NCT03288883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

September 7, 2017

Last Update Submit

February 11, 2021

Conditions

Genitourinary Syndrome of Menopause

Outcome Measures

Primary Outcomes (14)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Fractional Microablative CO2-laser

ACTIVE COMPARATOR
Device: Fractional Microablative CO2-laser

Photothermal Non-ablative Erbium:YAG-laser

ACTIVE COMPARATOR
Device: Photothermal Non-ablative Erbium:YAG-laser

Interventions

Photothermal Non-ablative Erbium:YAG-laserDEVICE

Laser treatment of the vagina for GSM

Photothermal Non-ablative Erbium:YAG-laser
Fractional Microablative CO2-laserDEVICE

Laser treatment of the vagina for GSM

Fractional Microablative CO2-laser

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urogynaecology Department, King's College Hospital

London, SE5 9RS, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 20, 2017

Study Start

July 1, 2018

Primary Completion

February 11, 2021

Study Completion

February 11, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)