RCT of Laser Therapy for GSM

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

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.

Study Overview

• Status: Completed
• Conditions: Genitourinary Syndrome of Menopause
• Intervention / Treatment: Device: Fractional Microablative CO2-laser; Device: Photothermal Non-ablative Erbium: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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Urogynaecology Department, King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fractional Microablative CO2-laser	Device: Fractional Microablative CO2-laser; Laser treatment of the vagina for GSM
Active Comparator: Photothermal Non-ablative Erbium:YAG-laser	Device: Photothermal Non-ablative Erbium:YAG-laser; Laser treatment of the vagina for GSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Dysuria- 10cm visual analogue scale	1 year
Frequency- 10cm visual analogue scale,	1 year
Urgency-10cm visual analogue scale	1 year
Urinary incontinence- 10cm visual analogue scale	1 year
Overall sexual satisfaction- Female sexual function index	1 year
Frequency- 3 day voiding diary	1 year
Urgency- 3 day voiding diary,	1 year
Urinary incontinence- 3 day voiding diary	1 year
Overall sexual satisfaction- 10cm visual analogue scale	1 year
Overall sexual satisfaction- frequency of sexual intercourse,	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life- patients global impression of improvement questionnaire		1 year
Quality of life- day to day impact of vaginal ageing questionnaire		1 year
Quality of life- kings health questionnaire		1 year
Global impression of improvement- day to day impact of vaginal ageing questionnaire		1 year
Global impression of improvement- patients global impression of improvement questionnaire		1 year
Global impression of improvement- kings health questionnaire		1 year
Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume		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.	VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))	1 year

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: Alexandra Hospital, Athens, Greece

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): February 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: RCTGSM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No