Stress Urinary Incontinence (SUI)
Conditions
Keywords
Stress urinary incontinence, Artificial urinary sphincters
Brief summary
Prospective, multicenter, single-arm study
Interventions
DEVICEArtificial Urinary Sphincter (AUS)
AUS implant
Sponsors
UroMems SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male subjects aged ≥ 22 years old * Able to read, comprehend and willing to sign an informed consent form * Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator * Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator Key
Exclusion criteria
* Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent * Poor candidate for surgical procedures and/or anesthesia, as determined by investigator * Currently implanted with an Active Implantable Medical Device (AIMD) * Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate at 26 weeks post-activation | 26 weeks | Proportion of subjects who report greater than or equal to 50% reduction in the 24 hour Pad Weight Test (PWT) at 26 weeks compared with Baseline |
Countries
France, United States
Contacts
CONTACTRoshini Jain
STUDY_DIRECTORRoshini Jain
UroMems SAS
Outcome results
None listed