VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

NCT ID: NCT06840314

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-03-31

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.

Detailed Description

This randomized controlled trial (RCT) aims to evaluate the efficacy of a novel vibrating pelvic floor therapeutic device (the "Kiwi") compared to traditional vaginal dilators in improving sexual function outcomes in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD).

The primary objective is to determine whether the Kiwi device leads to higher Female Sexual Function Index (FSFI) scores after four weeks of use compared to traditional dilators.

Secondary objectives include assessing improvements in:

• Sexual distress (Female Sexual Distress Scale - Desire/Arousal/Orgasm, FSDS-DAO)
• Pelvic pain (Vulvar Pain Assessment Questionnaire, VPAQ-screen subscale)
• Overall symptom severity (Patient Global Impression of Severity, PGI-S)
• Perceived improvement (Patient Global Impression of Improvement, PGI-I)

Participants (n=60) will be randomized into two arms:

1. Kiwi device group - a commercially available vibrating pelvic floor therapeutic product.

2. Traditional dilator group - a standard graduated cylindrical vaginal dilator set.

Participants will use their assigned device three times per week for 15 minutes per session over a four-week period. Data will be collected at baseline and at the end of the study using validated questionnaires.

The study hypothesizes that participants using the Kiwi device will demonstrate greater improvements in FSFI scores compared to those using traditional vaginal dilators, reflecting enhanced sexual function and reduced symptom severity.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pelvic floor therapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

No interventions assigned to this group

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.

Intervention Type: DEVICE

Other Intervention Names

PFPT; Pelvic floor physical therapy; pelvic floor massage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Iglesia, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery

Locations

MedStar Health

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Helen Y Zhang, MD

Role: CONTACT

helen.y.zhang@medstar.net

202-877-6526

Eun Sook Choi, MD

Role: CONTACT

eunsook.choi@medstar.net

202-877-6526

Facility Contacts

Kendra Green

Role: primary

kendra.s.green@medstar.net

202-997-4536

Helen Y Zhang, MD

Role: backup

helen.y.zhang@medstar.net

Other Identifiers

STUDY00008357

Identifier Type: -

Identifier Source: org_study_id