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NCT04705285 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04705285
Other study ID # 11145
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date September 15, 2021

Study information
Verified date January 2021
Source Pontificia Universidad Catolica de Chile
Contact Victor A Miranda, MD
Phone +56988291697
Email vmirandah@med.puc.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 15, 2021
Est. primary completion date June 21, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Chile Hospital Clinico de La Florida Santiago

Sponsors (1)
Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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