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

Primary Purpose

Stress Urinary Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Erbium Yag Laser

Pelvic Floor Training

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Hospital Clinico de La FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erbium:Yag Laser

Pelvic floor training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04705285

First Posted

August 1, 2020

Last Updated

January 11, 2021

Sponsor

Pontificia Universidad Catolica de Chile

1. Study Identification

Unique Protocol Identification Number

NCT04705285

Brief Title

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

Acronym

EFFECT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2019 (Actual)

Primary Completion Date

June 21, 2021 (Anticipated)

Study Completion Date

September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Erbium:Yag Laser

Arm Type

Experimental

Arm Description

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

Arm Title

Pelvic floor training

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Erbium Yag Laser

Intervention Description

Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month

Intervention Type

Behavioral

Intervention Name(s)

Pelvic Floor Training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in quality of life

Description

Time Frame

The questionnaire will be applied at baseline, 6 month and 1 year

Secondary Outcome Measure Information:

Title

Pad test

Description

Time Frame

at baseline, 6 month and 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Victor A Miranda, MD

Phone

+56988291697

vmirandah@med.puc.cl

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastian Viguera, MD

Phone

+56993316816

sebastian.viguera@gmail.com

Facility Information:

Facility Name

Hospital Clinico de La Florida

City

Santiago

Country

Chile

Individual Site Status

Recruiting

Facility Contact: