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Radiofrequency within the vagina in the treatment of involuntary urine loss: Randomized clinical trial

Transvaginal radio frequency in the treatment of urinary incontinence: Randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9wfww5
Enrollment
Unknown
Registered
2020-03-04
Start date
2020-05-01
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

Urinary incontinence

Interventions

In this study, transvaginal radiofrequency will be applied for the treatment of urinary incontinence in women. They will be subject to two groups (intervention group and control group). A total of 86
Procedure/surgery

Sponsors

Programa de Pós-Graduação em Gerontologia Biomédica da Pontifícia Universidade Católica do Rio Grande do Sul
Lead Sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: Women from the PUC gynecology outpatient clinic who are post menopausal, with a diagnosis of stress urinary incontinence or mixed stress urinary incontinence will be included, who have no urinary infection on urine examination and want to participate in the study.

Exclusion criteria

Exclusion criteria: Desire for surgical treatment for urinary incontinence, pelvic tumors, pelvic prolapses grade III and IV, previous surgery for urinary incontinence or genital prolapse, neurogenic bladder, patients with cardiac pacemakers and undergoing parallel physiotherapeutic treatment for urinary incontinence.

Design outcomes

Primary

MeasureTime frame
The use of the transvaginal radiofrequency technique, associated with the pelvic muscle strengthening exercise, is more effective in relation to the pelvic muscle strengthening exercise alone in the treatment of postmenopausal women with urinary incontinence. Verified through the quality of life questionnaire called International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), sexual questionnaire called Sexual Satisfaction The Female Sexual Function Index (FSFI) and voiding diary. Qualitative variables will be described using absolute and relative frequency and quantitative variables using mean and standard deviation. To assess the interaction between moment and group in the quantitative variables, the Generalized Estimation Equations (GHG) will be used. The association between qualitative variables and group will be through the chi-square test. Values ??of p <0.05 will be considered significant and the analyzes will be performed using the SPSS Software.

Secondary

MeasureTime frame
The use of the transvaginal radiofrequency technique, associated with the pelvic muscle strengthening exercise, is no longer effective in relation to the pelvic muscle strengthening exercise alone in the treatment of postmenopausal women with urinary incontinence. Verified through the quality of life questionnaire called International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), sexual questionnaire called Sexual Satisfaction The Female Sexual Function Index (FSFI) and voiding diary. Qualitative variables will be described using absolute and relative frequency and quantitative variables using mean and standard deviation. To assess the interaction between moment and group in the quantitative variables, the Generalized Estimation Equations (GHG) will be used. The association between qualitative variables and group will be through the chi-square test. Values ??of p <0.05 will be considered significant and the analyzes will be performed using the SPSS Software.

Countries

Brazil

Contacts

Public ContactLuísa Jorge

Pontifícia Universidade Católica do Rio Grande do Sul

lbragajorge@hotmail.com+55-053-981250478

Outcome results

None listed

Source: REBEC (via WHO ICTRP)