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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 November 2021
• Main ID: NCT02291432
• Date of registration: 11/11/2014
• Prospective Registration: Yes
• Primary sponsor: Cook MyoSite
• Public title: Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
• Scientific title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery: An Investigation of Cook MyoSite Autologous Muscle Derived Cells
• Date of first enrolment: February 19, 2015
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02291432
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Kenneth Peters, MD
• Affiliation: Beaumont Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Urological Manifestations

Lower Urinary Tract Symptoms

Urologic Diseases

Urination Disorders

Stress

Urinary Incontinence

Intervention(s)

Biological: autologous muscle-derived cells (AMDC)

Primary Outcome(s)

Volume of Post-void Residual (PVR) Urine [Time Frame: 1, 3, 6, and 12 months]

Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events [Time Frame: 24 months]

Secondary Outcome(s)

Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire [Time Frame: 1, 3, 6, and 12 months]

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 in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire [Time Frame: Baseline, 1, 3, 6, and 12 months]

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 From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) [Time Frame: 1, 3, 6, and 12 months]

Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire [Time Frame: 1, 3, 6, and 12 months]

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]

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]

Secondary ID(s)

13-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02291432