Vibrating Pelvic Floor Device for Painful Intercourse

(VIBRENT Trial)

Recruiting at 1 trial location

Overseen By Helen Y Zhang, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Pelvic radiation, Genital malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vibrating device called Kiwi to determine if it alleviates painful intercourse more effectively than traditional vaginal dilators. Researchers aim to assess whether the Kiwi device can improve sexual function and reduce distress and pain. Participants will be divided into two groups: one using the Kiwi device and the other using standard dilators, each for a short period weekly over four weeks. Women diagnosed with conditions causing pain during sex, such as vaginismus or dyspareunia, who have not used similar devices before, may be suitable for this study. Participants will complete surveys about their symptoms before and after using the devices to measure improvement. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Kiwi device is safe for use in women with genito-pelvic pain and penetration disorder?

Research has shown that the safety of energy-based devices like the Kiwi for vaginal symptoms remains uncertain, with limited information on side effects. In studies of similar devices, some participants reported increased comfort and muscle relaxation, suggesting ease of use for some individuals. However, due to the lack of extensive safety data, experiences may vary.

For those considering joining the trial, these findings indicate that while the Kiwi device might offer comfort to some, much remains to be learned about its safety. It is crucial to consult a healthcare provider to discuss any concerns or questions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kiwi device for painful intercourse because it offers a new approach to pelvic floor therapy with its unique vibration feature. Unlike traditional silicone dilator sets, which increase size in steps, Kiwi provides a tapered design that allows for a more gradual and continuous increase in diameter. This device also includes optional vibration settings to enhance muscle relaxation and improve comfort. Additionally, Kiwi's versatile design allows it to be used for both internal and external massages, targeting multiple muscle groups and providing broader therapeutic benefits.

What evidence suggests that the Kiwi device is effective for improving sexual function in women with genito-pelvic pain and penetration disorder?

Research has shown that the Kiwi vibrating pelvic floor device, which participants in this trial may receive, might improve sexual function in women with genito-pelvic pain and penetration disorder (GPPPD). Studies suggest that devices like the Kiwi, which provide both vibration and massage, can relax pelvic floor muscles and boost blood flow. Women who have used similar devices reported noticeable improvements in their sexual function. The Kiwi device's special design, with its tapered shape and multiple massage ends, offers more precise relief compared to traditional tools. While more research is needed, early results are promising for those looking to better manage GPPPD symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Cheryl Iglesia, MD

Principal Investigator

Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

Are You a Good Fit for This Trial?

This trial is for sexually active women over 18 with genito-pelvic pain and penetration disorder (GPPPD), which includes conditions like vaginismus, dyspareunia, and vulvodynia. Participants should be willing to use a therapeutic device three times a week.

Inclusion Criteria

I was assigned female at birth.

I have been diagnosed with pain or difficulty during sex not caused by substances or other health conditions.

Exclusion Criteria

I have untreated symptoms of menopause affecting my urinary tract or genitals.

History of female genital mutilation

Silicone allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to use either the Kiwi device or traditional vaginal dilators three times per week for 15 minutes per session over four weeks.

4 weeks

Baseline and end-of-study assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kiwi

Trial Overview

The study tests if the 'Kiwi' vibrating pelvic floor device improves sexual function more than traditional vaginal dilators in women with GPPPD. It measures sexual function scores, distress, pain relief, and symptom severity after four weeks of use.

How Is the Trial Designed?

Group I: Kiwi (Commercially available therapeutic vibrating pelvic floor product) Experimental Treatment 1 Intervention

Kiwi is a therapeutic vibrating pelvic floor product that includes an option for external massage and stimulation. The V- shaped massager, is designed to bridge anatomical variety and has three main massage ends. 1. The cylindrical end is comparable in application to traditional vaginal dilators. However, one significant difference is its tapered shape; this allows for continuous and gradual diameter increase, as opposed to discrete increments in the traditional dilator sets. The tapered end has an optional vibration mode with 4 different intensity settings. This cylindrical shape can also be used as a tool to apply external pressure point massage to the muscles of the urogenital triangle, such as the perineal muscle and the bulbospongiosus muscles. 2. A wider flat surface area has an additional motor to apply vibration to the glans clitoris. This end can also be used for massage. 3. The rounded bottom end of Kiwi can be used as a broad area massage tool.

Group II: Silicone Dilator Arm Active Control 1 Intervention

A commercially available set of graduated cylindrical vaginal dilators. The standard of care is a 6-piece, progressive-sizing, silicone dilator set. Dimensions of the silicone dilators are (WxH): (1) 0.7"x4.75", (2) 0.9"x5.25", (3) 1.0"x5.45", (4) 1.1"x5.85", (5) 1.3"x6.35", (6) 1.5"x6.85". These dilators are not battery powered, have no buttons, and no removable pieces.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Published Research Related to This Trial

The leva® Pelvic Digital Health System, which uses an intravaginal probe with MEMS accelerometer sensors, provides real-time feedback on pelvic floor muscle contractions, helping women perform pelvic floor muscle training (PFMT) more accurately.

