Stress Urinary IncontinenceNCT01648491
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
A study testing Muscle Biopsy and Injection of autologous stem cells in people with Stress Urinary Incontinence, run by Kenneth Peters, MD at 2 sites in United States.
Trial summary
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject. Read more about this study
- Who is it for?
- Ages 78 to 82 years, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Muscle Biopsy and Injection of autologous stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 78 to 82 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- urinary incontinence
- failed urinary incontinence (UI) treatments
Who cannot join
- does not meet inclusion criteria, gender and age limit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Muscle Biopsy, Injection of autologous stem cells
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle BiopsyProcedure or surgery
Biopsy of thigh muscle to obtain stem cell core.
Injection of autologous stem cellsBiological
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell treatment | Experimental | Muscle Biopsy and Injection of autologous stem cells Receives: Procedure: Muscle Biopsy; Biological: Injection of autologous stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study-Related Adverse Events
Measured: 6 months
Secondary outcomes (3)
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire
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.
Measured: Baseline and 6 months
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)
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.
Measured: 6 months
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2012
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Corewell Health East
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648491
- Sponsor's protocol ID
- 2011-204
- Status last verified
- Nov 2016
- First submitted
- 8 Mar 2012
- Last updated
- 10 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
- ClinicalTrials.gov ID
- NCT01648491
- Acronym / sponsor ID
- 2011-204
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Collaborators
- Corewell Health East
- Study start
- Oct 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Posted 10 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell treatment | Experimental | Procedure: Muscle Biopsy, Biological: Injection of autologous stem cellsMuscle Biopsy and Injection of autologous stem cells |
Who may qualify
- Ages
- 78 to 82 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- urinary incontinence
- failed urinary incontinence (UI) treatments
Key exclusion criteria (1 listed)
- does not meet inclusion criteria, gender and age limit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle BiopsyBiopsy of thigh muscle to obtain stem cell core. | Procedure or surgery | Stem Cell treatment |
| Injection of autologous stem cellsAfter autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. | Biological | Stem Cell treatment |
Primary outcome
Study-Related Adverse Events
Time frame: 6 months
3 secondary outcomes
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
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)
Time frame: 6 months
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Peters, MD principal investigator
Corewell Health East
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Biopsy and Injection of autologous stem cells in people with Stress Urinary Incontinence, run by Kenneth Peters, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study-Related Adverse Events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.