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Study of the use of Fractional Microablative CO2 LASER in the treatment of urinary symptoms in menopause

The use of Fractional Microablative CO2 LASER in the treatment of urinary symptoms of Menopausal Genitourinary Syndrome: a prospective cohort

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-524vx5c
Enrollment
Unknown
Registered
2024-12-16
Start date
2022-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genitourinary Syndrome

Interventions

This is a single-center, open, prospective cohort clinical study. Experimental group: 30 postmenopausal women, with urinary incontinence confirmed with urodynamics. They will receive laser application

Sponsors

Universidade Brasil
Lead Sponsor
Universidade Brasil
Collaborator

Eligibility

Sex/Gender
Female
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women defined by a physiological state, characterized by amenorrhea lasting more than one year, plasma follicle-stimulating hormone (FSH) levels greater than 40 U/l, and estradiol levels less than or equal to 25 pg/mL. Aged 45 years or older but younger than 80 years. Patients experiencing clinical symptoms of genitourinary syndrome of menopause (dryness, burning, stinging, vaginal itching, dyspareunia, and/or dysuria). Patients who exhibit clinical symptoms of urinary incontinence. Patients diagnosed via urodynamic study with stress urinary incontinence, overactive bladder, or mixed urinary incontinence. Patients with a cervical cytology exam within the last 6 months negative for neoplasia (for women over 65 years, the last negative cytology exam within the screening period established by the local Ministry of Health). Patients with a normal urine analysis (EAS – Elements of Abnormal Sediment), without any signs of urinary tract infection

Exclusion criteria

Exclusion criteria: Explicit refusal by the patient to participate in the study. Patients who have undergone surgical interventions to correct urinary incontinence at any time. Patients with urinary incontinence not directly or indirectly related to genitourinary syndrome of menopause (GSM), such as patients with neurogenic bladder. Patients with active genital infections (clinical and colposcopic diagnosis). Patients with a history of genital herpes who do not agree to prophylaxis with oral Acyclovir. Patients with a history of ulcerative colitis, Crohn's disease, or diarrhea due to intestinal disease, positive serology for HIV, hepatitis B, C, or genital condylomatosis. Immunosuppressed patients, chronic users of corticosteroids, patients with scleroderma, collagen diseases, or genitourinary tract neoplasia. Patients with thrombophilias or chronic users of anticoagulants or antiplatelet drugs. Patients with second or third-degree vaginal prolapse according to the Pelvic Organ Prolapse Quantification System (POP-Q). Patients with a history of photosensitivity. Patients who have previously undergone CO2 endovaginal laser treatment at any time

Design outcomes

Primary

MeasureTime frame
It is expected that patients undergoing CO2 laser treatment will experience regression of urinary incontinence

Secondary

MeasureTime frame
It is expected that patients undergoing CO2 laser treatment will experience an improvement in vaginal dryness;It is expected that patients undergoing CO2 laser treatment will show an improvement in dyspareunia;It is expected that patients undergoing CO2 laser treatment will experience improved sexual performance

Countries

Brazil

Contacts

Public ContactCatarina Dalbem

Universidade Brasil

nivaldo.parizotto@universidadebrasil.edu.br+55 (11) 20700000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)