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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy; Urinary Incontinence,Stress
• Intervention / Treatment: Device: Low-level laser therapy

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Pei-chi Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The consecutive women who received LLLT at the gynecologic outpatient clinic were retrospectively reviewed. Menopause was defined as no spontaneous menstruation for at least one year. GSM is defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptoms (LUTS) including urinary urgency, dysuria, and recurrent urinary tract infection after menopause. SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
genitourinary symptoms of menopause; 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 .	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).
stress urinary incontinence; 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-chi Wu, National Taiwan University Hospital

Publications and helpful links

General Publications

• 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)70243-0.
• Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728.
• 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.
• 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/s41598-022-06601-0.
• 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.
• Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Menopause; Stress urinary incontinence; Vaginal atrophy; Low-level laser therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Atrophy; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 202310054RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets analyzed during the study are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No