Vaginal Atrophy Clinical Trial
Official title:
The Efficacy of Low-level Laser Therapy in Relieving Vaginal Dryness and Lower Urinary Tract Symptoms
Verified date | November 2023 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 14, 2023 |
Est. primary completion date | August 14, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Pei-chi Wu | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
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
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
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. — 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
Palacios S. Assessing symptomatic vulvar, vaginal, and lower urinary tract atrophy. Climacteric. 2019 Aug;22(4):348-351. doi: 10.1080/13697137.2019.1600499. — 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. | 8 weeks | |
Secondary | Urinary incontinence | ICIQ-SF: International Consultation on Incontinence Questionnaire - Short Form. Scoring scale: 0-21. Higher scores mean a worse outcome. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04081805 -
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
|
N/A | |
Completed |
NCT04039555 -
Clinical Study to Compare the Efficacy of Erbium-Yag Laser or CO2RE Intimate Laser With Sham (COER)
|
N/A | |
Active, not recruiting |
NCT02704741 -
Clinical Study of the CO2RE Laser Device Performance for Vaginal Atrophy Treatments
|
N/A | |
Completed |
NCT01975129 -
A Pharmacokinetic Study of Vaginally and Intravenously Administered Oxytocin
|
Phase 2 | |
Completed |
NCT04735549 -
Vulvovaginal Atrophy Correction Using Neodymium Laser
|
N/A | |
Completed |
NCT04079218 -
Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial
|
Phase 4 | |
Completed |
NCT03063684 -
Fractional / Pixel CO2 Laser Treatment of Vulvar Atrophy and Lichen Sclerosus
|
N/A | |
Recruiting |
NCT05953090 -
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
|
N/A | |
Not yet recruiting |
NCT05483634 -
Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
|
||
Completed |
NCT04717245 -
Comparative Study: Vaginal Promestriene Use, Fractional CO2 LASER and Radiofrequency in the Vaginal Atrophy Treatment
|
N/A | |
Completed |
NCT02967510 -
Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005%, 0.002%, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women With Vulvovaginal Atrophy
|
Phase 2 | |
Completed |
NCT02937805 -
Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
|
N/A | |
Not yet recruiting |
NCT02571127 -
Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
|
Phase 4 | |
Completed |
NCT00238732 -
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
|
Phase 3 | |
Completed |
NCT02413008 -
A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting
|
Phase 2 | |
Completed |
NCT03493126 -
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
|
Phase 4 | |
Not yet recruiting |
NCT03238053 -
Laser Treatment of Genito-urinary Syndrome in Women
|
N/A | |
Terminated |
NCT01753102 -
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
|
Phase 3 | |
Terminated |
NCT05627791 -
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman
|
Phase 2/Phase 3 | |
Completed |
NCT00429806 -
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
|
Phase 1 |