Clinical trial NCT06136975: Low-level Laser Therapy for Genitourinary Syndromes and Stress Urinary Incontinence
Official title: The Efficacy of Low-level Laser Therapy in Relieving Vaginal Dryness and Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Atrophy
Urinary Incontinence,Stress
Keywords: Menopause
Stress urinary incontinence
Vaginal atrophy
Low-level laser therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 41
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The consecutive women who received LLLT at the gynecologic outpatient clinic were retrospectively reviewed. Menopause was defined as no spontaneous menstruation for at least one year. GSM is defined as vulvovaginal dryness and related symptoms, such as irritation, dyspareunia, or lower urinary tract symptoms (LUTS) including urinary urgency, dysuria, and recurrent urinary tract infection after menopause. SUI was defined as involuntary loss of urine on effort or physical exertion including sporting activities, or on sneezing or coughing.

Brief summary: Genitourinary syndrome of menopause (GSM) and stress urinary incontinence (SUI) are common for women. Low-level laser therapy (LLLT) was applied for wound healing, but there was no study regarding treatment effect of GSM and SUI. This retrospective study aims to assess the efficacy of LLLT in alleviating GSM and SUI.

Detailed description: Between September 2022 and August 2023, all women who received LLLT for GSM and SUI at the gynecologic outpatient clinic of a hospital were retrospectively reviewed. The treatment was once a week for eight weeks. Vaginal health index (VHI) and questionnaires before and after treatment for evaluation of lower urinary tract symptoms (LUTS) and quality of life are the outcome assessment.

Eligibility criteria: Inclusion Criteria:

* women with GSM and SUI
* Received LLLT at the gynecologic outpatient clinic

Exclusion Criteria:

* More or equal to stage 2 pelvic organ prolapse defined by pelvic organ prolapse-quantification system
* Ongoing urinary tract infection or vaginitis with the pathogen in the previous 2 weeks
* Bladder calculus
* Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
* A preexisting malignant pelvic tumor.

Primary outcomes:
measure: Vaginal health
timeFrame: 8 weeks
Secondary outcomes:
measure: Urinary incontinence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Pei-chi Wu
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-chi Wu
role: PRINCIPAL_INVESTIGATOR
References:
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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: 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: 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.
citation: Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499.
citation: Huang L, Zhang SW, Wu SL, Ma L, Deng XH. The Chinese version of ICIQ: a useful tool in clinical practice and research on urinary incontinence. Neurourol Urodyn. 2008;27(6):522-4. doi: 10.1002/nau.20546.