Low-level Laser Therapy in Genitourinary Symptoms of Menopause

Assessing the Efficacy of Low-Level Laser Therapy in Alleviating Genitourinary Symptoms of Menopause

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.

Study Overview

• Status: Recruiting
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Device: Low-level laser therapy

Detailed Description

A convenience sample of menopausal women aged more or equal to 45 years will be recruited from the gynecology clinic in our hospital and its branches. Participants will undergo an initial screening to confirm the presence of genitourinary symptoms associated with menopause. Inclusion criteria will encompass women experiencing symptoms such as urinary incontinence, vaginal dryness, dyspareunia, and decreased sexual satisfaction. The exclusion criteria will be diagnosed with advanced pelvic organ prolapse (more or equal to stage 2 prolapse by pelvic organ prolapse quantification system).

All participants will receive low-level laser therapy (LLLT) as the intervention. LLLT sessions will be conducted once a week for eight weeks. The laser therapy will be administered by a trained healthcare professional using a standard protocol, targeting the genitourinary area. The laser device will emit low-energy laser light, which is hypothesized to stimulate tissue regeneration, improve blood circulation, and alleviate symptoms in the genitourinary region.

Baseline assessments will be conducted prior to the initiation of LLLT, including demographic data collection and validated outcome measures to evaluate GSM and quality of life. These measures may include the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI), Vaginal Health Index (VHI), Incontinence Impact Questionnaire-7 (IIQ-7), Overactive Bladder Symptom Score (OABSS), Urogenital Distress Inventory-6 (UDI-6), Urgency Severity Scale (USS), King's Health Questionnaire (KHQ), and a urodynamic study with a 20-minute pad test. Follow-up assessments will be conducted immediately after the fourth- and eighth-week treatment period and at a three-month post-treatment follow-up. During these assessments, participants will complete the same validated outcome measures as the baseline assessment to evaluate changes in genitourinary symptoms and quality of life following LLLT.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-chi Wu, MD.; Phone Number: 0972651989; Email: peggywu0707@hotmail.com

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Pei-chi Wu, MD.; Phone Number: 0972651989; Email: peggywu0707@hotmail.com
    • Contact: Email: peggywu0707@hotmail.com
    • Principal Investigator: Pei-chi Wu, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Menopause women
• With genitourinary symptoms of menopause

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women with genitourinary symptoms of menopause; Receive low-level laser therapy	Device: Low-level laser therapy; 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.

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.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower urinary tract symptom: incontinence	ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.	20 weeks
Lower urinary tract symptom: general	UDI-6: Urogenital Distress Inventory-6. Scoring scale: 0-18. Higher scores mean a worse outcome.	20 weeks
Lower urinary tract symptom: life quality	IIQ-7: Incontinence Impact Questionnaire-7. Scoring scale: 0-21. Higher scores mean a worse outcome.	20 weeks
Lower urinary tract symptom: urgency	USS: Urgency Severity Scale. The USS is scored as 0 (no feeling of urgency), 1 (mild urgency), 2 (moderate urgency), 3 (severe urgency), or 4 (inability to hold urine).	20 weeks
Lower urinary tract symptom: overactive bladder	OABSS: Overactive Bladder Symptom Score. The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity.	20 weeks
Quality of life affected by lower urinary tract symptoms	KHQ: King's Health Questionnaire. It addresses nine different domains in 21 items with a Likert scale response options (range 1-4 and 1-5 on the first option). The domains are general health perception, incontinence impact, role limitations, physical and social limitations, personal relationships, emotions, sleep/energy, and severity coping measures. An additional independent scale with nine questions was designed to evaluate symptom severity perception. Scores for each domain are calculated through a complex system that manages missing values and results range from 0 to 100, with higher scores indicating a more impaired QoL.	20 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Taiwan University Hospital Beihu Branch
• Investigators: Principal Investigator: Pei-chi Wu, MD., 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Menopause; Vulvovaginal atrophy; Genitourinary symptom
• Other Study ID Numbers: 202307193DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets analyzed during the study are available from the PI upon reasonable request.
• IPD Sharing Time Frame: 3 years after finishing study.
• IPD Sharing Access Criteria: The datasets analyzed during the study are available from the PI upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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