Vibrating vs. Traditional Therapy for Painful Intercourse
This study is comparing a new vibrating pelvic floor device called "Kiwi" to traditional vaginal dilators for women who experience genito-pelvic pain/penetration disorder (GPPPD), which can include painful intercourse (dyspareunia) or muscle spasms (vaginismus). The goal is to see if the Kiwi device improves sexual function more effectively than traditional dilators. Researchers will measure sexual function using a questionnaire called the Female Sexual Function Index (FSFI) after four weeks. You may be able to join if you are a woman, 18 years or older, assigned female at birth, and have a diagnosis of GPPPD. The current status of this study is unclear, and it plans to enroll 60 participants.
- Study design
- This is a randomized controlled trial, meaning participants will be randomly assigned to either the Kiwi device group or the traditional dilator group. The study plans to enroll 60 women.
- What's involved
- You would use your assigned device three times per week for 15 minutes per session over a four-week period. Data will be collected at the beginning and end of the study using questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sexual function will be measured at four weeks, which is the end of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Cheryl Iglesia, MD · PRINCIPAL_INVESTIGATOR · Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Female Sexual Function Index (FSFI)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.