Study on safety and efficacy of urinary continence by administration of autologous adipose tissue-derived stem cells for stress urinary incontinence after radical prostatectomy - S-SE-UC-ADSC-SUI-ARP

Hitoshi Masuda0 sites10 target enrollmentNovember 24, 2022

Overview

No summary available.

Registry

who.int

Start Date

November 24, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

Male

Sponsor

Hitoshi Masuda

•1\. Male patients suffering from stress urinary incontinence that is ineffective or inadequately effective in behavior therapy and drug therapy, or that drug therapy is difficult to carry out and continues for 1 year or more
•after surgery.
•2\. Patients with stress urinary incontinence after radical radical prostatectomy, no recurrence or metastasis for 1 year or more after surgery, and prostate\-specific antigen (PSA) of 0\.1 ng / ml or less for 1 year or more after surgery.
•3\. Patients with a performance status (PS) score of 0 to 1 and no severe liver or renal dysfunction.
•4\. Patients over 18 years old at the time of consent acquisition.
•5\. Patients with an average daily urinary incontinence of 30 g or more and less than 400 g (mild to moderate) by a 24\-hour pad test during the screening period.
•6\. Patients who are judged by the investigator or the investigator to be able to accurately record the urination diary.
•7\. Patients who have received sufficient explanation about this study and have obtained written consent at their own free will.

•Patients who fall under any of the following are excluded.
•1\. Patients with urge incontinence, overflow incontinence, functional incontinence or reflex incontinence, or patients with these incontinences.
•2\. Patients who underwent surgery with incisions in the urinary and genital organs within 6 months before obtaining consent.
•3\. Patients who started behavior therapy or drug therapy within 3 months before obtaining consent.
•4\. Patients with diabetes insipidus.
•5\. Patients who have received local radiation therapy for the lower urinary tract.
•6\. Patients who have received culture or non\-culture ADSCs to the paraurethral region for the treatment of stress urinary incontinence.
•7\. Patients who received other cell therapy within 6 months before obtaining consent.
•8\. Patients who have participated in or are participating in other clinical trials within 3 months before obtaining consent.
•9\. Patients with lower urinary tract obstructive disease.