NCT04705285

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Erbium Yag Laser	Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month
BEHAVIORAL	Pelvic Floor Training	Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist

Timeline

• Start date: 2019-05-15
• Primary completion: 2021-06-21
• Completion: 2021-09-15
• First posted: 2021-01-12
• Last updated: 2021-01-12

Locations

1 site across 1 country: Chile