urinary incontinence
Conditions
Brief summary
Percentage of patients with 24-hour pad test showing a 50% reduction in pad weight after injecting ATIMP within he urethral sphincter compared to a placebo., Early frequency of SAEs (Serious Adverse Events) after injecting ATIMP within the urethral sphincter compared to a placebo., Long-term frequency of SAEs after injecting ATIMP within the urethral sphincter compared to a placebo.
Detailed description
Percentage of patients achieving visible sphincter contractility in flexible uretroscopy., Percantage of patients achieving improvement of bladder parameters and urinary continency measured in urodynamic test (cystometry and uroflowmetry)., Percentage of patients achieving improvement in lower urinary tract symptoms (LUTS), IPSS scale (minimum 20% reduction of LUTS symptoms measured in IPSS scale).
Sponsors
Nicolaus Copernicus University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with 24-hour pad test showing a 50% reduction in pad weight after injecting ATIMP within he urethral sphincter compared to a placebo., Early frequency of SAEs (Serious Adverse Events) after injecting ATIMP within the urethral sphincter compared to a placebo., Long-term frequency of SAEs after injecting ATIMP within the urethral sphincter compared to a placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving visible sphincter contractility in flexible uretroscopy., Percantage of patients achieving improvement of bladder parameters and urinary continency measured in urodynamic test (cystometry and uroflowmetry)., Percentage of patients achieving improvement in lower urinary tract symptoms (LUTS), IPSS scale (minimum 20% reduction of LUTS symptoms measured in IPSS scale). | — |
Countries
Poland
Outcome results
None listed