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Vaginal laser shows promise for menopause symptoms and incontinence

NCT ID NCT03681678

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study tested a fractional carbon dioxide laser treatment for women with vaginal and urinary symptoms like dryness, burning, pain during sex, and incontinence. One hundred women received three laser sessions about six weeks apart. The main goal was to see if symptoms improved, measured by a patient questionnaire four weeks after the first treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fractional carbon dioxide (fCO2) laser
What this could lead to
If successful, this laser treatment could offer a non-drug option to ease vaginal discomfort, pain during sex, and urinary issues in women.
What could go wrong
This is a small, early observational study with no comparison group, so results may not be widely applicable. Long-term safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

100 people

The number who actually took part.

Started

Oct 2018

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women meeting all of the inclusion criteria and non of the exclusion criteria may be enrolled in the study.

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female 2. 18 years of age or greater and 90 years of age or less 3. One or more of the following indications for fCO2 laser treatment: 1. Genitourinary symptoms of menopause, including after natural, medical- induced or surgical menopause 2. Vaginal dryness, burning, itching or dyspareunia not related to menopause 3. Stress urinary incontinence 4. Recurrent urinary tract infections (UTIs), defined as 4 or more in a year 5. Overactive bladder 4. Must sign the informed consent 5. Must be willing to comply with the study protocol Exclusion Criteria: 1. Contraindications to fCO2 laser treatment, such as: 1. Currently implanted synthetic pelvic mesh, sling or tape 2. Current or previous genital cancers 3. Radiation to the vaginal or colo-rectal tissue 4. Currently pregnant or less than 3 months following pregnancy 5. Undiagnosed vaginal or cervical lesions 2. Patients who have received vaginal fCO2 laser treatment within the past 12 months 3. Patients treated with vaginal estrogen within the past 3 months 4. Patients with undiagnosed vaginal bleeding 5. Active vulvar or vaginal infection, including herpes, candidiasis, etc. 6. Current urinary tract infection (UTI), confirmed by positive urine culture and patient-reported symptoms 7. Pelvic or vaginal surgery with the past 9 months 8. Pelvic organ prolapse beyond the introitus 9. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase the patient's risk, may affect the conduct of the study etc.) for the treatment and/or study 10. Participation in an investigational trial that used a study treatment, medication and/or biologic within 6 months or less prior to the date of the screening visit

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073, United States

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