Clinical trial NCT02291432: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Keywords: Urinary Incontinence, Stress
Tissue Therapy (Cell Therapy)
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events
timeFrame: 24 months
measure: Volume of Post-void Residual (PVR) Urine
timeFrame: 1, 3, 6, and 12 months
Secondary outcomes:
measure: Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)
timeFrame: 1, 3, 6, and 12 months
measure: Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight)
timeFrame: 1, 3, 6, and 12 months
measure: Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire
timeFrame: 1, 3, 6, and 12 months
measure: Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire
timeFrame: 1, 3, 6, and 12 months
measure: Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire
timeFrame: 1, 3, 6, and 12 months
measure: Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire
timeFrame: Baseline, 1, 3, 6, and 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Beaumont Hospital
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: