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Use of new technologies for the treatment of vaginal sequelae caused by radiotherapy.

Use of non-ablative radiofrequency and intravaginal CO2 laser in the treatment of genitourinary syndrome following cervical carcinoma radiotherapy: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2x4hqm
Enrollment
Unknown
Registered
2020-07-28
Start date
2020-01-06
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

Vaginal atresia

Interventions

#Intervention Group I: intravaginal non-ablative radiofrequency application(3 applications with 30-day intervals) 10 participants # Intervention Group II: Intravaginal CO2 laser application (3 applica
Drug
Procedure/surgery
Other
E02.808
E02.594

Sponsors

Faculdade de Medicina da Universidade Federal do Rio Grande do Sul
Lead Sponsor
Fundo de Incentivo à Pesquisa do Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Women over 18 years old, up to 50 years old, treated with external radiotherapy in the last 5 years, with genitourinary complaints, without residual tumor lesions and who accept to participate in the study, being informed about the procedures to be performed

Exclusion criteria

Exclusion criteria: Metastatic disease, tumor recurrence, previous treatment of genitourinary symptoms in the last month, presence of genital infection at the beginning of treatment, and women with collagenosis or HIV (Human Immunodeficiency Virus).

Design outcomes

Primary

MeasureTime frame
To evaluate the cytohistological effects (epithelial thickness, basal and parabasal cells, vascularization, neocolagen formation) of non-ablative fractional radiofrequency genitourinary syndrome treatment, CO2 laser compared to topical treatment with promestriene cream.—

Secondary

MeasureTime frame
1) Assess clinical improvement of genitourinary syndrome with the different treatments proposed ;2) Evaluate the sexual satisfaction of patients by applying the (Female Sexual Function Index (FSFI)) before and after treatment.;3) Evaluate the quality of life of patients before and after treatment by applying the quality of life questionnaire (WHOQoL-BREF).;4) Evaluate the degree of general satisfaction of patients with the proposed treatment through the grade given by the patient.;5) Evaluate, through cyto-histological and clinical parameters, if a treatment is superior in relation to the others evaluated—

Countries

Brazil

Contacts

Public ContactFernanda;Janete Grossi;Vettorazzi

Hospital de Clinicas de Porto Alegre;Faculdade de Medicina da Universidade Federal do Rio Grande do Sul

fernanda.grossi@yahoo.com.br;jvettorazzi@hcpa.edu.br55 54 999779235;55 051 33085232

Outcome results

None listed

Source: REBEC (via WHO ICTRP)