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

NCT03296241 | Completed

• 1 other identifier: SUI_ErYAG_Sham
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in ICIQ-UI SF score

  International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form

  at 3 months after intervention

Secondary Outcomes (5)

• Change from baseline in PISQ-12 score

  at 3 months after intervention

• Change from baseline in FSFI score

  at 3 months after intervention

• Change from baseline in perineometry variable maximal contraction pressure

  at 3 months after intervention

• Change from baseline in perineometry variable average contraction pressure

  at 3 months after intervention

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

  at 3 months after intervention

Other Outcomes (1)

• Side effects

  up to 3 months after intervention

Study Arms (2)

Laser

EXPERIMENTAL

One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.

Device: laser

Sham control

SHAM COMPARATOR

The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).

Device: sham control

Interventions

laser DEVICE

Also known as: IncontiLaseTM, IncontiLase

Laser

sham control DEVICE

Also known as: placebo

Sham control

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stress urinary incontinence
• sexually active
• at least one vaginal delivery

You may not qualify if:

• pelvic organ prolapse greater than stage I
• urgency or mixed UI
• infection
• previous gynaecologic surgery or irradiation
• refuse consent

Sponsors & Collaborators

• Dr Adolf Lukanovič: lead

Related Publications (1)

• Ippolito GM, Crescenze IM, Sitto H, Palanjian RR, Raza D, Barboglio Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal lasers for treating stress urinary incontinence in women. Cochrane Database Syst Rev. 2025 Jul 25;7(7):CD013643. doi: 10.1002/14651858.CD013643.pub2.

  PMID: 40709601 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Sexual Dysfunction, Physiological

Interventions

Lasers

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director of the Division of Gynecology

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

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 28, 2017
• Study Start: August 1, 2012
• Primary Completion: August 30, 2013
• Study Completion: August 30, 2013
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share