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Study of the effects of the fractional radiofrequency and microneedling in long-term on the outer region of the vagina in menopausal women

Evaluation of long-term effects of fractional radiofrequency and microneedling on external genitalia in menopausal women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-32jnbm
Enrollment
Unknown
Registered
2020-01-09
Start date
2020-02-10
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

Other noninflammatory disorders of vagina Menopausal and female climacteric states

Interventions

This research will assess the long-term effects of radiofrequency and microneedling on the external genitalia in menopausal women. The study is characterized as a randomized, blinded, prospective clin
Device
E02.808
E07.612
HP3.073.433.101

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Instituto Patrícia Froes
Collaborator

Eligibility

Sex/Gender
Female
Age
55 Years to 65 Years

Inclusion criteria

Inclusion criteria: In the inclusion criteria, participants must be between 55 and 65 years of age, with flaccidity in the vulvar region, post-menopausal period of up to 5 years, who had 2 to 3 normal births, not practicing physical activity, not being able to use hormone replacement therapy and with the ability to understand and preserve local sensitivity.

Exclusion criteria

Exclusion criteria: Exclusion criteria will apply to all participants who are pregnant, breastfeeding 3 months before treatment or planning to become pregnant during the study period, with active sexually transmitted disease, acute bacterial or viral infection, pacemaker carriers or other implanted electrical devices, malignant tumor, weakened immune system, collagen diseases, continuously using anti-inflammatory drugs, dermatological condition that requires systemic or topical therapy in the area of treatment and metallic implants. Participants who do not agree with the procedures, have a sensitivity disorder during therapy, or do not adapt to the schedules and procedures will be discontinued from the study.

Design outcomes

Primary

MeasureTime frame
Changes in vaginal sagging; through the Vaginal Laxity Questionnaire (VLQ) and photographs after 10 days, 01 month, 03 months, 06 months; on the basis of a change of at least 5% in changes during revaluations.;Improvement in menopausal symptoms and quality of life; using the Blatt and Kupperman menopausal index (IMBK) and the EQ-5D questionnaire, after 10 days, 01 months, 03 months, 06 months; from the verification of a variation of at least 5% in the scores during the revaluations.—

Secondary

MeasureTime frame
There will be no secondary outcomes.—

Countries

Brazil

Contacts

Public ContactRafaella Maia

Universidade Federal do Rio Grande do Norte

faella_maia@hotmail.com+55-084-20108515

Outcome results

None listed

Source: REBEC (via WHO ICTRP)