An interventional study of laser and sham control in Stress Urinary Incontinence, sponsored by Dr Adolf Lukanovič. Completed. Open to female participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Dr Adolf Lukanovič · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
Device: laser
The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
Device: sham control
Also known as: IncontiLaseTM, IncontiLase
Also known as: placebo
Change from baseline in ICIQ-UI SF score
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Time frame: at 3 months after intervention
Change from baseline in PISQ-12 score
The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 3 months after intervention
Side effects
Monitoring for side effects during and after intervention
Time frame: up to 3 months after intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Dr Adolf Lukanovič