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

• 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: Cook MyoSite
• Information provided by (Responsible Party): Cook MyoSite

Tracking Information

• First Submitted Date: November 11, 2014
• First Posted Date: November 14, 2014
• Results First Submitted Date: August 26, 2021
• Results First Posted Date: October 26, 2021
• Last Update Posted Date: November 1, 2021
• Actual Study Start Date: February 19, 2015
• Actual Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 27, 2021)

• Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events [ Time Frame: 24 months ]
  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.
• Volume of Post-void Residual (PVR) Urine [ Time Frame: 1, 3, 6, and 12 months ]
  Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.

Original Primary Outcome Measures (submitted: November 13, 2014)

• Rate of product-related serious adverse events [ Time Frame: 24 months ]
• Rate of product-related, biopsy procedure-related, and injection procedure-related adverse events [ Time Frame: 24 months ]
• Volume of post-void residual urine [ Time Frame: 12 months ]

Current Secondary Outcome Measures (submitted: September 27, 2021)

• Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) [ Time Frame: 1, 3, 6, and 12 months ]
  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.
• Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) [ Time Frame: 1, 3, 6, and 12 months ]
  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.
• Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire [ Time Frame: 1, 3, 6, and 12 months ]
  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.
• Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  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.
• Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  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.
• Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire [ Time Frame: 1, 3, 6, and 12 months ]
  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.
• Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire [ Time Frame: 1, 3, 6, and 12 months ]
  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.
• Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire [ Time Frame: Baseline, 1, 3, 6, and 12 months ]
  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.

Original Secondary Outcome Measures (submitted: November 13, 2014)

• Amount of urine leakage [ Time Frame: 12 months ]
• Change is patient-reported quality of life assessed by a questionnaire [ Time Frame: 12 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
• Official Title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
• Brief 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Urinary Incontinence
• Stress
• Urination Disorders
• Urologic Diseases
• Lower Urinary Tract Symptoms
• Urological Manifestations

Intervention

Biological: autologous muscle-derived cells (AMDC)

Cell treatment

Study Arms

Experimental: AMDC-USR

Cell treatment

Intervention: Biological: autologous muscle-derived cells (AMDC)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 2, 2019): 25
• Original Estimated Enrollment (submitted: November 13, 2014): 30
• Actual Study Completion Date: June 28, 2019
• Actual Primary Completion Date: June 28, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02291432
• Other Study ID Numbers: 13-11
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cook MyoSite
• Original Responsible Party: Cook Group Incorporated
• Current Study Sponsor: Cook MyoSite
• Original Study Sponsor: Cook Group Incorporated
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kenneth Peters, MD; Beaumont Hospital

• PRS Account: Cook MyoSite
• Verification Date: October 2021