Participants With Underactive Bladder (UAB)Phase 2NCT07906106
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
A Phase 2 study testing SFG-02 in people with Participants With Underactive Bladder (UAB), run by Juro Sciences Inc. at 16 sites in Japan.
Trial summary
The objective of this POC (Phase 2a) study is to evaluate the effect on Bladder Voiding Efficiency (BVE) as well as safety of SFG-02 transdermal formulation in participants with UAB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Participants With Underactive Bladder (UAB)
- What is being tested?
- SFG-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 16 sitesJapan
- Study dates
- 22 Aug 2026to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants must have at least 2 out of 3 symptoms of UAB (urinary hesitancy, straining to void, and/or weak urinary stream) for at least 3 months before entering the study
- Participants must meet the criteria for the study based on uroflowmetry assessments, ultrasound scans of the bladder, and a urodynamics study assessment at study entry
- If the participant uses clean intermittent self-catheterization (CISC), the participant must have been using CISC continuously for at least 3 months, and must not be completely dependent on CISC to empty their bladder
- Participants must have adequate kidney, liver, and heart function based on laboratory blood tests and electrocardiograms
Who cannot join
- Participants with clinically significant obstructions of lower urinary tract
- Participants with an upper or lower urinary tract infection, or a genital infection
- Participants with one or more bladder diverticula or any other condition that may affect the measurement of post-void residual (PVR) urine volume
- Participants with calculi (stones) in the ureter, bladder, or urethra
- Participants with vesicoureteral and/or renal reflux
- Participants with hydronephrosis
Show all 18Show fewer
- Participants with an indwelling urinary catheter
- Participants who rely on voiding assistance maneuvers to facilitate urination
- Participants with moderate-to-severe overactive bladder, defined by an OABSS, or participants with overactive bladder requiring treatment
- Participants with a low-compliance bladder
- Participants who are currently taking medications for voiding dysfunction
- Participants with increased pelvic floor muscle activity during voiding
- Participants with a history of bladder surgery
- Participants who have undergone surgery for urethral obstruction due to Benign Prostatic Hyperplasia (BPH) or for pelvic organ prolapse within the past 6 months
- Participants who have undergone surgery for urinary incontinence or any other pelvic surgery within the past 12 months
- Participants with chronic pelvic pain that may affect uroflowmetry results
- Participants with a history of pelvic radiation therapy
- Participants with overflow urinary incontinence
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Japan16 sites, 16 recruiting
- Recruiting
Clinical Site selected by Juro
Chiyoda-ku, Tokyo
Nihon University Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Chūō, Yamanashi
University of Yamanashi Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Fukuoka
Harasanshin Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Fukushima
Fukushima Medical University Hospital, +81-45-225-8858, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Katori-shi, Chiba
Chiba Prefectural Sawara Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Kumamoto
Sakurajyuji Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Meguro-ku, Tokyo
Toho University Ohashi Medical Center, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Mito, Ibaraki
Mito Medical Center, +81-45-225-8858, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Nagasaki
Nagasaki University Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Nagoya, Aichi-ken
JCHO Chukyo Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Ōbu, Aichi-ken
National Center for Geriatrics and Gerontology, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Saga
Nanri Urology Clinic, +81-45-225-8858, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Sapporo, Hokkaido
Sapporo Medical University Hospital, +81-45-225-8858, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Shinjuku-ku, Tokyo
Tokyo Women's Medical University Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Shizuoka
Shizuoka General Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
- Recruiting
Clinical Site selected by Juro
Yoshida-gun, Fukui
University of Fukui Hospital, +81-45-225-8858, contact@sfgsci.com
Juro Sciences, contact@sfgsci.com
About this study
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled Proof-of-concept (POC) Study of SFG-02 Transdermal Drug Delivery System Formulation in Participants With Underactive Bladder
The objective of this POC (Phase 2a) study is to evaluate the effect on Bladder Voiding Efficiency (BVE) as well as safety of SFG-02 transdermal formulation in participants with UAB.
