Vibrating Pelvic Floor Device for Painful Intercourse

(VIBRENT Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Kiwi for painful intercourse?

Research on vulvar vibration therapy, a similar treatment, shows that 73% of women reported less painful sex after starting the therapy, suggesting that vibration can help reduce pain during intercourse. ^{1 2 3 4 5}

Is the vibrating pelvic floor device generally safe for humans?

The safety of energy-based devices for vaginal symptoms is not well established, and existing data on side effects is limited. In a study of a similar device, some users reported issues like urination and defecation problems due to device displacement, and two cases of superficial vaginal mucosal ulceration were noted, which resolved on their own. ^{6 7 8 9 10}

How does the vibrating pelvic floor device treatment differ from other treatments for painful intercourse?

The vibrating pelvic floor device is unique because it uses vibration therapy, which has anti-pain properties and is based on physical therapy principles. This approach is different from other treatments like electrical stimulation or vaginal dilators, as it focuses on using vibration to improve sexual function and reduce pain during intercourse. ^{1 4 9 11 12}

What is the purpose of this trial?

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators. The main questions it aims to answer are: 1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators 2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators? Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief. Participants will: * Be randomly assigned to use either the Kiwi device or traditional vaginal dilators. * Use the assigned device three times per week for 15 minutes per session over four weeks. * Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

Research Team

Cheryl Iglesia, MD

Principal Investigator

Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

Eligibility Criteria

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.

I have had cancer in my reproductive organs.

History of female genital mutilation

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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 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]

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]

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]

References

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

Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. [2010]

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

Intravaginal electrical stimulation for the treatment of chronic pelvic pain. [2006]

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

A Customized System to Test Pelvic Floor Muscles Contraction: A Proof of Concept. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Patient perceptions of vulvar vibration therapy for refractory vulvar pain. [2021]

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

Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia. [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. United States pubmed.ncbi.nlm.nih.gov

Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Vaginal Dilators: Issues and Answers. [2021]

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

Clinical measurement of pelvic floor movement: evaluation of a new device. [2004]

11. England pubmed.ncbi.nlm.nih.gov

Genital vibration for sexual function and enhancement: a review of evidence. [2020]

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

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