Clinical trial NCT03296241: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: stress urinary incontinence
sexual dysfunction
laser
Er:YAG
vaginal laser
vaginal tightening
non-ablative
minimally-invasive
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 114
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients assigned randomly to two groups: laser-treatment group and sham (control) group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in ICIQ-UI SF score
timeFrame: at 3 months after intervention
Secondary outcomes:
measure: Change from baseline in PISQ-12 score
timeFrame: at 3 months after intervention
measure: Change from baseline in FSFI score
timeFrame: at 3 months after intervention
measure: Change from baseline in perineometry variable maximal contraction pressure
timeFrame: at 3 months after intervention
measure: Change from baseline in perineometry variable average contraction pressure
timeFrame: at 3 months after intervention
measure: Change from baseline in perineometry variable mean muscle endurance (stamina)
timeFrame: at 3 months after intervention
Other outcomes:
measure: Side effects
timeFrame: up to 3 months after intervention
Locations:
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