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

September 27, 2017 updated by: Dr Adolf Lukanovič

Non-ablative Er:Yttrium Aluminum Garnet (Er:YAG) Laser Therapy Effect on Stress Urinary Incontinence (SUI) Related Quality of Life and Sexual Function: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects their quality of life and sexual satisfaction and is one of the major reasons for gynaecological surgery. There is a need for effective non-invasive treatment alternatives. 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. Validated International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to assess the sexual function. Patients were monitored for discomfort and side-effects during treatment and follow up period.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • diagnosis of stress urinary incontinence
  • sexually active
  • at least one vaginal delivery

Exclusion Criteria:

  • pelvic organ prolapse greater than stage I
  • urgency or mixed UI
  • infection
  • previous gynaecologic surgery or irradiation
  • refuse consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser
One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
Device: laser
Other Names:
  • IncontiLaseTM
  • IncontiLase
Sham Comparator: Sham control
The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
Device: sham control
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in ICIQ-UI SF score
Time Frame: at 3 months after intervention
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
at 3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in PISQ-12 score
Time Frame: at 3 months after intervention
The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
at 3 months after intervention
Change from baseline in FSFI score
Time Frame: at 3 months after intervention
The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.
at 3 months after intervention
Change from baseline in perineometry variable maximal contraction pressure
Time Frame: at 3 months after intervention
Measured with Myomed 632 perineometer with the women in supine position.
at 3 months after intervention
Change from baseline in perineometry variable average contraction pressure
Time Frame: at 3 months after intervention
Measured with Myomed 632 perineometer with the women in supine position.
at 3 months after intervention
Change from baseline in perineometry variable mean muscle endurance (stamina)
Time Frame: at 3 months after intervention
Measured with Myomed 632 perineometer with the women in supine position.
at 3 months after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: up to 3 months after intervention
Monitoring for side effects during and after intervention
up to 3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Adolf Lukanovič

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

August 30, 2013

Study Completion (Actual)

August 30, 2013

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUI_ErYAG_Sham

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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