Laser Vaginal Treatment for SUI (NCT03671694) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Laser Vaginal Treatment for SUI
Canada144 participantsStarted 2018-09-19
Plain-language summary
RCT designed to answer the question:
Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?
Who can participate
Age range
18 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
. Female patient, aged 18 years or older at the time of enrollment,
. primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation; for a duration of at least 3 months (patient can be rescreened after this time interval has passed).
. The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it.
. objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
. Bladder capacity ≥200cc
. Post void residual ≤100cc with Stage I or lower pelvic organ prolapse
Exclusion criteria
. Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is \<12 months post partum
. Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula)
. Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum
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.