Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser
sham control
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Laser
Sham control
Arm Description
One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
Outcomes
Primary Outcome Measures
Change from baseline in ICIQ-UI SF score
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Secondary Outcome Measures
Change from baseline in PISQ-12 score
The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
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.
Change from baseline in perineometry variable maximal contraction pressure
Measured with Myomed 632 perineometer with the women in supine position.
Change from baseline in perineometry variable average contraction pressure
Measured with Myomed 632 perineometer with the women in supine position.
Change from baseline in perineometry variable mean muscle endurance (stamina)
Measured with Myomed 632 perineometer with the women in supine position.
Full Information
NCT ID
NCT03296241
First Posted
September 21, 2017
Last Updated
September 27, 2017
Sponsor
Dr Adolf Lukanovič
1. Study Identification
Unique Protocol Identification Number
NCT03296241
Brief Title
Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2012 (Actual)
Primary Completion Date
August 30, 2013 (Actual)
Study Completion Date
August 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Adolf Lukanovič
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients assigned randomly to two groups: laser-treatment group and sham (control) group
Masking
ParticipantOutcomes Assessor
Masking Description
Patients are unaware of the assignment. 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.
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Experimental
Arm Description
One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
Intervention Type
Device
Intervention Name(s)
laser
Other Intervention Name(s)
IncontiLaseTM, IncontiLase
Intervention Type
Device
Intervention Name(s)
sham control
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change from baseline in ICIQ-UI SF score
Description
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Time Frame
at 3 months after intervention
Secondary Outcome Measure Information:
Title
Change from baseline in PISQ-12 score
Description
The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
Time Frame
at 3 months after intervention
Title
Change from baseline in FSFI score
Description
The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.
Time Frame
at 3 months after intervention
Title
Change from baseline in perineometry variable maximal contraction pressure
Description
Measured with Myomed 632 perineometer with the women in supine position.
Time Frame
at 3 months after intervention
Title
Change from baseline in perineometry variable average contraction pressure
Description
Measured with Myomed 632 perineometer with the women in supine position.
Time Frame
at 3 months after intervention
Title
Change from baseline in perineometry variable mean muscle endurance (stamina)
Description
Measured with Myomed 632 perineometer with the women in supine position.
Time Frame
at 3 months after intervention
Other Pre-specified Outcome Measures:
Title
Side effects
Description
Monitoring for side effects during and after intervention
Time Frame
up to 3 months after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
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