Laser Vaginal Treatment for SUI

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Procedure: Erbium-YAG laser vaginal treatment

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laser treatment; Erbium-YAG laser treatment to the vagina	Procedure: Erbium-YAG laser vaginal treatment; Erbium-YAG laser vaginal treatment
Placebo Comparator: sham treatment; sham treatment with laser placebo	Procedure: Erbium-YAG laser vaginal treatment; Erbium-YAG laser vaginal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Number of participants with any reported adverse effects: local burn, bleeding, irritation, infection, vaginal discharge etc.	6,12 24 months post treatment

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Patricia Lee, MD, Sunnybrook Health Sciences Centre

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): November 24, 2023
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: laser treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: Sunnybrook_womens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No