Can a laser fix bladder leaks? new study tests vaginal treatment for urine control
NCT ID NCT03671694
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a laser applied to the vagina can help women with stress urinary incontinence (leaking urine when coughing, sneezing, or exercising). About 144 women will receive the laser treatment and be followed for 6 months. The main goal is to see if the treatment reduces urine leakage and improves quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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144 people
The number who actually took part.
- Started
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Sep 2018
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patient, aged 18 years or older at the time of enrollment, 2. 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). 3. The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it. 4. objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc 5. Bladder capacity ≥200cc 6. Post void residual ≤100cc with Stage I or lower pelvic organ prolapse Exclusion Criteria: 1. Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is \<12 months post partum 2. Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula) 3. Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum 4. Current chemo/ radiotherapy; history of pelvic radiation 5. Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury) 6. Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms 7. History of synthetic sling 8. Pelvic surgery \< 3 months 9. Current evaluation or treatment for chronic pelvic pain 10. Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening 11. Participation in another treatment intervention that might interfere with the results of this trial 12. Patient has a medical condition or disorder that may limit life expectancy or that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, urinary symptoms, and/or data). 13. Patient has ambulatory 24 hour pad test, where the increased pad weight is \< 3 grams. 14. Patient is non-ambulatory (ambulatory with assistive devices allowed)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, M4N 3M5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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