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

Phase 1

Completed

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

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

Registration Number: NCT02291432

Lead Sponsor: Cook MyoSite

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 25

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMDC-USR	autologous muscle-derived cells (AMDC)	Cell treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire	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 Improvement (PGI-I) Questionnaire	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 Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire	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.
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight)	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)	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 Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ)	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.
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire	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.
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire	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.

Trial Locations

Locations (5): University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
McKay Urology
🇺🇸
Charlotte, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States