Urinary IncontinencePhase 1/2NCT02291432
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
A Phase 1/2 study testing autologous muscle-derived cells (AMDC) in people with Urinary Incontinence and Stress, run by Cook MyoSite at 5 sites in United States.
Trial summary
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Stress, Urination Disorders
- What is being tested?
- autologous muscle-derived cells (AMDC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Feb 2015to 28 Jun 2019
- Phase
- Phase 1/2
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, at least 18 years old, with primary symptoms of SUI following prostate surgery,
- Patient has undergone prostate surgery but has not undergone radiation therapy, cryotherapy, or high-intensity focused ultrasound of the prostate,
- SUI severity should be ≥10 g and <400 g of urine leakage over 24 hours,
- Patient has failed to achieve acceptable resolution of SUI symptoms following prior therapy.
Who cannot join
- Symptoms of only urge urinary incontinence,
- Symptoms of stress urinary incontinence prior to prostate surgery,
- Routinely has more than 2 episodes of awakening to void during normal sleeping hours,
- Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy,
- Previously treated with a periurethral balloon or adjustable sling for urinary incontinence,
- Symptoms of overflow incontinence
- Additional medical restrictions as specified in the Clinical Investigation Plan,
- Additional anatomical restrictions as specified in the Clinical Investigation Plan.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Hospital
Atlanta, Georgia, 30322
McKay Urology
Charlotte, North Carolina, 28207
University of Miami School of Medicine
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
Read the detailed description
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
- Conditions
- Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations
- Being tested
- autologous muscle-derived cells (AMDC)
- Keywords
- Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy)
- Medical subject headings
- Urinary Incontinence, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous muscle-derived cells (AMDC)Biological
Cell treatment
| Study group | Role | What they receive |
|---|---|---|
| AMDC-USR | Experimental | Cell treatment Receives: Biological: autologous muscle-derived cells (AMDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events
Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.
Measured: 24 months
Volume of Post-void Residual (PVR) Urine
Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.
Measured: 1, 3, 6, and 12 months
Secondary outcomes (8)
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)
Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.
Measured: 1, 3, 6, and 12 months
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)
Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.
Measured: 1, 3, 6, and 12 months
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire
Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL.
Measured: 1, 3, 6, and 12 months
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)
Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.
Measured: Baseline, 1, 3, 6, and 12 months
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.
Measured: Baseline, 1, 3, 6, and 12 months
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit.
Measured: 1, 3, 6, and 12 months
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire
Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 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. Percentages of participants in each category were determined at each visit.
Measured: 1, 3, 6, and 12 months
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire
SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms.
Measured: Baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study start19 Feb 2015
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Peters, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291432
- Sponsor's protocol ID
- 13-11
- Status last verified
- Oct 2021
- First submitted
- 11 Nov 2014
- Last updated
- 1 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No