Recruiting

VIBRating vs. Traditional Therapy

Sponsor:

Medstar Health Research Institute

Code:

NCT06840314

Conditions

Genito-Pelvic Pain/Penetration Disorder

Dyspareunia

Vaginismus

Pelvic Pain

Vestibulodynia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pelvic floor therapy

Study Details

Brief 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.

Conditions

Genito-Pelvic Pain/Penetration Disorder

Dyspareunia

Vaginismus

Pelvic Pain

Vestibulodynia

Study ID

NCT06840314

Start date

Mar 1, 2025

Status verified date

May, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Helen Y Zhang, MD

202-877-6526helen.y.zhang@medstar.net

Eun Sook Choi, MD

202-877-6526eunsook.choi@medstar.net

Locations

MedStar Health

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Kendra Green

202-997-4536kendra.s.green@medstar.net

Helen Y Zhang, MD

helen.y.zhang@medstar.net

Principal Investigator:

Cheryl Iglesia, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

May 21, 2025

Last verified

May, 2025

Keywords

  • genito-pelvic pain/penetration disorder
  • dyspareunia
  • entry dyspareunia
  • vaginismus
  • pelvic pain
  • female sexual function
  • pain with sex
  • vulvodynia
  • vestibulodynia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-05-21.