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

Not Applicable

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04705285
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief 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.

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2020-08-01
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12
• Primary Completion: 2021-06-21
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in quality of life	The questionnaire will be applied at baseline, 6 month and 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Pad test	at baseline, 6 month and 1 year	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.

Trial Locations

Locations (1)

Hospital Clinico de La Florida; 🇨🇱 Santiago, Chile