IRB Study Number 25-993
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Glickman Urological and Kidney Institute
Description
This is a prospective, multicenter, non-randomized, single-arm study where subjects will be implanted with the UroActive® device and followed up to 5 years post-device activation. Enrolled subjects who meet study eligibility will proceed with device activation after a successful UroActive® implant. Subjects with an unsuccessful implant will be followed for an additional 2 weeks for any adverse events. A total of up to 140 enrolled subjects for up to 91 activated subjects will be included in the study at up to 25 sites (up to 15 centers in US and 10 centers in France). At least half of the subjects are expected to be enrolled at the US sites. The number of radiated and non-radiated subjects will be determined on a site basis. Study participants will be followed as per study schedule as shown in the study schematic
Inclusion Criteria
Enrolled subjects must meet all of the inclusion criteria and none of the exclusion criteria to
proceed in the study.
1.
Male subjects aged ≥ 22 years old
2.
Able to read, comprehend and willing to sign an informed consent form
3.
Able and willing to comply with study required procedures, visits and follow-upinvestigations (e.g., completing 3-day bladder diary, wear 24-hour pads)
4.
Has adequate cognitive and manual capabilities to operate the UroActive® device, as assessed by the investigator
5.
Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator
6.
Life expectancy ≥ 5 years as assessed by the investigator
7.
At least ≥ 100 g in 24-hour pad-weight test at Baseline visit.
8.
Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
9.
Failed approved non-invasive therapies for the treatment of SUI
Exclusion Criteria
Enrolled subjects must meet all of the inclusion criteria and none of the exclusion criteria to
proceed in the study.
1.
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
2.
Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
3.
History of neurological conditions (e.g., Parkinson’s disease, stroke, spinal cord injury) that may impact bladder function or study participation, as assessed by the investigator
4.
Likely needs any of the procedures (e.g., radiation therapy) or plans to participate in any of the activities that may be contraindicated (or warnings) with the use of UroActive® device in the next 12 months (post implant)
5.
Any planned procedure requiring urethral catheterization 12 months after implant procedure (including intermittent catheterization), except for diagnostic purposes
6.
Known allergies to UroActive® implantable components that may confound study outcomes
7.
Uncontrolled diabetes mellitus defined by glycosylated hemoglobin (HbA1C) levels of > 8%
8.
Known history of bleeding diathesis or coagulopathy, as determined by investigator
9.
History of recurrent bladder stones in the past 12 months prior to Informed Consent
10.
History of immunosuppression or use of systemic immunosuppressive medications or therapies
11.
Previously had or currently has a device implanted (AUS and/or Sling) or undergone bulking procedures for treatment of SUI or urge incontinence. Previous ProACT are not excluded if removed at least 6 months prior to informed consent
12.
Currently implanted with an Active Implantable Medical Device (AIMD)
13.
Body Mass Index (BMI) ≥ 35 kg/m2 at baseline
14.
Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
15.
Irresolvable detrusor hyperreflexia or bladder instability
16.
Currently using an indwelling catheter, condom catheter or penile clamps for treatment of their incontinence symptoms and not willing to discontinue its use as needed during the study
17.
Post-void residual volume greater than 75 ml or a history of difficulty emptying the bladder, as assessed by the investigator
18.
Unstable symptomatic urethral strictures requiring long term treatment
