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Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

Primary Purpose

Genitourinary Syndrome of Menopause

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radiofrequency non ablative
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genitourinary Syndrome of Menopause

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome and who agree to voluntarily participate in the research.

Exclusion Criteria:

  • will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months

Sites / Locations

  • Centro de Atenção ao Assoalho PelvicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Radiofrequency ON and Kinesiotherapy

Radiofrequency OFF and Kinesiotherapy

Arm Description

The radiofrequency application protocol with CAPENERGY device, which has two electrodes: an active one, which will be introduced into the vagina, using a condom and gel to the emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The temperature used in the treatment will be 41° C, which this parameter will be placed in the equipment, maintained for 2 minutes at the anterior wall and 2 others minutes at the posterior wall. Five RF sessions will be performed, with a seven-day interval between them. For the application, participants will be placed in supine position. The session will be quick, with an average duration of 20 minutes. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.

The patient will be in supine decubitus, the vaginal probe of the radiofrequency apparatus will be introduced, with the gel previously heated. The radiofrequency will be off. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.

Outcomes

Primary Outcome Measures

Change in Cell maturation index
% cells parabasal, % intermediate cells and superficial cells
Change in Vaginal PH
During the fertile years of life, the vaginal pH ranges from 3.5 to 4.5. At menopause, vaginal Ph increases to above 4.5. The higher the vaginal Ph, the greater the degree of atrophy

Secondary Outcome Measures

Numeric Visual Scale
Will be evaluated vaginal dryness, pain during intercourse, vaginal laxity, burning sensation and itching, on a scale of 0 to 10, being 0 asymptomatic and 10 the maximum of symptoms
Questionnaire of quality of life specified urinary incontinence
The ICIQ-SF
Female Sexual Function Index
FSFI
Female Genital Self-image Scale

Full Information

First Posted
March 15, 2018
Last Updated
June 21, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
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1. Study Identification

Unique Protocol Identification Number
NCT03506594
Brief Title
Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause
Official Title
Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genitourinary Syndrome of Menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency ON and Kinesiotherapy
Arm Type
Active Comparator
Arm Description
The radiofrequency application protocol with CAPENERGY device, which has two electrodes: an active one, which will be introduced into the vagina, using a condom and gel to the emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The temperature used in the treatment will be 41° C, which this parameter will be placed in the equipment, maintained for 2 minutes at the anterior wall and 2 others minutes at the posterior wall. Five RF sessions will be performed, with a seven-day interval between them. For the application, participants will be placed in supine position. The session will be quick, with an average duration of 20 minutes. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.
Arm Title
Radiofrequency OFF and Kinesiotherapy
Arm Type
Placebo Comparator
Arm Description
The patient will be in supine decubitus, the vaginal probe of the radiofrequency apparatus will be introduced, with the gel previously heated. The radiofrequency will be off. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.
Intervention Type
Device
Intervention Name(s)
Radiofrequency non ablative
Intervention Description
The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand device with capacitive transfer method using non-ablative handle with active electrode placed intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer and when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.
Primary Outcome Measure Information:
Title
Change in Cell maturation index
Description
% cells parabasal, % intermediate cells and superficial cells
Time Frame
Each 3 months pos treatment, until one year
Title
Change in Vaginal PH
Description
During the fertile years of life, the vaginal pH ranges from 3.5 to 4.5. At menopause, vaginal Ph increases to above 4.5. The higher the vaginal Ph, the greater the degree of atrophy
Time Frame
Each 3 months pos treatment, until one year
Secondary Outcome Measure Information:
Title
Numeric Visual Scale
Description
Will be evaluated vaginal dryness, pain during intercourse, vaginal laxity, burning sensation and itching, on a scale of 0 to 10, being 0 asymptomatic and 10 the maximum of symptoms
Time Frame
one week, one month, three months, six months, nine months and one year
Title
Questionnaire of quality of life specified urinary incontinence
Description
The ICIQ-SF
Time Frame
one week, one month, three months, six months, nine months and one year
Title
Female Sexual Function Index
Description
FSFI
Time Frame
one week, one month, three months, six months, nine months and one year
Title
Female Genital Self-image Scale
Time Frame
one week, one month, three months, six months, nine months and one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome and who agree to voluntarily participate in the research. Exclusion Criteria: will be excluded from the study participants with limited understanding, with neurological degenerative chronic diseases, sensory deficit in the genital region, users of pacemaker and intrauterine device of cooper and women under hormone therapy under six months
Facility Information:
Facility Name
Centro de Atenção ao Assoalho Pelvico
City
Salvador
State/Province
Ba
ZIP/Postal Code
40.290-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia V Lordelo, Phd
Phone
+5571988592400
Email
pvslordelo@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34717608
Citation
Pinheiro C, Costa T, Amorim de Jesus R, Campos R, Brim R, Teles A, Vilas Boas A, Lordelo P. Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study. BMC Womens Health. 2021 Oct 30;21(1):379. doi: 10.1186/s12905-021-01518-8.
Results Reference
derived

Learn more about this trial

Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

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