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Effect of the Radiofrequency and Pelvic Muscle Training in the Treatment of Women with Vaginal Laxity.

Effect of Fractionated Microablative Radiofrequency and Pelvic Floor Muscle Training in the Treatment of Women with Vaginal Laxity: Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2zdvfp
Enrollment
Unknown
Registered
2020-02-19
Start date
2019-11-01
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

Sexual Dysfunction, Physiological

Interventions

Pelvic Floor Muscle Training Group: 34 women complaining of vaginal laxity will perform 12 pelvic floor muscle training sessions, 1 session per week, completing 12 weeks of treatment (3 months). Patie
Procedure/surgery
Other
E02.779

Sponsors

Faculdade de Ciência Médicas da Universidade Estadual de Campinas
Lead Sponsor
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Will be included women 18 years of age onwards and complaining of vaginal laxity assessed by the direct question and Vaginal Laxity Questionnaire, and willingness to participate in therapies at the dates and places scheduled for the proposed treatment.

Exclusion criteria

Exclusion criteria: Patients with decompensated cardiac and metabolic diseases, as well as pacemaker use; cognitive impairment; peripheral or central neurological disorders; presence of any cancer; presence of cervical dysplasia; history of active urinary or vaginal infection; presence of pelvic organ prolapse stage 2 onwards; patients undergoing physical therapy treatment with pelvic floor training; use of estrogen vaginally in the last 6 months; degree of force of contraction of the pelvic floor muscles equal to zero according to the Modified Oxford Scale and patients who have already undergone prolapse or sling correction surgery will be excluded.

Design outcomes

Primary

MeasureTime frame
Improvement of the pelvic floor support structures is expected through 3 sessions of vaginal microablative radiofrequency application over a 12 week treatment period. A subjective 7 point scale will be applied to answer the question: How are you feeling right now (vaginal looseness or tightness and sexual satisfaction) compared to starting treatment? 1 improved markedly, 2 improved moderately, 3 improved slightly, 4 no change, 5 slightly worse, 6 moderately worse, 7 much worse.;Improvement of the pelvic floor support structures is expected through 12 training sessions of the pelvic floor muscles with daily home care increment over a 12-week treatment period. A subjective 7 point scale will be applied to answer the question: How are you feeling now (levels of looseness or vaginal tightness and sexual satisfaction) compared to the start of treatment? 1 has improved markedly, 2 has improved moderately, 3 has improved slightly, 4 no change, 5 slightly worse, 6 moderately worse, 7 much worse.

Secondary

MeasureTime frame
Clinically evaluate through the direct question (yes or no) and through the Vaginal Laxity Questionnaire the sensation of looseness of the vaginal opening perceived by the woman and or sexual partner during penetration.;To evaluate the clinical conditions of women linked to the sexual act, as well as female sexual function and dyspareunia using the validated Female Sexual Function Index (FSFI) questionnaire and the Marinoff scale.;To evaluate vaginal symptoms using the questionnaire validated by the International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS).;To assess female sexual distress using the Female Sexual Distress Scale-Revised scale.;To evaluate the urinary loss of women investigated through the International Consultation on Incontinence Questionnaire Short Form (ICIQ UI-SF), which allows us to qualify and quantify the urinary loss and to investigate its impact on the quality of life.;To evaluate urethral mobility by observing the difference in urethral positioning at rest and during the Valsalva Maximum maneuver during clinical evaluation.;To evaluate the anterior and posterior vaginal wall descent, as well as the vagina apex (uterus or vaginal dome after hysterectomy), investigated using the Pelvic Organ Prolapse Quantification (POP-Q) instrument for prolapse assessment and staging.;To evaluate the contraction pressure and function of the pelvic floor muscles by the following methods: bidigital palpation during the grader vaginal touch using the Modified Oxford Scale at 5 levels: zero or absent (no signs of muscle contraction), 1 minimal muscle strength (signs of discrete contractility, no joint movement), 2 weak muscle strength (mobility in all normal directions, elimination of gravity), 3 regular muscle strength (movements of normal amplitude against the action of gravity), 4 good muscle strength (full mobility against the action of gravity and a certain degree of resistance); 5 normal muscle strength (complete mobility again

Countries

Brazil

Contacts

Public ContactGlaucia Varella Pereira

Faculdade de Ciência Médicas da Universidade Estadual de Campinas

glauciavarella@gmail.com55 037 999977771

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 14, 2026