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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Device: Erbium Yag Laser; Behavioral: Pelvic Floor Training

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Hospital Clinico de La Florida
    • Contact: Sebastian Viguera, MD; Phone Number: +56993316816; Email: sebastian.viguera@gmail.com
    • Principal Investigator: Victor Miranda, MD
    • Sub-Investigator: Sebastian Viguera, MD
    • Sub-Investigator: Sarita Donoso
    • Sub-Investigator: Gloria Alonso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Erbium Yag Laser; Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month
Active Comparator: Pelvic floor training; 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; Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): June 21, 2021
• Study Completion (Anticipated): September 15, 2021

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 11145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No