Intravaginal Device for Genitourinary Syndrome

Recruiting at 1 trial location

Overseen By Orla O'Loughlin

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: AVeta Medical

Must not be taking: Hormone therapies, Anticoagulants

Disqualifiers: Bleeding disorders, STDs, Genital infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 16 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop using hormone therapies and certain anticoagulants (blood thinners) before joining. You also need to stop using your current vaginal lubricants and moisturizers during the study.

What data supports the effectiveness of the VITA AV Clinical System treatment for genitourinary syndrome?

Research on similar treatments, like intravaginal laser therapy, suggests they may help improve symptoms of genitourinary syndrome by increasing tissue thickness and blood flow, although more evidence is needed to confirm these effects. ^{1 2 3 4 5}

Is the intravaginal device for genitourinary syndrome safe for humans?

The safety of intravaginal devices, including those using laser technology, is not well established, and the FDA has issued warnings about their use without sufficient evidence. More research is needed to understand their long-term safety and potential side effects. ^{1 6 7 8 9}

What is the purpose of this trial?

This pilot study aims to evaluate the safety and effectiveness of the VITA AV Clinical System over a period of up to three months after the last treatment, compared to a sham device. The study focuses on improving vaginal signs and symptoms of Genitourinary Syndrome of Menopause (GSM) in post-menopausal women who experience moderate to severe pain during intercourse (dyspareunia). Long-term follow-up visits will assess the ongoing effectiveness and durability of the treatment, while also collecting safety data.

Research Team

Nancy Philips

Principal Investigator

IMA Clinical Research

Eligibility Criteria

This trial is for post-menopausal women with moderate to severe pain during intercourse due to Genitourinary Syndrome of Menopause (GSM). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I have been sexually active in the last month.

Normal Papanicolaou test within the past year (or should be done 2 weeks before the trial begins). Subject can ONLY participate on negative results

I plan to be sexually active at least twice a month during the trial.

Exclusion Criteria

I do not have any active genital infections.

Abnormal Papanicolaou test within the past year

Positive pregnancy test or planned pregnancy during the study period

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive the VITA AV Clinical System or sham device treatment over four sessions at 4-week intervals

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person), 1 visit (phone call)

Long-term Follow-up

Long-term follow-up visits to assess ongoing effectiveness and durability of the treatment

12 months

3 visits (in-person), 1 visit (phone call)

Treatment Details

Interventions

• VITA AV Clinical System

Trial Overview The VITA AV Clinical System, a medical device designed to alleviate symptoms of GSM, is being tested against a sham (no treatment) device. The study will monitor the safety and effectiveness up to three months after the last treatment and include long-term follow-up visits.

Participant Groups

Group I: Active Treatment Experimental Treatment 1 Intervention

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a white connector component, part number 10531-01, to allow the vacuum to be delivered to the vaginal tissue when then vacuum pump is activated.

Group II: Sham Treatment Placebo Group 1 Intervention

The VITA AV Clinical System (consisting of the VITA AV Probe Kit and the Medela Pump), has a black connector component, part number 10531-02, to block and prevent the vacuum from being delivered to the vaginal tissue when then vacuum pump is activated.

Who Is Running the Clinical Trial?

AVeta Medical

Lead Sponsor

Trials

2

Recruited

70+

Findings from Research

A review of 42 medical device reports on vaginal energy-based devices revealed that most patient complaints, including vaginal pain and urinary symptoms, were not severe, with serious adverse events being rare (only 3.5% reported third-degree burns).

The majority of complaints were reported after the FDA's July 30, 2018 warning, suggesting that increased awareness and potential litigation may have influenced reporting rates, highlighting the need for further research on the safety and efficacy of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Wallace, SL., Sokol, ER., Enemchukwu, EA.[2021]

The pilot study involving 85 women with severe vulvovaginal atrophy (VVA) showed that treatment with Vaginal Soft gels significantly improved sexual function and vaginal health, particularly in postmenopausal and recurrent vulvovaginitis patients.

The treatment was found to be effective without causing systemic or local side effects, making it a suitable option for patients who cannot use hormonal therapies, although results were less significant in postpartum women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis. Maniglio, P., Ricciardi, E., Meli, F., et al.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

No. 358-Intravaginal Laser for Genitourinary Syndrome of Menopause and Stress Urinary Incontinence. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ospemifene in the Management of Vulvar and Vaginal Atrophy: Focus on the Assessment of Patient Acceptability and Ease of Use. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Female sexual dysfunction and lower urinary tract symptoms associated with vulvovaginal atrophy symptoms: Results of the GENJA study. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Short-Term Efficacy and Safety of Non-Ablative Laser Treatment Alone or with Estriol or Moisturizers in Postmenopausal Women with Vulvovaginal Atrophy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of CO2 laser therapy on vaginal microcirculatory parameters in an animal model for genitourinary syndrome of menopause. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

A pilot study of soft gel technology: a new vaginal device to improve the symptomatology of vulvovaginal atrophy in post-partum, menopause and in patients with recurrent vulvovaginitis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The REJOICE trial: a phase 3 randomized, controlled trial evaluating the safety and efficacy of a novel vaginal estradiol soft-gel capsule for symptomatic vulvar and vaginal atrophy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. [2020]