Laser Vaginal Treatment for SUI

Study Overview
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Brief Summary
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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
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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).

Official Title
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Laser Vaginal Treatment for Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Erbium-YAG laser vaginal treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser treatment<br>Erbium-YAG laser treatment to the vagina | Procedure: Erbium-YAG laser vaginal treatment<br>* Erbium-YAG laser vaginal treatment<br>|
| Placebo Comparator: sham treatment<br>sham treatment with laser placebo | Procedure: Erbium-YAG laser vaginal treatment<br>* Erbium-YAG laser vaginal treatment<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser treatment