Laser Vaginal Treatment for SUI

NCT03671694 | Active Not Recruiting DMC

• 1 other identifier: Sunnybrook_womens
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Stress Urinary Incontinence

Keywords

laser treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects

  6,12 24 months post treatment

Study Arms (2)

laser treatment

ACTIVE COMPARATOR

Erbium-YAG laser treatment to the vagina

Procedure: Erbium-YAG laser vaginal treatment

sham treatment

PLACEBO COMPARATOR

sham treatment with laser placebo

Procedure: Erbium-YAG laser vaginal treatment

Interventions

Erbium-YAG laser vaginal treatment PROCEDURE

Erbium-YAG laser vaginal treatment

laser treatment; sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Lee, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: only the care provider (who is not involved with recruitment or evaluation of patients' outcomes) will be aware of the treatment assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: September 19, 2018
• Primary Completion: November 24, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)