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Completed

NCT Number: NCT06136975

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Pei-chi Wu

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Level Laser Therapy

Device

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).

Primary outcomes

  1. Vaginal health

    Time frame: 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 outcomes

  1. Urinary incontinence

    Time frame: 8 weeks

    ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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