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

NCT ID: NCT04705285

Last Updated: 2021-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-09-15

Brief Summary

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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

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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.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Erbium Yag Laser

Intervention Type DEVICE

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

Pelvic floor training

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

Group Type ACTIVE_COMPARATOR

Pelvic Floor Training

Intervention Type BEHAVIORAL

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

Interventions

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Erbium Yag Laser

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

Intervention Type DEVICE

Pelvic Floor Training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinico de La Florida

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Victor A Miranda, MD

Role: CONTACT

+56988291697

Sebastian Viguera, MD

Role: CONTACT

+56993316816

Facility Contacts

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Sebastian Viguera, MD

Role: primary

+56993316816

Other Identifiers

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11145

Identifier Type: -

Identifier Source: org_study_id

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