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NCT06136975 Clinical Trial

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

Vaginal Atrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06136975
Other study ID # 202310054RIND
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2022
Est. completion date August 14, 2023

Study information
Verified date November 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date August 14, 2023
Est. primary completion date August 14, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
Taiwan Pei-chi Wu Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)7 — View Citation

Gambacciani M, Palacios S. Laser therapy for the restoration of vaginal function. Maturitas. 2017 May;99:10-15. doi: 10.1016/j.maturitas.2017.01.012. Epub 2017 Feb 4. — View Citation

Huang L, Zhang SW, Wu SL, Ma L, Deng XH. The Chinese version of ICIQ: a useful tool in clinical practice and research on urinary incontinence. Neurourol Urodyn. 2008;27(6):522-4. doi: 10.1002/nau.20546. — View Citation

Long CY, Wu PC, Chen HS, Lin KL, Loo Z, Liu Y, Wu CH. Changes in sexual function and vaginal topography using transperineal ultrasound after vaginal laser treatment for women with stress urinary incontinence. Sci Rep. 2022 Mar 2;12(1):3435. doi: 10.1038/s — View Citation

Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499. — View Citation

Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728. — View Citation

Rola P, Doroszko A, Derkacz A. The Use of Low-Level Energy Laser Radiation in Basic and Clinical Research. Adv Clin Exp Med. 2014 September-October;23(5):835-842. doi: 10.17219/acem/37263. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal health 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. 8 weeks
Secondary Urinary incontinence ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome. 8 weeks
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