Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorUromedica
About this trial
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.
Eligibility criteria
Qualifiers
Female at least 22 years old
Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
Provocative pad weight of greater than 11.0 grams
Candidate for surgical intervention
Disqualifiers
Pregnant or lactating
Life expectancy of less than 5 years
Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
Has auto-immune disease
Trial design
Treatments tested in this trial
- Adjustable Continence Therapy for Women (ACT)
Treatment groups
167 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov