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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06136975
Enrollment
41
Registered
2023-11-18
Start date
2022-09-30
Completion date
2023-08-14
Last updated
2023-11-18

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

Conditions

Urinary Incontinence,Stress, Vaginal Atrophy

Keywords

Menopause, Stress urinary incontinence, Vaginal atrophy, Low-level laser therapy

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.

Interventions

DEVICELow-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).

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal health8 weeksVaginal 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

MeasureTime frameDescription
Urinary incontinence8 weeksICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.

Countries

Taiwan

Outcome results

None listed

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