Erb:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence

Study Overview
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Brief Summary
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This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.

Detailed Description
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This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders. Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.

Official Title
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Erbium:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence: a Pilot Randomized Controlled Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: Erbium Yag Laser
* Behavioral: Pelvic Floor Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to Moderated Stress Urinary Incontinence Exclusion Criteria: Mixed Urinary incontinence Pelvic organ prolase greater than stage 2 Previous surgery for stress urinary incontinence and/or pelvic organ prolapse Severe Stress urinary incontinence

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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No

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: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erbium:Yag Laser<br>Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other. | Device: Erbium Yag Laser<br>* Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month<br>|
| Active Comparator: Pelvic floor training<br>Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist. | Behavioral: Pelvic Floor Training<br>* Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | In order to measure quality of life, we are going to use the International Consultation on Incontinence Questionnaire Short Form (ICQI-SF), validate to spanish and in Chile. A higher score in this scale means a worse outcome for the patient. | The questionnaire will be applied at baseline, 6 month and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pad test | A 24 h Pad test will be applied. The pad will be weighted after 24 h of use and the difference between the dry pad and the wet pad is going to be recorded. A great difference means a worse outcome for the patient. | at baseline, 6 month and 1 year |