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

Tokai National Higher Education and Research System

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence , Stress

Treatments: Biological: Periurethral injection of autologous ADRCs and adipose tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT02529865

CAMCR-005

UMIN000017901 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Male

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

ADRCs and Adipose tissue

Experimental group

Description:

Periurethral injection of autologous adipose derived regenerative cells and adipose tissue

Treatment:

Biological: Periurethral injection of autologous ADRCs and adipose tissue