Loss urinary treatment with heat waves and pelvic floor exercises.

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2019
INTERVENTION: Behavioural Fractional microablative radiofrequency group in which 39 participants will be submitted to three applications, 1 every month for 3 months. The Wavetronic 6000 Touch device will be used with the Megapulse HF FRAXX system (Loktal Medical Electronics, São Paulo, Brazil), equipped with an electronic circuit of energy fractionation, connected to a vaginal pen with 64 microagulhas of 200? in diameter and 1mm in length, mounted on a teflon support and divided into an eight‐column array with eight needles each. By pressing the foot switch, these 64 needles are energized simultaneously and the energy release is randomized into eight‐needle columns in a predefined sequence, which does not allow two adjacent columns to fire in sequence, preventing the thermal sum of the columns. This allows the cooling between the points and the preservation of tissues adjacent to the vaporized points, so that neocolagenesis and neoelastogenesis occur through fibroblastic stimulation. Each shot of the pen performs 64 microablations in the mucosa. The participant will be positioned in dorsal decubitus with flexed and abducted lower limbs, in a lithotomy position. In the vestibule and in the vaginal opening, lidocaine spray will be applied 10% 3 minutes before the procedure. A disposable vaginal speculum will then be introduced, then antisepsis will be performed with 0.2% aqueous chlorhexidine, cleaning with 0.9% sterile saline to remove the excess vaginal contents with gauze. The sequential application of microbial radiofrequency to the vaginal walls under direct vision will be performed by moving the speculum when necessary. In the vestibule, the application will occur only in the vaginal introitus, not including clitoris, clitoral foreskin and minor lips. The electrode will always be held parallel, lightly touching the mucosa with each shot. The average procedure time will be 15 to 20 minutes. For post‐treatment care, the use of 5% dexpanthenol solution in the vaginal opening, two to three t Physical Therapy Modalities Procedure/surgery Pulsed Radiofrequency Treatment CONDITION: Climacteric N00‐N99 Postmenopausal atrophic vaginitis Sexual Health Stress incontinence Stress urinary incontinence; climacteric; vaginal atrophy; sexual dysfunction; ; Unspecified urinary incontinence ; Postmenopausal atrophic vaginitis ; Sexual Health ; Climacteric ; Stress incontinence Unspecified urinary incontinence PRIMARY OUTCOME: Fractional microablative radiofrequency, pelvic floor muscle training, and the combination of the two treatments will show significant improvement in stress urinary incontinence. The association of fractional microablative radiofrequency with pelvic floor muscle training will present higher success rates in the treatment of stress urinary incontinence than the two therapy alone. SECONDARY OUTCOME: Expected outcome 1: Both fractional microablative radiofrequency and pelvic floor muscle training will result in improved contractility of pelvic floor muscles, but associated techniques will promote a more significant result; Expected outcome 2: both fractional microablative radiofrequency and pelvic floor muscle training will result in improved urethral and bladder neck mobility, mucosal thickness and vaginal wall through ultrasound, but the associated techniques will promote a more significant outcome Expected outcome 3: only groups with fractional microablative radiofrequency will result in improvement of vaginal trophism Expected outcome 4: only groups with fractional microablative radiofrequency will result in improved sexual function. INCLUSION CRITERIA: Women between 45 and 65 years of age with symptoms of stress urinary incontinence and mixed urinary incontinence with predominance of the stress component identified through anamnesis and with availability to attend the therapies at the date and places scheduled for the proposed treatment.
Epistemonikos ID: c47eb116d7c171e93ba76776a7671eece83d8ce5
First added on: Aug 24, 2024