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

NCT06136975 | Completed

• 1 other identifier: 202310054RIND
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy; Urinary Incontinence,Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Urinary incontinence

  8 weeks

Study Arms (2)

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

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

Interventions

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).

genitourinary symptoms of menopause; stress urinary incontinence

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• women with GSM and SUI
• Received LLLT at the gynecologic outpatient clinic

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Pei-chi Wu

Taipei, 100, Taiwan

Location

Related Publications (7)

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

  PMID: 33534428 RESULT

• 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.

  PMID: 28364861 RESULT

• 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.

  PMID: 35236871 RESULT

• 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.

  PMID: 25491701 RESULT

• 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.

  PMID: 8694033 RESULT

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

  PMID: 31157569 RESULT

• 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.

  PMID: 18351586 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Pei-chi Wu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: September 30, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)