Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence

Urinary Incontinence , Stress Clinical Trial

— ADRESU  

Official title:

Open-label, Multi-center, Single Arm Study to Evaluate the Efficacy and Safety of Periurethral Injection of Autologous Adipose Derived Regenerative Cells (ADRCs) for the Treatment of Male Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529865
• Other study ID #: CAMCR-005
• Secondary ID: UMIN000017901
• Status: Completed
• Phase: Phase 3
• Start date: July 29, 2015
• Est. completion date: March 7, 2019

Study information

• Verified date: November 2019
• Source: Nagoya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence , Stress
• Urinary Incontinence, Stress

Intervention

Biological:
• Periurethral 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.

Locations

Country	Name	City	State
Japan	Kanazawa University Hospital	Kanazawa	Ishikawa
Japan	Shinshu University Hospital	Matsumoto	Nagano
Japan	Nagoya university Hospital	Nagoya	Aichi
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Urine leakage volume by 24-hour pad test		Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Secondary	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
Secondary	Number of incontinence episodes per day		Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Secondary	Number of pads used per day		Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Secondary	QOL score (ICIQ-SF and KHQ)		Baseline, 26 and 52 weeks after intervention
Secondary	Patient overall satisfaction		Baseline, 26 and 52 weeks after intervention
Secondary	Urodynamic parameters (MUCP, FPL and ALPP)		Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Secondary	Blood flow at the injection site measured by transrectal ultrasonography		Baseline,12, 26 and 52 weeks after intervention
Secondary	Injection site evaluated by pelvis MRI scan		Baseline, 2, 26 and 52 weeks after intervention