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RecruitingNCT07906106Updated Oct 30, 2026

A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)

A Phase 2 interventional study of SFG-02 and Placebo in Participants With Underactive Bladder (UAB), sponsored by Juro Sciences Inc.. Recruiting at 16 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Juro Sciences Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • Participants With Underactive Bladder (UAB)

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)
03

In context

Urinary Bladder, Underactive

31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.

This study's planned enrollment of 70 is close to the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.

Browse Urinary Bladder, Underactive studies →

Lead sponsor

Juro Sciences Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Participants with 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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    SFG-02 Transdermal Formulation

    4-Week Placebo Run-in Period followed by SFG-02 Application for 8 weeks

    Drug: SFG-02

  • Placebo comparator
    Placebo Transdermal Formulation

    4-Week Placebo Run-in Period followed by Placebo Application for 8 weeks

    Drug: Placebo

Interventions

  • DrugSFG-02

    Transdermal formulation containing SFG-02 1.6 mg once a day

  • DrugPlacebo

    placebo once a day

06

What researchers measure

Primary outcomes

  1. Bladder Voiding Efficiency (BVE)

    BVE is calculated by a fraction (%) of bladder volume evacuated (\[voided volume\]/\[bladder volume prior to voiding\] × 100).

    Time frame: The change from Baseline (Week 4) to Week 12

07

Study locations

16 of 16 sites recruiting
  • Clinical Site selected by Juro
    Nagoya, Aichi-ken, Japan
    Recruiting
  • Clinical Site selected by Juro
    Ōbu, Aichi-ken, Japan
    Recruiting
  • Clinical Site selected by Juro
    Katori-shi, Chiba, Japan
    Recruiting
  • Clinical Site selected by Juro
    Yoshida-gun, Fukui, Japan
    Recruiting
  • Clinical Site selected by Juro
    Sapporo, Hokkaido, Japan
    Recruiting
  • Clinical Site selected by Juro
    Mito, Ibaraki, Japan
    Recruiting
  • Clinical Site selected by Juro
    Chiyoda-ku, Tokyo, Japan
    Recruiting
  • Clinical Site selected by Juro
    Meguro-ku, Tokyo, Japan
    Recruiting
  • Clinical Site selected by Juro
    Shinjuku-ku, Tokyo, Japan
    Recruiting
  • Clinical Site selected by Juro
    Chūō, Yamanashi, Japan
    Recruiting
  • Clinical Site selected by Juro
    Fukuoka, Japan
    Recruiting
  • Clinical Site selected by Juro
    Fukushima, Japan
    Recruiting
  • Clinical Site selected by Juro
    Kumamoto, Japan
    Recruiting
  • Clinical Site selected by Juro
    Nagasaki, Japan
    Recruiting
  • Clinical Site selected by Juro
    Saga, Japan
    Recruiting
  • Clinical Site selected by Juro
    Shizuoka, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07906106
Lead sponsor
Juro Sciences Inc.
Responsible party
Sponsor
First posted
Oct 30, 2026
Start date
Aug 22, 2026
Primary completion
Feb 28, 2028 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Oct 30, 2026

Study contacts

Juro Sciences
Contact
contact@sfgsci.com
+81-45-225-8858

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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