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

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ClinicalTrials.gov Identifier: NCT02529865
Recruitment Status : Active, not recruiting
First Posted : August 20, 2015
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Momokazu Gotoh, Nagoya University

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence , Stress Biological: Periurethral injection of autologous ADRCs and adipose tissue Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 29, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Urine leakage volume by 24-hour pad test [ Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention ]
  3. 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 ]
  4. Number of incontinence episodes per day [ Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention ]
  5. Number of pads used per day [ Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention ]
  6. QOL score (ICIQ-SF and KHQ) [ Time Frame: Baseline, 26 and 52 weeks after intervention ]
  7. Patient overall satisfaction [ Time Frame: Baseline, 26 and 52 weeks after intervention ]
  8. Urodynamic parameters (MUCP, FPL and ALPP) [ Time Frame: Baseline, 2, 4, 12, 26 and 52 weeks after intervention ]
  9. Blood flow at the injection site measured by transrectal ultrasonography [ Time Frame: Baseline,12, 26 and 52 weeks after intervention ]
  10. Injection site evaluated by pelvis MRI scan [ Time Frame: Baseline, 2, 26 and 52 weeks after intervention ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529865


Locations
Japan
Nagoya university Hospital
Nagoya, Aichi, Japan, 466-8560
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Shinshu University Hospital
Matsumoto, Nagano, Japan, 390-8621
Dokkyo Medical University Hospital
Shimotsuga, Tochigi, Japan, 321-0293
Sponsors and Collaborators
Nagoya University
Investigators
Principal Investigator: Momokazu Gotoh, M.D., Ph.D. Department of Urology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Momokazu Gotoh, MD, PhD, Professor at Department of Urology, Nagoya University Hospital, Nagoya University
ClinicalTrials.gov Identifier: NCT02529865     History of Changes
Other Study ID Numbers: CAMCR-005
UMIN000017901 ( Other Identifier: UMIN Clinical Trials Registry )
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by Momokazu Gotoh, Nagoya University:
Cell Transplantation

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders