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Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)

NCT03296241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2017-09-28

No results posted yet for this study

Summary

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114 premenopausal parous women with SUI were randomized in two groups of 57 women; a laser intervention group and sham control (placebo) group. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group. Patients were blinded to the allocation. At baseline and 3 months after treatment patients were clinically examined, answered questionnaires for SUI severity sexual function assessment and their pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the laser group will be compared to the improvement in the sham group.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

laser

DEVICE

sham control

Sponsors & Collaborators

  • Dr Adolf Lukanovič

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2013-08-30
Completion
2013-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03296241 on ClinicalTrials.gov