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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

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