The purpose of this study is to evaluate the efficacy and safety of periurethral injection of autologous Adipose Derived Regenerative Cells (ADRCs) in male stress urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
1 mL of the isolated ADRC is injected into the region of the external urethral sphincter, and another 4 mL of the ADRC and 16mL autologous adipose cells is injected under the urethral mucosa.
Nagoya university Hospital
Nagoya, Aichi-ken, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time frame: Baseline and 52 weeks (LOCF) after intervention
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Urine leakage volume by 24-hour pad test
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of incontinence episodes per day
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of pads used per day
Time frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
QOL score (ICIQ-SF and KHQ)
Time frame: Baseline, 26 and 52 weeks after intervention
Patient overall satisfaction
Time frame: Baseline, 26 and 52 weeks after intervention
Urodynamic parameters (MUCP, FPL and ALPP)
Time frame: Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Blood flow at the injection site measured by transrectal ultrasonography
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Time frame: Baseline,12, 26 and 52 weeks after intervention
Injection site evaluated by pelvis MRI scan
Time frame: Baseline, 2, 26 and 52 weeks after intervention