VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT06840314
Status
Recruiting
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Conditions

  • Dyspareunia
  • Genito-Pelvic Pain/Penetration Disorder
  • Pelvic Pain
  • Vaginismus
  • Vestibulodynia
  • Vulvodynia (Chronic Vulvar Pain)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelvic floor therapy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
May 2025
Primary completion
Nov 30, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Kiwi (Commercially available therapeutic vibrating pelvic floor product)
    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.
  • Active Comparator: Silicone Dilator Arm
    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.

Primary Outcome Measure

Female Sexual Function Index (FSFI) [ Time Frame: Four weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MedStar HealthWashington D.C.District of Columbia20010
Kendra Green
[email protected]
202-997-4536
Helen Y Zhang, MD
[email protected]
Helen Y Zhang, MD (SUB_INVESTIGATOR)
Eun Sook Choi, MD (SUB_INVESTIGATOR)
Lauren Cosgriff, MD (SUB_INVESTIGATOR)
Cheryl Iglesia, MD (PRINCIPAL_INVESTIGATOR)
Ariana Davis, MD (SUB_INVESTIGATOR)

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