Laser Vaginal Treatment for SUI
Primary Purpose
Stress Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Erbium-YAG laser vaginal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring laser treatment
Eligibility Criteria
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
- 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)
Sites / Locations
- Sunnybrook Health Sciences Centre, University of TorontoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
laser treatment
sham treatment
Arm Description
Erbium-YAG laser treatment to the vagina
sham treatment with laser placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adverse effects
Number of participants with any reported adverse effects: local burn, bleeding, irritation, infection, vaginal discharge etc.
Full Information
NCT ID
NCT03671694
First Posted
September 12, 2018
Last Updated
April 12, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT03671694
Brief Title
Laser Vaginal Treatment for SUI
Official Title
Laser Vaginal Treatment for Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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?
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
laser treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
only the care provider (who is not involved with recruitment or evaluation of patients' outcomes) will be aware of the treatment assignments
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laser treatment
Arm Type
Active Comparator
Arm Description
Erbium-YAG laser treatment to the vagina
Arm Title
sham treatment
Arm Type
Placebo Comparator
Arm Description
sham treatment with laser placebo
Intervention Type
Procedure
Intervention Name(s)
Erbium-YAG laser vaginal treatment
Intervention Description
Erbium-YAG laser vaginal treatment
Primary Outcome Measure Information:
Title
SUI cure
Description
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.
Time Frame
6 months post treatment
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Number of participants with any reported adverse effects: local burn, bleeding, irritation, infection, vaginal discharge etc.
Time Frame
6,12 24 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne Lawrence, BSc
Phone
4164806100
Ext
2309
Email
joanne.lawrence@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Lee, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Lawrence, BSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Laser Vaginal Treatment for SUI
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