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Clinical Trials/NCT06136975
NCT06136975
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country41 target enrollmentSeptember 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaginal Atrophy
Sponsor
National Taiwan University Hospital
Enrollment
41
Locations
1
Primary Endpoint
Vaginal health
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2022
End Date
August 14, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Urinary incontinence(8 weeks)

Study Sites (1)

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