Laser Vaginal Treatment for Stress Urinary Incontinence

STATUS

Recruiting
End date

Jun 30, 2023
participants needed

182
sponsor

Sunnybrook Health Sciences Centre

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Updated on 27 October 2022

See if I qualify

Joanne Lawrence, BSc

Primary Contact

Sunnybrook Health Sciences Centre, University of Toronto (7.2 mi away) Contact

cough

incontinence

prolapse

leakage of urine

Accepts healthy volunteers

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?

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).

Details

Condition	Stress Urinary Incontinence
Treatment	Erbium-YAG laser vaginal treatment
Clinical Study Identifier	NCT03671694
Sponsor	Sunnybrook Health Sciences Centre
Last Modified on	27 October 2022

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Eligibility		Yes	No	Not Sure
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)

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Laser Vaginal Treatment for Stress Urinary Incontinence

Joanne Lawrence, BSc

Sunnybrook Health Sciences Centre, University of Toronto (7.2 mi away) Contact