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

Pontificia Universidad Catolica de Chile

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Device: Erbium Yag Laser; Behavioral: Pelvic Floor Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04705285

11145

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Erbium:Yag Laser

Experimental group

Description:

Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other.

Treatment:

Device: Erbium Yag Laser

Pelvic floor training

Active Comparator group

Description:

Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist.

Treatment:

Behavioral: Pelvic Floor Training