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Completed

NCT Number: NCT01648491

Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

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Key information

Conditions

Stress Urinary Incontinence 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

78 year–82 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital - Royal Oak, Royal Oak, Michigan, United States

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About this study

Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • urinary incontinence
  • failed urinary incontinence (UI) treatments

Exclusion criteria

  • does not meet inclusion criteria, gender and age limit

Treatment and study plan

Muscle biopsy

Procedure

Biopsy of thigh muscle to obtain stem cell core.

Injection of autologous stem cells

Biological

After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.

Primary outcomes

  1. Study-Related Adverse Events

    Time frame: 6 months

Secondary outcomes

  1. Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire

    Time frame: Baseline and 6 months

    The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible.

  2. Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)

    Time frame: 6 months

    The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.

  3. Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)

    Time frame: 6 months

    The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.

Sponsors and collaborators

Lead sponsor

Kenneth Peters, MD

Other

Collaborators

  • Corewell Health East

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Jul 24, 2012
Registry last updated
Jan 10, 2017

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.

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