Urinary Incontinence , Stress
Conditions
Keywords
Cell Transplantation
Brief summary
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.
Interventions
BIOLOGICALPeriurethral injection of autologous ADRCs and adipose tissue
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.
Sponsors
Nagoya University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males with stress urinary incontinence with insufficient effect by behavioral therapy or pharmacotherapy persisting more than 1 year after either of the following surgical procedure: * Patients with symptoms after radical prostatectomy for localized prostate cancer and currently without relapse/metastasis, and PSA level less than 0.1 ng/mL for over 1 year * Patients with symptoms after transurethral prostatectomy or laser prostatectomy for prostatic hyperplasia, and PSA level less than 4.0 ng/mL over 1 year * Age of 20 or above * Mild to moderate urinary incontinence on the 24-hour pad test * Patients who can keep a bladder diary in a satisfactory manner * Patients who are willing and able to give signed consent
Exclusion criteria
* \- Concurrent with any other types of urinary incontinence * History of urinary or reproductive surgery within 6 months * History of behavioral therapy or pharmacotherapy within 3 months * Concurrent with diabetes insipidus * History of radiotherapy in the lower urinary tract * History of ADRCs treatment for stress urinary incontinence * History of any type of cell therapy within 6 months * Participation in any other clinical trial within 3 months * Concurrent with lower urinary tract obstruction * Concurrent with urolithiasis, urinary tract infection or interstitial cystitis * History of recurrent urinary tract infection * History of malignant neoplasm within 5 years or a suspicion of it * Life expectancy of less than 1 year * Any other patients whom the trial investigator deemed ineligible to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test | Baseline and 52 weeks (LOCF) after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention |
| Urine leakage volume by 24-hour pad test | 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 | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention |
| Number of incontinence episodes per day | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention |
| Patient overall satisfaction | Baseline, 26 and 52 weeks after intervention |
| QOL score (ICIQ-SF and KHQ) | Baseline, 26 and 52 weeks after intervention |
| Urodynamic parameters (MUCP, FPL and ALPP) | Baseline, 2, 4, 12, 26 and 52 weeks after intervention |
| Blood flow at the injection site measured by transrectal ultrasonography | Baseline,12, 26 and 52 weeks after intervention |
| Injection site evaluated by pelvis MRI scan | Baseline, 2, 26 and 52 weeks after intervention |
| Number of pads used per day | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention |
Countries
Japan
Outcome results
None listed