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

Stress Clinical Trial

Official title:

Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291432
• Other study ID #: 13-11
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 19, 2015
• Est. completion date: June 28, 2019

Study information

• Verified date: October 2021
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• autologous muscle-derived cells (AMDC)
Cell treatment

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	McKay Urology	Charlotte	North Carolina
United States	University of Miami School of Medicine	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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.	1, 3, 6, and 12 months
Secondary	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.	1, 3, 6, and 12 months
Secondary	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.	1, 3, 6, and 12 months
Secondary	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.	1, 3, 6, and 12 months
Secondary	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.	Baseline, 1, 3, 6, and 12 months
Secondary	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.	Baseline, 1, 3, 6, and 12 months
Secondary	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.	1, 3, 6, and 12 months
Secondary	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.	1, 3, 6, and 12 months
Secondary	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.	Baseline, 1, 3, 6, and 12 months