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

November 13, 2019 updated by: Momokazu Gotoh, Nagoya University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline and 52 weeks (LOCF) after intervention
Baseline and 52 weeks (LOCF) after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Urine leakage volume by 24-hour pad test
Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
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
Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of incontinence episodes per day
Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Number of pads used per day
Time Frame: Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
Baseline, 2, 4, 12, 26, 38 and 52 weeks after intervention
QOL score (ICIQ-SF and KHQ)
Time Frame: Baseline, 26 and 52 weeks after intervention
Baseline, 26 and 52 weeks after intervention
Patient overall satisfaction
Time Frame: Baseline, 26 and 52 weeks after intervention
Baseline, 26 and 52 weeks after intervention
Urodynamic parameters (MUCP, FPL and ALPP)
Time Frame: Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Baseline, 2, 4, 12, 26 and 52 weeks after intervention
Blood flow at the injection site measured by transrectal ultrasonography
Time Frame: Baseline,12, 26 and 52 weeks after intervention
Baseline,12, 26 and 52 weeks after intervention
Injection site evaluated by pelvis MRI scan
Time Frame: Baseline, 2, 26 and 52 weeks after intervention
Baseline, 2, 26 and 52 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nagoya University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Momokazu Gotoh, M.D., Ph.D., Department of Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAMCR-005
  • UMIN000017901 (Other Identifier: UMIN Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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