Trial Outcomes & Findings for RF Rejuvenation for Pelvic Floor and Vagina (NCT NCT03536819)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

3 months

Results posted on

2020-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Overall Study STARTED	20
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only subjects that finished all visits were analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=20 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Age, Continuous	51.8 years n=15 Participants • Only subjects that finished all visits were analyzed
Sex: Female, Male Female	15 Participants n=15 Participants • Only subjects that finished all visits were analyzed
Sex: Female, Male Male	0 Participants n=15 Participants • Only subjects that finished all visits were analyzed
Race/Ethnicity, Customized White Non-Hispanic	18 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=20 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=20 Participants
Intentional muscle contraction using Biofeedback EMS	9.69 mV STANDARD_DEVIATION 5.65 • n=15 Participants • Only subjects that finished all visits were analyzed
Urinary Incontinence symptoms International Consultation on Incontinence Questionnaire ICIQ	5.71 score on a scale STANDARD_DEVIATION 3.53 • n=15 Participants • Only subjects that finished all visits were analyzed
Female Sexual Function Index (FSFI)	23.10 score on a scale STANDARD_DEVIATION 6.50 • n=15 Participants • Only subjects that finished all visits were analyzed
Pelvic Floor Impact Questionnaire (PFIQ-7)	18.73 score on a scale STANDARD_DEVIATION 25.67 • n=15 Participants • Only subjects that finished all visits were analyzed
Questionnaire for Urinary Incontinence Diagnosis (QUID)	9.67 score on a scale STANDARD_DEVIATION 6.74 • n=15 Participants • Only subjects that finished all visits were analyzed
PISQ-12 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire	32.67 score on a scale STANDARD_DEVIATION 5.19 • n=15 Participants • Only subjects that finished all visits were analyzed
Pelvic Floor Distress Inventory (PFDI-20)	84.93 score on a scale STANDARD_DEVIATION 55.08 • n=15 Participants • Only subjects that finished all visits were analyzed

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS	13.13 mV Standard Deviation 5.96

PRIMARY outcome

Timeframe: 3 months

Observation, assessment and recording of reactions

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Recording of Adverse Events (Safety)	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness	3.53 score on a scale Standard Deviation 3.36

SECONDARY outcome

Timeframe: 3 months

FSFI - Subjective assessment of efficacy on sexual dysfunction symptoms, using the Female Sexual Function Index 2-36, increasing scores demonstrate improvement)

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness	26.19 score on a scale Standard Deviation 6.53

SECONDARY outcome

Timeframe: 3 months

PFIQ-7 - Subjective assessment of quality of life change using Pelvic Floor Impact Questionnaire, 0-300, lower scores demonstrate improvement

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness	12.7 score on a scale Standard Deviation 21.57

SECONDARY outcome

Timeframe: 3 months

QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI.

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Urinary Incontinence Symptoms	6.87 score on a scale Standard Deviation 5.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Sexual Function Associated With Pelvic Floor Weakness	35.6 score on a scale Standard Deviation 6.95

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Participants receive Votiva treatment Votiva: The applicator uses radio-frequency energy to treat the vaginal canal
Evaluate Quality of Life With Pelvic Floor Conditions	77.64 score on a scale Standard Deviation 43.84

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maria Shusterman, Clinical Director

Inmode Ltd

Phone: 9057070975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place