RCT of Laser Therapy for GSM (NCT03288883) | Clinical Trial Compass
CompletedNot Applicable
RCT of Laser Therapy for GSM
United Kingdom88 participantsStarted 2018-07-01
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
9
Overall sexual satisfaction- Female sexual function index
Timeframe: 1 year
10
Frequency- 3 day voiding diary
Timeframe: 1 year
11
Urgency- 3 day voiding diary,
Timeframe: 1 year
12
Urinary incontinence- 3 day voiding diary
Timeframe: 1 year
13
Overall sexual satisfaction- 10cm visual analogue scale
Timeframe: 1 year
14
Overall sexual satisfaction- frequency of sexual intercourse,