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NCT07906106
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Conditions: Participants With Underactive Bladder (UAB)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 70
Sponsor: Juro Sciences Inc.
Location: Clinical Site selected by Juro Nagoya Aichi-ken
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
Eligibility Criteria
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 electrocardiograms
Exclusion Criteria:
* 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
* 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
Source: ClinicalTrials.gov (NCT07906106). StuddyBuddy aggregates publicly available trial information.