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Evaluation of the Sexual Function and Vaginal environment of menopausal women before and after treatment.

Evaluation of the Sexual Function and Vaginal Microbiota Fractionated Microablative Radiofrequency for the Treatment of Genitourinary Menopause Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-94dx93
Enrollment
Unknown
Registered
2018-07-02
Start date
2020-12-07
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

Female urogenital diseases and pregnancy complications, postmenopause, atrophy, sexual dysfunction physiological, urinary incontinence, vulvovaginitis.

Interventions

A clinical trial will be conducted with 138 patients. Participants will be divided into three groups: One group will consist of 46 patients who have not undergone any type of treatment or hormone use
E02.319
SP4.026.292.658

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Sex/Gender
Female
Age
55 Years to 65 Years

Inclusion criteria

Inclusion criteria: The study will include healthy postmenopausal women (55 to 65 years old, with whom at least 12 months have passed since last menstrual period or bilateral oophorectomy), who are still sexually active, with GSM, plasma gonadotropin and presenting serum estradiol levels in the postmenopausal range (FSH >40 U/L; estradiol <25 pg/ml) as well as negative Papanicolaou (Pap) smear for cervical cancer precursor cells.

Exclusion criteria

Exclusion criteria: Women who have used any form of hormonal (systemic or local) therapy in the last six months, lubricants or vaginal moisturizers in the past month, suffering from active genital infections (diagnosis by GRAM stain and Multiplex-PCR), and any disease that would interfere following the protocol.

Design outcomes

Primary

MeasureTime frame
The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia, and dysuria), using the 11-point Visual Analog Scale (VAS).—

Secondary

MeasureTime frame
The Secondary outcome includes the sexual function, using the Female Sexual Index (FSFI), vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume, and pH vaginal), using the Vaginal Health Index (VHI), the quality of life using the Short Form 12 (SF-12) to assess physical (PCS12) and mental (MCS12) component, beyond the vaginal microbiota, and cell maturation.—

Countries

Brazil

Contacts

Public ContactAna Gonçalves

Universidade Federal do Rio Grande do Norte

anakatherine_ufrnet@yahoo.com.br+55-084-999828237

Outcome results

None listed

Source: REBEC (via WHO ICTRP)