Symptoms Associated With Pelvic Floor Weakness
Conditions
Brief summary
Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.
Detailed description
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.
Interventions
DEVICEVotiva
The applicator uses radio-frequency energy to treat the vaginal canal
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will receive the treatment
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult females between the ages of 35-75, seeking treatments for pelvic floor relaxation syndrome or atrophic vaginitis, which include but are not limited to: pelvic floor laxity, decreased muscle contraction in the pelvic floor, urinary incontinence, sexual dysfunction. * Participants must have an evaluation by the Pelvic Floor Physical Therapists. All participants must have a minimum of 30% below average reading on initial assessment of internal or external pelvic floor contraction in order to be included in the study. * Negative PAP smear and pelvic exam done within last 1 year. * The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography). * The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other treatment methods in the treatment areas such surgeries,CO2 treatment, other radiofrequency treatments and fillers injections for the last 12 months and during the entire study period.
Exclusion criteria
* Internal defibrillator, pacemaker, bladder stimulator or any other implanted electrical device anywhere in the body * Permanent metal implant in the treatment area * History of pelvic floor radiation * Any surgery in the treatment area in the last 3 months * Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles * Pregnancy and nursing * Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications * Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen. * Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary and hormonal virilization * Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema,vitiligo,herpes and rash. * History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin * Severe concurrent conditions, such as cardiac disorders, sensory disturbances. * Use of Isotretinoin (Accutane®) within 6 months prior to treatment. * Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria. * Any other previous treatments in the vaginal or perineal area, such as CO2 laser or RF performed on the same area. * Any surgical procedure in the vaginal area within the past 12 months. * Recent tan from sun, sunbeds or chemicals or planned excessive sun exposure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS | 3 months | 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) |
| Recording of Adverse Events (Safety) | 3 months | Observation, assessment and recording of reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness | 3 months | PFIQ-7 - Subjective assessment of quality of life change using Pelvic Floor Impact Questionnaire, 0-300, lower scores demonstrate improvement |
| Evaluate Urinary Incontinence Symptoms | 3 months | QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI. |
| Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness | 3 months | 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. |
| Evaluate Quality of Life With Pelvic Floor Conditions | 3 months | 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. |
| Evaluate Sexual Function Associated With Pelvic Floor Weakness | 3 months | 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. |
| Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness | 3 months | FSFI - Subjective assessment of efficacy on sexual dysfunction symptoms, using the Female Sexual Function Index 2-36, increasing scores demonstrate improvement) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Participants receive Votiva treatment
Votiva: The applicator uses radio-frequency energy to treat the vaginal canal | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 51.8 years |
| Female Sexual Function Index (FSFI) | 23.10 score on a scale STANDARD_DEVIATION 6.5 |
| Intentional muscle contraction using Biofeedback EMS | 9.69 mV STANDARD_DEVIATION 5.65 |
| Pelvic Floor Distress Inventory (PFDI-20) | 84.93 score on a scale STANDARD_DEVIATION 55.08 |
| Pelvic Floor Impact Questionnaire (PFIQ-7) | 18.73 score on a scale STANDARD_DEVIATION 25.67 |
| PISQ-12 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire | 32.67 score on a scale STANDARD_DEVIATION 5.19 |
| Questionnaire for Urinary Incontinence Diagnosis (QUID) | 9.67 score on a scale STANDARD_DEVIATION 6.74 |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 18 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
| Urinary Incontinence symptoms International Consultation on Incontinence Questionnaire ICIQ | 5.71 score on a scale STANDARD_DEVIATION 3.53 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS | 13.13 mV | Standard Deviation 5.96 |
Primary
Recording of Adverse Events (Safety)
Observation, assessment and recording of reactions
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Recording of Adverse Events (Safety) | 0 participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness | 12.7 score on a scale | Standard Deviation 21.57 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Quality of Life With Pelvic Floor Conditions | 77.64 score on a scale | Standard Deviation 43.84 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness | 26.19 score on a scale | Standard Deviation 6.53 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Sexual Function Associated With Pelvic Floor Weakness | 35.6 score on a scale | Standard Deviation 6.95 |
Secondary
Evaluate Urinary Incontinence Symptoms
QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Urinary Incontinence Symptoms | 6.87 score on a scale | Standard Deviation 5.26 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness | 3.53 score on a scale | Standard Deviation 3.36 |