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Trial record 2 of 12 for:    cook myosite

Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291432
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : October 26, 2021
Last Update Posted : November 1, 2021
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Urinary Incontinence
Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Intervention Biological: autologous muscle-derived cells (AMDC)
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AMDC-USR
Hide Arm/Group Description Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Period Title: Overall Study
Started 25
Muscle Biopsy 25
AMDC Injection 23
1-Month Follow Up 23
3-Month Follow Up 23
6-Month Follow Up 23
12-Month Follow Up 23
Completed 23
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title AMDC-USR
Hide Arm/Group Description Single intraurethral injection of 150 x 10^6 autologous muscle-derived cells (AMDCs).
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  32.0%
>=65 years
17
  68.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
67
(49 to 78)
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Participant Age Number Analyzed 25 participants
67.2  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
0
   0.0%
Male
25
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   4.0%
White
24
  96.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
Urinary Incontinence Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Pure Stress Urinary Incontinence
4
  16.0%
Mixed Urinary Incontinence, Stress Predominant
17
  68.0%
Mixed Urinary Incontinence, Urge Predominant
4
  16.0%
24-hour Pad Test Weight   [1] 
Median (Full Range)
Unit of measure:  Grams
Number Analyzed 25 participants
109.1
(4.1 to 431)
[1]
Measure Description: A test in which the participant wears specific absorbent pads dispensed by the clinic. The pads are weighed to record the pre-test weight prior to dispensing to the participant. The participant must wear the absorbent pads for 24 hours. The participant returns the used absorbent pads to the clinic, and the clinic records the post-test weight to determine urinary leakage for the 24 hour period. The difference in weights represent the amount of urine leaked.
Incontinence Quality of Life (I-QOL)   [1] 
Median (Full Range)
Unit of measure:  Scores on scales
Number Analyzed 25 participants
59.1
(0 to 87.5)
[1]
Measure Description: The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to 100, with higher scores indicating a better QOL.
International Consultation on Incontinence Questionnaire (ICIQ)   [1] 
Median (Full Range)
Unit of measure:  Scores on scales
Number Analyzed 25 participants
13
(7 to 18)
[1]
Measure Description: 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.
International Prostate Symptom Score (IPSS)   [1] 
Median (Full Range)
Unit of measure:  Scores on scales
Number Analyzed 25 participants
9
(1 to 33)
[1]
Measure Description: 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.
International Index of Erectile Function (IIEF)   [1] 
Median (Full Range)
Unit of measure:  Scores on scales
Number Analyzed 25 participants
13
(5 to 25)
[1]
Measure Description: The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction (ED). Scored from 5 to 25, with lower scores indicating less ED symptoms.
Patient Global Impression of Severity (PGI-S) Questionnaire   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Normal
0
   0.0%
Mild
8
  32.0%
Moderate
13
  52.0%
Severe
4
  16.0%
[1]
Measure Description: 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.
1.Primary Outcome
Title Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled (biopsied)
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: events
Study product-related serious adverse events 0
Study Product-related adverse events 2
Injection procedure-related adverse events 0
Biopsy procedure-related adverse events 12
2.Primary Outcome
Title Volume of Post-void Residual (PVR) Urine
Hide Description Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: millileters
Post void residual volume 1 month
0
(0 to 52)
Post void residual volume 3 months
0
(0 to 37)
Post void residual volume 6 months
0
(0 to 142)
Post void residual volume 12 months
0
(0 to 22)
3.Secondary Outcome
Title Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)
Hide Description 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.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: grams
24 hour pad weight at 1 month
101.2
(5.3 to 674.3)
24 hour pad weight at 3 months
59.5
(18.1 to 357)
24 hour pad weight at 6 months
104.9
(9.2 to 359.5)
24 hour pad weight at 12 months
85.7
(13.5 to 319.7)
4.Secondary Outcome
Title Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)
Hide Description 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.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
≥50% reduction in 24 hour pad weight at 1 month
2
   8.7%
≥50% reduction in 24 hour pad weight at 3 months
4
  17.4%
≥50% reduction in 24 hour pad weight at 6 months
4
  17.4%
≥50% reduction in 24 hour pad weight at 12 months
7
  30.4%
5.Secondary Outcome
Title Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire
Hide Description 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.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: points
Change in I-QOL total score at 1 month
-6.8
(-14.8 to 6.8)
Change in I-QOL total score at 3 months
0
(-27.3 to 9.1)
Change in I-QOL total score at 6 months
-9.1
(-37.5 to 12.5)
Change in I-QOL total score at 12 months
-9.1
(-36.4 to 14.8)
6.Secondary Outcome
Title Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)
Hide Description 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.
Time Frame Baseline, 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: scores on a scale
Change in ICIQ score at 1 month
0
(-2 to 7)
Change in ICIQ score at 3 months
0
(-3 to 7)
Change in ICIQ score at 6 months
0
(-3 to 7)
Change in ICIQ score at 12 months
1
(-1 to 16)
7.Secondary Outcome
Title Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire
Hide Description 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.
Time Frame Baseline, 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: scores on a scale
Change in I-PSS score at 1 month
1
(-4 to 8)
Change in I-PSS score at 3 months
1
(-8 to 10)
Change in I-PSS score at 6 months
1
(-6 to 15)
Change in I-PSS score at 12 months
1
(-3 to 10)
8.Secondary Outcome
Title Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire
Hide Description 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.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
PGI-S score at 1 month Normal
1
   4.3%
Mild
3
  13.0%
Moderate
13
  56.5%
Severe
6
  26.1%
PGI-S score at 3 months Normal
0
   0.0%
Mild
8
  34.8%
Moderate
12
  52.2%
Severe
3
  13.0%
PGI-S score at 6 months Normal
0
   0.0%
Mild
9
  39.1%
Moderate
11
  47.8%
Severe
3
  13.0%
PGI-S score at 12 months Normal
1
   4.3%
Mild
6
  26.1%
Moderate
13
  56.5%
Severe
3
  13.0%
9.Secondary Outcome
Title Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire
Hide Description 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.
Time Frame 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
PGI-I score at 1 month Very much better
1
   4.3%
Much better
0
   0.0%
A little better
4
  17.4%
No change
18
  78.3%
A little worse
0
   0.0%
PGI-I score at 3 months Very much better
0
   0.0%
Much better
1
   4.3%
A little better
12
  52.2%
No change
9
  39.1%
A little worse
1
   4.3%
PGI-I score at 6 months Very much better
0
   0.0%
Much better
3
  13.0%
A little better
11
  47.8%
No change
7
  30.4%
A little worse
2
   8.7%
PGI-I score at 12 months Very much better
0
   0.0%
Much better
4
  17.4%
A little better
11
  47.8%
No change
5
  21.7%
A little worse
3
  13.0%
10.Secondary Outcome
Title Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire
Hide Description 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.
Time Frame Baseline, 1, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects injected
Arm/Group Title AMDC-USR
Hide Arm/Group Description:
Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Number of Participants Analyzed 23
Median (Full Range)
Unit of Measure: scores on a scale
Change in IEEF-5 score at 1 month
0
(-9 to 8)
Change in IEEF-5 score at 3 months
0
(-7 to 8)
Change in IEEF-5 score at 6 months
0
(-11 to 4)
Change in IEEF-5 score at 12 months
0
(-8 to 7)
Time Frame Adverse events were monitored from enrollment through study exit - 24 months total.
Adverse Event Reporting Description All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
 
Arm/Group Title AMDC-USR
Hide Arm/Group Description Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs)
All-Cause Mortality
AMDC-USR
Affected / at Risk (%)
Total   0/25 (0.00%)    
Hide Serious Adverse Events
AMDC-USR
Affected / at Risk (%) # Events
Total   4/25 (16.00%)    
Cardiac disorders   
Myocardial infarction  1  1/25 (4.00%)  1
Infections and infestations   
Pneumonia  1  1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders   
Spinal column stenosis  1  1/25 (4.00%)  1
Spondylolisthesis  1  1/25 (4.00%)  1
Nervous system disorders   
Cerebrovascular accident  1  1/25 (4.00%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/25 (4.00%)  2
1
Term from vocabulary, MedDRA version 15.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMDC-USR
Affected / at Risk (%) # Events
Total   9/25 (36.00%)    
Gastrointestinal disorders   
Abdominal Pain  1 [1]  2/25 (8.00%)  2
Infections and infestations   
Sinusitis  1 [1]  2/25 (8.00%)  7
Laceration  1 [1]  2/25 (8.00%)  2
Injury, poisoning and procedural complications   
Post procedural contusion  1 [2]  2/25 (8.00%)  2
Post procedural swelling  1 [3]  1/25 (4.00%)  1
Procedural hypotension  1 [3]  1/25 (4.00%)  1
Procedural nausea  1 [3]  1/25 (4.00%)  1
Procedural pain  1 [2]  3/25 (12.00%)  3
Fall  1 [1]  2/25 (8.00%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1 [4]  2/25 (8.00%)  2
Nervous system disorders   
Hypoaesthesia  1 [3]  1/25 (4.00%)  1
Renal and urinary disorders   
Micturition urgency  1 [5]  1/25 (4.00%)  1
Pollakiuria  1 [5]  1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Erythema  1 [3]  1/25 (4.00%)  1
Hyperhidrosis  1 [3]  1/25 (4.00%)  1
1
Term from vocabulary, MedDRA version 15.0
Indicates events were collected by systematic assessment
[1]
AEs Not Related to Study Product or Procedures with ≥5% Frequency
[2]
Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency
[3]
Biopsy Procedure-Related Adverse Event
[4]
1 Event Biopsy Procedure-Related Adverse Event, 1 Event Not Related to Study Product or Procedures, AEs with ≥5% Frequency
[5]
Study Product-Related Adverse Event
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ron Jankowski, PhD
Organization: Cook MyoSite Incorporated
Phone: 412-963-7380
EMail: Ron.Jankowski@CookMyosite.com
Layout table for additonal information
Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT02291432    
Other Study ID Numbers: 13-11
First Submitted: November 11, 2014
First Posted: November 14, 2014
Results First Submitted: August 26, 2021
Results First Posted: October 26, 2021
Last Update Posted: November 1, 2021