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

Completed

• Conditions: Vaginal Atrophy; Urinary Incontinence,Stress
• Interventions: Device: Low-level laser therapy

• Registration Number: NCT06136975
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2022-09-30
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
genitourinary symptoms of menopause	Low-level laser therapy	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 .
stress urinary incontinence	Low-level laser therapy	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pei-chi Wu; 🇨🇳 Taipei, Taiwan