Participants will:
- Apply the study patches every day for 12 weeks and wear each patch for a full day
- Visit the clinic once every 2 to 4 weeks for checkups and tests
- Keep diaries about their bladder symptoms and the times they change their study patches
- Being tested
- SFG-02, Placebo
- Keywords
- Impaired Detrusor Contractility, Hypotonic Bladde, Placebo-controlled, Double Blind, Japan, Lower Urinary Tract Dysfunction (LUTD), Bladder Voiding Efficiency (BVE), Detrusor Underactivity (DU), Post-Void Residual (PVR) urine volume, Underactive Bladder (UAB), Proof of Concept (POC)
- Medical subject headings
- Urinary Bladder, Underactive, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFG-02Drug
Transdermal formulation containing SFG-02 1.6 mg once a day
PlaceboDrug
placebo once a day
| Study group | Role | What they receive |
|---|---|---|
| SFG-02 Transdermal Formulation | Active comparator | 4-Week Placebo Run-in Period followed by SFG-02 Application for 8 weeks Receives: Drug: SFG-02 |
| Placebo Transdermal Formulation | Placebo comparator | 4-Week Placebo Run-in Period followed by Placebo Application for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Voiding Efficiency (BVE)
BVE is calculated by a fraction (%) of bladder volume evacuated ([voided volume]/[bladder volume prior to voiding] × 100).
Measured: The change from Baseline (Week 4) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start22 Aug 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants With Underactive Bladder (UAB)Studies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juro Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906106
- Sponsor's protocol ID
- SFG-02-201
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Placebo-controlled Proof-of-concept (POC) Study of SFG-02 Transdermal Drug Delivery System Formulation in Participants With Underactive Bladder
- ClinicalTrials.gov ID
- NCT07906106
- Acronym / sponsor ID
- SFG-02-201
- Keywords
- Impaired Detrusor Contractility, Hypotonic Bladde, Placebo-controlled, Double Blind, Japan, Lower Urinary Tract Dysfunction (LUTD), Bladder Voiding Efficiency (BVE), Detrusor Underactivity (DU)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Juro Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 30 Oct 2026 (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 objective of this POC (Phase 2a) study is to evaluate the effect on Bladder Voiding Efficiency (BVE) as well as safety of SFG-02 transdermal formulation in participants with UAB.
Participants will:
- Apply the study patches every day for 12 weeks and wear each patch for a full day
- Visit the clinic once every 2 to 4 weeks for checkups and tests
- Keep diaries about their bladder symptoms and the times they change their study patches
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 |
|---|---|---|
| SFG-02 Transdermal Formulation | Active comparator | Drug: SFG-024-Week Placebo Run-in Period followed by SFG-02 Application for 8 weeks |
| Placebo Transdermal Formulation | Placebo comparator | Drug: Placebo4-Week Placebo Run-in Period followed by Placebo Application for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must have at least 2 out of 3 symptoms of UAB (urinary hesitancy, straining to void, and/or weak urinary stream) for at least 3 months before entering the study
- Participants must meet the criteria for the study based on uroflowmetry assessments, ultrasound scans of the bladder, and a urodynamics study assessment at study entry
- If the participant uses clean intermittent self-catheterization (CISC), the participant must have been using CISC continuously for at least 3 months, and must not be completely dependent on CISC to empty their bladder
- Participants must have adequate kidney, liver, and heart function based on laboratory blood tests and electrocardiograms
Key exclusion criteria (18 listed)
- Participants with clinically significant obstructions of lower urinary tract
- Participants with an upper or lower urinary tract infection, or a genital infection
- Participants with one or more bladder diverticula or any other condition that may affect the measurement of post-void residual (PVR) urine volume
- Participants with calculi (stones) in the ureter, bladder, or urethra
- Participants with vesicoureteral and/or renal reflux
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 |
|---|---|---|
| SFG-02Transdermal formulation containing SFG-02 1.6 mg once a day | Drug | SFG-02 Transdermal Formulation |
| Placeboplacebo once a day | Drug | Placebo Transdermal Formulation |
Primary outcome
Bladder Voiding Efficiency (BVE)
Time frame: The change from Baseline (Week 4) to Week 12
BVE is calculated by a fraction (%) of bladder volume evacuated ([voided volume]/[bladder volume prior to voiding] × 100).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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.
16 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 SFG-02 in people with Participants With Underactive Bladder (UAB), run by Juro Sciences Inc. at 16 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 4 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juro Sciences (+81-45-225-8858, contact@sfgsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Voiding Efficiency (BVE) (time frame: The change from Baseline (Week 4) to Week 12). 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 30 Oct 2026.