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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296241
• Other study ID #: SUI_ErYAG_Sham
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: September 27, 2017
• Start date: August 1, 2012
• Est. completion date: August 30, 2013

Study information

• Verified date: September 2017
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 30, 2013
• Est. primary completion date: August 30, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• laser

• sham control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr Adolf Lukanovic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	Monitoring for side effects during and after intervention	up to 3 months after intervention
Primary	Change from baseline in ICIQ-UI SF score	International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form	at 3 months after intervention
Secondary	Change from baseline in PISQ-12 score	The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire	at 3 months after intervention
Secondary	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.	at 3 months after intervention
Secondary	Change from baseline in perineometry variable maximal contraction pressure	Measured with Myomed 632 perineometer with the women in supine position.	at 3 months after intervention
Secondary	Change from baseline in perineometry variable average contraction pressure	Measured with Myomed 632 perineometer with the women in supine position.	at 3 months after intervention
Secondary	Change from baseline in perineometry variable mean muscle endurance (stamina)	Measured with Myomed 632 perineometer with the women in supine position.	at 3 months after intervention