Low-level Laser Therapy in Genitourinary Symptoms of Menopause

NCT06074120 | Completed DMC

• 1 other identifier: 202307193DIND
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The study will employ a prospective single-arm design involving menopausal women who present with genitourinary symptoms of menopause (GSM). Due to the preliminary nature of this study and the absence of a control group, the primary objective is to evaluate the feasibility and potential efficacy of low-level laser therapy in alleviating GSM in this population.

Conditions

Menopause Related Conditions

Keywords

Genitourinary symptom; Vulvovaginal atrophy; Menopause

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.

  20 weeks

Secondary Outcomes (6)

• Lower urinary tract symptom: incontinence

  20 weeks

• Lower urinary tract symptom: general

  20 weeks

• Lower urinary tract symptom: life quality

  20 weeks

• Lower urinary tract symptom: urgency

  20 weeks

• Lower urinary tract symptom: overactive bladder

  20 weeks

Study Arms (1)

Women with genitourinary symptoms of menopause

EXPERIMENTAL

Receive low-level laser therapy

Device: Low-level laser therapy

Interventions

Low-level laser therapy DEVICE

Low-level laser therapy would be introduced via a vaginal probe (gain medium: Gallium-Aluminum-Arsenide, wavelength 660nm) for 30 minutes per treatment, once a week, for 8 courses.

Women with genitourinary symptoms of menopause

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopause women
• With genitourinary symptoms of menopause

You may not qualify if:

• Acute or chronic infection of the genitourinary tract
• Advanced pelvic organ prolapse (\>= stage 2 on pelvic organ prolapse quantification system)
• History of pelvic malignancy
• Unstable blood pressure
• Fever
• Abnormal sensory nerve
• Abnormal coagulation

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Beihu Branch: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (6)

• 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 BACKGROUND

• 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

• Filippini M, Porcari I, Ruffolo AF, Casiraghi A, Farinelli M, Uccella S, Franchi M, Candiani M, Salvatore S. CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis. J Sex Med. 2022 Mar;19(3):452-470. doi: 10.1016/j.jsxm.2021.12.010. Epub 2022 Jan 29.

  PMID: 35101378 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

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Pei-chi Wu, MD.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 10, 2023
• Study Start: January 12, 2024
• Primary Completion: July 4, 2025
• Study Completion: February 26, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years after finishing study.
• Access Criteria: The datasets analyzed during the study are available from the PI upon reasonable request.

Locations

TW (1)