Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06136975

Collaborator

(none)

Enrollment

Location

10.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the efficacy of LLLT in alleviating GSM and SUI.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Atrophy Urinary Incontinence,Stress	Device: Low-level laser therapy

Detailed Description

Between September 2022 and August 2023, all women who received LLLT for GSM and SUI at the gynecologic outpatient clinic of a hospital were retrospectively reviewed. The treatment was once a week for eight weeks. Vaginal health index (VHI) and questionnaires before and after treatment for evaluation of lower urinary tract symptoms (LUTS) and quality of life are the outcome assessment.

Study Design

Study Type:

Observational

Actual Enrollment :

41 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Efficacy of Low-level Laser Therapy in Relieving Vaginal Dryness and Lower Urinary Tract Symptoms

Actual Study Start Date :

Sep 30, 2022

Actual Primary Completion Date :

Aug 14, 2023

Actual Study Completion Date :

Aug 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
genitourinary symptoms of menopause Women with genitourinary symptoms of menopause (GSM). Menopause was defined as no spontaneous menstruation for at least one year. GSM defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptom (LUTS) including urinary urgency, dysuria and recurrent urinary tract infection after menopause .	Device: Low-level laser therapy The treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2).
stress urinary incontinence Women with stress urinary incontinence (SUI). SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.	Device: Low-level laser therapy The treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2).

Arm

Intervention/Treatment

genitourinary symptoms of menopause

Women with genitourinary symptoms of menopause (GSM). Menopause was defined as no spontaneous menstruation for at least one year. GSM defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptom (LUTS) including urinary urgency, dysuria and recurrent urinary tract infection after menopause .

Device: Low-level laser therapy

The treatment was once a week for eight weeks. The patient was in a supine position. The gain medium of the laser was Gallium-Aluminum-Arsenide. The laser was introduced into vagina via a silicon vaginal probe inserted by a doctor for 30 minutes (wavelength 660nm, power density 18.17mW/cm2, energy density 0.018J/cm2s, total energy density 32.4J/cm2).

stress urinary incontinence

Women with stress urinary incontinence (SUI). SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.

Device: Low-level laser therapy

Outcome Measures

Primary Outcome Measures

Vaginal health [8 weeks]
Vaginal health index, each of these 5 items is evaluated by means of a scale from 1 (none) to 5 (excellent) and then the average of the scores is calculated. A value of ≤15 (= cut-off) is generally considered for the diagnosis of low vaginal health.

Secondary Outcome Measures

Urinary incontinence [8 weeks]
ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women with GSM and SUI
Received LLLT at the gynecologic outpatient clinic

Exclusion Criteria:

More or equal to stage 2 pelvic organ prolapse defined by pelvic organ prolapse-quantification system
Ongoing urinary tract infection or vaginitis with the pathogen in the previous 2 weeks
Bladder calculus
Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
A preexisting malignant pelvic tumor.