Low-level Laser Therapy in Genitourinary Symptoms of Menopause

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National Taiwan University

Status

Enrolling

Conditions

Menopause Related Conditions

Treatments

Device: Low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06074120
202307193DIND

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

Female

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Women with genitourinary symptoms of menopause
Experimental group
Description:
Receive low-level laser therapy
Treatment:
Device: Low-level laser therapy

Trial contacts and locations

0

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Central trial contact

Pei-chi Wu, MD.

Data sourced from clinicaltrials.gov

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