NCT06840314 · Medstar Health Research Institute
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
(VIBRENT)
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Pelvic floor therapy
Once randomized to either the vibrating pelvic floor massage arm or the traditional vaginal dilator arm, they will receive instructions on frequency of device use and will use manufacturer's instructions for specifics of device use. We will not dictate more specific instructions on use, nor is this standard of care, as every patient is unique and will need to retain autonomy in terms of how quickly they progress in the use of the product. They will then complete a survey at 4 weeks which includes measures of sexual function and pelvic pain, as well of global impressions of improvement in their symptoms.
Primary outcome measures
Female Sexual Function Index (FSFI)
Time frame: Four weeks
FSFI is considered the gold standard for the measurement of sexual function in women. It's a 19-item questionnaire that uses a 5 point Likert scale ranging from 1-5, with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is multipled by a domain factor ratio (0.6 for desire, 0.3 for arousal, 0.3 for lubrication, 0.4 for orgasm, 0.4 for satisfaction, and 0.4 for pain) in order to place all domain tools on a comparable scale. The subsequent scores are summed to derive a total FSFI score. The possible range of scores is 2-36. A score less than or equal to 26.55 reflects clinically relevant sexual dysfunction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Assigned female at birth
- Age ≥ 18 years old
- Genito-pelvic pain/penetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)
Exclusion criteria
- Current or prior use of a therapeutic vaginal device used to treat GPPPD
- Unmanaged genitourinary syndrome of menopause
- History of pelvic radiation
- History of genital tract malignancy
- History of female genital mutilation
- History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
- Silicone allergy
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 21, 2025 · Source of record for eligibility and locations