RCT of Laser Therapy for GSM

NCT ID: NCT03288883

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-02-11

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.

Conditions

Genitourinary Syndrome of Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fractional Microablative CO2-laser

Group Type: ACTIVE_COMPARATOR

Fractional Microablative CO2-laser

Intervention Type: DEVICE

Laser treatment of the vagina for GSM

Photothermal Non-ablative Erbium:YAG-laser

Group Type: ACTIVE_COMPARATOR

Photothermal Non-ablative Erbium:YAG-laser

Intervention Type: DEVICE

Laser treatment of the vagina for GSM

Interventions

Photothermal Non-ablative Erbium:YAG-laser

Laser treatment of the vagina for GSM

Intervention Type: DEVICE

Fractional Microablative CO2-laser

Laser treatment of the vagina for GSM

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandra Hospital, Athens, Greece

OTHER

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Urogynaecology Department, King's College Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

RCTGSM

Identifier Type: -

Identifier Source: org_study_id