Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.
This study will evaluate the effects of radiofrequency on pelvic floor strength and the change in associated symptoms through direct measurement and patient reporting. The patients will undergo two separate evaluation appointments then receive two treatments. One group will receive a sham treatment and the other will receive the treatment. The sham group will be offered treatment at the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The applicator uses radio-frequency energy to treat the vaginal canal
Midwest Plastic Surgery
LaGrange, Illinois, United States
Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS
There is no signal normalization, this measurement tool is used to measure change in Pelvic Floor Muscle function. Pelvic floor muscle Contractions amplitude are measured in mV (microvolt) 1\. Peak internal Pelvic Floor Contractions (steadily higher scores demonstrate improvement)
Time frame: 3 months
Recording of Adverse Events (Safety)
Observation, assessment and recording of reactions
Time frame: 3 months
Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness
ICIQ-Subjective assessment of efficacy on Urinary Incontinence symptoms using the International Consultation on Incontinence Questionnaire ( lower scores demonstrate improvement). The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. Scoring scale: 0-21.
Time frame: 3 months
Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness
FSFI - Subjective assessment of efficacy on sexual dysfunction symptoms, using the Female Sexual Function Index 2-36, increasing scores demonstrate improvement)
Time frame: 3 months
Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness
PFIQ-7 - Subjective assessment of quality of life change using Pelvic Floor Impact Questionnaire, 0-300, lower scores demonstrate improvement
Time frame: 3 months
Evaluate Urinary Incontinence Symptoms
QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months
Evaluate Sexual Function Associated With Pelvic Floor Weakness
PISQ-12 short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire . PISQ12 score calculator evaluates sexual function in women with urinary incontinence or pelvic organ prolapse. Score 0-48. Higher number demonstrate improvement.
Time frame: 3 months
Evaluate Quality of Life With Pelvic Floor Conditions
PFDI-20. Pelvic Floor Distress Inventory . The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI). It is a health-related quality of life questionnaire for women with pelvic floor conditions. The PFDI-20 is comprised of 3 scales, which include the Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), and the Colorectal-Anal Distress Inventory-8. Score 0-300 Lower score demonstrate improvement.
Time frame: 3 months