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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence , Stress
• Intervention / Treatment: Biological: Periurethral injection of autologous ADRCs and adipose tissue

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Nagoya University Hospital
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADRCs and Adipose tissue; Periurethral injection of autologous adipose derived regenerative cells and adipose tissue	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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
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

Collaborators and Investigators

• Sponsor: Nagoya University
• Investigators: Principal Investigator: Momokazu Gotoh, M.D., Ph.D., Department of Urology

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2015
• Primary Completion (Actual): March 7, 2019
• Study Completion (Actual): March 7, 2019

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cell Transplantation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: CAMCR-005; UMIN000017901 (Other Identifier: UMIN Clinical Trials Registry)