Menopause Related Conditions Clinical Trial
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei City |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Taiwan University Hospital Beihu Branch |
Taiwan,
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)7 — View 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/ — View 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. — View 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/s — View Citation
Phillips NA, Bachmann GA. The genitourinary syndrome of menopause. Menopause. 2021 Feb 1;28(5):579-588. doi: 10.1097/GME.0000000000001728. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Lower urinary tract symptom: general | UDI-6: Urogenital Distress Inventory-6. Scoring scale: 0-18. Higher scores mean a worse outcome. | 20 weeks | |
Secondary | Lower urinary tract symptom: life quality | IIQ-7: Incontinence Impact Questionnaire-7. Scoring scale: 0-21. Higher scores mean a worse outcome. | 20 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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