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Completed

NCT Number: NCT03296241

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laser

Device

Other names: IncontiLaseTM, IncontiLase

sham control

Device

Other names: placebo

Primary outcomes

  1. Change from baseline in ICIQ-UI SF score

    Time frame: at 3 months after intervention

    International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form

Secondary outcomes

  1. Change from baseline in PISQ-12 score

    Time frame: at 3 months after intervention

    The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire

  2. Change from baseline in FSFI score

    Time frame: at 3 months after intervention

    The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.

  3. Change from baseline in perineometry variable maximal contraction pressure

    Time frame: at 3 months after intervention

    Measured with Myomed 632 perineometer with the women in supine position.

  4. Change from baseline in perineometry variable average contraction pressure

    Time frame: at 3 months after intervention

    Measured with Myomed 632 perineometer with the women in supine position.

  5. Change from baseline in perineometry variable mean muscle endurance (stamina)

    Time frame: at 3 months after intervention

    Measured with Myomed 632 perineometer with the women in supine position.

Other outcomes

  1. Side effects

    Time frame: up to 3 months after intervention

    Monitoring for side effects during and after intervention

Sponsors and collaborators

Lead sponsor

Dr Adolf Lukanovič

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 28, 2017
Registry last updated
Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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