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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04705285

Acronym

EFFECT

Enrollment

Registered

2021-01-12

Start date

2019-05-15

Completion date

2021-09-15

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

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.

Interventions

DEVICEErbium Yag Laser

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

BEHAVIORALPelvic Floor Training

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in quality of life	The questionnaire will be applied at baseline, 6 month and 1 year	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

Measure	Time frame	Description
Pad test	at baseline, 6 month and 1 year	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.

Countries

Chile

Contacts

Primary ContactVictor A Miranda, MD

vmirandah@med.puc.cl+56988291697

Backup ContactSebastian Viguera, MD

sebastian.viguera@gmail.com+56993316816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026