Vaginal LaxityNCT03280446
Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.
A study testing Intragen fractional radiofrequency with NeuViVa in people with Vaginal Laxity and Urinary Incontinence, run by SHERRY Thomas at 1 site in United States.
Trial summary
This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Laxity, Urinary Incontinence, Sexual Dysfunction
- What is being tested?
- Intragen fractional radiofrequency with NeuViVa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female adult subjects presenting, clinically, with VL, and has expressed interest in treatment will be considered eligible for the study. Enrollment of subject will depend on meeting the following criteria:
- Voluntarily signed informed consent form
- Ages ≥ 18
- Completed urine pregnancy examination with negative result if premenopausal
- Self-reported perceptions of vaginal laxity defined as "very loose," "moderately loose," or slightly loose" on the Vaginal Laxity Questionnaire.
- Up to Baden-Walker Grade 2 or Stage 2 Pelvic Organ Prolapse (≤ 1 cm past hymen)
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- Papanicolaou smear cytology within 36 months prior to treatment showing no dysplasia
- Subject willing to take valacyclovir at 100 mg PO q12h x 3 for history recurrent episode of HSV
- or 1000mg PO q daily x 5 days
Who cannot join
- Baden-Walker System Severe pelvic prolapse (≥ Stage 3); Pelvic organ prolapse up to
- 1 cm beyond the hymenal ring.
- Active STD (e.g. genital herpes, condylomata)
- Body mass index ≥ 35
- Previous reconstructive vaginal surgery, vaginal lasers, or vaginal injections of fat or fillers within 6 months.
- Current urinary tract infection
Show all 11Show fewer
- Actively participating in, or planning on participating in, pelvic floor muscle strengthening exercises.
- Presence of pacemaker, AICD, or other electrical health maintenance device.
- Immunosuppression (pathological or medication induced, such as steroids, methotrexate) inflammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30-day washout period of such drugs prior to treatment.They were using anti-inflammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30 days washout period of such drugs prior to treatment.
- Those with clinically significant anxiety or depression that may prohibit completion of treatments and/or suffering a medical problem that might interfere with wound healing.
- All subjects on oral contraceptives prior to enrollment are encouraged to take these throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The American Association of Female Pelvic Medicine Specialists, Inc.
Agoura Hills, California, 91301
Sherry Thomas, MD, 818-991-0988, drsherrythomas@yahoo.com
Sharan Dhaliwal, 8189910988
About this study
This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.
Read the detailed description
A total of thirty (30) subjects will be enrolled and assigned to a single treatment arm, receiving active treatment clinic, with the visits consisting of three (3) treatment administrations and post-procedure visits days 30, 180 and 360. Pre-menopausal and post-menopausal women between ages over 18, vaginal delivery, with up to moderate pelvic prolapse 2 cm past the hymen, and self-reported vaginal laxity score of "very loose", moderately loose", or "slightly loose" as defined by theVaginal Laxity Questionnaire (VLQ) will be evaluated and enrolled after having met all inclusion and exclusion criteria.
The treatment administration phase will consist of three (3) treatments,delivered approximately on-month apart. Subjects will be placed on the treatment table in the dorsal lithotomy position. The monopolar return pad will be placed on the subject buttock and to the RF generator.Coupling fluid will be used as a lubricant and will be reapplied throughout the treatment as needed. The treatment area is approximately 20+ cm2 and consist of the outside perineum and entire vaginal circumference along the length of the vagina to include the apex. For treatment of the labia majora, the treatment tip will be applied across the entire anatomical region. The treatment tip is applied to the perineum bilaterally from the lowest edge of the mons pubis to the perineal body and laterally to the crural folds to achieve vulvar and perineal temperatures of between 40-45 degrees celsius for approximately 5 minutes or more of total heat time per area. The labia majora and perineal areas will take approximately 10-15 minutes to complete. This is followed by treating the epithelial surface of the vaginal opening and advancing to the length of the vaginal canal with the treatment occurring along the vaginal walls, floor, and ceiling. The entire vaginal area will be treated in a circumferential area by delivering the RF in a systematic fashion at 5 separate delivery position starting the most distal portion of the vagina. The probe is slowly retracted at 1 cm intervals and circumferentially delivered again at 5 positions on another circumferentially manner moving the probe clockwise or counter clockwise or counter clockwise. To include the entire length of the urethra and bladder will be included in the treatment. Total vaginal treatment time will be 15-20 minutes. Safety measures will include monitoring of adverse events including pain or burns or infections during and after the procedure. Evaluations will be conducted with the visits at days 30, 90 and 150 days post-procedure.
During and after treatment administration, subjects will be asked to assess the self- reported pain experience using a 10 scale VAS, with "0" being no pain and "10" being the worst pain imaginable. Descriptive statistics will be generated on all demographic, medical history, and physical examination findings including means and standard deviations, for continuous, and frequencies and percentages for categorical variables.
- Conditions
- Vaginal Laxity, Urinary Incontinence, Sexual Dysfunction
- Being tested
- Intragen fractional radiofrequency with NeuViVa
- Medical subject headings
- Urinary Incontinence, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragen fractional radiofrequency with NeuViVaDevice
The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.
| Study group | Role | What they receive |
|---|---|---|
| 30 pre-menopause and post-menopause women | Experimental | Thirty healthy women with mild to moderate pelvic prolapse above the ages of 18 seeking treatment for vaginal laxity Receives: Device: Intragen fractional radiofrequency with NeuViVa |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).
