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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03296241

Enrollment

114

Registered

2017-09-28

Start date

2012-08-01

Completion date

2013-08-30

Last updated

2017-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, sexual dysfunction, laser, Er:YAG, vaginal laser, vaginal tightening, non-ablative, minimally-invasive

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.

Interventions

DEVICElaser

DEVICEsham control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes 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.

Intervention model description

Patients assigned randomly to two groups: laser-treatment group and sham (control) group

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in ICIQ-UI SF score	at 3 months after intervention	International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form

Secondary

Measure	Time frame	Description
Change from baseline in PISQ-12 score	at 3 months after intervention	The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
Change from baseline in FSFI score	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.
Change from baseline in perineometry variable average contraction pressure	at 3 months after intervention	Measured with Myomed 632 perineometer with the women in supine position.
Change from baseline in perineometry variable mean muscle endurance (stamina)	at 3 months after intervention	Measured with Myomed 632 perineometer with the women in supine position.
Change from baseline in perineometry variable maximal contraction pressure	at 3 months after intervention	Measured with Myomed 632 perineometer with the women in supine position.

Other

Measure	Time frame	Description
Side effects	up to 3 months after intervention	Monitoring for side effects during and after intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026