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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000017901 | Other Identifier | UMIN Clinical Trials Registry |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRCs and Adipose tissue | Experimental | Periurethral injection of autologous adipose derived regenerative cells and adipose tissue |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periurethral injection of autologous ADRCs and adipose tissue | Biological | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Momokazu Gotoh, M.D., Ph.D. | Department of Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya university Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Kanazawa University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2403377 | Background | Shaw CF 3rd, Isab AA, Coffer MT, Mirabelli CK. Gold(I) efflux from auranofin-treated red blood cells. Evidence for a glutathione-gold-albumin metabolite. Biochem Pharmacol. 1990 Sep 15;40(6):1227-34. doi: 10.1016/0006-2952(90)90387-z. | |
| 2243546 | Background | Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11. |
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| 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 |
| Number of pads used per day | Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention |
| QOL score (ICIQ-SF and KHQ) | Baseline, 26 and 52 weeks after intervention |
| Patient overall satisfaction | 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 |
| Kanazawa |
| Ishikawa-ken |
| 920-8641 |
| Japan |
| Shinshu University Hospital | Matsumoto | Nagano | 390-8621 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-gun | Tochigi | 321-0293 | Japan |
| 28946874 | Derived | Shimizu S, Yamamoto T, Nakayama S, Hirakawa A, Kuwatsuka Y, Funahashi Y, Matsukawa Y, Takanari K, Toriyama K, Kamei Y, Narimoto K, Yamanishi T, Ishizuka O, Mizuno M, Gotoh M. Design of a single-arm clinical trial of regenerative therapy by periurethral injection of adipose-derived regenerative cells for male stress urinary incontinence in Japan: the ADRESU study protocol. BMC Urol. 2017 Sep 25;17(1):89. doi: 10.1186/s12894-017-0282-7. |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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