Skip to main content
OpenTrials
Completed

NCT Number: NCT02529865

Clinical Trial of Autologous Adipose Derived Regenerative Cells 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence , Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya university Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periurethral injection of autologous ADRCs and adipose tissue

Biological

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nagoya University

Other

Registry information

Official study 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

Acronym: ADRESU

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 20, 2015
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.