The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to base line.
Measured: 12 month
Secondary outcomes (1)
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms.
To seasures improvement in subject sexual satisfaction and Urogynecological symptoms using sexual satisfaction Questionnaire (SSQ) and GRA (Global Response Assessment)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start23 Aug 2017
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal LaxityStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SHERRY Thomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SHERRY Thomas, The American Association of Female Pelvic Medicine Specialists, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280446
- Sponsor's protocol ID
- IG-VL-101
- Status last verified
- Mar 2018
- First submitted
- 1 Sep 2017
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.
- ClinicalTrials.gov ID
- NCT03280446
- Acronym / sponsor ID
- IG-VL-101
- Conditions
- Vaginal Laxity, Urinary Incontinence, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SHERRY ThomasUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.
Detailed description
A total of thirty (30) subjects will be enrolled and assigned to a single treatment arm, receiving active treatment clinic, with the visits consisting of three (3) treatment administrations and post-procedure visits days 30, 180 and 360. Pre-menopausal and post-menopausal women between ages over 18, vaginal delivery, with up to moderate pelvic prolapse 2 cm past the hymen, and self-reported vaginal laxity score of "very loose", moderately loose", or "slightly loose" as defined by theVaginal Laxity Questionnaire (VLQ) will be evaluated and enrolled after having met all inclusion and exclusion criteria.
The treatment administration phase will consist of three (3) treatments,delivered approximately on-month apart. Subjects will be placed on the treatment table in the dorsal lithotomy position. The monopolar return pad will be placed on the subject buttock and to the RF generator.Coupling fluid will be used as a lubricant and will be reapplied throughout the treatment as needed. The treatment area is approximately 20+ cm2 and consist of the outside perineum and entire vaginal circumference along the length of the vagina to include the apex. For treatment of the labia majora, the treatment tip will be applied across the entire anatomical region. The treatment tip is applied to the perineum bilaterally from the lowest edge of the mons pubis to the perineal body and laterally to the crural folds to achieve vulvar and perineal temperatures of between 40-45 degrees celsius for approximately 5 minutes or more of total heat time per area. The labia majora and perineal areas will take approximately 10-15 minutes to complete. This is followed by treating the epithelial surface of the vaginal opening and advancing to the length of the vaginal canal with the treatment occurring along the vaginal walls, floor, and ceiling. The entire vaginal area will be treated in a circumferential area by delivering the RF in a systematic fashion at 5 separate delivery position starting the most distal portion of the vagina. The probe is slowly retracted at 1 cm intervals and circumferentially delivered again at 5 positions on another circumferentially manner moving the probe clockwise or counter clockwise or counter clockwise. To include the entire length of the urethra and bladder will be included in the treatment. Total vaginal treatment time will be 15-20 minutes. Safety measures will include monitoring of adverse events including pain or burns or infections during and after the procedure. Evaluations will be conducted with the visits at days 30, 90 and 150 days post-procedure.
During and after treatment administration, subjects will be asked to assess the self- reported pain experience using a 10 scale VAS, with "0" being no pain and "10" being the worst pain imaginable. Descriptive statistics will be generated on all demographic, medical history, and physical examination findings including means and standard deviations, for continuous, and frequencies and percentages for categorical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 pre-menopause and post-menopause women | Experimental | Device: Intragen fractional radiofrequency with NeuViVaThirty healthy women with mild to moderate pelvic prolapse above the ages of 18 seeking treatment for vaginal laxity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy female adult subjects presenting, clinically, with VL, and has expressed interest in treatment will be considered eligible for the study. Enrollment of subject will depend on meeting the following criteria:
- Voluntarily signed informed consent form
- Ages ≥ 18
- Completed urine pregnancy examination with negative result if premenopausal
- Self-reported perceptions of vaginal laxity defined as "very loose," "moderately loose," or slightly loose" on the Vaginal Laxity Questionnaire.
Key exclusion criteria (11 listed)
- Baden-Walker System Severe pelvic prolapse (≥ Stage 3); Pelvic organ prolapse up to
- 1 cm beyond the hymenal ring.
- Active STD (e.g. genital herpes, condylomata)
- Body mass index ≥ 35
- Previous reconstructive vaginal surgery, vaginal lasers, or vaginal injections of fat or fillers within 6 months.
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 |
|---|---|---|
| Intragen fractional radiofrequency with NeuViVaThe Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe. | Device | 30 pre-menopause and post-menopause women |
Primary outcome
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ).
Time frame: 12 month
The primary outcome measure is the mean change in the severity of the vaginal Laxity (VL) and in female Sexual Function Inventory (FSFI) by using VLQ, assessment and visual analog scale compared to base line.
1 secondary outcome
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of urogynecological symptoms.
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intragen fractional radiofrequency with NeuViVa in people with Vaginal Laxity and Urinary Incontinence, run by SHERRY Thomas 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherry Thomas, MD (8189910988, drsherrythomas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity using the vaginal laxity questionnaire (VLQ). (time frame: 12 month). 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 23 Mar 2018.