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.

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NCT06840314

VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Recruiting
NAAges 18+InterventionalTreatment
Medstar Health Research Institute
~60 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:Pelvic floor therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Female Sexual Function Index (FSFI)
Measured over Four weeks
Genito-Pelvic Pain/Penetration Disorder
Dyspareunia
Vaginismus
Pelvic Pain
Vestibulodynia
Vulvodynia (Chronic Vulvar Pain)
1 sites across 1 states
District of Columbia1
  • Cheryl Iglesia, MD · PRINCIPAL_INVESTIGATOR · Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

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Eligibility criteria

Inclusion

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

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
  • 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.