RCT of Laser Therapy for GSM

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

Fractional Microablative CO2-laser Versus Photothermal Non-ablative Erbium:YAG-laser for the Management of Genitourinary Syndrome of Menopause: A Non-inferiority, Single-blind Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288883
• Other study ID #: RCTGSM
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: February 11, 2021

Study information

• Verified date: February 2021
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Dryness and dyspareunia with moderate to severe intensity

2. Vaginal Health Index <15

3. Absence of menstruation for at least 12 months

4. Recent Negative Pap-smear test (For women over 65 years old a negative pap smear test up to the age of 65).

Exclusion Criteria:

1. Not willing to abstain from vaginal intercourse for one week following the laser-therapy

2. Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)

3. Acute urinary tract infections (UTIs)

4. 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)

5. Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection

6. Active or history of genital herpes

7. Prolapse stages > II (according to the POP-Q system)

8. History of radiotherapy for cervical or uterine cancer

9. Medical condition that may interfere with participants' compliance to the protocol

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Intervention

Device:
• Photothermal Non-ablative Erbium:YAG-laser
Laser treatment of the vagina for GSM
• Fractional Microablative CO2-laser
Laser treatment of the vagina for GSM

Locations

Country	Name	City	State
United Kingdom	Urogynaecology Department, King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Alexandra Hospital, Athens, Greece

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dryness - 10cm visual analogue scale		1 year
Primary	Dyspareunia- 10cm visual analogue scale		1 year
Primary	Itching- 10cm visual analogue scale		1 year
Primary	Burning- 10cm visual analogue scale		1 year
Primary	Dysuria- 10cm visual analogue scale		1 year
Primary	Frequency- 10cm visual analogue scale,		1 year
Primary	Urgency-10cm visual analogue scale		1 year
Primary	Urinary incontinence- 10cm visual analogue scale		1 year
Primary	Overall sexual satisfaction- Female sexual function index		1 year
Primary	Frequency- 3 day voiding diary		1 year
Primary	Urgency- 3 day voiding diary,		1 year
Primary	Urinary incontinence- 3 day voiding diary		1 year
Primary	Overall sexual satisfaction- 10cm visual analogue scale		1 year
Primary	Overall sexual satisfaction- frequency of sexual intercourse,		1 year
Secondary	Quality of life- patients global impression of improvement questionnaire		1 year
Secondary	Quality of life- day to day impact of vaginal ageing questionnaire		1 year
Secondary	Quality of life- kings health questionnaire		1 year
Secondary	Global impression of improvement- day to day impact of vaginal ageing questionnaire		1 year
Secondary	Global impression of improvement- patients global impression of improvement questionnaire		1 year
Secondary	Global impression of improvement- kings health questionnaire		1 year
Secondary	Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume		1 year
Secondary	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.	VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))	1 year