Study on urinary continence effect of adipose-derived stem cell administration on stress urinary incontinence
- Conditions
- Stress urinary incontinence after radical pros tatectomy
- Registration Number
- JPRN-jRCTb030220456
- Lead Sponsor
- Hitoshi Masuda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 10
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.
10. Patients with urinary tract stones (urinary tract stones, urinary tract stones, bladder stones, etc.), urinary tract infections (pyelonephritis, cystitis, etc.) or interstitial cystitis.
11. Patients with a history of recurrent urinary tract infection (onset more than 3 times within 6 months before obtaining consent).
12. Patients who have malignant neoplasms or have a history of malignant neoplasms within 5 years before obtaining consent, or patients who are judged to be possible malignant tumors by various tests (patients who meet the selection criterion 2. are excluded.)
13. Patients who have a life expectancy of less than one year at the time of consent acquisition.
14. Patients with or suspected of having a serious infection (infection requiring treatment by intravenous administration of antibacterial, antifungal or antiviral drugs).
15. Syphilis serum reaction positive (one of the following tests using cardiolipin as an antigen: RPR card test, aggregation method, glass plate method, automation method), HCV antibody positive, HBs antigen positive or HIV antibody positive, or HTLV at the time of screening test -1 antibody positive patients.
16. Patients with serious complications (liver disease, renal disease, heart disease, lung disease, blood disease, autoimmune disease, etc.).
17. Patients with a history of or complicated thromboembolism (cerebral infarction, myocardial infarction, deep venous thrombosis, pulmonary embolism, etc.).
18. Patients with a history of hypersensitivity to perflubutane preparations, lidocaine injection components or amide-type local anesthetics, or patients with allergies to casein, gelatin, eggs or egg products.
19. Patients who are considered to need administration of butyrophenone-based, phenothiazine-based antipsychotics, alpha blockers, catecholamines such as isoproterenol, and adrenergic agonists (except when used during fat aspiration) on the day of surgery.
20. Patients taking antiplatelet or anticoagulant drugs and having difficulty withdrawing.
21. Other patients who are judged to be inappropriate by the investigator or the subinvestigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence rate of adverse events
- Secondary Outcome Measures
Name Time Method The following evaluation will be performed on the amount of urinary incontinence. <br>(1) Rate of decrease in urinary incontinence<br>(2) Urinary incontinence amount<br>(3) Rate of decrease in the number of urinary incontinence<br>(4) Number of urinary incontinence per day<br>(5) Number of urine pads per day<br>(6) Urinary incontinence symptom QOL score