Stress Urinary Incontinence
Conditions
Interventions
Injection of autologous adipose derived regenerative cells and adipose tissue
Sponsors
Nagoya University Hospital
Cytori Therapeutics, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) 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 for over 1 year 2) Age of 20 or above 3) Mild to moderate urinary incontinence on the 24-hour pad test 4) Patients who can keep a bladder diary in a satisfactory manner 5) Patients who are willing and able to give signed consent
Exclusion criteria
Exclusion criteria: 1) Concurrent with any other types of urinary incontinence than stress urinary incontinence 2) History of urinary or reproductive surgery within 6 months prior to the consent 3) History of behavioral therapy or pharmacotherapy within 3 months prior to the consent 4) Concurrent with diabetes insipidus 5) History of radiotherapy in the lower urinary tract 6) History of ADRCs treatment for stress urinary incontinence 7) History of any type of cell therapy within 6 months prior to the consent 8) Participation in any other clinical trial within 3 months prior to the consent 9) Concurrent with lower urinary tract obstruction 10) Concurrent with urolithiasis, urinary tract infection or interstitial cystitis 11) History of recurrent urinary tract infection 12) History of malignant neoplasm within 5 years prior to the consent or a suspicion of it (Patients with a history of radical prostatectomy for localized prostate cancer without relapse/metastasis over 1 year may be enrolled) 13) Life expectancy of less than 1 year 14) Any other patients whom the trial investigator deemed ineligible to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients at 52 weeks with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of patients at each evaluation time point with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test 2) Urine leakage volume at each evaluation time point by 24-hour pad test 3) Rate of patients at each evaluation time point with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline 4) Number of incontinence episodes per day at each evaluation time point 5) Number of pads used per day at each evaluation time point 6) QOL score (ICIQ-SF and KHQ) at each evaluation time point 7) Patient overall satisfaction at each evaluation time point 8) Urodynamic parameters (MUCP, FPL and ALPP) at each evaluation time point 9) Blood flow at the injection site measured by transrectal ultrasonography at each evaluation time point 10) Injection site evaluated by pelvis MRI scan at each evaluation time point | — |
Countries
Japan
Contacts
Public ContactShinobu Shimizu
Nagoya University Hospital ADRESU Clinical Trial Management Office
Outcome results
None listed