UnknownNot Applicable

Laser Therapy for Treatment of Genitourinary Syndrome of Menopause (GSM) in Postmenopausal Women

Spain189 participantsStarted 2022-07-01

Plain-language summary

This is a prospective, multi-centre, double blinded, randomized controlled trial, which will be conducted under a common protocol. The aim of this study is to evaluate the efficacy of vaginal laser for treatment of GSM (Genitourinary Syndrome of Menopause) compared to the sham procedure in postmenopausal women. The study population is female subjects \> 18 years old with symptoms of genitourinary syndrome of menopause (GSM) who have not menstruated for at least 5 years.

Who can participate

Age range

18 Years

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: * Women of any age with established menopause of 5 years or more who report genitourinary discomfort, dyspareunia, sequelae, genital atrophy, voiding discomfort, voiding urgency or urinary incontinence. Postmenopausal status is defined if patients have at least 12 continuous months of amenorrhea for no other apparent reason or permanently elevated follicle-stimulating hormone (FSH) blood levels (≥30 mIU/mL). * Patients who have had cancer treatment already completed and in the process of remission. * Sexually active * Nulliparous or who have had vaginal deliveries or caesarean section * That they do not receive hormone replacement therapy in any of its routes of administration. If you received HRT, 4 months must have elapsed since stopping treatment before starting the trial protocol. * Motivated and committed to complete the trial Exclusion Criteria: * According to the pelvic organ prolapse quantification system \[POP-Q\], POP\>Stage 2, , severe urinary or fecal incontinence (FI) or any disease that could influence the study protocol. In addition, patients will be advised to refrain from vaginal practices for three days prior to each biopsy (one at the beginning and one at the end of treatment). * Women who are not sexually active, do not have coital relationships, either with a partner or alone * Women with recurrent cystitis or candidiasis * Women with little motivation to participate in the trial * Minors * Patients who do not have the ability to co…

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.

What they're measuring

Change from Baseline in Vaginal pH

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment

Change from Baseline in the deep musculature with the PERFECT protocol

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment

Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment

Trial details

NCT IDNCT05305209

SponsorUniversity of Malaga

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

Contact for this trial

Rocío Martín-Valero, PhD

34 951 952 858 rovalemas@uma.es

View on ClinicalTrials.gov More Genitourinary Syndrome of Menopause trials

Plain-language summary

Who can participate

Age range

18 Years

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.

What they're measuring

Change from Baseline in Vaginal pH

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment

Change from Baseline in the deep musculature with the PERFECT protocol

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment

Analysis of the impact on QoL (Quality of life) with the FSFI (Female Sexual Function Index) questionnaire.

Timeframe: The evaluation will be done at baseline before treatment and 6 weeks post treatment