AzTrials
AzTrials

Menopause Related ConditionsNCT06074120

Low-level Laser Therapy in Genitourinary Symptoms of Menopause

A study testing Low-level laser therapy in people with Menopause Related Conditions, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 45 to 85 years, women only
Conditions the study is for
Menopause Related Conditions
What is being tested?
Low-level laser therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteTaiwan
Study dates
12 Jan 2024to 26 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Menopause women
  • With genitourinary symptoms of menopause

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, Taiwan, 100

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Low-level laser therapy
Keywords
Genitourinary symptom, Vulvovaginal atrophy, Menopause

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-level laser therapyDevice

    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.

Study groups in NCT06074120
Study groupRoleWhat they receive
Women with genitourinary symptoms of menopauseExperimentalReceive low-level laser therapy
Receives: Device: Low-level laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 weeks

Secondary outcomes (6)

  1. Lower urinary tract symptom: incontinence

    ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome.

    Measured: 20 weeks

  2. Lower urinary tract symptom: general

    UDI-6: Urogenital Distress Inventory-6. Scoring scale: 0-18. Higher scores mean a worse outcome.

    Measured: 20 weeks

  3. Lower urinary tract symptom: life quality

    IIQ-7: Incontinence Impact Questionnaire-7. Scoring scale: 0-21. Higher scores mean a worse outcome.

    Measured: 20 weeks

  4. 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).

    Measured: 20 weeks

  5. 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.

    Measured: 20 weeks

  6. 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.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start12 Jan 2024
  3. Primary completion4 Jul 2025
  4. Study completion26 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074120
Sponsor's protocol ID
202307193DIND
Status last verified
Mar 2026
First submitted
24 Sep 2023
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets analyzed during the study are available from the PI upon reasonable request.

Publications

  • 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.

    PubMed 25491701

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

    PubMed 33534428

  • 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.

    PubMed 28364861

  • 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.

    PubMed 35236871

  • 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.

    PubMed 35101378

  • 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.

    PubMed 8694033

  • Wu PC, Lin HH, Chen CH, Kuo YS. Evaluation of photobiomodulation therapy for genitourinary syndrome of menopause: A single-center prospective study. PLoS One. 2026 Jun 22;21(6):e0351765. doi: 10.1371/journal.pone.0351765. eCollection 2026.

    PubMed 42329990

Questions about this trial

What is this clinical trial studying?

A study testing Low-level laser therapy in people with Menopause Related Conditions, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal health (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06074120, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in