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

Primary Purpose

Urinary Incontinence , Stress

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Periurethral injection of autologous ADRCs and adipose tissue
Sponsored by
Nagoya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence , Stress focused on measuring Cell Transplantation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya university Hospital
  • Kanazawa University Hospital
  • Shinshu University Hospital
  • Dokkyo Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADRCs and Adipose tissue

Arm Description

Periurethral injection of autologous adipose derived regenerative cells and adipose tissue

Outcomes

Primary Outcome Measures

Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test

Secondary Outcome Measures

Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Urine leakage volume by 24-hour pad test
Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Number of incontinence episodes per day
Number of pads used per day
QOL score (ICIQ-SF and KHQ)
Patient overall satisfaction
Urodynamic parameters (MUCP, FPL and ALPP)
Blood flow at the injection site measured by transrectal ultrasonography
Injection site evaluated by pelvis MRI scan

Full Information

First Posted
August 18, 2015
Last Updated
November 13, 2019
Sponsor
Nagoya University
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1. Study Identification

Unique Protocol Identification Number
NCT02529865
Brief Title
Clinical Trial of Autologous Adipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 29, 2015 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
March 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nagoya University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence , Stress
Keywords
Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADRCs and Adipose tissue
Arm Type
Experimental
Arm Description
Periurethral injection of autologous adipose derived regenerative cells and adipose tissue
Intervention Type
Biological
Intervention Name(s)
Periurethral injection of autologous ADRCs and adipose tissue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time Frame
Baseline and 52 weeks (LOCF) after intervention
Secondary Outcome Measure Information:
Title
Rate of patients with improvement in urine leakage volume as greater than 50% reduction from baseline by 24-hour pad test
Time Frame
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Title
Urine leakage volume by 24-hour pad test
Time Frame
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Title
Rate of patients with improvement in the number of incontinence episodes per day as greater than 50% reduction from baseline
Time Frame
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Title
Number of incontinence episodes per day
Time Frame
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Title
Number of pads used per day
Time Frame
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Title
QOL score (ICIQ-SF and KHQ)
Time Frame
Baseline, 26 and 52 weeks after intervention
Title
Patient overall satisfaction
Time Frame
Baseline, 26 and 52 weeks after intervention
Title
Urodynamic parameters (MUCP, FPL and ALPP)
Time Frame
Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Title
Blood flow at the injection site measured by transrectal ultrasonography
Time Frame
Baseline,12, 26 and 52 weeks after intervention
Title
Injection site evaluated by pelvis MRI scan
Time Frame
Baseline, 2, 26 and 52 weeks after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momokazu Gotoh, M.D., Ph.D.
Organizational Affiliation
Department of Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya university Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
2403377
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. doi: 10.1016/0006-2952(90)90387-z.
Results Reference
background
PubMed Identifier
2243546
Citation
Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. MD Comput. 1990 Sep-Oct;7(5):302-11.
Results Reference
background
PubMed Identifier
28946874
Citation
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.
Results Reference
derived

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

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