Clinical trial NCT06074120: Low-level Laser Therapy in Genitourinary Symptoms of Menopause
Official title: Assessing the Efficacy of Low-Level Laser Therapy in Alleviating Genitourinary Symptoms of Menopause
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause Related Conditions
Keywords: Genitourinary symptom
Vulvovaginal atrophy
Menopause
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital Beihu Branch
First posted: 2023-10-10
Enrollment: 28
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal health
timeFrame: 20 weeks
Secondary outcomes:
measure: Lower urinary tract symptom: incontinence
timeFrame: 20 weeks
measure: Lower urinary tract symptom: general
timeFrame: 20 weeks
measure: Lower urinary tract symptom: life quality
timeFrame: 20 weeks
measure: Lower urinary tract symptom: urgency
timeFrame: 20 weeks
measure: Lower urinary tract symptom: overactive bladder
timeFrame: 20 weeks
measure: Quality of life affected by lower urinary tract symptoms
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-chi Wu, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728.
citation: 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.
citation: 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.
citation: 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.
citation: 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.