Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder (NCT06283498) | Clinical Trial Compass
By InvitationNot Applicable
Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder
United States, Colombia32 participantsStarted 2023-11-10
Plain-language summary
The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladder
The main questions it aims to answer are:
•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]
Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.
Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment.
Who can participate
Age range
21 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 21-80 years old, inclusive
* Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.
* Urinary incontinence, predominant urgency incontinence for at least one episode on a 3-days diary.
* Reporting at least "moderate bother" on Item 2 on the UDI, "Do you experience a strong feeling of urgency to empty your bladder" (on new patient paperwork)
* \>8 micturitions and \>3 urgency episodes per 24 hours on a 3-day bladder diary (see Appendix 2)
* 1 UUI episode on a 3-day bladder diary (see Appendix 2)
* Not currently taking anti-muscarinic or beta3 agonist therapy (after at least a 2-week wash-out period)
* Post-void residual (PVR) ≤ 100 ml NOTE: it may include Subjects with a single PVR of \>100 ml followed by two consecutive PVR measurements of ≤100 ml in the study. We will record the final acceptable PVR measurement in the data.
* Ability and willingness to self-catheterize in case this is necessary.
* With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up
Exclusion Criteria:
* Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.
* Any per…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in urgency incontinence episodes after 3 month