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
• Interventions: Device: Erbium Yag Laser; Behavioral: Pelvic Floor Training

• 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

Arm && Interventions

Group	Intervention	Description
Erbium:Yag Laser	Erbium Yag Laser	Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other.
Pelvic floor training	Pelvic Floor Training	Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist.

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