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Tests treatment safety and results for Urge Urinary Incontinence
Official title Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
ClinicalTrials.gov ID: NCT07456865
What this study is testing
- What it's testing
- The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Candidate for Altaviva™ therapy per Altaviva™ labeling
- Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- If taking OAB medications, people should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment...
- Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
You likely can't join if
- Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
- Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling
- Have progressive, systemic neurological disease
- Have clinically significant peripheral neuropathy in the lower leg
- Severe, uncontrolled diabetes
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
See the full eligibility criteria
- Candidate for Altaviva™ therapy per Altaviva™ labeling
- Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- If taking OAB medications, people should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary
- Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
- Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
- Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling
- Have progressive, systemic neurological disease
- Have clinically significant peripheral neuropathy in the lower leg
- Severe, uncontrolled diabetes
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
- Current symptomatic urinary tract infection
- Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect...
- Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months
- History of a prior implantable tibial neuromodulation system
- Patients who are pregnant or planning to become pregnant during the course of the study
- Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results
The study team makes the final eligibility decision.
Where it's taking place
- Homewood, Alabama, United States
- Idaho Falls, Idaho, United States
- St Louis, Missouri, United States
- Greensboro, North Carolina, United States
- Cleveland, Ohio, United States
- Gahanna, Ohio, United States
- Allentown, Pennsylvania, United States
- West Columbia, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Arlington, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Homewood, Alabama, United States; Idaho Falls, Idaho, United States; St Louis, Missouri, United States; Greensboro, North Carolina, United States; Cleveland, Ohio, United States; Gahanna, Ohio, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.