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Trial record 17 of 153 for:    Recruiting, Not yet recruiting, Available Studies | menopause

RCT of Laser Therapy for GSM

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ClinicalTrials.gov Identifier: NCT03288883
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Richard, 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.

Condition or disease Intervention/treatment Phase
Genitourinary Syndrome of Menopause Device: Photothermal Non-ablative Erbium:YAG-laser Device: Fractional Microablative CO2-laser Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 4, 2019
Estimated Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




Primary Outcome Measures :
  1. Dryness - 10cm visual analogue scale [ Time Frame: 1 year ]
  2. Dyspareunia- 10cm visual analogue scale [ Time Frame: 1 year ]
  3. Itching- 10cm visual analogue scale [ Time Frame: 1 year ]
  4. Burning- 10cm visual analogue scale [ Time Frame: 1 year ]
  5. Dysuria- 10cm visual analogue scale [ Time Frame: 1 year ]
  6. Frequency- 10cm visual analogue scale, [ Time Frame: 1 year ]
  7. Urgency-10cm visual analogue scale [ Time Frame: 1 year ]
  8. Urinary incontinence- 10cm visual analogue scale [ Time Frame: 1 year ]
  9. Overall sexual satisfaction- Female sexual function index [ Time Frame: 1 year ]
  10. Frequency- 3 day voiding diary [ Time Frame: 1 year ]
  11. Urgency- 3 day voiding diary, [ Time Frame: 1 year ]
  12. Urinary incontinence- 3 day voiding diary [ Time Frame: 1 year ]
  13. Overall sexual satisfaction- 10cm visual analogue scale [ Time Frame: 1 year ]
  14. Overall sexual satisfaction- frequency of sexual intercourse, [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of life- patients global impression of improvement questionnaire [ Time Frame: 1 year ]
  2. Quality of life- day to day impact of vaginal ageing questionnaire [ Time Frame: 1 year ]
  3. Quality of life- kings health questionnaire [ Time Frame: 1 year ]
  4. Global impression of improvement- day to day impact of vaginal ageing questionnaire [ Time Frame: 1 year ]
  5. Global impression of improvement- patients global impression of improvement questionnaire [ Time Frame: 1 year ]
  6. Global impression of improvement- kings health questionnaire [ Time Frame: 1 year ]
  7. Vaginal health index score- 5 components, elasticity, epithelial integrity, pH, moisture and fluid volume [ Time Frame: 1 year ]
  8. 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. [ Time Frame: 1 year ]
    VMV = ((1x%superficial)+(0.5x%intermediate)+0xparabasal))



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288883


Contacts
Contact: Richard Flint, MBBCH 0203 299 3568 richard.flint@nhs.nt

Sponsors and Collaborators
King's College Hospital NHS Trust

Responsible Party: Richard, Clinical Research Fellow, Urogynaecology Dept., King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03288883     History of Changes
Other Study ID Numbers: RCTGSM
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes