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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Participants receive Votiva treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Votiva | Device | The applicator uses radio-frequency energy to treat the vaginal canal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Recording of Adverse Events (Safety) | Observation, assessment and recording of reactions | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Kouris, MD | Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Plastic Surgery | LaGrange | Illinois | 60525 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only subjects that finished all visits were analyzed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | mV | 3 months |
|
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Shusterman, Clinical Director | Inmode Ltd | 9057070975 | maria.shusterman@inmodemd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2017 | Sep 8, 2020 | Prot_006.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2017 | Sep 8, 2020 | SAP_007.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2017 | Sep 8, 2020 | ICF_008.pdf |
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Subjects will receive the treatment
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| 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) | 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 | 3 months |
| Evaluate Urinary Incontinence Symptoms | QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI. | 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. | 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. | 3 months |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Only subjects that finished all visits were analyzed | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Intentional muscle contraction using Biofeedback EMS | EMS Biofeedback using a vaginal sensor for evaluation of Pelvic floor muscle strength. 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) | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | mV |
|
| Urinary Incontinence symptoms International Consultation on Incontinence Questionnaire ICIQ | 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. | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
| Female Sexual Function Index (FSFI) | FSFI - Subjective assessment of efficacy on sexual dysfunction symptoms, using the Female Sexual Function Index 2-36, increasing scores demonstrate improvement) | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
| Pelvic Floor Impact Questionnaire (PFIQ-7) | PFIQ-7 - Subjective assessment of quality of life change using Pelvic Floor Impact Questionnaire, 0-300, lower scores demonstrate improvement | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
| Questionnaire for Urinary Incontinence Diagnosis (QUID) | QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI. | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
| PISQ-12 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire | 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. | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
| Pelvic Floor Distress Inventory (PFDI-20) | 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. | Only subjects that finished all visits were analyzed | Mean | Standard Deviation | score on a scale |
|
|
|
| Primary | Recording of Adverse Events (Safety) | Observation, assessment and recording of reactions | Posted | Number | participants | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Evaluate Urinary Incontinence Symptoms | QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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