A new wearable device design, featuring a ring with an extension, was tested on 10 subjects and showed improved retention and better detection of vaginal shape and motion during exercises, enhancing user acceptability and effectiveness of PFMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction. Bohorquez, J., McKinney, J., Keyser, L., et al.[2021]

In a clinical trial with 39 women suffering from advanced genital prolapse, 81.5% showed improvement in prolapse after using the Colpexin Sphere for 16 weeks, indicating its effectiveness as a treatment option.

The device was well-received, with 92.6% of participants willing to recommend it, although some reported minor issues with urination and defecation due to displacement, and two cases of superficial vaginal ulceration that resolved on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. Lukban, JC., Aguirre, OA., Davila, GW., et al.[2018]

The Vagette, a galvanic device used for pelvic floor stimulation, significantly improved pelvic muscle strength in patients with urinary stress incontinence, as measured by a Kegel meter.

This improvement was observed in a short treatment period, suggesting that the Vagette could be a beneficial short-term therapy for urinary stress incontinence and pelvic relaxation before considering surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of the effects of galvanic vaginal muscle stimulation in urinary stress incontinence and sexual dysfunction. Scott, RS., Hsueh, GS.[2019]

Vaginal dilators are commonly used by women with sexual pain syndromes to reduce anxiety and pain during penetrative intercourse, but there is a lack of standardized protocols for their use, leading to varied patient experiences.

A survey of over 1,000 women using a novel electronic dilator, Milli, revealed that many patients feel empowered and optimistic despite their initial anxiety, and factors like longer treatment duration and the use of soothing music may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal Dilators: Issues and Answers. Liu, M., Juravic, M., Mazza, G., et al.[2021]

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]

A study involving 24 women with chronic pelvic pain showed that intravaginal electrical stimulation significantly reduced pain levels immediately after treatment and continued to provide relief at 2 weeks, 4 weeks, and 7 months post-treatment.

The treatment also led to a significant decrease in complaints of dyspareunia (pain during intercourse), indicating its potential effectiveness in improving overall pelvic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravaginal electrical stimulation for the treatment of chronic pelvic pain. de Oliveira Bernardes, N., Bahamondes, L.[2006]

A new device for measuring pelvic floor movement was tested on 28 healthy volunteers, showing good reproducibility and minimal discomfort during use.

The device could be beneficial for pelvic floor training, as it effectively measures movements and allows for biofeedback, although one participant experienced a vasovagal reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical measurement of pelvic floor movement: evaluation of a new device. Morren, GL., Ryn, AK., Hallböök, O., et al.[2004]

A study involving 49 women with vulvodynia showed that vulvar vibration therapy (VVT) is considered an acceptable and satisfactory treatment, with 83% of participants expressing satisfaction with the therapy.

Participants reported significant improvements in their symptoms, with 73% indicating that sex became less painful after starting VVT, highlighting its potential efficacy as a safe and inexpensive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions of vulvar vibration therapy for refractory vulvar pain. Zolnoun, D., Lamvu, G., Steege, J.[2021]

Intravaginal electrical stimulation (IVES) significantly reduced chronic pelvic pain (CPP) in women compared to a placebo, with 80% of those starting with active IVES reporting lower pain scores after treatment.

In a crossover study of 26 women, those who initially received placebo showed a notable improvement in pain levels when switched to active IVES, indicating its efficacy in managing CPP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. de Bernardes, NO., Marques, A., Ganunny, C., et al.[2010]

Vibratory stimulation, often associated with sex toys, has evidence supporting its use in treating various sexual dysfunctions, including erectile dysfunction, ejaculatory dysfunction, and anorgasmia.

The use of genital vibrators is positively correlated with increased sexual desire and overall sexual function, suggesting they may be beneficial for a range of sexual health issues in both men and women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: a review of evidence. Rullo, JE., Lorenz, T., Ziegelmann, MJ., et al.[2020]

A novel intravaginal device has been developed to provide real-time assessment of pelvic floor muscle contractions, distinguishing between different muscle groups and pressures, which is crucial for improving pelvic floor dysfunctions.

This device was validated in a pilot study with healthy adult women, indicating its potential to enhance proprioception and personalized training for pelvic floor muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Customized System to Test Pelvic Floor Muscles Contraction: A Proof of Concept. Tabbakha, NE., Bahillo, A., Jimenez-Martin, A., et al.[2023]

In a pilot study involving 50 postmenopausal women, both 50 μg and 100 μg doses of estradiol cream significantly reduced intercourse pain scores by 75% after 12 weeks, indicating its efficacy in treating moderate to severe dyspareunia.

There was no significant difference in pain relief between the two doses of estradiol cream, suggesting that both strengths are effective, and the treatment also led to substantial improvement in tenderness of the vulvar vestibule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia. Goetsch, MF., Garg, B., Lillemon, J., et al.[2023]

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Vibrating Pelvic Floor Device for Painful Intercourse

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The study hypothesizes that participants using the Kiwi device will demonstrate greater improvements in FSFI scores compared to those using ...

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This randomized controlled trial (RCT) aims to evaluate the efficacy of a novel vibrating pelvic floor therapeutic device (the "Kiwi") compared ...

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Kiwi

Shallow insertion with clitoral vibration can help your muscles and nervous system relax. And that's the goal! To feel comfortable and in control.

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