2024

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
TAS-303 3mg	Experimental	Drug: TAS-303
TAS-303 6mg	Experimental	Drug: TAS-303
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 79 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
Patient is positive in 1-hour pad weight test

Key exclusion criteria (6 listed)

Patient has predominant or primary urge incontinence according to investigator judgment
Patient had a prior surgical SUI treatment
Patient is diagnosed stageII or more of Pelvic Organ Prolapse
Patient has symptoms of Urinary tract infection (UTI)
Patient is positive pregnancy test

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-303Oral administration for 8 weeks, once daily.	Drug	TAS-303 3mg, TAS-303 6mg
PlaceboOral administration for 8 weeks, once daily.	Drug	Placebo

Primary outcome

Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)

13 secondary outcomes

Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period
Time frame: At Week 8 in the treatment period
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Any Adverse Events
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Adverse Drug Reactions
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Serious Adverse Events
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration
Time frame: Baseline to Week 8 (8 weeks in treatment period)

Results and safety

Results posted to the registry on 26 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAS-303 3 mg	85	84
TAS-303 6 mg	86	81
Placebo	85	82

Primary outcome: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8

Time frame: Baseline to Week 8 (8 weeks in treatment period). Mean (Standard Deviation). Unit: episodes

Measure	TAS-303 3 mg n = 84	TAS-303 6 mg n = 80	Placebo n = 81
IEF per 24 hours at baseline	2.9 (2.3)	2.5 (1.5)	2.6 (1.7)
IEF per 24 hours at Week 8	2.0 (2.3)	1.7 (1.7)	1.9 (1.9)

Population analysed: PPS was used for the analysis.

Primary outcome: Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8

Time frame: Baseline to Week 8 (8 weeks in treatment period). Mean (Standard Deviation). Unit: Percentage change

Measure	TAS-303 3 mg n = 84	TAS-303 6 mg n = 80	Placebo n = 81
Value	-34.7 (39.9)	-35.4 (39.0)	-28.1 (47.3)

TAS-303 3 mg vs Placebo: Mean Difference (Final Values): -6.7 (95% CI -20.1 to 6.7), p = 0.329, t-test, 2 sided
TAS-303 6 mg vs Placebo: Mean Difference (Final Values): -7.3 (95% CI -20.9 to 6.2), p = 0.285, t-test, 2 sided

Population analysed: PPS was used for the analysis.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 8 (8 weeks in treatment period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAS-303 3 mg	0 of 85 (0%)	31 of 85 (36.5%)	0 of 85
TAS-303 6 mg	0 of 86 (0%)	20 of 86 (23.3%)	0 of 86
Placebo	0 of 85 (0%)	26 of 85 (30.6%)	0 of 85

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Stress Urinary Incontinence

RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy

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.

1 site 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 in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 1 site 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 3 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 26 Sep 2024. 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 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?

Yes. Results are posted in the registry (first posted 26 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 (time frame: Baseline to Week 8 (8 weeks in treatment period)). The study lists 2 primary outcomes in all. 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 NCT02906683.

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 26 Sep 2024.