Phase 2
N=25
Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery
Urinary Incontinence · Stress · Urination Disorders · Urologic Diseases · Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT02291432 ↗Enrolled (actual)
25
Serious AEs
16.0%
Results posted
Oct 2021
Primary outcome: Primary: Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events — 0; 2; 0; 12 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- autologous muscle-derived cells (AMDC) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Cook MyoSite
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events |
0; 2; 0; 12 | — |
| PRIMARY Volume of Post-void Residual (PVR) Urine |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) |
101.2; 59.5; 104.9; 85.7 | — |
| SECONDARY Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) |
2; 4; 4; 7 | — |
| SECONDARY Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire |
-6.8; 0; -9.1; -9.1 | — |
| SECONDARY Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) |
0; 0; 0; 1 | — |
| SECONDARY Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire |
1; 1; 1; 1 | — |
| SECONDARY Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire |
1; 3; 13; 6; 0; 8 | — |
| SECONDARY Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire |
1; 0; 4; 18; 0; 0 | — |
| SECONDARY Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire |
0; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02291432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.