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.
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
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.
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.
- Conditions
- Menopause Related Conditions
- 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 group | Role | What they receive |
|---|---|---|
| Women with genitourinary symptoms of menopause | Experimental | Receive 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.
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)
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
Lower urinary tract symptom: general
UDI-6: Urogenital Distress Inventory-6. Scoring scale: 0-18. Higher scores mean a worse outcome.
Measured: 20 weeks
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
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
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
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.
- First posted10 Oct 2023
- Study start12 Jan 2024
- Primary completion4 Jul 2025
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Menopause Related ConditionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Beihu Branch
- Responsible party
- Sponsor
- Investigators
- Pei-chi Wu, MD., Principal investigator, National Taiwan University Hospital
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 25491701Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728.
PubMed 33534428Gambacciani 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 28364861Long 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 35236871Filippini 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 35101378Bump 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 8694033Wu 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