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

NCT04705285 | Unknown DMC

• 1 other identifier: 11145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pad test

  at baseline, 6 month and 1 year

Study Arms (2)

Erbium:Yag Laser

EXPERIMENTAL

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

Pelvic floor training

ACTIVE COMPARATOR

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

Interventions

Erbium Yag Laser DEVICE

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

Erbium:Yag Laser

Pelvic Floor Training BEHAVIORAL

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

Pelvic floor training

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to Moderated Stress Urinary Incontinence

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico de La Florida

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Victor A Miranda, MD

CONTACT

+56988291697; vmirandah@med.puc.cl

Sebastian Viguera, MD

CONTACT

+56993316816; sebastian.viguera@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: January 12, 2021
• Study Start: May 15, 2019
• Primary Completion: June 21, 2021
• Study Completion: September 15, 2021
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)