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

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
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

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Device: laser
* Device: sham control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients assigned randomly to two groups: laser-treatment group and sham (control) group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule. | Device: laser<br> <br> * Other names: IncontiLase;|
| Sham Comparator: Sham control<br>The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo). | Device: sham control<br> <br> * 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 | 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 | The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire | at 3 months after intervention | 
| Change from baseline in FSFI score | 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 | 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 | 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) | Measured with Myomed 632 perineometer with the women in supine position. | at 3 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive