Symptoms Associated With Pelvic Floor WeaknessNCT03536819
RF Rejuvenation for Pelvic Floor and Vagina
A study testing Votiva in people with Symptoms Associated With Pelvic Floor Weakness, run by InMode MD Ltd. at 1 site in United States.
Trial summary
Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Symptoms Associated With Pelvic Floor Weakness
- What is being tested?
- Votiva
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radio-frequency Rejuvenation for Pelvic Floor and Vagina
Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.
Read the 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.
- Being tested
- Votiva
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VotivaDevice
The applicator uses radio-frequency energy to treat the vaginal canal
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants receive Votiva treatment Receives: Device: Votiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- Peak internal Pelvic Floor Contractions (steadily higher scores demonstrate improvement)
Measured: 3 months
Recording of Adverse Events (Safety)
Observation, assessment and recording of reactions
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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
Measured: 3 months
Evaluate Urinary Incontinence Symptoms
QUID - Questionnaire for Urinary Incontinence Diagnosis. QUID- scaled 0-15, larger values indicating worse UI.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start17 Nov 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Symptoms Associated With Pelvic Floor WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will receive the treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Kouris, MD, Principal investigator, Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536819
- Sponsor's protocol ID
- DO607404A
- Status last verified
- Oct 2020
- First submitted
- 8 May 2018
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radio-frequency Rejuvenation for Pelvic Floor and Vagina
- ClinicalTrials.gov ID
- NCT03536819
- Acronym / sponsor ID
- DO607404A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 29 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will receive the treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: VotivaParticipants receive Votiva treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VotivaThe applicator uses radio-frequency energy to treat the vaginal canal | Device | Treatment |
Primary outcome
Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS
Time frame: 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)
Time frame: 3 months
Observation, assessment and recording of reactions
6 secondary outcomes
Evaluate Urinary Symptoms Associated With Pelvic Floor Weakness
Time frame: 3 months
Evaluate Sexual Dysfunction Symptoms Associated With Pelvic Floor Weakness
Time frame: 3 months
Evaluate Quality of Life Symptoms Associated With Pelvic Floor Weakness
Time frame: 3 months
Evaluate Urinary Incontinence Symptoms
Time frame: 3 months
Evaluate Sexual Function Associated With Pelvic Floor Weakness
Time frame: 3 months
Evaluate Quality of Life With Pelvic Floor Conditions
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Kouris, MD principal investigator
Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Votiva in people with Symptoms Associated With Pelvic Floor Weakness, run by InMode MD Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of RF on Pelvic Floor Measured by Intentional Muscle Contraction Using Biofeedback EMS (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.