Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

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.
    

Intervention name(s): laser; sham control
Intervention type(s): Device; Device
Other intervention name(s): IncontiLaseTM; IncontiLase; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients assigned randomly to two groups: laser-treatment group and sham (control) group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress urinary incontinence; sexual dysfunction; laser; Er:YAG; vaginal laser; vaginal tightening; non-ablative; minimally-invasive