RCT of Laser Therapy for GSM
- Conditions
- Genitourinary Syndrome of Menopause
- Interventions
- Device: Fractional Microablative CO2-laser
- Registration Number
- NCT03288883
- Lead Sponsor
- King's College Hospital NHS Trust
- Brief Summary
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
- Detailed Description
Genitourinary Syndrome of Menopause (GSM) is the new terminology for "vulvovaginal (VVA)". Although women may present with some or all of the clinical signs and symptoms, the most common symptom of VVA/GSM is vaginal dryness. Vaginal dryness appears early at menopause with a subsequent increase of prevalence as postmenopausal years' progresses and is associated with rising occurrence of lower urinary tract symptoms (LUTS).
The therapeutic management of GSM includes lubricants and moisturizers as a first line therapy and low-dose vaginal estrogens as a second one, especially for women with a history of estrogen dependent cancer. However, lubricants and moisturizers can only be used for symptoms relief during sexual intercourse. They do not restore the local pathophysiology and they are inefficacious when LUTS are present. However, the quality of evidence is low or very-low when estrogens efficacy is compared to placebo, while the risk to the endometrial thickness with sustained vaginal estrogen use is not clear.
Recently, intravaginal laser therapy has been proposed for the management of GSM. There are currently two lasers available. All available studies consistently suggest that both lasers (CO2-laser and Er:YAG-laser) are safe and have a high efficacy on alleviating vaginal dryness and dyspareunia, as well as restoring the local pathophysiology. Additionally, data regarding CO2-laser indicate LUTS improvement, as well as sexual function-satisfaction and quality of women's life. Relevant published data are not available for the Er:YAG-laser. Moreover, there is lack of studies comparing the 2 laser-technologies for the management of postmenopausal women with GSM.
The aim of the current study is to assess whether the CO2-laser results in superior alleviation of GSM symptoms compare to Er:YAG-laser. Specifically, we will compare objective and subjective measurements of symptoms and clinical signs of GSM, between groups of postmenopausal women with GSM receiving treatment with CO2-laser or Er:YAG-laser.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 88
- Dryness and dyspareunia with moderate to severe intensity
- Vaginal Health Index <15
- Absence of menstruation for at least 12 months
- Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
- Acute urinary tract infections (UTIs)
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during screening physical exam (e.g., perineal body)
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- Active or history of genital herpes
- Prolapse stages > II (according to the POP-Q system)
- History of radiotherapy for cervical or uterine cancer
- Medical condition that may interfere with participants' compliance to the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fractional Microablative CO2-laser Fractional Microablative CO2-laser -
- Primary Outcome Measures
Name Time Method Overall sexual satisfaction- 10cm visual analogue scale 1 year Urgency- 3 day voiding diary, 1 year Overall sexual satisfaction- frequency of sexual intercourse, 1 year Dysuria- 10cm visual analogue scale 1 year Frequency- 10cm visual analogue scale, 1 year Urgency-10cm visual analogue scale 1 year Overall sexual satisfaction- Female sexual function index 1 year Frequency- 3 day voiding diary 1 year Urinary incontinence- 3 day voiding diary 1 year Dryness - 10cm visual analogue scale 1 year Dyspareunia- 10cm visual analogue scale 1 year Itching- 10cm visual analogue scale 1 year Burning- 10cm visual analogue scale 1 year Urinary incontinence- 10cm visual analogue scale 1 year
- Secondary Outcome Measures
Name Time Method Global impression of improvement- patients global impression of improvement questionnaire 1 year Quality of life- patients global impression of improvement questionnaire 1 year Global impression of improvement- day to day impact of vaginal ageing questionnaire 1 year Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume 1 year Global impression of improvement- kings health questionnaire 1 year Quality of life- day to day impact of vaginal ageing questionnaire 1 year Quality of life- kings health questionnaire 1 year Vaginal maturation value- vaginal smear stained with papanicolaou technique and VMI value is evaluated by defining the percentage of superficial, intermediate and paranasal epithelial cells on smear. 1 year VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))
Trial Locations
- Locations (1)
Urogynaecology Department, King's College Hospital
🇬🇧London, United Kingdom