VIBRENT- VIBRating Vs Traditional Therapy for Treatment of ENTry Dyspareunia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Washington, D.c.
MedStar Health
RECRUITING
Washington
Contact Information
Primary
Helen Y Zhang, MD
helen.y.zhang@medstar.net
202-877-6526
Backup
Eun Sook Choi, MD
eunsook.choi@medstar.net
202-877-6526
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
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) 0.7x4.75, (2) 0.9x5.25, (3) 1.0x5.45, (4) 1.1x5.85, (5) 1.3x6.35, (6) 1.5x6.85. These dilators are not battery powered, have no buttons, and no removable pieces.
Related Therapeutic Areas
Sponsors
Leads: Medstar Health Research Institute

This content was sourced from clinicaltrials.gov