Detrusor UnderactivityPhase 2NCT03175029

Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

A Phase 2 study testing TAC-302 in people with Detrusor Underactivity and Overactive Bladder, 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 TAC-302 in detrusor underactivity patients with overactive bladder. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Detrusor Underactivity, Overactive Bladder
What is being tested?: TAC-302
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 195 participants
Where: 1 siteJapan
Study dates: 9 Sep 2017to 27 Mar 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
To meet the detrusor underactivity criteria by urodynamic study

Who cannot join

Neurogenic bladder by the central nervous system diseases.
StageIII or more cystocele of pelvic organ prolapse quantification system (women)
Prostate volume ≥30mL (Men)
Any symptoms of Urinary tract infection (UTI)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Taiho Pharmaceutical Co., Ltd selected site
Kumamoto

Other trials in Japan

About this study

The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.

Read the detailed description

The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study.

Male; bladder contractility index (BCI)
Female; projected isovolumetric pressure (PIP) 1

Conditions: Detrusor Underactivity, Overactive Bladder
Being tested: TAC-302, Placebo
Keywords: Lower Urinary Tract Symptoms
Medical subject headings: Urinary Bladder, Underactive, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAC-302Drug
TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
PlaceboDrug
Placebo administered orally twice per day after meals, for 12 weeks.

Study groups in NCT03175029
Study group	Role	What they receive
TAC-302	Experimental	Not described Receives: Drug: TAC-302
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.

Changes in the Mean BCI for Male From Baseline to Week 12
BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists.
Measured: Baseline to Week 12
Changes in the Mean PIP1 for Female From Baseline to Week 12
PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists.
Measured: Baseline to Week 12

Secondary outcomes (12)

Changes in the Mean BVE From Baseline to Week 12 (Overall)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Measured: Baseline to Week 12
Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Measured: Baseline to Week 12
Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.
Measured: Baseline to Week 12
Number of Micturitions Per 24 Hours at Baseline and Week 12
On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study.
Measured: Baseline to Week 12
Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12
On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study.
Measured: Baseline to Week 12
Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12
Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe.
Measured: Baseline to Week 12
Number of Participants With Adverse Events
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Drug Reactions
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Serious Adverse Events
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Death
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Discontinuation
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Interruption
In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.
Measured: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

Timeline

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

9 Sep 201727 Mar 2020

First posted5 Jun 2017
Study start9 Sep 2017
Primary completion1 Nov 2019
Study completion27 Mar 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Detrusor UnderactivityStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03175029
Sponsor's protocol ID: 10054040
Status last verified: Dec 2024
First submitted: 25 May 2017
Last updated: 20 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7.
PubMed 36205739

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 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
Recruiting
Akyva First In Human
Underactive Bladder
Not yet recruiting
The Effect of Detrusor Underactivity in Determining Outcomes After Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia
Detrusor Underactivity, Transurethral Resection of the Prostate (TURP)
Recruiting
TURP Inpatient With Underactive Bladder With BOO
TURP Syndrome, Retention, Urinary
Not yet recruiting
EEP in Patients With Urodynamically Proven DU/DA
Lower Urinary Tract Symptoms, Lower Urinary Tract Obstructive Syndrome

All Detrusor Underactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
ClinicalTrials.gov ID: NCT03175029
Acronym / sponsor ID: 10054040
Conditions: Detrusor Underactivity, Overactive Bladder
Keywords: Lower Urinary Tract Symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Sep 2017 (actual)
Primary completion: 1 Nov 2019 (actual)
Study completion: 27 Mar 2020 (actual)
First posted: 5 Jun 2017 (actual)
Results: Posted 20 Jan 2025

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 TAC-302 in detrusor underactivity patients with overactive bladder.

