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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

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring laser treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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Laser Vaginal Treatment for SUI

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