Vibrating Pelvic Floor Device for Painful Intercourse
(VIBRENT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byCheryl Iglesia, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medstar Health Research Institute
Disqualifiers: Pelvic radiation, Genital malignancy, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1491112Eligibility 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 am 18 years old or older.
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
+4 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Kiwi (Commercially available therapeutic vibrating pelvic floor product)Experimental Treatment1 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 ArmActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MedStar HealthWashington, United States
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Who Is Running the Clinical Trial?
Medstar Health Research InstituteLead Sponsor
References
Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. [2010]To assess the efficacy of intravaginal electrical stimulation (IVES) or placebo in women with chronic pelvic pain (CPP) with no apparent cause.
Intravaginal electrical stimulation for the treatment of chronic pelvic pain. [2006]To evaluate the efficacy of intravaginal electrical stimulation in women with chronic pelvic pain (CPP).
A Customized System to Test Pelvic Floor Muscles Contraction: A Proof of Concept. [2023]Studies show that there is a high prevalence of pelvic floor dysfunctions which negatively affect the quality of life of people who suffer from them. The few sensory mechanisms that pelvic floor muscles have to inform the brain of their situation can make it difficult to perform voluntary contractions or identify risk factors. Currently, there is no consensus to improve this proprioception. This work introduces the development of a novel intravaginal device that is connected to a mobile data acquisition system and able to discern the correct contraction of the pelvic floor muscles versus contraction of adjacent muscles or abdominal thrust efforts. A cross-sectional pilot clinical study has been carried out to validate this end with healthy adult nulliparous woman with good pelvic floor muscles contraction capability in supine position.Clinical relevance- The proposed system allows a personalized and real-time assessment of the contractile capability of the pelvic floor muscles (PFM), distinguishing between muscular plans (deep/superficial PFM), between sides (right/left PFM), and between pressures from the PFM and intra-abdominal muscles (IAP). The development of an intravaginal device which is able to simultaneously measure all these features is an important advancement in this field since it can provide information in real time on the contraction capability of all the PFM as well as on the influence of the IAP during different PFM exercises.
Patient perceptions of vulvar vibration therapy for refractory vulvar pain. [2021]The objective of this study was to describe acceptability of vulvar vibration therapy (VVT), a novel treatment approach to vulvodynia. We included women with vulvodynia who attended the Pelvic Pain Clinic and had used VVT for at least two weeks. Participants completed a three-page, 65-item, questionnaire assessing demographics, VVT usage and responses to Likert statements regarding accessibility, comfort and symptom response to VVT. Of 69 qualifying patients, results from 49 (72%) were eligible for analysis. Participants were primarily white, married and well-educated, with a median age of 30 (range 19-68 years). Median duration of vulvar pain and dyspareunia was two years (0-23) and three years (0-30), respectively. Median duration of VVT was five months (1-18) and three days per week (0.5-7). Fully, 83% said that, "vibrator treatment is an acceptable treatment", 83% said that they were "satisfied with vibrator treatment", 76% endorsed vibrator as comfortable to use, 73% indicated that sex is less painful since starting vibration treatment and 88% would recommend VVT to others. We conclude that the therapeutic rationale for VVT is based on the anti-nocioceptive properties of vibration and on the favorable response of vulvodynia to physical therapy. Vulvar vibration therapy is safe, inexpensive and, in this survey, acceptable to most patients, many of whom described improvement in symptoms.
Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia. [2023]To compare efficacies of two strengths of estradiol cream applied to the vulvar vestibule and use of silicone lubricant to reduce intercourse pain scores in postmenopausal women with moderate/severe dyspareunia.
Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning.
Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction. [2021]Urinary incontinence (UI) is experienced by an estimated 51% of women in the U.S. and often results from impaired function or weakening of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a frontline nonsurgical treatment, yet a number of symptomatic individuals cannot accurately perform a pelvic floor muscle contraction with simple verbal or written instruction. Long-term adherence to PFMT regimens is often a barrier to resolution of symptoms. Various biofeedback tools have been utilized to aid correct pelvic floor muscle performance and adherence. One novel device, the leva® Pelvic Digital Health System, utilizes an intravaginal probe embedded with MEMS accelerometer sensors that allow real-time visualization of the shape and motion of the vagina during PFMT. Early positive results with this device prompted design of a wearable version. The purpose of this study was to design a wearable, wireless clinical research device to optimize MEMS accelerometer sensor placement to detect maximal movement during a pelvic floor muscle exercise (PFME) and to test the form factor for retention and user acceptability. The device comprised a ring designed to sit at the fornix with an extension following the length of the vagina. This paper presents design components and results from clinical testing of 10 subjects. It was determined that a ring form factor alone, similar to other vaginal rings (pessaries, estrogen rings) provided less accurate visual information about PFME performance. By contrast, we determined that a ring with an extension allowed for device retention and improved real-time detection of vaginal shape and motion during PFMT.
Safety and effectiveness of Colpexin Sphere in the treatment of pelvic organ prolapse. [2018]Our objective was to determine the safety and effectiveness of Colpexin Sphere in women with advanced genital prolapse. A total of 39 subjects were enrolled in our prospective multicenter clinical trial, and 27 completed the full 16-week assessment. At baseline, subjects were fitted with a sphere, instructed on insertion and removal, and educated on a regimen of pelvic floor muscle exercises performed with the device in place. Efficacy was evaluated by a baseline vs 16-week comparison of pelvic organ prolapse staging and pelvic floor muscle strength assessment. Safety evaluation included, but was not limited to, an assessment of vaginal mucosal integrity. Subjects also completed a patient satisfaction questionnaire at the end of the study. Improvement in the prolapse of at least one vaginal segment was seen in 81.5% of the subjects, while 63% exhibited improved muscle function on digital examination at 16 weeks. Twenty-five (92.6%) would recommend the device to treat prolapse, and most found it easy to insert (96.3%) and remove (100%). In short-term usage, problems with urination (29.6%) and defecation (72%) were reported, primarily due to device displacement. Two subjects developed superficial vaginal mucosal ulceration, which resolved spontaneously. No significant adverse events were reported.
Vaginal Dilators: Issues and Answers. [2021]Vaginal dilators are often prescribed to facilitate an adaptive brain-body connection to decrease anxiety and pain that can be experienced in anticipation of sexual intercourse among populations of women with sexual pain syndromes. Postmenopausal women, cancer survivors, and women with a wide variety of pelvic floor disorders who experience genito-pelvic pain/penetration disorder (GPPPD) are often advised to incorporate vaginal dilators into their pelvic floor rehabilitation program and treatment regimens to enable penetrative intercourse with less pain. However, little is known about the behaviors of dilator users, what treatment protocols are most effective, how patients are currently using their dilators, and how effective are clinicians in helping their patients achieve success with their dilation therapy.
Clinical measurement of pelvic floor movement: evaluation of a new device. [2004]A new device that measures pelvic floor movement clinically was evaluated.
Genital vibration for sexual function and enhancement: a review of evidence. [2020]Vibration, as provided by a genital vibrator, is commonly regarded as a tool to enhance sexual pleasure and in modern day society falls under the category of a sex toy. However, the vibrator was not originally intended to be a toy, and its benefits reach far beyond that of a plaything. This article is a narrative review of the current evidence regarding the use of vibratory stimulation for the treatment of sexual dysfunction and/or sexual and relationship enhancement. The literature indicates that vibratory stimulation has evidence-based support for the treatment of erectile dysfunction, ejaculatory dysfunction and anorgasmia. Vibratory stimulation is positively correlated with increased sexual desire and overall sexual function. It has also shown benefit for sexual arousal difficulties and pelvic floor dysfunction. Though definitive evidence is lacking, genital vibration is a potential treatment for sexual dysfunction related to a wide variety of sexual health concerns in men and women.
A clinical study of the effects of galvanic vaginal muscle stimulation in urinary stress incontinence and sexual dysfunction. [2019]A preliminary study was designed to test the effect of pelvic for pelvic floor stimulation using the Vagette, a galvanic device, on the symptoms of urinary stress incontinence and pelvic relaxation. A significant improvement in pelvic muscle strength was observed as measured by the Kegel meter. This effect was seen within a short period of treatment. It is suggested from the study that the Vagette may be used for short-term therapeutic trial for urinary stress incontinence and pelvic relaxation before surgery is considered.