Detailed description

Male; bladder contractility index (BCI)
Female; projected isovolumetric pressure (PIP) 1

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TAC-302	Experimental	Drug: TAC-302
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
To meet the detrusor underactivity criteria by urodynamic study

Key exclusion criteria (4 listed)

Neurogenic bladder by the central nervous system diseases.
StageIII or more cystocele of pelvic organ prolapse quantification system (women)
Prostate volume ≥30mL (Men)
Any symptoms of Urinary tract infection (UTI)

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
TAC-302TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.	Drug	TAC-302
PlaceboPlacebo administered orally twice per day after meals, for 12 weeks.	Drug	Placebo

Primary outcome

Changes in the Mean BCI for Male From Baseline to Week 12
Time frame: Baseline to Week 12
BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists.
Changes in the Mean PIP1 for Female From Baseline to Week 12
Time frame: Baseline to Week 12
PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists.

12 secondary outcomes

Changes in the Mean BVE From Baseline to Week 12 (Overall)
Time frame: Baseline to Week 12
Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)
Time frame: Baseline to Week 12
Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)
Time frame: Baseline to Week 12
Number of Micturitions Per 24 Hours at Baseline and Week 12
Time frame: Baseline to Week 12
Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12
Time frame: Baseline to Week 12
Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12
Time frame: Baseline to Week 12
Number of Participants With Adverse Events
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Drug Reactions
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Serious Adverse Events
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Death
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Discontinuation
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Interruption
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

Results and safety

Results posted to the registry on 20 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAC-302	52	49
Placebo	24	23

Primary outcome: Changes in the Mean BCI for Male From Baseline to Week 12

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Score on a scale

Measure	TAC-302 n = 27	Placebo n = 11
BCI at baseline	64.604 (16.569)	61.339 (16.629)
BCI at Week 12	75.156 (21.076)	60.513 (16.708)

TAC-302: Mean Difference (Final Values): 10.552 (95% CI 5.514 to 15.590), p <0.001, t-test, 2 sided
Placebo: Mean Difference (Final Values): -0.826 (95% CI -8.676 to 7.023), p = 0.819, t-test, 2 sided
TAC-302 vs Placebo: Mean Difference (Final Values): 11.378 (95% CI 2.345 to 20.411), p = 0.015, t-test, 2 sided

Population analysed: PPS was used for the analysis. This analysis was conducted only in male patients in the PPS.

Primary outcome: Changes in the Mean PIP1 for Female From Baseline to Week 12

Time frame: Baseline to Week 12. Mean (Standard Deviation). Unit: Score on a scale

Measure	TAC-302 n = 15	Placebo n = 7
PIP1 at baseline	18.769 (6.591)	20.561 (7.524)
PIP1 at Week 12	29.373 (9.369)	25.487 (9.581)

TAC-302: Mean Difference (Final Values): 10.604 (95% CI 5.753 to 15.455), p <0.001, t-test, 2 sided
Placebo: Mean Difference (Final Values): 4.926 (95% CI -2.121 to 11.973), p = 0.138, t-test, 2 sided
TAC-302 vs Placebo: Mean Difference (Final Values): 5.678 (95% CI -2.375 to 13.731), p = 0.157, t-test, 2 sided

Population analysed: PPS was used for the analysis. This analysis was conducted only in female patients in the PPS.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAC-302	2 of 52 (3.8%)	24 of 52 (46.2%)	0 of 52
Placebo	1 of 24 (4.2%)	9 of 24 (37.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36205739Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7.

Related trials for Detrusor Underactivity

RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
Recruiting
Akyva First In Human
Underactive Bladder
Not yet recruiting
The Effect of Detrusor Underactivity in Determining Outcomes After Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia
Detrusor Underactivity, Transurethral Resection of the Prostate (TURP)
Recruiting
TURP Inpatient With Underactive Bladder With BOO
TURP Syndrome, Retention, Urinary
Not yet recruiting
EEP in Patients With Urodynamically Proven DU/DA
Lower Urinary Tract Symptoms, Lower Urinary Tract Obstructive Syndrome

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 TAC-302 in people with Detrusor Underactivity and Overactive Bladder, 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 4 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 20 Jan 2025. 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 20 Jan 2025). 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?

Changes in the Mean BCI for Male From Baseline to Week 12 (time frame: Baseline to Week 12). 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 NCT03175029, 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 20 Jan 2025.