Stress Urinary IncontinenceNCT03671694
Laser Vaginal Treatment for SUI
A study testing Erbium-YAG laser vaginal treatment in people with Stress Urinary Incontinence, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Erbium-YAG laser vaginal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2018to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Current chemo/ radiotherapy; history of pelvic radiation
- Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
- Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms
Show all 14Show fewer
- History of synthetic sling
- Pelvic surgery < 3 months
- Current evaluation or treatment for chronic pelvic pain
- Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening
- Participation in another treatment intervention that might interfere with the results of this trial
- 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).
- Patient has ambulatory 24 hour pad test, where the increased pad weight is < 3 grams.
- Patient is non-ambulatory (ambulatory with assistive devices allowed)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, M4N 3M5
About this study
Official title: Laser Vaginal Treatment for Stress Urinary Incontinence
RCT designed to answer the question:
Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?
Read the detailed description
This is a double blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm followed by an open label trial at 6 months for any sham treatment arm participants who do not meet treatment success.
The primary goal is to compare the subjective success rates for the resolution of UI for the vaginal laser treatment at 6 months. Secondary aims include an assessment of complications, resolution of SUI symptoms (objective and subjective measures), patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 182 patients. At the 6-month post treatment evaluation, the treatment allocation will be unmasked. The trial will be of approximately 3 years in duration (1 year to recruit and 2 years for follow up).
- Conditions
- Stress Urinary Incontinence
- Being tested
- Erbium-YAG laser vaginal treatment
- Keywords
- laser treatment
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium-YAG laser vaginal treatmentProcedure or surgery
Erbium-YAG laser vaginal treatment
| Study group | Role | What they receive |
|---|---|---|
| laser treatment | Active comparator | Erbium-YAG laser treatment to the vagina Receives: Procedure: Erbium-YAG laser vaginal treatment |
| sham treatment | Placebo comparator | sham treatment with laser placebo Receives: Procedure: Erbium-YAG laser vaginal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUI cure
ICIQ questionnaire: The International Consultation on Incontinence Questionnaire (ICIQ) is a subjective measure of the severity of urinary loss and quality of life for those with incontinence.
With the short form, there are 3 questions with a multi-choice selection of responses with each response having an assigned score. The total score (additive from the 3 questions) are between 0 - 21. Higher scores are indicative of greater severity.
Measured: 6 months post treatment
Secondary outcomes (1)
Adverse effects
Number of participants with any reported adverse effects: local burn, bleeding, irritation, infection, vaginal discharge etc.
Measured: 6,12 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start19 Sep 2018
- Primary completion24 Nov 2023
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Lee, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671694
- Sponsor's protocol ID
- Sunnybrook_womens
- Status last verified
- Apr 2026
- First submitted
- 12 Sep 2018
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
PubMed 40709601
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Vaginal Treatment for Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03671694
- Acronym / sponsor ID
- Sunnybrook_womens
- Conditions
- Stress Urinary Incontinence
- Keywords
- laser treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT designed to answer the question:
Does the application of Erbium: YAG laser treatment to the vagina improve urine control for women with SUI?
Detailed description
This is a double blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm followed by an open label trial at 6 months for any sham treatment arm participants who do not meet treatment success.
The primary goal is to compare the subjective success rates for the resolution of UI for the vaginal laser treatment at 6 months. Secondary aims include an assessment of complications, resolution of SUI symptoms (objective and subjective measures), patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 182 patients. At the 6-month post treatment evaluation, the treatment allocation will be unmasked. The trial will be of approximately 3 years in duration (1 year to recruit and 2 years for follow up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| laser treatment | Active comparator | Procedure: Erbium-YAG laser vaginal treatmentErbium-YAG laser treatment to the vagina |
| sham treatment | Placebo comparator | Procedure: Erbium-YAG laser vaginal treatmentsham treatment with laser placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- Current chemo/ radiotherapy; history of pelvic radiation
- Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erbium-YAG laser vaginal treatmentErbium-YAG laser vaginal treatment | Procedure or surgery | laser treatment, sham treatment |
Primary outcome
SUI cure
Time frame: 6 months post treatment
ICIQ questionnaire: The International Consultation on Incontinence Questionnaire (ICIQ) is a subjective measure of the severity of urinary loss and quality of life for those with incontinence. With the short form, there are 3 questions with a multi-choice selection of responses with each response having an assigned score. The total score (additive from the 3 questions) are between 0 - 21. Higher scores are indicative of greater severity.
1 secondary outcome
Adverse effects
Time frame: 6,12 24 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 40709601Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Lee, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium-YAG laser vaginal treatment in people with Stress Urinary Incontinence, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUI cure (time frame: 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03671694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.