Status:
COMPLETED
RCT of Laser Therapy for GSM
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
Alexandra Hospital, Athens, Greece
Conditions:
Genitourinary Syndrome of Menopause
Eligibility:
FEMALE
Phase:
NA
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 measurem...
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 VV...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Not willing to abstain from vaginal intercourse for one week following the laser-therapy
- Use of hormonal therapy within 6 months prior to study inclusion (systemic or local)
- 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
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03288883
Start Date
July 1 2018
End Date
February 11 2021
Last Update
February 12 2021
Active Locations (1)
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1
Urogynaecology Department, King's College Hospital
London, United Kingdom, SE5 9RS